felbamate 400 MG Oral Tablet
INDICATIONS AND USAGE Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see WARNINGS ). Felbamate tablets 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 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.
alvogen inc.
OVAL WHITE FE 400 ALV550
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HOW SUPPLIED
FELBAMATE Tablets, USP contain 400 mg or 600 mg of
FELBAMATE, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, bisected tablet “FE 400” debossed on bisect side (upper) and “ALV550” on opposite side (bottom) of the tablet. They are available as follows: NDC 47781-627-01 bottles of 100 tablets The 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, bisected tablet “FE 600” debossed on bisect side (upper) and “ALV551” on opposite side (bottom) of the tablet. They are available as follows: NDC 47781-630-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . PI267-00 Rev. 08/2018
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