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Drug Catalog - Product Detail

LEVETIRACETAM TB 500MG 120

NDC Mfr Size Str Form
43547-0222-15 SOLCO HEALTHCARE 120 500MG TABLET
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Description
11 DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (pink), 500 mg (pink), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc, and additional agents listed below: 250 mg, 500 mg, and 750 mg tablets: Opadry II Pink 40L94198, which contains D&C Red No.27; FD&C Blue No.2; FD&C Red No. 40; FD&C Yellow No. 6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin. 1000 mg tablets: Opadry II white Y-22-7719, which contains hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin. USP dissolution test is pending. Levetiracetam Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Levetiracetam tablets, USP, 250 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and "221" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-221-15). Levetiracetam tablets, USP, 500 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and"222" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-222-15), and 1,000 tablets (NDC 43547-222-11). Levetiracetam tablets, USP, 750 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and"223" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-223-15). Levetiracetam tablets, USP, 1000 mg are white to off-white, modified capsules shaped, bi-convex, scored film-coated tablets, debossed "SLC" and"224" on either side of the score and plain on the other side. They are supplied in containers of 60 tablets (NDC 43547-224-06). 16.2 Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Levetiracetam is indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients one month of age and older with epilepsy ( 1.1 ) Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) 1.1 Partial Onset Seizures Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic 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. 1.3 Primary Generalized Tonic-Clonic Seizures 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.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 ) 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 Group Creatinine Clearance (mL/min/1.73m 2 ) 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 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Every 24 hours Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3