Levetiracetam

Levetiracetam Manufacturers

• Remedyrepack Inc.
  

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  Levetiracetam | Remedyrepack Inc.

  

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  Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1). For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1)

  Partial Onset Seizures

  1 Month to < 6 Months:  7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily (2.2) 6 Months to < 4 Years:  10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily (2.2) 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.2) Adults 16 Years and Older:  500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily (2.2)

  Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

  500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3)

  Primary Generalized Tonic-Clonic Seizures

  6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4) Adults 16 Years and Older:  500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.4)

  Adult Patients with Impaired Renal Function

  Dose adjustment is recommended, based on the patient’s estimated creatinine clearance (2.5, 8.6)

   

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
  
  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  
  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

   

  Adults 16 Years and Older
  

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients
  

  1 Month to < 6 Months

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).  In the clinical trial, the mean daily dose was 35 mg/kg in this age group.  The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).  Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                           Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) =   -------------------------------------------------------------

                                                                  100 mg/mL

   

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

   

  Adults 16 Years and Older
  
  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
  
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

   

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency    Normal
  > 80
  500 to 1,500
  Every 12 hours
     Mild
  50 – 80
  500 to 1,000
  Every 12 hours
     Moderate
  30 – 50
  250 to 750
  Every 12 hours
     Severe
  < 30
  250 to 500
  Every 12 hours
     ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

   

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• Remedyrepack Inc.
  

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  Levetiracetam | Gurwitch Products

  

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  For sunscreen use apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor

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• Direct Rx
  

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  Levetiracetam | Direct Rx

  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance
  (mL/min/1.73 m2) Dosage (mg) Frequency *Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal >80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe <30 250 to 500 Every 12 hours ESRD patients using dialysis ----- 500 to 1000* Every 24 hours* Close

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  Levetiracetam tablet is given orally with or without food. The levetiracetam tablets dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

   

   

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

   

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg)

                                                       - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

                                                                     100 mg/mL

   

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

   

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

   

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                                      [140-age (years)] x weight (kg)

  CLcr =                - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - (x 0.85 for female patients)

                                       72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                                                  CLcr (mL/min)

  CLcr (mL/min/1.73m2)=                 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - x 1.73

                                                                                    BSA subject (m2)

  Table 1:  Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance
  (mL/min/1.73m2) Dosage
  (mg) Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,0001 1Every 24 hours 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.

   

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  Levetiracetam Tablet is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 16: Dosing Adjustment Regimen For Adult Patients With  Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients
          using dialysis ---- 500 to 1,000 1Every 24 h

   

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• Gen-source Rx
  

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  Levetiracetam | Gen-source Rx

  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
  
  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  
  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures
  

  Adults 16 Years and Older
  
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.
  
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients
   
  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  
  
  4 Years to < 16 Years
   
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
  
  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
  
  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
  
  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients
   
  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
  
                                                        Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) =      ------------------------------------------------------
                                                                          ­     100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy
  

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures
  

  Adults 16 Years and Older
  
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
   
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function
  

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)

  
  
  

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  
  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
     Normal
  > 80
  500 to 1,500
  Every 12 hours
     Mild
  50 – 80
  500 to 1,000
  Every 12 hours
     Moderate
  30 – 50
  250 to 750
  Every 12 hours
     Severe
  < 30
  250 to 500
  Every 12 hours
     ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  Total daily dose (mL/day) =           Daily dose (mg/kg/day) x patient weight (kg)       
                                                                                100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older
  
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
   
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
  CLcr =           [140-age (years)] x weight (kg)            (x 0.85 for female patients)
                        72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73 m2) =             CLcr (mL/min)             x 1.73
                                                       BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Normal
  

  > 80
  

  500 to 1,500
  

  Every 12 hours
  

  Mild
  

  50 – 80
  

  500 to 1,000
  

  Every 12 hours
  

  Moderate
  

  30 – 50
  

  250 to 750
  

  Every 12 hours
  

  Severe
  

  < 30
  

  250 to 500
  

  Every 12 hours
  

  ESRD patients using dialysis
  

  ―
  

  500 to 1,0001
  

  Every 24 hours1
  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose , a consistent increase in response with increased dose has not been shown. [see CLINICAL STUDIES ( )] 14.1

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution . Only whole tablets should be administered. [see DOSAGE AND ADMINISTRATION ( )] 2.1

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CL ) in mL/min must first be calculated using the following formula: cr

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group
  Creatinine Clearance
  (mL/min/1.73 m 2)
  Dosage (mg)
  Frequency
  * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal
  >80
  500 to 1,500
  Every 12 hours
  Mild
  50 to 80
  500 to 1,000
  Every 12 hours
  Moderate
  30 to 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 500
  Every 12 hours
  ESRD patients using dialysis
  -----
  500 to 1000 *
  Every 24 hours *
  

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  ---

  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of  1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg.  Patients with body weight < 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 9 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 9: Levetiracetam Tablet Weight-Based Dosing Guide For Children

    Daily Dose Patient Weight
    20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1x 250 mg
  tablet BID) 1000 mg/day
  (1x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID)  
  >40 kg
    1000 mg/day
  (1x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                          Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -----------------------------------------------------------------

                                                               100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 10. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                      [140-age (years)] x weight (kg)

          CLcr =  --------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 10: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group
    Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency
    * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 Every 24 h*

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  Levetiracetam Tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 year of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 m/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 9 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 9: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 - 40 kg 500 mg/day
  (1 x 250 mg tablet BID) 1000 mg/day
  (1 x 500 mg tablet BID) 1500 mg/day
  (1 x 750 mg tablet BID) > 40 kg 1000 mg/day
  (1 x 500 mg tablet BID) 2000 mg/day
  (2 x 500 mg tablet BID) 3000 mg/day
  (2 x 750 mg tablet BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = —————————————————————      

                                                                        100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 10. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)
  CLcr = —————————————————       (x 0.85 for female patients)
                   72 x serum creatinine (mg/dL)

  Table 10: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1Every 24 h

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  Levetiracetam Tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 year of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients ages 4 To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 m/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 9 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Patient Weight Daily Dose 20 mg/kg/day(BID dosing) 40 mg/kg/day(BID dosing) 60 mg/kg/day(BID dosing) 20.1 - 40 kg 500 mg/day(1 x 250 mg tablet BID) 1000 mg/day(1 x 500 mg tablet BID) 1500 mg/day(1 x 750 mg tablet BID) > 40 kg 1000 mg/day(1 x 500 mg tablet BID) 2000 mg/day(2 x 500 mg tablet BID) 3000 mg/day(2 x 750 mg tablet BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = —————————————————————      

                                                                        100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 10. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)
  CLcr = —————————————————       (x 0.85 for female patients)
                   72 x serum creatinine (mg/dL)

  Table 10: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1Every 24 h Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide for Children Daily Dose Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day 
  (1 x 750 mg
  tablet BID) > 40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance Dosage Frequency (mL/min) (mg) * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended. Normal > 80 500 to 1500 Every 12 h Mild 50 to 80 500 to 1000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis — 500 to 1000 * Every 24 h

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 9 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 9: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 10. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 10: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

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  2.1 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1,000 mg/day, given astwice-daily dosing (500 mg twice daily). Additional dosing increments may begiven (1,000 mg/day additional every 2 weeks) to a maximum recommended dailydose of 3,000 mg. There is no evidence that doses greater than 3,000 mg/dayconfer additional benefit.

  
  

  Pediatric Patients

  1 Month to < 6Months

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In theclinical trial, the mean daily dose was 35 mg/kg in this age group. Theeffectiveness of lower doses has not been studied.

  
  

  6 Months to < 4Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If apatient cannot tolerate a daily dose of 50 mg/kg, the daily dose may bereduced. In the clinical trial, the mean daily dose was 47 mg/kg in this agegroup.

  
  

  4 Years to < 16Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If apatient cannot tolerate a daily dose of 60 mg/kg, the daily dose may bereduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximumdaily dose was 3,000 mg/day.

  2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1,000 mg/day, given as twice-dailydosing (500 mg twice daily). Increase the dosage by 1,000 mg/day every 2 weeksto the recommended daily dose of 3,000 mg. The effectiveness of doses lowerthan 3,000 mg/day has not been studied.

  2.3 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1,000 mg/day, given as twice-dailydosing (500 mg twice daily). Increase dosage by 1,000 mg/day every 2 weeks tothe recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000mg/day has not been adequately studied.

  
  

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has notbeen adequately studied.

  2.4 Switching from Oral Dosing

  When switching from oral levetiracetam,the initial total daily intravenous dosage of levetiracetamshould be equivalent to the total daily dosage and frequency of oral levetiracetam.

  2.5 Switching to Oral Dosing

  At the end of the intravenous treatment period, the patient may beswitched to levetiracetam oraladministration at the equivalent daily dosage and frequency of the intravenousadministration.

  2.6 Preparation and Administration Instructions

  Levetiracetam injection is for intravenous use only and should be diluted in 100 mLof a compatible diluent prior to administration. If a smaller volume isrequired (e.g., pediatric patients), the amount of diluent should be calculatedto not exceed a maximum levetiracetam concentration of 15 mg per mL of dilutedsolution. Consideration should also be given to the total daily fluid intake ofthe patient. Levetiracetam injectionshould be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mglevetiracetam (500 mg/5 mL).

  
  

  Parenteral drug products should be inspected visually for particulatematter and discoloration prior to administration whenever solution andcontainer permit. Product with particulate matter or discoloration should notbe used.

  
  

  Any unused portion of the levetiracetaminjection vial contents should be discarded.

  
  

  Adults

  See Table 1 for the recommended preparation and administration of levetiracetam injection for adults to achieve adose of 500 mg, 1,000 mg, or 1,500 mg.

  
  
  
  Table 1: Preparation and Administration of Levetiracetam Injection for Adults Dose
  Withdraw Volume
  Volume of Diluent
  Infusion Time
  500 mg
  5 mL (5 mL vial)
  100 mL
  15 minutes
  1,000 mg
  10 mL (two 5 mL vials)
  100 mL
  15 minutes
  1,500 mg
  15 mL (three 5 mL vials)
  100 mL
  15 minutes
  
  
  
  

  For example, to prepare a 1,000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of acompatible diluent and administer intravenously as a 15-minute infusion.
  Pediatric Patients

  When using levetiracetaminjection for pediatric patients, dosing is weight-based (mg per kg).

  
  

  The following calculation should be used to determine the appropriatedaily dose of levetiracetam injection forpediatric patients: Daily dose (mg/kg/day) x patient weight (kg)
  

  2.7 Dosage Adjustments in Adult Renal Impairment

  Levetiracetam dosing must be individualized according to the patient’s renalfunction status. Recommended dosage adjustments for adults with renalimpairment are shown in Table 2. Information is unavailable for dosageadjustments in pediatric patients with renal impairment. In order to calculatethe dose recommended for adult patients with renal impairment, creatinineclearance adjusted for body surface area must be calculated. To do this anestimate of the patient’s creatinine clearance (CLcr) in mL/min must first becalculated using the following formula:

   

  Then CLcr is adjusted for body surface area (BSA) as follows:

   

  
  
  Table 2: Dosage Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group
  Creatinine Clearance (mL/min/1.73m2)
  Dosage (mg)
  Frequency
  Normal
  > 80
  500 to 1,500
  Every 12 hours
  Mild
  50 to 80
  500 to 1,000
  Every 12 hours
  Moderate
  30 to 50
  250 to 750
  Every 12 hours
  Severe
  < 30
  250 to 500
  Every 12 hours
  ESRD patients using dialysis
  -------
  500 to 1,0001
  Every 24 hours* 
  
  
  2.8 Compatibility and Stability

  Levetiracetam injection was found to be physically compatible and chemically stablewhen mixed with the following diluents and antiepileptic drugs for at least 24hours and stored in polyvinyl chloride (PVC) bags at controlled roomtemperature 15° to 30°C (59° to 86°F).

  
  

  Diluents

  Sodium chloride (0.9%) injection, USP

  Lactated Ringer’s injection

  Dextrose 5% injection, USP

  
  

  Other Antiepileptic Drugs

  Lorazepam

  Diazepam

  Valproate sodium

  
  

  There is no data to support the physicalcompatibility of levetiracetam injectionwith antiepileptic drugs that are not listed above.

