Drug Catalog - Product Detail
FELBAMATE ORAL SUSPENSION SUSP 600MG/5ML 240ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0686-88 | AMNEAL PHARMACEUTICALS | 240 | 600MG/5ML | SUSPENSION |
PACKAGE FILES
Generic Name
FELBAMATE
Substance Name
FELBAMATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202385
Description
DESCRIPTION Felbamate, USP is an antiepileptic available as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate, USP molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for felbamate oral suspension, USP 600 mg/5 mL are bubble gum flavor, carboxymethyl cellulose sodium, FD&C Yellow No. 6, FD&C Red No. 40, glycerin, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, purified water, saccharin sodium, simethicone, and sorbitol. 8e2ca93c-figure-01
How Supplied
HOW SUPPLIED Felbamate Oral Suspension, USP, 600 mg/5 mL , is a pink-colored bubble gum flavored suspension; available in 8 oz bottles (NDC 65162-686-88) and 16 oz bottles (NDC 65162-686-90). Shake suspension well before using. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2017-03
Indications & Usage
INDICATIONS AND USAGE Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Dosage and Administration
DOSAGE AND ADMINISTRATION Felbamate oral suspension has been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As felbamate oral suspension is added to or substituted for existing AEDs, it is strongly recommended to reduce the dosage of those AEDs in the range of 20% to 33% to minimize side effects (see Drug Interactions subsection). Dosage Adjustment in the Renally Impaired: Felbamate should be used with caution in patients with renal dysfunction. In the renally impaired, starting and maintenance doses should be reduced by one-half (see CLINICAL PHARMACOLOGY / Pharmacokinetics and PRECAUTIONS ). Adjunctive therapy with medications which affect felbamate plasma concentrations, especially AEDs, may warrant further reductions in felbamate daily doses in patients with renal dysfunction. Adults (14 years of age and over) The majority of patients received 3600 mg/day in clinical trials evaluating its use as both monotherapy and adjunctive therapy. Monotherapy: (Initial therapy) Felbamate oral suspension has not been systematically evaluated as initial monotherapy. Initiate felbamate oral suspension at 1200 mg/day in divided doses three or four times daily. The prescriber is advised to titrate previously untreated patients under close clinical supervision, increasing the dosage in 600-mg increments every 2 weeks to 2400 mg/day based on clinical response and thereafter to 3600 mg/day if clinically indicated. Conversion to Monotherapy: Initiate felbamate oral suspension at 1200 mg/day in divided doses three or four times daily. Reduce the dosage of concomitant AEDs by one-third at initiation of felbamate oral suspension therapy. At week 2, increase the felbamate oral suspension dosage to 2400 mg/day while reducing the dosage of other AEDs up to an additional one-third of their original dosage. At week 3, increase the felbamate oral suspension dosage up to 3600 mg/day and continue to reduce the dosage of other AEDs as clinically indicated. Adjunctive Therapy: Felbamate oral suspension should be added at 1200 mg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma concentrations of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate oral suspension by 1200 mg/day increments at weekly intervals to 3600 mg/day. Most side effects seen during felbamate oral suspension adjunctive therapy resolve as the dosage of concomitant AEDs is decreased. Table 6 Dosage Table (adults) Dosage reduction of concomitant AEDs WEEK 1 REDUCE original dose by 20% to 33%* WEEK 2 REDUCE original dose by up to an additional 1/3* WEEK 3 REDUCE as clinically indicated Felbamate Oral Suspension Dosage 1200 mg/day Initial dose 2400 mg/day Therapeutic dosage range 3600 mg/day Therapeutic dosage range *See Adjunctive and Conversion to Monotherapy sections. While the above felbamate oral suspension conversion guidelines may result in a felbamate oral suspension 3600 mg/day dose within 3 weeks, in some patients titration to a 3600 mg/day felbamate oral suspension, USP dose has been achieved in as little as 3 days with appropriate adjustment of other AEDs. Children with Lennox-Gastaut Syndrome (Ages 2 to 14 years) Adjunctive Therapy: Felbamate oral suspension should be added at 15 mg/kg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma levels of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate oral suspension by 15 mg/kg/day increments at weekly intervals to 45 mg/kg/day. Most side effects seen during felbamate oral suspension adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.