Monograph Details
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Central Nervous System
> Seizure disorders
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FELBATOL |
| Manufacturer |
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Meda Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Carbamate. |
| Generic Name |
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Felbamate 400mg, 600mg; scored tabs. |
| Also |
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• FELBATOL SUSPENSION
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| Indications |
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Not a first-line treatment. Partial seizures with or without generalization in adults. Adjunct in Lennox-Gastaut syndrome in children. |
| Children |
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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 literature). |
| Adults |
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See literature. ≥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 literature). Renal dysfunction: reduce initial and maintenance dose by one-half. |
| Contraindications |
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History of hepatic dysfunction or blood dyscrasias. |
| Precautions |
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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 |
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Increases serum levels of phenytoin, valproate, carbamazepine metabolite. Decreases carbamazepine levels. Serum levels decreased by phenytoin, carbamazepine. |
| Adverse Reactions |
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Anorexia, vomiting, insomnia, nausea, headache; rare: primary hepatotoxicity, aplastic anemia. |
| How Supplied |
Tabs—100
Susp—4oz, 8oz, 32oz |
| Additional Resources |
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• Related Prescribing Note |
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