Felbamate

Indications

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 (summary)

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.

Contraindications

CONTRAINDICATIONS Felbamate oral suspension is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.

Warnings and precautions

WARNINGS See Boxed Warning regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs) including felbamate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Storage and supply

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) . Dispense in a tight container.

Source: Felbamate (Felbamate) — US FDA prescribing information, 2024-10-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.