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  Levetiracetam | Methapharm, Inc.

  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 13 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 13: Levetiracetam Tablet Weight-Based Dosing Guide For Children Daily Dose
    Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                     Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = ———————————————————————       
                                                                           100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 14. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)
  CLcr =—————————————————       (x 0.85 for female patients)
                   72 x serum creatinine (mg/dL)

  Table 14: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1Every 24 h

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  Levetiracetam | Rebel Distributors Corp

  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam Tablets are given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight
  Daily Dose
  
  20 mg/kg/day
  (BID dosing)
  40 mg/kg/day
  (BID dosing)
  60 mg/kg/day
  (BID dosing)
  20.1-40 kg
  500 mg/day
  (1 X 250 mg tablet BID)
  1000 mg/day
  (1 X 500 mg tablet BID)
  1500 mg/day
  (1 X 750 mg tablet BID)
  >40 kg
  1000 mg/day
  (1 X 250 mg tablet BID)
  2000 mg/day
  (2 X 500 mg tablet BID)
  3000 mg/day
  (2 X 750 mg tablet BID)
  

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)

  CLcr = -------------------------------------------- (x 0.85 for female patients)

                 72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group
  Creatinine Clearance
  (mL/min)
  Dosage
  (mg)
  Frequency
  

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Normal
  Mild
  Modrate
  Severe
  ESRD patients
  Using dialysis
  >80
  50-80
  30-50
  <30
  
  ----
  500 to 1,500
  500 to 1,000
  250 to 750
  250 to 500
  
  500 to 1000
  Every 12 h
  Every 12 h
  Every 12 h
  Every 12 h
  
  1Every 24 h
  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 *Every 24 h

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  ---

  Levetiracetam Tablet isindicated as adjunctive treatment of partial onset seizures in adults andchildren 4 years of age and older with epilepsy.

  Levetiracetam Tablet isindicated as adjunctive therapy in the treatment of myoclonic seizures inadults and adolescents 12 years of age and older with juvenile myoclonicepilepsy.

  
  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment ofprimary generalized tonic-clonic seizures in adults and children 6 years of ageand older with idiopathic generalized epilepsy. Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

   Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  
  Patient Weight
  Daily Dose
   20 mg/kg/day
  (BID dosing)
  40 mg/kg/day
  (BID dosing)
  60 mg/kg/day
  (BID dosing)
  20.1 to 40 kg
       500 mg/day
  (1 x 250 mg
  tablet BID)
       1000 mg/day
  (1 x 500 mg
  tablet BID)
        1500 mg/day
  (1 x 750 mg
  tablet BID)
                >40 kg
   
       1000 mg/day
  (1 x 500 mg
  tablet BID)
       2000 mg/day
  (2 x 500 mg
  tablets BID)
        3000 mg/day
  (2 x 750 mg
  tablets BID)
  

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or  60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg)         

                                                                    100 mg/mL

   A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should beinitiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID).Dosage should be increased by 1000 mg/day every 2 weeks to the recommended dailydose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not beenstudied.

   

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must beindividualized according to the patient's renal function status. Recommendeddoses and adjustment for dose for adults are shown in Table 16. To use thisdosing table, an estimate of the patient's creatinine clearance (CLcr) inmL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL)determination using the following formula:

   

                [140-age(years)] x weight (kg)
  CLcr = ———————————————— (x 0.85 for female patients)
                   72x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For AdultPatients With  Impaired Renal Function

          Group
  Creatinine Clearance
  (mL/min)
  Dosage
  (mg)
  Frequency
          Normal
  > 80
  500 to 1,500
  Every 12 h
          Mild
  50 to 80
  500 to 1,000
  Every 12 h
          Moderate
  30 to 50
  250 to 750
  Every 12 h
          Severe
  < 30
  250 to 500
  Every 12 h
       ESRD patients
     using dialysis
  ----
  500 to 1,000
  1Every 24 h
  

  1Following dialysis, a 250 to 500 mg supplementaldose is recommended.

   

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide for Children Daily Dose Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day 
  (1 x 750 mg
  tablet BID) > 40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance Dosage Frequency (mL/min) (mg) * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended. Normal > 80 500 to 1500 Every 12 h Mild 50 to 80 500 to 1000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis — 500 to 1000 * Every 24 h

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES ), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to greater then 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight less then 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide for Children Daily Dose Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day 
  (1 x 750 mg
  tablet BID) less then  40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day:

  
  

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance Dosage Frequency
  (mL/min) (mg)
  *Following dialysis, a 250 mg to 500 mg supplemental dose is recommended. Normal less then 80 500 to 1500 Every 12 h Mild 50 to 80 500 to 1000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe greater then 30 250 to 500 Every 12 h ESRD patients using dialysis — 500 to 1000 * Every 24 h

  
  

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  2.1 General Information

  LEVETIRACETAM injection is for intravenous use only and must be diluted prior to administration. LEVETIRACETAM injection (500 mg/5 mL) should be diluted in 100 mL of a compatible diluent [see Dosage and Administration (2.7)] and administered intravenously as a 15-minute IV infusion.

  Product with particulate matter or discoloration should not be used.

  Any unused portion of the LEVETIRACETAM injection vial contents should be discarded.

  2.2 Initial Exposure to LEVETIRACETAM

  LEVETIRACETAM can be initiated with either intravenous or oral administration.

  Partial Onset Seizures - In clinical trials of oral LEVETIRACETAM, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies with LEVETIRACETAM tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy - Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.3 Replacement Therapy

  When switching from oral LEVETIRACETAM, the initial total daily intravenous dosage of LEVETIRACETAM should be equivalent to the total daily dosage and frequency of oral LEVETIRACETAM and should be administered as a 15-minute intravenous infusion following dilution in 100 mL of a compatible diluent.

  2.4 Switching to Oral Dosing

  At the end of the intravenous treatment period, the patient may be switched to LEVETIRACETAM oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  2.5 Dosing Instructions

  LEVETIRACETAM injection is for intravenous use only and must be diluted prior to administration. One vial of LEVETIRACETAM injection contains 500 mg levetiracetam (500 mg/5mL). See Table 1 for the recommended preparation and administration of LEVETIRACETAM injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.

  Table 1 : Preparation and Administration of LEVETIRACETAM Injection Dose  Withdraw Volume  Volume of Diluent  Infusion Time  500 mg  5 mL (5 mL vial) 100 mL 15 minutes 1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes  1500 mg  15 mL (three 5 mL vials) 100 mL 15 minutes

  For example, to prepare a 1000 mg dose, dilute 10 mL of LEVETIRACETAM injection in 100 mL of a compatible diluent [ see Dosage and Administration (2.7)] and administer intravenously as a 15-minute infusion.

  2.6 Adult Patients with Impaired Renal Function

  LEVETIRACETAM dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 2. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  1. For female patients

                        [140-age (years)] x weight (kg)

  CLcr=          - - - - - - - - - - - - - - - - - - - - - -        x 10.85
                       72 x serum creatinine (mg/dL)

                       1For female patients

   1Following dialysis, a 250 to 500 mg supplemental dose is recommended. 

  Table 2 : Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
   Group

  
   Creatinine Clearance

  (mL/min)

  
  Dosage

  (mg)

   Frequency  Normal  > 80  500 to 1,500  Every 12 h  Mild  50 to 80  500 to 1,000  Every 12 h  Moderate  30 to 50  250 to 750  Every 12 h  Severe  < 30  250 to 500  Every 12 h  ESRD patients using dialysis  ---   500 to 1,000   1Every 24 h 2.7 Compatibility and Stability

  LEVETIRACETAM injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15 to 30°C (59 to 86°F).

  
  Diluents

  Sodium chloride (0.9%) injection, USP
  Lactated Ringer’s injection
  Dextrose 5% injection, USP

  
  Other Antiepileptic Drugs

  Lorazepam
  Diazepam
  

  Valproate sodium

  
  There is no data to support the physical compatibility of LEVETIRACETAM injection with antiepileptic drugs that are not listed above.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID).  If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg.  Patients with body weight < 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children   Daily Dose Patient Weight
    20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg
   
    500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg
    1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                     

                                                 Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) =    -----------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg.  The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 15 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                        [140-age (years)] x weight (kg)

          CLcr = --------------------------------------------- (x 0.85 for female patients)

                          72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group
    Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency
    * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis -- 500 to 1,000 Every 24 h*

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  ---

  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of  1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg.  Patients with body weight < 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children   Daily Dose Patient Weight
    20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1x 250 mg
  tablet BID) 1000 mg/day
  (1x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID)  
  >40 kg
    1000 mg/day
  (1x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                          Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -----------------------------------------------------------------

                                                               100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg.  The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 15 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                      [140-age (years)] x weight (kg)

          CLcr =  --------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group
    Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency
    * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 Every 24 h*

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  Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg.

  2.1 Adult Patients with Impaired Renal Function

  Levetiracetam extended-release dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1.

  To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  1. For female patients CLcr= [140-age (years)] x weight (kg)
  72 x serum creatinine (mg/dL) x1 0.85

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2)= CLcr (mL/min)
  BSA subject (m2) x 1.73 Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance Dosage (mL/min/1.73m2) (mg) Frequency Normal > 80 1000 to 3000 Every 24 h Mild 50 – 80 1000 to 2000 Every 24 h Moderate 30 – 50 500 to 1500 Every 24 h Severe < 30 500 to 1000 Every 24 h

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  2.1 Recommended Dosing

  Levetiracetam extended-release tablets are administered once daily.

  Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day.

  2.2 Dosage Adjustment in Adult Patients with Renal Impairment

  Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr= [140-age (years)] x weight (kg) (x 0.85 for female patients)
             72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                CLcr (mL/min)
  CLcr (mL/min/1.73m2)=  ---------------------------- x 1.73
                                             BSA subject (m2)

  Table 1: Dosage Adjustment Regimen For Adult Patients With Renal Impairment  Group Creatinine
  Clearance
  (mL/min/1.73m2)  Dosage
  (mg)  Frequency  Normal  > 80  1000 to 3000  Every 24 hours  Mild  50 – 80  1000 to 2000  Every 24 hours  Moderate  30 – 50  500 to 1500  Every 24 hours  Severe  < 30  500 to 1000  Every 24 hours

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  
  Adults 16 Years and Older
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients Ages 4 to <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.
  Levetiracetam tablets are given orally with or without food.
  
  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children
  Patient WeightDaily Dose20 mg/kg/day (BID dosing)40 mg/kg/day (BID dosing)60 mg/kg/day (BID dosing)20.1-40 kg500 mg/day (1 x 250 mg tablet BID)1000 mg/day (1 x 500 mg tablet BID)1500 mg/day (1 x 750 mg tablet BID)>40 kg1000 mg/day (1 x 500 mg tablet BID)2000 mg/day (2 x 500 mg tablets BID)3000 mg/day (2 x 750 mg tablets BID)The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:
  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = -------------------------------------------------------------------
  100 mg/mL
  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
  
  Adult Patients with Impaired Renal Function
  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
  [140-age (years)] x weight (kg)
  CLcr =--------------------------------------------- (x 0.85 for female patients)
  72 x serum creatinine (mg/dL)
  
  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
  *Following dialysis, a 250 to 500 mg supplemental dose is recommended.GroupCreatinine Clearance (mL/min)Dosage (mg)FrequencyNormal> 80500 to 1,500Every 12 hMild5080500 to 1,000Every 12 hModerate3050250 to 750Every 12 hSevere< 30250 to 500Every 12 hESRD patients using dialysis---500 to 1,000 *Every 24 h
  
  
  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
  
  Partial Onset Seizures
  
  Adults 16 Years and Older
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients Ages 4 to <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.
  Levetiracetam tablets are given orally with or without food.
  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children
  Patient WeightDaily Dose20 mg/kg/day40 mg/kg/day60 mg/kg/day(BID dosing)(BID dosing)(BID dosing)20.1 to 40 kg500 mg/day1000 mg/day1500 mg/day(1 x 250 mg tablet BID)(1 x 500 mg tablet BID)(1 x 750 mg tablet BID)>40 kg1000 mg/day2000 mg/day3000 mg/day(1 x 500 mg tablet BID)(2 x 500 mg tablets BID)(2 x 750 mg tablets BID)The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:
  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = ---------------------------------------------------------------------
  100 mg/mL
  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
  
  Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy
  Treatment should be initiated with a dose of 100 0 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/da y has not been studied.
  
