Lotus Pharmaceutical Co., Ltd. Nantou Plant

Lotus Pharmaceutical Co., Ltd. Nantou Plant Drugs

• Levetiracetam
  

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  Levetiracetam

  

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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 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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  Manefit Bling Bling Wrinkle Gold Hydro Gel Mask

  

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  Women 17 years of age or older: take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

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