Generic Name and Formulations:
Felbamate 400mg, 600mg; scored tabs.
Mylan Specialty L.P.
Indications for FELBATOL:
Not a first-line treatment. Partial seizures with or without generalization in adults. Adjunct in Lennox-Gastaut syndrome in children.
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.
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).
History of hepatic dysfunction or blood dyscrasias.
Aplastic anemia. Hepatic failure.
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.
Increases serum levels of phenytoin, valproate, carbamazepine metabolite. Decreases carbamazepine levels. Serum levels decreased by phenytoin, carbamazepine.
Anorexia, vomiting, insomnia, nausea, headache; rare: primary hepatotoxicity, aplastic anemia.
Tabs—100; Susp—4oz, 8oz, 32oz
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