felbamate 400 MG Oral Tablet

INDICATIONS AND USAGE Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are 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 tablets, USP 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.

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] pain` `[3] fatigue` `[4] off label use` `[5] nausea` `[6] arthralgia` `[7] rheumatoid arthritis` `[8] headache` `[9] toxicity to various agents` `[10] diarrhoea`

4 years ago

OVAL YELLOW AN 734

HOW SUPPLIED

FELBAMATE Tablets, USP, 400 mg , are yellow, oval shaped, biconvex tablets, with a bisect on one side and “AN 734” on the other side. They are available as follows: Bottles of 30 count: NDC 65162-734-03 Bottles of 90 count: NDC 65162-734-09 Bottles of 270 count: NDC 65162-734-27 Bottles of 500 count: NDC 65162-734-50

FELBAMATE Tablets, USP, 600 mg , are peach, oval shaped, biconvex tablets, with a bisect on one side and “AN 735” on the other side. They are available as follows: Bottles of 30 count: NDC 65162-735-03 Bottles of 90 count: NDC 65162-735-09 Bottles of 180 count: NDC 65162-735-18 Bottles of 270 count: NDC 65162-735-27 Bottles of 500 count: NDC 65162-735-50 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Amneal Pharmaceuticals LLC

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