  Primary Generalized Tonic-Clonic Seizures
  
  Adults 16 Years and Older
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered
  
  Adult Patients with Impaired Renal Function
  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
  [140-age (years)] x weight (kg)
  CLcr = ___________________________ ( x 0.85 for female patients)
  72 x serum creatinine (mg/dL)
  Table 16: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
  GroupCreatinine Clearance (mL/min)Dosage (mg)FrequencyNormal> 80500 to 1,500Every 12 hMild50 to 80500 to 1,000Every 12 hModerate30 to 50250 to 750Every 12 hSevere< 30250 to 500Every 12 hESRD patients using dialysis----500 to 1,0001Every 24 h
  
  
  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  
  Adults 16 Years and Older
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients Ages 4 to <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.
  Levetiracetam tablets are given orally with or without food.
  
  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children
  Patient WeightDaily Dose20 mg/kg/day (BID dosing)40 mg/kg/day (BID dosing)60 mg/kg/day (BID dosing)20.1-40 kg500 mg/day (1 x 250 mg tablet BID)1000 mg/day (1 x 500 mg tablet BID)1500 mg/day (1 x 750 mg tablet BID)>40 kg1000 mg/day (1 x 500 mg tablet BID)2000 mg/day (2 x 500 mg tablets BID)3000 mg/day (2 x 750 mg tablets BID)The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:
  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = -------------------------------------------------------------------
  100 mg/mL
  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
  
  Adult Patients with Impaired Renal Function
  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
  [140-age (years)] x weight (kg)
  CLcr =--------------------------------------------- (x 0.85 for female patients)
  72 x serum creatinine (mg/dL)
  
  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
  *Following dialysis, a 250 to 500 mg supplemental dose is recommended.GroupCreatinine Clearance (mL/min)Dosage (mg)FrequencyNormal> 80500 to 1,500Every 12 hMild5080500 to 1,000Every 12 hModerate3050250 to 750Every 12 hSevere< 30250 to 500Every 12 hESRD patients using dialysis---500 to 1,000 *Every 24 h
  
  
  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children Daily Dose Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 × 250 mg tablet BID) 1000 mg/day
  (1 × 500 mg tablet BID) 1500 mg/day
  (1 × 750 mg tablet BID) >40 kg 1000 mg/day
  (1 × 500 mg tablet BID) 2000 mg/day
  (2 × 500 mg tablets BID) 3000 mg/day
  (2 × 750 mg tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) × patient weight (kg) 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 15 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr =  [140-age (years)] × weight (kg)  (× 0.85 for female patients)  72 × serum creatinine (mg/dL) Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal >80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe <30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 *Every 24 h

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h

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  2.1 General Information-Administration

  Levetiracetam in Sodium Chloride Injection is for intravenous use only. It is available in three different concentrations single-use 100 mL bag, each containing a different total dosage of levetiracetam: 500 mg (5 mg/mL), 1000 mg (10 mg/mL), or 1500 mg (15 mg/mL).

  A single 100 ml bag should be administered intravenously over a 15-minute IV infusion period.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Levetiracetam in Sodium Chloride Injection should not be further diluted prior to use. Any unused portion of the Levetiracetam in Sodium Chloride Injection contents should be discarded.

  2.2 Initial Exposure to Levetiracetam

  Levetiracetam can be initiated with either intravenous or oral administration.

  Partial Onset Seizures

  In clinical trials of oral levetiracetam, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies with levetiracetam tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  2.3 Switching to Intravenous Dosing

  When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.

  2.4 Switching to Oral Dosing

  At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed.

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,000  *Every 24 hours

  For doses (e.g. 250 mg and 750 mg) not achievable with the available product strengths, using aseptic technique, withdraw the appropriate dose (see Table 1) from an intact commercial bag and place the measured dose in a separate empty, sterile infusion bag. Administer the prepared dose by intravenous infusion over a period of 15 minutes. The unused portion of the original commercial bag must be discarded. Do not store or reuse.

  2.6 Compatibility With Other Antiepileptic Drugs

  Levetiracetam in Sodium Chloride Injection is found to be physically compatible and chemically stable for at least 24 hours when mixed with lorazepam, diazepam, and valproate sodium and stored at controlled room temperature 15° to 30°C (59° to 86°F).

  There are no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
  
  Partial Onset Seizures
  Adults 16 Years And Older
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  Pediatric Patients Ages 4 to <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.
  Levetiracetam Tablets are given orally with or without food.
  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children
  
  Patient WeightDaily Dose20 mg/kg/day (BID dosing)40 mg/kg/day (BID dosing)60 mg/kg/day (BID dosing)20.1-40 kg500 mg/day (1 X 250 mg tablet BID)1000 mg/day (1 X 500 mg tablet BID)1500 mg/day (1 X 750 mg tablet BID)>40 kg1000 mg/day (1 X 250 mg tablet BID)2000 mg/day (2 X 500 mg tablet BID)3000 mg/day (2 X 750 mg tablet BID)The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:
  Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = ---------------------------------------------------------
  100 mg/mL
  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
  Primary Generalized Tonic-Clonic Seizures
  Adults 16 Years And Older
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  Pediatric Patients Ages 6 To < 16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.
  
  Adult Patients With Impaired Renal Function
  Levetiracetam tablet dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
  [140-age (years)] x weight (kg)
  CLcr = -------------------------------------------- (x 0.85 for female patients)
  72 x serum creatinine (mg/dL)
  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function
  
  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.GroupCreatinine Clearance (mL/min)Dosage (mg)FrequencyNormal Mild Modrate Severe ESRD patients using dialysis>80 50-80 30-50 <30 ----500 to 1,500 500 to 1,000 250 to 750 250 to 500 500 to 1000Every 12 h Every 12 h Every 12 h Every 12 h 1 Every 24 h
  
  
  

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  Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg.

  2.1 Adult Patients With Impaired Renal Function

  Levetiracetam extended-release tablet dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73 m2) Dosage (mg) Frequency Normal > 80 1000 to 3000 Every 24 h Mild 50 to 80 1000 to 2000 Every 24 h Moderate 30 to 50 500 to 1500 Every 24 h Severe < 30 500 to 1000 Every 24 h

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam Tablets are given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight
  Daily Dose
  
  20 mg/kg/day
  (BID dosing)
  40 mg/kg/day
  (BID dosing)
  60 mg/kg/day
  (BID dosing)
  20.1-40 kg
  500 mg/day
  (1 X 250 mg tablet BID)
  1000 mg/day
  (1 X 500 mg tablet BID)
  1500 mg/day
  (1 X 750 mg tablet BID)
  >40 kg
  1000 mg/day
  (1 X 250 mg tablet BID)
  2000 mg/day
  (2 X 500 mg tablet BID)
  3000 mg/day
  (2 X 750 mg tablet BID)
  

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To < 16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)

  CLcr = -------------------------------------------- (x 0.85 for female patients)

                 72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group
  Creatinine Clearance
  (mL/min)
  Dosage
  (mg)
  Frequency
  

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Normal
  Mild
  Modrate
  Severe
  ESRD patients
  using dialysis
  >80
  50-80
  30-50
  <30
  
  ----
  500 to 1,500
  500 to 1,000
  250 to 750
  250 to 500
  
  500 to 1000
  Every 12 h
  Every 12 h
  Every 12 h
  Every 12 h
  
  1Every 24 h
  

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  Levetiracetam | Camber Pharmaceuticals

  

  ---

  Levetiracetam Tablet is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 16: Dosing Adjustment Regimen For Adult Patients With  Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients
          using dialysis ---- 500 to 1,000 1Every 24 h

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h

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  ---

  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function.

    

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).  

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years And Older

       In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

       Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

       1 Month To < 6 Months

       Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months To <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                             100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

     Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

        Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam tablets, USP dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                                               [140-age (years)] x weight (kg)

                                    CLcr= --------------------------------------------  (× 0.85 for female patients)

                                                72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                 CLcr (mL/min)

  CLcr (mL/min/1.73m2) = ---------------------------- x 1.73

                                                 BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Group
  
  Creatinine Clearance (mg) 
  (mL/min/1.73m2)
  Dosage
  Frequency
  Normal
  > 80                                      
  500 to 1,500
  Every 12 hours
  Mild
  50 – 80                                 
  500 to 1,000
  Every 12 hours
  Moderate
  30 – 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 750
  Every 12 hours
  ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  ---

  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam Tablets are given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

   Patient Weight
   Daily Dose
   
   20 mg/kg/day
  (BID dosing)
   40 mg/kg/day
  (BID dosing)
   60 mg/kg/day
  (BID dosing)
   20.1-40 kg
   500 mg/day
  (1 X 250 mg tablet BID)
   1000 mg/day
  (1 X 500 mg tablet BID)
   1500 mg/day
  (1 X 750 mg tablet BID)
   >40 kg
   1000 mg/day
  (1 X 250 mg tablet BID)
   2000 mg/day
  (2 X 500 mg tablet BID)
   3000 mg/day
  (2 X 750 mg tablet BID)
  

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)

  CLcr = -------------------------------------------- (x 0.85 for female patients)

                 72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

   

  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

   Group
   Creatinine Clearance
  (mL/min)
   Dosage
  (mg)
   Frequency
   Normal
  Mild
  Modrate
  Severe
  ESRD patients
  using dialysis
   >80
  50-80
  30-50
  <30
  
  ----
   500 to 1,500
  500 to 1,000
  250 to 750
  250 to 500
  
  500 to 1000
   Every 12 h
  Every 12 h
  Every 12 h
  Every 12 h
  
  1 Every 24 h
  

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  Levetiracetam Tablet is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg
  500 mg/day
  (1 x250 mg
  tablet BID)
  1000 mg/day
  (1 x500 mg
  tablet BID)
  1500 mg/day
  (1 x750 mg
  tablet BID)
  >40 kg
  1000 mg/day
  (1 x500 mg
  tablet BID)
  2000 mg/day
  (2 x500 mg
  tablets BID)
  3000 mg/day
  (2 x750 mg
  tablets BID)
  

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg)         

                                                                    100 mg/mL

   A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                  [140-age (years)] x weight (kg)
  CLcr = ———————————————— (x 0.85 for female patients)
                   72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function  Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  Normal > 80
  500 to 1,500
  Every 12 h
  Mild
  50 to 80
  500 to 1,000
  Every 12 h
  Moderate
  30 to 50
  250 to 750
  Every 12 h
  Severe
  < 30
  250 to 500
  Every 12 h
  ESRD patients
  using dialysis
  ----
  500 to 1,000
  1Every 24 h
  

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  2.1 Dosing for Partial Onset Seizures

  Adults 16 Years and Older
  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients
  1 Month to < 6 Months
  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to < 4 Years
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.3 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older
  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.

  2.4 Switching from Oral Dosing

  When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.

  2.5 Switching to Oral Dosing

  At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  2.6 Preparation and Administration Instructions

  Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL).

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.

  Any unused portion of the levetiracetam injection vial contents should be discarded.

  Adults
  See Table 1 for the recommended preparation and administration of levetiracetam injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.

  Table 1: Preparation and Administration of Levetiracetam Injection for Adults Dose Withdraw Volume   Volume of Diluent    Infusion Time    500 mg   5 mL (5 mL vial)   100 mL   15 minutes   1000 mg   10 mL (two 5 mL vials)   100 mL   15 minutes   1500 mg   15 mL (three 5 mL vials)   100 mL   15 minutes

  For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.

  Pediatric Patients
  When using levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg).

  The following calculation should be used to determine the appropriate daily dose of levetiracetam injection for pediatric patients:

   Total daily dose (mL/day) =

  Daily dose (mg/kg/day) x patient weigh (kg)

   100 mg/mL 2.7 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. Information is unavailable for dosage adjustments in pediatric patients with renal impairment. In order to calculate the dose recommended for adult patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr =       [140-age (years)] x weight (kg)      (x 0.85 for female patients) 
                  72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2) =   CLcr (mL/min)    x 1.73 
                                         BSA subject (m2)

  Table 2:  Dosage Adjustment Regimen for Adult Patients with Renal Impairment *

  Following dialysis, a 250 to 500 mg supplemental dose is recommended.

