Restil 40 Number 9

Restil 40 Number 9 Manufacturers

• Paramesh Banerji Life Sciences Llc
  

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  Restil 40 Number 9 | Fresenius Kabi Usa, Llc

  

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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 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.

  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-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.

  2.3 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-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 (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 injection 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 for adults to achieve a dose 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 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 weight (kg)
  100 mg/mL
  2.7 Dosage Adjustments in Adult Patients with Renal Impairment

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

  Table 2:  Dosage 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 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.

  2.8 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 20° to 25°C (68° to 77°F) [see USP].

  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.

  2.1 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.

  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-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 Switching from Oral Dosing

  When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam injection 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 for adults to achieve a dose 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 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 weight (kg)
  100 mg/mL
  2.7 Dosage Adjustments in Adult Patients with Renal Impairment

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

  Table 2:  Dosage 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 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.

  2.8 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 20° to 25°C (68° to 77°F) [see USP].

  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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