FELBAMATE

Other

Brand names: Felbamate

Pregnancy: Category COral

Mechanism of Action

Mechanism of Action The mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Felbamate is effective in mice and rats in the maximal electroshock test, the subcutaneous pentylenetetrazol seizure test, and the subcutaneous picrotoxin seizure test. Felbamate also exhibits anticonvulsant activity against seizures induced by intracerebroventricular administration of glutamate in rats and N-methyl-D,L-aspartic acid in mice. Protection against maximal electroshock-induced seizures suggests that felbamate may reduce seizure spread, an effect possibly predictive of efficacy in generalized tonic-clonic or partial seizures. Protection against pentylenetetrazol-induced seizures suggests that felbamate may increase seizure threshold, an effect considered to be predictive of potential efficacy in absence seizures. Receptor-binding studi

Indications

INDICATIONS AND USAGE Felbamate oral suspension

and has provided written acknowledgement

felbamate 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.

Contraindications

• CONTRAINDICATIONS Felbamate oral suspension
• USP is contraindicated in patients with known hypersensitivity to felbamate oral suspension
• 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.

FDA Warnings

ACCORDINGLY, FELBAMATE ORAL SUSPENSION SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS )
THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST
THERE ARE TOO FEW FELBAMATE ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME'S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK
ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBAMATE ORAL SUSPENSION REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Drowsiness

1-10%

Condition Worsened

1-10%

Fatigue

1-10%

Vomiting

0.1-1%

Falls

0.1-1%

Diarrhea

0.1-1%

Weight Loss

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral