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Felbamate

    Brands

    DEA Class;  Rx

    Common Brand Names; Felbatol

    • Anticonvulsants, Other

    Oral anticonvulsant agent chemically similar to meprobamate, but does not possess muscle-relaxant activity. Used for partial seizures in adults and Lennox-Gastaut syndrome in children and adults. Aplastic anemia and acute hepatic failure limit use to seizures refractory to other agents; close monitoring for emerging or worsening suicidal thoughts/behavior or depression is recommended.

    Indicated for the treatment of partial seizures with or without generalization in adults.

    For the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.

    Hypersensitivity to carbamates; history of blood dyscrasia, hepatic impairment

    Adjunctive therapy

    • Nausea (34.2%)
    • Vomiting (16.7%)
    • Constipation (11.4%)
    • Dyspepsia (12.3%)
    • Anorexia (19.3%)
    • Dyspepsia (12.3%)

    Lennox-Gastaut

    • Anorexia (55%)
    • Somnolence (48%)
    • URI (46-50%)
    • Vomiting (39%)
    • Nervousness (16-20%)
    • Insomnia (16.1%)
    • Purpura (11-15%)
    • Fever (22.6%)
    • