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Felbatol Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Felbamate 600mg/5mL.
Pharmacological Class
Carbamate.
See Also
How Supplied
Tabs—100; Susp—4oz, 8oz, 32oz
Manufacturer
Generic Availability
YES
Felbatol Suspension Indications
Indications
Not a first-line treatment. Partial seizures with or without generalization in adults. Adjunct in Lennox-Gastaut syndrome in children.
Felbatol Suspension Dosage and Administration
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).
Felbatol Suspension Contraindications
Contraindications
History of hepatic dysfunction or blood dyscrasias.
Felbatol Suspension Boxed Warnings
Boxed Warning
Aplastic anemia. Hepatic failure.
Felbatol Suspension Warnings/Precautions
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.
Felbatol Suspension Pharmacokinetics
See Literature
Felbatol Suspension Interactions
Interactions
Increases serum levels of phenytoin, valproate, carbamazepine metabolite. Decreases carbamazepine levels. Serum levels decreased by phenytoin, carbamazepine.
Felbatol Suspension Adverse Reactions
Adverse Reactions
Anorexia, vomiting, insomnia, nausea, headache; rare: primary hepatotoxicity, aplastic anemia.
Felbatol Suspension Clinical Trials
See Literature
Felbatol Suspension Note
Not Applicable
Felbatol Suspension Patient Counseling
See Literature
