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FELBATOL
Seizure disorders
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Drug Name:

FELBATOL Rx

Generic Name and Formulations:
Felbamate 400mg, 600mg; scored tabs.

Company:
Mylan Specialty L.P.

Therapeutic Use:

Indications for FELBATOL:

Not a first-line treatment. Partial seizures with or without generalization in adults. Adjunct in Lennox-Gastaut syndrome in children.

Adult:

See full labeling. ≥14yrs: initial monotherapy: 1.2g/day in 3–4 divided doses, increase by 600mg every 2 weeks to 2.4g/day and up to 3.6g/day if needed. Conversion to monotherapy/adjunctive therapy: 1.2g/day in 3–4 divided doses, increase to 2.4g/day at week 2, and to 3.6g/day at week 3. Dosages of concomitant anticonvulsant drugs should be reduced upon the initiation of felbamate therapy and weekly thereafter (see full labeling). Renal dysfunction: reduce initial and maintenance dose by ½.

Children:

Lennox-Gastaut: ≥2yrs: 15mg/kg per day in 3–4 divided doses, increase dose by 15mg/kg per day at 1 week intervals to 45mg/kg per day. Dose of concomitant anticonvulsant drug should be reduced upon the initiation of felbamate therapy (see full labeling).

Contraindications:

History of hepatic dysfunction or blood dyscrasias.

Warnings/Precautions:

Increased risk of aplastic anemia or hepatic failure. Do full baseline hematologic evaluations and hepatic function tests before, during, and after therapy; discontinue if hepatic tests are abnormal or bone marrow depression occurs; consult hematologist if hematological abnormalities occur. Suicidal tendencies (monitor). Adjust dose of and monitor other anticonvulsants. Avoid abrupt cessation. Obtain written informed consent. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Increases serum levels of phenytoin, valproate, carbamazepine metabolite. Decreases carbamazepine levels. Serum levels decreased by phenytoin, carbamazepine.

See Also:

FELBATOL SUSPENSION

Pharmacological Class:

Carbamate.

Adverse Reactions:

Anorexia, vomiting, insomnia, nausea, headache; rare: primary hepatotoxicity, aplastic anemia.

Generic Availability:

YES

How Supplied:

Tabs—100; Susp—4oz, 8oz, 32oz

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