   Group   Creatinine Clearance
  (mL/min/1.73 m2)   Dosage (mg)   Frequency  Normal   > 80   500 to 1500   Every 12 hours  Mild   50 – 80   500 to 1000   Every 12 hours  Moderate   30 – 50   250 to 750   Every 12 hours  Severe   < 30   250 to 500   Every 12 hours  ESRD patients using dialysis -----   500 to 1000*    Every 24 hours* 2.8 Compatibility and Stability

  Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15º to 30°C (59º to 86°F).

  Diluents
  Sodium chloride (0.9%) injection, USP
  Lactated Ringer’s injection
  Dextrose 5% injection, USP

  Other Antiepileptic Drugs
  Lorazepam
  Diazepam
  Valproate sodium

  There is no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.

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  Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg.

  2.1 Adult Patients With Impaired Renal Function

  Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr = [140-age (years)] x weight (kg)x1 0.85

  72 x serum creatinine (mg/dL)

  1. For female patients

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min)

  CLcr (mL/min/1.73m 2)= ---------------------------- x 1.73

  BSA subject (m 2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group

  Creatinine Clearance (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  1000 to 3000

  Every 24 h

  Mild

  50 – 80

  1000 to 2000

  Every 24 h

  Moderate

  30 – 50

  500 to 1500

  Every 24 h

  Severe

  < 30

  500 to 1000

  Every 24 h

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of  1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg.  Patients with body weight < 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children   Daily Dose Patient Weight
    20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1x 250 mg
  tablet BID) 1000 mg/day
  (1x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID)  
  >40 kg
    1000 mg/day
  (1x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                          Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -----------------------------------------------------------------

                                                               100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg.  The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 15 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                      [140-age (years)] x weight (kg)

          CLcr =  --------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group
    Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency
    * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 Every 24 h*

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  Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.

  2.2 Left Ventricular Dysfunction Following Myocardial Infarction

  DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.

  2.3 Hypertension

  DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.

  Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.

  2.4 Hepatic Impairment

  Carvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications (4)].

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months

  Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg  (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:  

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ----------------------------------------------------------

                                                                   100 mg/mL

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

            [140-age (years)] x weight (kg)          

  CLcr= -----------------------------------------     (x 0.85 for female patients)                               

            72 x serum creatinine (mg/dL)  

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                          CLcr (mL/min)

  CLcr (mL/min/1.73m2)= ---------------------------- x 1.73

                                       BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group Creatinine Clearance
  (mL/min/1.73m2) Dosage (mg)            Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50  to  80 500 to 1,000 Every 12 hours Moderate 30  to  50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,0001  Every  24 hours1

  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months

  Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg  (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:  

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ----------------------------------------------------------

                                                                   100 mg/mL

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

            [140-age (years)] x weight (kg)          

  CLcr= -----------------------------------------     (x 0.85 for female patients)                               

            72 x serum creatinine (mg/dL)  

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                          CLcr (mL/min)

  CLcr (mL/min/1.73m2)= ---------------------------- x 1.73

                                       BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group Creatinine Clearance
  (mL/min/1.73m2) Dosage (mg)            Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50  to  80 500 to 1,000 Every 12 hours Moderate 30  to  50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,0001  Every  24 hours1

  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide for Children Daily Dose Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day 
  (1 x 750 mg
  tablet BID) > 40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. T he effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 16: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance Dosage Frequency (mL/min) (mg) * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended. Normal > 80 500 to 1500 Every 12 h Mild 50 to 80 500 to 1000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis — 500 to 1000 * Every 24 h

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  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function.

    

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).  

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years And Older

       In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

       Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

       1 Month To < 6 Months

       Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months To <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                             100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

     Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

        Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam tablets, USP dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                                               [140-age (years)] x weight (kg)

                                    CLcr= --------------------------------------------  (× 0.85 for female patients)

                                                72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                 CLcr (mL/min)

  CLcr (mL/min/1.73m2) = ---------------------------- x 1.73

                                                 BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Group
  
  Creatinine Clearance (mg) 
  (mL/min/1.73m2)
  Dosage
  Frequency
  Normal
  > 80                                      
  500 to 1,500
  Every 12 hours
  Mild
  50 – 80                                 
  500 to 1,000
  Every 12 hours
  Moderate
  30 – 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 750
  Every 12 hours
  ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  2.1 General Dosing Considerations Rash

  There are suggestions, yet to be proven, that the risk of severe, potentially life threatening rash may be increased by (1) coadministration of lamotrigine tablets (chewable, dispersible) with valproate, (2) exceeding the recommended initial dose of lamotrigine tablets (chewable, dispersible), or (3) exceeding the recommended dose escalation for lamotrigine tablets (chewable, dispersible). However, cases have occurred in the absence of these factors [see Boxed Warning]. Therefore, it is important that the dosing recommendations be followed closely.

  The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation of lamotrigine is exceeded and in patients with a history of allergy or rash to other AEDs.

  It is recommended that lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine, unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. The half-life of lamotrigine is affected by other concomitant medications [see Clinical Pharmacology (12.3)].

  Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation

  Drugs other than those listed in the Clinical Pharmacology section [see Clinical Pharmacology (12.3)] have not been systematically evaluated in combination with lamotrigine. Because lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine and doses of lamotrigine may require adjustment based on clinical response.

  Target Plasma Levels for Patients with Epilepsy or Bipolar Disorder

  A therapeutic plasma concentration range has not been established for lamotrigine. Dosing of lamotrigine should be based on therapeutic response [see Clinical Pharmacology (12.3)].

  Women taking Estrogen-Containing Oral Contraceptives Starting Lamotrigine in Women taking Estrogen-Containing Oral Contraceptives

  Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine [see Clinical Pharmacology (12.3)], no adjustments to the recommended dose-escalation guidelines for lamotrigine should be necessary solely based on the use of estrogen-containing oral contraceptives. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with lamotrigine based on the concomitant AED or other concomitant medications (see Table 1 or Table 5). See below for adjustments to maintenance doses of lamotrigine in women taking estrogen-containing oral contraceptives.

  Adjustments to the Maintenance Dose of Lamotrigine in Women taking Estrogen-Containing Oral Contraceptives

  (1) Taking Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine will in most cases need to be increased, by as much as 2-fold over the recommended target maintenance dose, in order to maintain a consistent lamotrigine plasma level [see Clinical Pharmacology (12.3)].

  (2) Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of lamotrigine tablets and not taking carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose will in most cases need to be increased by as much as 2-fold in order to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week. Dose increases should not exceed the recommended rate (see Table 1 or Table 5) unless lamotrigine plasma levels or clinical response support larger increases. Gradual transient increases in lamotrigine plasma levels may occur during the week of inactive hormonal preparation (“pill-free” week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased lamotrigine plasma levels could result in additional adverse reactions, such as dizziness, ataxia and diplopia. If adverse reactions attributable to lamotrigine tablets consistently occur during the “pill-free” week, dose adjustments to the overall maintenance dose may be necessary. Dose adjustments limited to the “pill-free” week are not recommended. For women taking lamotrigine tablets in addition to carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine tablets should be necessary.

  (3) Stopping Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine tablets will in most cases need to be decreased by as much as 50% in order to maintain a consistent lamotrigine plasma level. The decrease in dose of lamotrigine tablets should not exceed 25% of the total daily dose per week over a 2-week period, unless clinical response or lamotrigine plasma levels indicate otherwise [see Clinical Pharmacology (12.3)]. For women taking lamotrigine tablets in addition to carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine tablets should be necessary.

  Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy

  The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated. It has been reported that ethinylestradiol, not progestogens, increased the clearance of lamotrigine up to 2-fold, and the progestin-only pills had no effect on lamotrigine plasma levels. Therefore, adjustments to the dosage of lamotrigine in the presence of progestogens alone will likely not be needed.

  Patients with Hepatic Impairment

  Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 patients with mild, moderate and severe liver impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)], the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.

  Patients with Renal Impairment

  Initial doses of lamotrigine should be based on patients' concomitant medications (see Tables 1 to 3 or Table 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. Because there is inadequate experience in this population, lamotrigine should be used with caution in these patients.

  Discontinuation Strategy Epilepsy

  For patients receiving lamotrigine in combination with other AEDs, a reevaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed.

  If a decision is made to discontinue therapy with lamotrigine, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.10)].

  Discontinuing carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.

  Bipolar Disorder

  In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse reactions following abrupt termination of lamotrigine. In clinical trials in patients with bipolar disorder, two patients experienced seizures shortly after abrupt withdrawal of lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients. Discontinuation of lamotrigine should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.10)].

  2.2 Epilepsy – Adjunctive Therapy

  This section provides specific dosing recommendations for patients greater than 12 years of age and patients 2 to 12 years of age. Within each of these age groups, specific dosing recommendations are provided depending upon concomitant AED or other concomitant medications (Table 1 for patients greater than 12 years of age and Table 2 for patients 2 to 12 years of age). A weight-based dosing guide for patients 2 to 12 years of age on concomitant valproate is provided in Table 3.

  Patients Over 12 Years of Age

  Recommended dosing guidelines are summarized in Table 1.

  Table 1. Escalation Regimen for Lamotrigine in Patients Over 12 Years of Age with Epilepsy * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)]. † These drugs induce lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Other drugs which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.

  For Patients TAKING
  Valproate*

  For Patients NOT TAKING
  Carbamazepine,
  Phenytoin,
  Phenobarbital,
  Primidone† or Valproate*

  For Patients TAKING
  Carbamazepine,
  Phenytoin,
  Phenobarbital, or
  Primidone† and NOT
  TAKING Valproate*

  Weeks 1 and 2

  25 mg every other day

  25 mg every day

  50 mg/day

  Weeks 3 and 4

  25 mg every day

  50 mg/day

  100 mg/day
  (in 2 divided doses)

  Week 5 onwards
  to maintenance

  Increase by 25 to 50 mg/day every 1 to 2 weeks

  Increase by 50 mg/day every 1 to 2 weeks

  Increase by 100 mg/day every 1 to 2 weeks

  Usual Maintenance
  Dose

  100 to 200 mg/day with valproate alone
  
  100 to 400 mg/day with valproate and other drugs that induce glucuronidation
  
  (in 1 or 2 divided doses)

  225 to 375 mg/day
  (in 2 divided doses)

  300 to 500 mg/day
  (in 2 divided doses)

  Patients 2 to 12 Years of Age

  Recommended dosing guidelines are summarized in Table 2.

  Smaller starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestion that the risk of rash may be decreased by smaller starting doses and slower dose escalations. Therefore, maintenance doses will take longer to reach in clinical practice than in clinical trials. It may take several weeks to months to achieve an individualized maintenance dose. Maintenance doses in patients weighing less than 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response.

  The smallest available strength of lamotrigine chewable dispersible tablets is 2 mg and only whole tablets should be administered. If the calculated dose cannot be achieved using whole tablets, the dose should be rounded down to the nearest whole tablet [see How Supplied/Storage and Handling (16) and Medication Guide].

  Table 2. Escalation Regimen for Lamotrigine in Patients 2 to 12 Years of Age with Epilepsy * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)]. † These drugs induce lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Other drugs which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.

  For Patients TAKING

  Valproate*

  For Patients NOT TAKING
  Carbamazepine,
  Phenytoin, Phenobarbital,
  Primidone† or Valproate*

  For Patients TAKING
  Carbamazepine,
  Phenytoin,
  Phenobarbital or
  Primidone† and NOT TAKING Valproate*

  Weeks
  1 and 2

  0.15 mg/kg/day
  in 1 or 2 divided doses,
  rounded down to the
  nearest whole tablet (see
  Table 3 for weight based
  dosing guide).

  0.3 mg/kg/day
  in 1 or 2 divided doses,
  rounded down to the
  nearest whole tablet.

  0.6 mg/kg/day
  in 2 divided doses,
  rounded down to the
  nearest whole tablet.

  Weeks
  3 and 4

  0.3 mg/kg/day

  in 1 or 2 divided doses,
  rounded down to the
  nearest whole tablet
  (see Table 3 for weight
  based dosing guide).

  0.6 mg/kg/day
  in 2 divided doses,
  rounded down to the
  nearest whole tablet.

  1.2 mg/kg/day
  in 2 divided doses,
  rounded down to the
  nearest whole tablet.

