Avenoc

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• Laboratoires Boiron
  

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  Avenoc | Laboratoires Boiron

  

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  Adults 21 years of age and older: If you are taking this medicine to relieve a hangover, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved, or as directed by a doctor.
  Adults and children 12 years of age and older: If you are taking this medicine to relieve an upset stomach, nausea, or heartburn, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved, or as directed by a doctor.
  

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• Laboratoires Boiron
  

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  Avenoc | Boca Pharmacal, Llc

  

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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 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

  Information describing the use of levetiracetam tablets 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 3,000 mg/day.

  For Levetiracetam tablets, 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 1,500 mg (750 mg twice daily).

  For Levetiracetam tablets, USP 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 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 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 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:

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

  Table 1: Dosing Adjustment Regimen For Adult Patients With Renal Impairment  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 1,0001 Every 24 hours1

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

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