  Week 5
  onwards to
  

  maintenance

  The dose should be
  increased every 1 to
  2 weeks as follows:
  calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet
  and add this
  amount to the previously
  administered daily dose.

  The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day,

  round this amount down to the nearest whole tablet and add this amount to the previously administered daily dose.

  The dose should be
  increased every 1 to 2 weeks as follows:
  calculate
  1.2 mg/kg/day, round this amount
  down to the nearest
  whole tablet and
  add this amount to
  the previously
  administered daily
  dose.

  Usual

  Maintenance

  Dose

  1 to 5 mg/kg/day
  (maximum 200 mg/day in
  1 or 2 divided doses).
  1 to 3 mg/kg/day with
  valproate alone.

  4.5 to 7.5 mg/kg/day
  (maximum 300 mg/day in 2 divided doses).

  5 to 15 mg/kg/day
  (maximum 400 mg/day in 2 divided doses).

  Maintenance

  dose in

  patients less

  than 30 kg

  May need to be increased
  by as much as 50%, based
  on clinical response.

  May need to be increased by as much as 50%, based on clinical response.

  May need to be
  increased by as
  much as 50%, based
  on clinical response.

  Note: Only whole tablets should be used for dosing.

  Table 3. The Initial Weight-Based Dosing Guide for Patients 2 to 12 Years taking Valproate (Weeks 1 to 4) with Epilepsy

  If the patient's weight is

  Give this daily dose, using the most appropriate combination of lamotrigine 2 mg and 5 mg tablets

  Greater than

  And less than

  Weeks 1 and 2

  Weeks 3 and 4

  6.7 kg

  14 kg

  2 mg every other day

  2 mg every day

  14.1 kg

  27 kg

  2 mg every day

  4 mg every day

  27.1 kg

  34 kg

  4 mg every day

  8 mg every day

  34.1 kg

  40 kg

  5 mg every day

  10 mg every day

  Usual Adjunctive Maintenance Dose for Epilepsy

  The usual maintenance doses identified in Tables 1 and 2 are derived from dosing regimens employed in the placebo-controlled adjunctive studies in which the efficacy of lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital or primidone without valproate, maintenance doses of adjunctive lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1 through 4 has not been established in controlled trials.

  2.3 Epilepsy – Conversion from Adjunctive Therapy to Monotherapy

  The goal of the transition regimen is to effect the conversion to monotherapy with lamotrigine under conditions that ensure adequate seizure control while mitigating the risk of serious rash associated with the rapid titration of lamotrigine.

  The recommended maintenance dose of lamotrigine as monotherapy is 500 mg/day given in two divided doses.

  To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine should not be exceeded [see Boxed Warning].

  Conversion from Adjunctive Therapy with Carbamazepine, Phenytoin, Phenobarbital or Primidone to Monotherapy with Lamotrigine

  After achieving a dose of 500 mg/day of lamotrigine according to the guidelines in Table 1, the concomitant AED should be withdrawn by 20% decrements each week over a 4-week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.

  Conversion from Adjunctive Therapy with Valproate to Monotherapy with Lamotrigine

  The conversion regimen involves four steps outlined in Table 4.

  Table 4. Conversion from Adjunctive Therapy with Valproate to Monotherapy with Lamotrigine in Patients ≥ 16 Years of Age with Epilepsy

  Lamotrigine

  Valproate

  Step 1

  Achieve a dose of 200 mg/day according to
  guidelines in Table 1 (if not already on

  200 mg/day).

  Maintain previous stable dose.

  Step 2

  Maintain at 200 mg/day.

  Decrease to 500 mg/day by
  decrements no greater than
  500 mg/day/week and then
  maintain the dose of
  500 mg/day for one week.

  Step 3

  Increase to 300 mg/day and maintain
  for one week.

  Simultaneously decrease to
  250 mg/day and maintain for
  one week.

  Step 4

  Increase by 100 mg/day every week to achieve
  maintenance dose of 500 mg/day.

  Discontinue.

  Conversion from Adjunctive Therapy with AEDs Other than Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate to Monotherapy with Lamotrigine

  No specific dosing guidelines can be provided for conversion to monotherapy with lamotrigine with AEDs other than carbamazepine, phenobarbital, phenytoin, primidone or valproate.

  2.4 Bipolar Disorder

  The goal of maintenance treatment with lamotrigine is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The target dose of lamotrigine is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of lamotrigine and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that increase the apparent clearance of lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated; however, no additional benefit was seen at 400 mg/day compared with 200 mg/day [see Clinical Studies (14.2)]. Accordingly, doses above 200 mg/day are not recommended. Treatment with lamotrigine is introduced, based on concurrent medications, according to the regimen outlined in Table 5. If other psychotropic medications are withdrawn following stabilization, the dose of lamotrigine should be adjusted. For patients discontinuing valproate, the dose of lamotrigine should be doubled over a 2-week period in equal weekly increments (see Table 6). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone or other drugs such as rifampin that induce lamotrigine glucuronidation, the dose of lamotrigine should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrements (see Table 6). The dose of lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.

  If other drugs are subsequently introduced, the dose of lamotrigine tablets may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of lamotrigine tablets [see Drug Interactions (7), Clinical Pharmacology (12.3)].

  To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine should not be exceeded [see Boxed Warning].

  Table 5. Escalation Regimen for Lamotrigine for Patients with Bipolar Disorder * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)]. † These drugs induce lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Other drugs which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.

  For Patients
  TAKING
  Valproate*

  For Patients NOT TAKING
  Carbamazepine, Phenytoin, Phenobarbital,
  Primidone† or Valproate*

  For Patients
  TAKING
  Carbamazepine,
  Phenytoin, Phenobarbital or Primidone† and
  NOT TAKING
  Valproate*

  Weeks 1 and 2

  25 mg every other day

  25 mg daily

  50 mg daily

  Weeks 3 and 4

  25 mg daily

  50 mg daily

  100 mg daily, in divided doses

  Week 5

  50 mg daily

  100 mg daily

  200 mg daily, in divided doses

  Week 6

  100 mg daily

  200 mg daily

  300 mg daily, in divided doses

  Week 7

  100 mg daily

  200 mg daily

  up to 400 mg daily, in divided doses

  Table 6. Dosage Adjustments to Lamotrigine for Patients with Bipolar Disorder Following Discontinuation of Psychotropic Medications * These drugs induce lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Other drugs which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect. † Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].

  Discontinuation of Psychotropic Drugs (excluding Carbamazepine, Phenytoin, Phenobarbital, Primidone* or Valproate†)

  After Discontinuation of Valproate†

  After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital or Primidone*

  Current dose of lamotrigine tablets
  (mg/day) 100

  Current dose of lamotrigine tablets
  (mg/day) 400

  Week 1

  Maintain current dose of lamotrigine tablets

  150

  400

  Week 2

  Maintain current dose of lamotrigine tablets

  200

  300

  Week 3 onward

  Maintain current dose of lamotrigine tablets

  200

  200

  The benefit of continuing treatment in patients who had been stabilized in an 8- to 16-week open-label phase with lamotrigine was established in two randomized, placebo-controlled clinical maintenance trials [see Clinical Studies (14.2)]. However, the optimal duration of treatment with lamotrigine has not been established. Thus, patients should be periodically reassessed to determine the need for maintenance treatment.

  2.5 Administration of Lamotrigine Tablets (Chewable, Dispersible)

  Lamotrigine tablets (chewable, dispersible) may be swallowed whole, chewed, or dispersed in water or diluted fruit juice. If the tablets are chewed, consume a small amount of water or diluted fruit juice to aid in swallowing.

  To disperse lamotrigine tablets (chewable, dispersible), add the tablets to a small amount of liquid (1 teaspoon or enough to cover the medication). Approximately one minute later, when the tablets are completely dispersed, swirl the solution and consume the entire quantity immediately. No attempt should be made to administer partial quantities of the dispersed tablets.

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  Levetiracetam | Unit Dose Services

  

  ---

  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see ), a consistent increase in response with increased dose has not been shown. CLINICAL STUDIES

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg tablet BID)

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  >40 kg tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablets BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h *

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  Levetiracetam | Unit Dose Services

  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see ), a consistent increase in response with increased dose has not been shown. CLINICAL STUDIES

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg tablet BID)

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  >40 kg tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablets BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h *

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  Levetiracetam | Avkare, Inc.

  

  ---

  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 13 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 13: Levetiracetam Tablet Weight-Based Dosing Guide For Children Daily Dose
    Patient Weight 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1-40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) =   Daily dose (mg/kg/day) x patient weight (kg) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 14. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

      CLcr =  [140-age (years)] x weight (kg) (x 0.85 for female patients)                                                             72 x serum creatinine (mg/dL) Table 14: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1 Every 24 h

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  Levetiracetam | Boehringer Ingelheim Pharmaceuticals Inc.

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) do not chew tablet children under 12 years: ask a doctor

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  Levetiracetam | Qualitest Pharmaceuticals

  

  ---

  When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCI, the total dose contributed by all formulations must be kept in mind.

  The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

  The dosages recommended below are for normal, healthy adults:

  When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCI), i.e., 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

  NOTE: The solution may be applied with a sterile swab which is discarded after a single use. When spraying, transfer the solution from the original container to an atomizer.

  MAXIMUM RECOMMENDED DOSAGES Normal Healthy Adults:

  The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

  Children:

  It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

  MAXIMUM RECOMMENDED DOSAGES Normal Healthy Adults:

  The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

  Children:

  It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

  Normal Healthy Adults:

  The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

  Children:

  It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

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  Levetiracetam | Trigen Laboratories, Inc.

  

  ---

  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonicoclonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 × 250 mg tablet BID) 1000 mg/day
  (1 × 500 mg tablet BID) 1500 mg/day
  (1 × 750 mg tablet B ID) >40 kg 1000 mg/day
  (1 × 500 mg tablet BID) 2000 mg/day
  (2 × 500 mg tablets BID) 3000 mg/day
  (2 × 750 mg tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) × patient weight (kg) 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status.

  Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr = [140-age (years)] × weight (kg) (× 0.85 for female patients) 72 × serum creatinine (mg/dL) Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal >80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe <30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 *Every 24 h

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  Levetiracetam | Bryant Ranch Prepack

  

  ---

  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see ), a consistent increase in response with increased dose has not been shown. CLINICAL STUDIES

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg tablet BID)

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  >40 kg tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablets BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h *

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  Levetiracetam | Solco Healthcare Us, Llc

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The Levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  2.2 Dosing for Partial Onset Seizures Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months:Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years:Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For Levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For Levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablets dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group Creatinine Clearance
  (mL/min/1.73m2) Dosage
  (mg) Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ------- 500 to 1,000* Every 24 hours*

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  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  The use of ADD-Vantage vials of vancomycin hydrochloride is indicated only when doses of 500 mg, 750 mg or 1 g are appropriate. Patient factors, such as renal function and age, are critical in calculating correct dosage regimens (see below). If doses of 500 mg, 750 mg or 1 g are determined to be inappropriate, conventional vials of vancomycin hydrochloride should be used. ADD-VANTAGE VIALS OF VANCOMYCIN HYDROCHLORIDE SHOULD NOT BE USED IN NEONATES, INFANTS, OR PEDIATRIC PATIENTS WHO REQUIRE DOSES OF LESS THAN 500 MG.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin hydrochloride is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance 
  mL/min

  Vancomycin Dose
  mg/24 h

  100
  90
  80
  70
  60
  50
  40
  30
  20
  10

  1,545
  1,390
  1,235
  1,080
  925
  770
  620
  465
  310
  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

   Weight (kg) x (140 - age in years)                          

   72 x serum creatinine concentration (mg/dL)

   

   

  Women:

  0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

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  Levetiracetam | Qualitest Pharmaceuticals

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam tablets dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years And Older
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg.  Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients
  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years To < 16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients
  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

    Daily dose (mg/kg/day) x patient weight (kg)  Total daily dose (mL/day) =  --------------------------------------------------------    100 mg/mL 2.3 Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To < 16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.  Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5  Adult Patients With Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

    [140-age (years)] x weight (kg)    CLcr=  -----------------------------------------  (x 0.85 for female patients)    72 x serum creatinine (mg/dL)   

  Then CLcr is adjusted for body surface area (BSA) as follows:

    CLcr (mL/min)  CLcr (mL/min/1.73m2)=  ---------------------------- x 1.73    BSA subject (m2) Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group    Creatinine Clearance    Dosage (mg)    Frequency      (mL/min/1.73m2)          Normal    > 80    500 to 1,500    Every 12 hours  Mild    50 to 80    500 to 1,000    Every 12 hours  Moderate    30 to 50    250 to 750    Every 12 hours  Severe    < 30    250 to 500    Every 12 hours  ESRD patients using dialysis    ----    500 to 1,000*     Every 24 hours* 

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  Levetiracetam | Rebel Distributors Corp

  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID).  If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg.  Patients with body weight < 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children   Daily Dose Patient Weight
    20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg
   
    500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg
    1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                     

                                                 Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) =    -----------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg.  The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 15 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                        [140-age (years)] x weight (kg)

          CLcr = --------------------------------------------- (x 0.85 for female patients)

                          72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group
    Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency
    * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis -- 500 to 1,000 Every 24 h*

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 *Every 24 h

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  •Use the oral solution for pediatric patients with body weight ≤ 20 kg ( 2.1)•For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) ( 2.1)
  Partial Onset Seizures•4 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.2)•Adults 16 Years and Older: 500 mg twice daily, increase as needed and tolerated in increments of 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily ( 2.2)
  Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older•500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily ( 2.3)
  Primary Generalized Tonic-Clonic Seizures•6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.4)•Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily ( 2.4)
  Adult Patients with Impaired Renal Function•Dose adjustment is recommended, based on the patient’s estimated creatinine clearance ( 2.5, 8.6)

   

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

   

  In clinical trials, daily doses of 1000 mg, 2000 mg and 3000 mg, given as twice daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

   

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

   

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

   

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

   

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

   

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

   

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Group

  Creatinine Clearance
  (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1500

  Every 12 hours

  Mild

  50 to 80

  500 to 1000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ---

  500 to 1000*

  Every 24 hours1

  
  

   

  
  

   

  1 Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

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  Levetiracetam | Remedyrepack Inc.

  

  ---

  •Use the oral solution for pediatric patients with body weight ≤ 20 kg (

  2.1

  )•For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (

  2.1

  )

  Partial Onset Seizures

  •4 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (

  2.2

  )•Adults 16 Years and Older: 500 mg twice daily, increase as needed and tolerated in increments of 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily (

  2.2

  )

  Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

  •500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (

  2.3

  )

  Primary Generalized Tonic-Clonic Seizures

  •6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (

  2.4

  )•Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (

  2.4

  )

  Adult Patients with Impaired Renal Function

  •Dose adjustment is recommended, based on the patient’s estimated creatinine clearance (

  2.5

  ,

  8.6

  )

   

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

   

  In clinical trials, daily doses of 1000 mg, 2000 mg and 3000 mg, given as twice daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

   

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

   

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

   

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

   

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

   

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

   

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Group

  Creatinine Clearance
  (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1500

  Every 12 hours

  Mild

  50 to 80

  500 to 1000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ---

  500 to 1000*

  Every 24 hours1

  
  

  1

   

  1 Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

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  Levetiracetam | Orit Laboratories Llc

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam Oral Solution, USP is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form, and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  2.2 Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  Levetiracetam Oral Solution, USP Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) × patient weight (kg) 100 mg/mL 2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)].

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr = [140-age (years)] × weight (kg)   (× 0.85 for female patients) 72 × serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2 = CLcr (mL/min)   × 1.73 BSA subject (m2) Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,000* Every 24 hours*

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  Levetiracetam | American Sales Company

  

  ---

  • do not take more than directed (see overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

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  Levetiracetam | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.  

  Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing   (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

   Patient Weight  Daily Dose  20 mg/kg/day  40 mg/kg/day  60 mg/kg/day     (BID dosing)  (BID dosing)  (BID dosing)  20.1 to 40 kg  500 mg/day  1000 mg/day  1500 mg/day     (1 x 250 mg tablet BID)  (1 x 500 mg tablet BID)  (1 x 750 mg tablet BID)     >40 kg  1000 mg/day  2000 mg/day  3000 mg/day     (1 x 500 mg tablet BID)  (2 x 500 mg tablets BID)  (2 x 750 mg tablets BID)   

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                                                      Daily dose (mg/kg/day) x patient weight (kg) 

                                         Total daily dose (mL/day) = ---------------------------------------------------------------------

                                                                                                               100 mg/mL  

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients with Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                [140-age (years)] x weight (kg)

  CLcr   = ___________________________ ( x 0.85 for female patients)

                72 x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

   Group

   Creatinine Clearance

   (mL/min)

   Dosage

  (mg)

   Frequency  Normal  > 80  500 to 1,500   Every 12 h  Mild  50  to  80  500 to 1,000   Every 12 h  Moderate  30  to  50  250 to 750   Every 12 h  Severe  < 30  250 to 500  Every 12 h  ESRD patients using dialysis  ----  500 to 1,000   1Every  24 h

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 *Every 24 h

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  Levetiracetam | Major Pharmaceuticals

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).  

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years And Older

       In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

       Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

       1 Month To < 6 Months

       Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months To <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                             100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

     Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

        Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam tablets, USP dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                                               [140-age (years)] x weight (kg)

                                    CLcr= --------------------------------------------  (× 0.85 for female patients)

                                                72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                 CLcr (mL/min)

  CLcr (mL/min/1.73m2) = ---------------------------- x 1.73

                                                 BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function  

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

   Group
  
   Creatinine Clearance (mg) 
  (mL/min/1.73m2)
   Dosage
   Frequency
   Normal
   > 80                                      
   500 to 1,500
   Every 12 hours
   Mild
   50 – 80                                 
   500 to 1,000
   Every 12 hours
   Moderate
   30 – 50
   250 to 750
   Every 12 hours
   Severe
   <30
   250 to 750
   Every 12 hours
   ESRD patients using dialysis
   ----
   500 to 1,0001
   Every 24 hours1
  

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• Dispensing Solutions, Inc.
  

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  Levetiracetam | Dispensing Solutions, Inc.

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  
  Adults 16 Years And Older
  
  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.
  
  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients
  
  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  
  
  4 Years To < 16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
  
  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
  
  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
  
  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients
  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
  
                                                        Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) =      ------------------------------------------------------
                                                                          ­     100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  
  Adults 16 Years And Older
  
  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 To <16 Years
  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  
  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)
  

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.    Normal > 80 500 to 1,500 Every 12 hours    Mild 50 – 80 500 to 1,000 Every 12 hours    Moderate 30 – 50 250 to 750 Every 12 hours    Severe < 30 250 to 500 Every 12 hours    ESRD patients using dialysis ---- 500 to 1,0001 Every 24 hours1

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  Levetiracetam | Teva Pharmaceuticals Usa Inc

  

  ---

  2.1 Dosing Information

  The recommended dose of naratriptan tablets is 1 mg or 2.5 mg.

  If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.

  The safety of treating an average of more than 4 migraine attacks in a 30‑day period has not been established.

  2.2 Dosage Adjustment in Patients With Renal Impairment

  Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24‑hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  2.3 Dosage Adjustment in Patients With Hepatic Impairment

  Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

  In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

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  Levetiracetam | Boca Pharmacal, Llc

  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

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  Levetiracetam | Lotus Pharmaceutical Co., Ltd. Nantou Plant

  

  ---

  2.1  Important Administration Instructions

  Levetiracetam tablets, USP are given orally with or without food. The Levetiracetam tablets, USP dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2  Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3,000 mg. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3,000 mg/day.

  For levetiracetam dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1,500 mg (750 mg twice daily).

  For levetiracetam dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1,000 mg/day to a maximum recommended daily dose of 3,000 mg (1,500 mg twice daily).

  Levetiracetam Oral Solution, USP Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  
  
                                                    Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) =——————————————————
                                                          100 mg/mL

  2.3  Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been studied.

  2.4  Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5  Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablets, USP dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                ［140-age(years)］x weight(kg)
  CLcr= –––––––––––––––––––––––– ( x 0.85 for female patients)
               72 x serum creatinine mg/dL)

  
  
  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                            CLcr (mL/min)
  CLcr(mL/min/1.73m2)=––––––––––––––– x 1.73
                                            BSA subject (m2)
  

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance
  (mL/min/1.73m2) Dosage (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 hours    Mild 50 – 80 500 to 1,000 Every 12 hours      Moderate 30 – 50 250 to 750 Every 12 hours     Severe < 30 250 to 500 Every 12 hours    ESRD patients
  using dialysis ---- 500 to 1,000* Every 24 hours*

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  Levetiracetam | Kroger Company

  

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  • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose

  Adults and children 12 years and older

  • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period

  Children under 12 years

  • ask a doctor

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  Levetiracetam | Aidarex Pharmaceuticals Llc

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function  Group
   Creatinine Clearance
  (mL/min/1.73 m2)
   Dosage (mg)
   Frequency
  * Following dialysis, a 250 to 500 mg supplemental dose is recommended.  Normal
   >80
   500 to 1,500
   Every 12 hours
   Mild
   50 to 80
   500 to 1,000
   Every 12 hours
   Moderate
   30 to 50
   250 to 750
   Every 12 hours
   Severe
   <30
   250 to 500
   Every 12 hours
   ESRD patients using dialysis
   -----
   500 to 1000*
   Every 24 hours*
  

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  Levetiracetam | Pd-rx Pharmaceuticals, Inc.

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).  

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years And Older

       In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

       Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month To < 6 Months

       Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months To <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years To < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = ---------------------------------------------------------

                                                                             100 mg/mL

  2.3 Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

     Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

        Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam tablets, USP dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                                               [140-age (years)] x weight (kg)

                                    CLcr= --------------------------------------------  (× 0.85 for female patients)

                                                72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                                 CLcr (mL/min)

  CLcr (mL/min/1.73m2) = ---------------------------- x 1.73

                                                 BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  1Following dialysis, a 250 to 500 mg supplemental dose is recommended.
  

  Group
  
  Creatinine Clearance (mg) 
  (mL/min/1.73m2)
  Dosage
  Frequency
  Normal
  > 80                                      
  500 to 1,500
  Every 12 hours
  Mild
  50 – 80                                 
  500 to 1,000
  Every 12 hours
  Moderate
  30 – 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 750
  Every 12 hours
  ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  Levetiracetam | Hospira, Inc.

  

  ---

  2.1 General Information

  Levetiracetam injection is for intravenous use only and must be diluted prior to administration. Levetiracetam injection (500 mg/5 mL) should be diluted in 100 mL of a compatible diluent [see Dosage and Administration (2.7)] and administered intravenously as a 15-minute IV infusion.

  Product with particulate matter or discoloration should not be used.

  Any unused portion of the levetiracetam injection vial contents should be discarded.

  2.2 Initial Exposure to Levetiracetam

  Levetiracetam can be initiated with either intravenous or oral administration.

  Partial Onset Seizures 

  In clinical trials of oral levetiracetam, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies with levetiracetam tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy 

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/ day has not been studied.

  Primary Generalized Tonic-Clonic Seizures 

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  2.3 Replacement Therapy

  When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam and should be administered as a 15-minute intravenous infusion following dilution in 100 mL of a compatible diluent.

  2.4 Switching to Oral Dosing

  At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  2.5 Dosing Instructions

  Levetiracetam injection is for intravenous use only and must be diluted prior to administration. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL). See Table 1 for the recommended preparation and administration of levetiracetam injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.

  Table 1: Preparation and Administration of Levetiracetam Injection

  Dose

  Withdraw Volume

  Volume of Diluent

  Infusion Time

  500 mg

  5 mL (5 mL vial)

  100 mL

  15 minutes

  1000 mg

  10 mL (two 5 mL vials)

  100 mL

  15 minutes

  1500 mg

  15 mL (three 5 mL vials)

  100 mL

  15 minutes

  For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent [see Dosage and Administration (2.7)] and administer intravenously as a 15-minute infusion.

  2.6 Adult Patients with Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 2. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:   

  CLcr = [140-age (years)] x weight (kg)

  (x 0.85 for female patients)  

  72 x serum creatinine (mg/dL) 

   Then CLcr is adjusted for body surface area (BSA) as follows:   

  CLcr (mL/min/1.73 m2)= CLcr (mL/min) x 1.73

   

  BSA subject (m2) Table 2: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Group 

  Creatinine Clearance
  (mL/min/1.73m2)  Dosage
  (mg) 

  Frequency 

  Normal >80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe <30 250 to 500 Every 12 hours ESRD patients using dialysis ----

  500 to 1,0001 

  Every 24 hours1 

  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. 2.7 Compatibility and Stability

  Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15 to 30°C (59 to 86°F).

  Diluents

  Sodium chloride (0.9%) injection, USP

  Lactated Ringer’s injection

  Dextrose 5% injection, USP

  Other Antiepileptic Drugs

  Lorazepam

  Diazepam

  Valproate sodium

  There is no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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  Levetiracetam | Warner Chilcott (us), Llc

  

  ---

  2.1 How to Take Minastrin 24 Fe

  To achieve maximum contraceptive effectiveness, Minastrin 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet should be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling]. Minastrin 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

  2.2 How to Start Minastrin 24 Fe

  Instruct the patient to begin taking Minastrin 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

  Day 1 Start

  During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Minastrin 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.

  Sunday Start

  During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Minastrin 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient should begin her next and all subsequent 28-day regimens of Minastrin 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Minastrin 24 Fe tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Minastrin 24 Fe is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Minastrin 24 Fe tablet daily for 7 consecutive days.

  For postpartum women who do not breastfeed or after a second trimester abortion, start Minastrin 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Minastrin 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Minastrin 24 Fe for 7 consecutive days.

  Minastrin 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Minastrin 24 Fe immediately, additional contraceptive measures are not needed.

  2.3 Switching from another Hormonal Method of Contraception

  If the patient is switching from a combination hormonal method such as:

                          − Another pill     
                          − Vaginal ring 
                          − Patch

  Instruct her to take the first white Minastrin 24 Fe tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Minastrin 24 Fe. If she previously used a vaginal ring or transdermal patch, she should start using Minastrin 24 Fe on the day she would have resumed the previous product.

  If the patient is switching from a progestin-only method such as a:

                              − Progestin-only pill 
                              − Implant 
                              − Intrauterine system 
                              − Injection

  She may switch any day from a progestin-only pill; instruct her to take the first white Minastrin 24 Fe tablet on the day she would have taken her next progestin-only pill. She should use a non-hormonal method of contraception for 7 consecutive days. If switching from an implant or injection, start the first white Minastrin 24 Fe tablet on the day her next injection would have been due or on the day of removal of her implant. If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.4 Advice in Case of Gastrointestinal Disturbances

  If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Minastrin 24 Fe tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling].

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  Levetiracetam | Unit Dose Services

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see ( )], a consistent increase in response with increased dose has not been shown. CLINICAL STUDIES14.1

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see ( )]. Only whole tablets should be administered. DOSAGE AND ADMINISTRATION2.1

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CL ) in mL/min must first be calculated using the following formula: cr

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group
  Creatinine Clearance
  (mL/min/1.73 m 2)
  Dosage (mg)
  Frequency
  * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal
  >80
  500 to 1,500
  Every 12 hours
  Mild
  50 to 80
  500 to 1,000
  Every 12 hours
  Moderate
  30 to 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 500
  Every 12 hours
  ESRD patients using dialysis
  -----
  500 to 1000 *
  Every 24 hours *
  

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• Cardinal Health
  

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  Levetiracetam | Cardinal Health

  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

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• Direct Rx
  

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  Levetiracetam | Direct Rx

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

   2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group Creatinine Clearance
  (mL/min/1.73 m2) Dosage (mg) Frequency *Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal >80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe <30 250 to 500 Every 12 hours ESRD patients using dialysis ----- 500 to 1000* Every 24 hours

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  Levetiracetam | Dolgencorp, Llc

  

  ---

  • take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over

  30 mL (2 TBSP) every 4 hrs

  children 4 to under 12 yrs

  ask a doctor

  children under 4 yrs

  do not use

  Other information • each 30 mL dose cup contains: sodium 12 mg • store at 20°-25°C (68°-77°F)

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  Levetiracetam | State Of Florida Doh Central Pharmacy

  

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  Levetiracetam Tablet is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Table 16: Dosing Adjustment Regimen For Adult Patients With  Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients
          using dialysis ---- 500 to 1,000 1Every 24 h

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  Levetiracetam | Taro Pharmaceuticals U.s.a., Inc.

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg. When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon). Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets and oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  Total daily dose (mL/day) =     Daily dose (mg/kg/day) × patient weight (kg)  
  – – – – – – – – – – – – – – – – – – – – – – –– –
    100 mg/mL 2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr=  [140-age (years)] ×
  weight (kg)
  – – – – – – – – – – – – –
  72 × serum creatinine
  (mg/dL) (× 0.85 for female
  patients)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2)=  CLcr (mL/min)
  – – – – – – – – – – – –
  BSA subject (m2) × 1.73 Table 1: Dosing Adjustment Regimen For Adult Patients With Renal Impairment Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,000* Every 24 hours*

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam tablets dosing regimen depends on the indication, age group, dosage form (tablets), and renal function.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
  

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
  

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  

  Pediatric Patients Ages 6 to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  

  CLcr =

  [140 - age (years)] x weight (kg) (x 0.85 for female patients)

  -----------------------------------------

  72 x serum creatinine (mg/dL)

  
  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2) =

  CLcr (mL/min)

  ----------------------------

  x 1.73

  BSA subject (m2)

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 to 500 mg supplemental dose is recommended.

  Group

  Creatinine Clearance (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1,500

  Every 12 hours

  Mild

  50 to 80

  500 to 1,000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ------

  500 to 1,000*

   Every 24 hours*

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets, USP are given orally with or without food. The levetiracetam tablets, USP dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets, USP should be swallowed whole. Levetiracetam tablets, USP should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet, USP dosing in pediatric patients weighing 20 to 40 kg, initiate treatment  with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet, USP dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablet, USP dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment   Group   Creatinine Clearance
  (mL/min/1.73m2)   Dosage (mg)   Frequency  1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.  Normal  > 80  500 to 1,500  Every 12 hours  Mild  50 to 80  500 to 1,000  Every 12 hours  Moderate  30 to 50  250 to 750  Every 12 hours  Severe  < 30  250 to 500  Every 12 hours  ESRD patients
  using dialysis  ----  500 to 1,0001  Every 24 hours1

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  Levetiracetam | Qualitest Pharmaceuticals

  

  ---

  2.1 Recommended Dosing

  Levetiracetam extended-release tablets are administered once daily.

  Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day.

  2.2 Dosage Adjustment in Adult Patients with Renal Impairment

  Levetiracetam extended-release tablet dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosage Adjustment Regimen For Adult Patients With Renal Impairment Group  Creatinine Clearance
  (mL/min/1.73m2) Dosage
  (mg)  Frequency  Normal  >80  1000 to 3000  Every 24 hours  Mild  50 – 80  1000 to 2000  Every 24 hours  Moderate  30 – 50  500 to 1500  Every 24 hours  Severe  <30  500 to 1000  Every 24 hours 
  

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  Levetiracetam extended-release tablets are administered once daily.

  Treatment should be initiated with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended once daily dose of 3000 mg.

  2.1 Adult Patients With Impaired Renal Function

  Levetiracetam extended-release tablet dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group

  Creatinine Clearance (mL/min/1.73 m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  1000 to 3000

  Every 24 hours

  Mild

  50 to 80

  1000 to 2000

  Every 24 hours

  Moderate

  30 to 50

  500 to 1500

  Every 24 hours

  Severe

  < 30

  500 to 1000

  Every 24 hours

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  ---

  Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Nifedipine extended-release tablets are an extended-release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7 to 14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.

  If discontinuation of nifedipine extended-release tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

  Coadministration of nifedipine with grapefruit juice is to be avoided (see CLINICAL PHARMACOLOGY  and PRECAUTIONS).

  Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended-release dosage form has been prescribed.

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group
  Creatinine Clearance
  (mL/min/1.73 m2)
  Dosage (mg)
  Frequency
  Normal
  >80
  500 to 1,500
  Every 12 hours
  Mild
  50 to 80
  500 to 1,000
  Every 12 hours
  Moderate
  30 to 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 500
  Every 12 hours
  ESRD patients using dialysis
  -----
  500 to 1000*
  Every 24 hours*
  

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  ---

  Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients. In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period.

  The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions.

  Elderly Patients

  In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

  Psychotic Disorders

  Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level. Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients).

  Hospitalized Patients Acute Schizophrenic or Manic States

  It is recommended that initial treatment be with chlorpromazine HCl injection until patient is controlled. Usually patient becomes quiet and cooperative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods. In general, dosage levels should be lower in the elderly, the emaciated and the debilitated.

  Less Acutely Disturbed

  25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily.

  Outpatients

  10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.

  More Severe Cases

  25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semi-weekly intervals until patient becomes calm and cooperative.

  Prompt Control Of Severe Symptoms

  Initial treatment should be with intramuscular chlorpromazine. Subsequent doses should be oral, 25 to 50 mg t.i.d.

  Nausea and Vomiting

  10 to 25 mg q4 to 6h, p.r.n., increased, if necessary.

  Presurgical Apprehension

  25 to 50 mg, 2 to 3 hours before the operation.

  Intractable Hiccups

  25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral therapy is indicated.

  Acute Intermittent Porphyria

  25 to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients.

  Chlorpromazine should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving. It should not be used in conditions for which specific pediatric dosages have not been established.

  Severe Behavioral Problems Outpatients

  Select route of administration according to severity of patient's condition and increase dosage gradually as required. Oral: ¼ mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child – 10 mg q4 to 6h).

  Hospitalized Patients

  As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders higher dosages (50 to 100 mg daily and in older children, 200 mg daily or more) may be necessary. There is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced by doses beyond 500 mg per day.

  Nausea and Vomiting

  Dosage and frequency of administration should be adjusted according to the severity of the symptoms and response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary. Oral: ¼ mg/lb body weight (e.g., 40 lb child – 10 mg q4 to 6h).

  Presurgical Apprehension

  ¼ mg/lb body weight orally 2 to 3 hours before operation.

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group
  Creatinine Clearance
  (mL/min/1.73 m2)
  Dosage (mg)
  Frequency
  * Following dialysis, a 250 to 500 mg supplemental dose is recommended.

  Normal
  

  >80
  

  500 to 1,500
  

  Every 12 hours
  

  Mild
  

  50 to 80
  

  500 to 1,000
  

  Every 12 hours
  

  Moderate
  

  30 to 50
  

  250 to 750
  

  Every 12 hours
  

  Severe
  

  <30
  

  250 to 500
  

  Every 12 hours
  

  ESRD patients using dialysis
  

  -----
  

  500 to 1000*
  

  Every 24 hours*
  

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  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg and 3000 mg, given as twice daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

    

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

  Group

  Creatinine Clearance
  (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1500

  Every 12 hours

  Mild

  50 to 80

  500 to 1000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ---

  500 to 1000*

  Every 24 hours*

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  Levetiracetam | Pd-rx Pharmaceuticals, Inc.

  

  ---

  There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with Metformin HCl, USP or any other pharmacologic agent. Dosage of Metformin HCl, USP must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of Metformin HCl, USP is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age).

  Metformin HCl, USP should be given in divided doses with meals. Metformin HCl, USP should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

  During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to Metformin HCl, USP and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Metformin HCl, USP, either when used as monotherapy or in combination with sulfonylurea or insulin.

  Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

  Short-term administration of Metformin HCl, USP may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

  Recommended Dosing Schedule

  Adults - In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

  The usual starting dose of Metformin HCl Tablets, USP is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, Metformin HCl, USP may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.

  If higher doses of metformin are required, Metformin HCl, USP should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

  Pediatrics - The usual starting dose of Metformin HCl, USP is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

  Transfer From Other Antidiabetic Therapy

  When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to Metformin HCl, USP, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

  Concomitant Metformin HCl, USP and Oral Sulfonylurea Therapy in Adult Patients

  If patients have not responded to four weeks of the maximum dose of Metformin HCl, USP monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing Metformin HCl, USP at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).

  With concomitant Metformin HCl, USP and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on Metformin HCl, USP 500 mg and glyburide 20 mg were titrated to 1000/20 mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of Metformin HCl, USP and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant Metformin HCl, USP and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)

  If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of Metformin HCl, USP and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without Metformin HCl, USP.

  Concomitant Metformin HCl, USP and Insulin Therapy in Adult Patients

  The current insulin dose should be continued upon initiation of Metformin HCl, USP therapy. Metformin HCl, USP therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of Metformin HCl, USP should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for Metformin HCl, USP. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and Metformin HCl, USP. Further adjustment should be individualized based on glucose-lowering response.

  Specific Patient Populations

  Metformin HCl, USP is not recommended for use in pregnancy. Metformin HCl, USP is not recommended in patients below the age of 10 years.

  The initial and maintenance dosing of Metformin HCl, USP should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Metformin HCl, USP.

  Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)

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  Levetiracetam | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients 1 Month to < 6 Months

  Initiate treatment with a daily dose of 14 mg/kg in two divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to < 4 Years

  Initiate treatment with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

    

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

  Group

  Creatinine Clearance
  (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1500

  Every 12 hours

  Mild

  50 to 80

  500 to 1000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ---

  500 to 1000*

  Every 24 hours*

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  Levetiracetam | Aurobindo Pharma Limited

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
  
  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  
  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older
  

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  
  

  Pediatric Patients
  

  1 Month to < 6 Months

  
  

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).  In the clinical trial, the mean daily dose was 35 mg/kg in this age group.  The effectiveness of lower doses has not been studied.

  
  

  6 Months to <4 Years:

  
  

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).  Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  
  

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  
  

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  
  

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  
  

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  
  

                                                           Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) =   -------------------------------------------------------------

                                                                  100 mg/mL

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy
  

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures
  

  Adults 16 Years and Older
  
  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
  
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment
  

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)

  
  
  

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  
  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
     Normal
  > 80
  500 to 1,500
  Every 12 hours
     Mild
  50 – 80
  500 to 1,000
  Every 12 hours
     Moderate
  30 – 50
  250 to 750
  Every 12 hours
     Severe
  < 30
  250 to 500
  Every 12 hours
     ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  Levetiracetam | Bryant Ranch Prepack

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group
  Creatinine Clearance
  (mL/min/1.73 m2)
  Dosage (mg)
  Frequency
  * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal
  >80
  500 to 1,500
  Every 12 hours
  Mild
  50 to 80
  500 to 1,000
  Every 12 hours
  Moderate
  30 to 50
  250 to 750
  Every 12 hours
  Severe
  <30
  250 to 500
  Every 12 hours
  ESRD patients using dialysis
  -----
  500 to 1000*
  Every 24 hours*
  

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• Cardinal Health
  

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  Levetiracetam | Cardinal Health

  

  ---

  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg and 3000 mg, given as twice daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

  Group

  Creatinine Clearance
  (mL/min/1.73m2)

  Dosage (mg)

  Frequency

  Normal

  > 80

  500 to 1500

  Every 12 hours

  Mild

  50 to 80

  500 to 1000

  Every 12 hours

  Moderate

  30 to 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

  ---

  500 to 1000*

  Every 24 hours*

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  Levetiracetam | Citron Pharma Llc

  

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  Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed.
  
  Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.

  2.1 Mania
  

  Divalproex sodium delayed-release tablets are administered orally. The recommended initial dose is 750 mg daily in divided doses. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In placebo-controlled clinical trials of acute mania, patients were dosed to a clinical response with a trough plasma concentration between 50 and 125 mcg/mL. Maximum concentrations were generally achieved within 14 days. The maximum recommended dosage is 60 mg/kg/day.
  
  There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during divalproex sodium delayed-release tablets treatment of an acute manic episode. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium delayed-release tablets in such longer-term treatment. Although there are no efficacy data that specifically address longer-term antimanic treatment with divalproex sodium delayed-release tablets, the safety of divalproex sodium delayed-release tablets in long-term use is supported by data from record reviews involving approximately 360 patients treated with divalproex sodium delayed-release tablets for greater than 3 months.

  2.2 Epilepsy
  

  Divalproex sodium delayed-release tablets are administered orally. Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures. As the divalproex sodium delayed-release tablets dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see Drug Interactions (7.2)].
  
  Complex Partial Seizures
  
  For adults and children 10 years of age or older.
  
  Monotherapy (Initial Therapy)
  
  Divalproex sodium delayed-release tablets have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
  
  The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
  
  Conversion to Monotherapy
  
  Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
  
  Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of divalproex sodium delayed-release tablets therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.
  
  Adjunctive Therapy
  
  Divalproex sodium delayed-release tablets may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. If the total daily dose exceeds 250 mg, it should be given in divided doses.
  
  In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see Clinical Studies (14.2)]. However, since valproate may interact with these or other concurrently administered AEDs as well as other drugs, periodic plasma concentration determinations of concomitant AEDs are recommended during the early course of therapy [see Drug Interactions (7)].
  
  Simple and Complex Absence Seizures
  
  The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should be given in divided doses.
  
  A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect. However, therapeutic valproate serum concentrations for most patients with absence seizures is considered to range from 50 to 100 mcg/mL. Some patients may be controlled with lower or higher serum concentrations [see Clinical Pharmacology (12.3)].
  
  As the divalproex sodium delayed-release tablets dosage is titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see Drug Interactions (7.2)].
  
  Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
  
  In epileptic patients previously receiving valproic acid therapy, divalproex sodium delayed-release tablets should be initiated at the same daily dose and dosing schedule. After the patient is stabilized on divalproex sodium delayed-release tablets, a dosing schedule of two or three times a day may be elected in selected patients.

  2.3 Migraine
  

  Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches in adults.
  
  Divalproex sodium delayed-release tablets are administered orally. The recommended starting dose is 250 mg twice daily. Some patients may benefit from doses up to 1,000 mg/day. In the clinical trials, there was no evidence that higher doses led to greater efficacy.

  2.4 General Dosing Advice
  

  Dosing in Elderly Patients
  
  Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence. The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response [see Warnings and Precautions (5.14), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
  
  Dose-Related Adverse Reactions
  
  The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia) may be dose-related. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males) [see Warnings and Precautions (5.8)]. The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
  
  G.I. Irritation
  
  Patients who experience G.I. irritation may benefit from administration of the drug with food or by slowly building up the dose from an initial low level.

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 10: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient Weight Daily Dose Daily Dose Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1-40 kg 500 mg/day
  (1 x 250 mg
  tablet BID) 1000 mg/day
  (1 x 500 mg
  tablet BID) 1500 mg/day
  (1 x 750 mg
  tablet BID) >40 kg 1000 mg/day
  (1 x 500 mg
  tablet BID) 2000 mg/day
  (2 x 500 mg
  tablets BID) 3000 mg/day
  (2 x 750 mg
  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  
                                                            Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) = ———————————————————————
                                                            100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  
                         [140-age (years)] x weight (kg)
  CLcr = ————————————————— (x 0.85 for female patients)
                         72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended   Normal > 80 500 to 1,500 Every 12 h Mild 50 - 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 *Every 24 h

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  Levetiracetam | Tahitian Noni International Inc.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
  
  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  
  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older
  
  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
  
  Pediatric Patients
  
  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  
  4 Years to < 16 Years
  
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg.  The maximum daily dose was 3000 mg/day.
  
  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
  
  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
  
  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients
  
  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
  
                                                      Daily dose (mg/kg/day) x patient weight (kg)
  Total daily dose (mL/day) =   -----------------------------------------------------------
                                                                                      100 mg/mL

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy
  

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures
  

  Adults 16 Years and Older
  
  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
  
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment
  

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)

  
  
  

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  
  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
     Normal
  > 80
  500 to 1,500
  Every 12 hours
     Mild
  50 – 80
  500 to 1,000
  Every 12 hours
     Moderate
  30 – 50
  250 to 750
  Every 12 hours
     Severe
  < 30
  250 to 500
  Every 12 hours
     ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

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  Levetiracetam | State Of Florida Doh Central Pharmacy

  

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  Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonicoclonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient Weight Daily Dose 20 mg/kg/day
  (BID dosing) 40 mg/kg/day
  (BID dosing) 60 mg/kg/day
  (BID dosing) 20.1 to 40 kg 500 mg/day
  (1 × 250 mg tablet BID) 1000 mg/day
  (1 × 500 mg tablet BID) 1500 mg/day
  (1 × 750 mg tablet B ID) >40 kg 1000 mg/day
  (1 × 500 mg tablet BID) 2000 mg/day
  (2 × 500 mg tablets BID) 3000 mg/day
  (2 × 750 mg tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) × patient weight (kg) 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must be individualized according to the patient's renal function status.

  Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr = [140-age (years)] × weight (kg) (× 0.85 for female patients) 72 × serum creatinine (mg/dL) Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance
  (mL/min) Dosage
  (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal >80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe <30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 *Every 24 h

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  [see Indications and Usage (1) and Clinical Pharmacology (12.3)]

  2.1 Community-Acquired Pneumonia

  The recommended dose of ZITHROMAX for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

  2.2 Pelvic Inflammatory Disease

  The recommended dose of ZITHROMAX for injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

  2.3 Preparation of the Solution for Intravenous Administration

  The infusate concentration and rate of infusion for ZITHROMAX for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. ZITHROMAX for injection should not be given as a bolus or as an intramuscular injection.

  Reconstitution

  Prepare the initial solution of ZITHROMAX for injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial, and shaking the vial until all of the drug is dissolved. Since ZITHROMAX for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hr when stored below 30°C (86°F).

  Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.

  Dilute this solution further prior to administration as instructed below.

  Dilution

  To provide azithromycin over a concentration range of 1.0–2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:

  Normal Saline (0.9% sodium chloride)
  1/2 Normal Saline (0.45% sodium chloride)
  5% Dextrose in Water
  Lactated Ringer's Solution
  5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
  5% Dextrose in Lactated Ringer's Solution
  5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
  5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
  Normosol®-M in 5% Dextrose
  Normosol®-R in 5% Dextrose

  When used with the Vial-Mate® drug reconstitution device, please reference the Vial-Mate® instructions for assembly and reconstitution.

  Final Infusion Solution Concentration (mg/mL) Amount of Diluent (mL) 1.0 mg/mL 500 mL 2.0 mg/mL 250 mL

  Other intravenous substances, additives, or medications should not be added to ZITHROMAX for injection, or infused simultaneously through the same intravenous line.

  Storage

  When diluted according to the instructions (1.0 mg/mL to 2.0 mg/mL), ZITHROMAX for injection is stable for 24 hr at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).

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  Levetiracetam | Rite Aid

  

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  do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

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  Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1). For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1)

  Partial Onset Seizures

  1 Month to < 6 Months:  7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily (2.2) 6 Months to < 4 Years:  10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily (2.2) 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.2) Adults 16 Years and Older:  500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily (2.2)

  Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

  500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3)

  Primary Generalized Tonic-Clonic Seizures

  6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4) Adults 16 Years and Older:  500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.4)

  Adult Patients with Impaired Renal Function

  Dose adjustment is recommended, based on the patient’s estimated creatinine clearance (2.5, 8.6)

   

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
  
  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.  Prescribe the  oral solution or tablets for pediatric patients with body weight above 20 kg.
  
  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  
  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

   

  Adults 16 Years and Older
  

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients
  

  1 Month to < 6 Months

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).  In the clinical trial, the mean daily dose was 35 mg/kg in this age group.  The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).  Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                                           Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) =   -------------------------------------------------------------

                                                                  100 mg/mL

   

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

   

  Adults 16 Years and Older
  
  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
  
  Pediatric Patients Ages 6 to <16 Years
  
  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

   

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
  
                       [140-age (years)] x weight (kg)
  CLcr = ----------------------------------------------(x 0.85 for female patients)
                       72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:
  
                                                     CLcr (mL/min)
  CLcr (mL/min/1.73 m2) = -------------------------- x 1.73
                                                     BSA subject (m2)

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73 m2) Dosage
  (mg) Frequency    Normal
  > 80
  500 to 1,500
  Every 12 hours
     Mild
  50 – 80
  500 to 1,000
  Every 12 hours
     Moderate
  30 – 50
  250 to 750
  Every 12 hours
     Severe
  < 30
  250 to 500
  Every 12 hours
     ESRD patients using dialysis
  ----
  500 to 1,0001
  Every 24 hours1
  

   

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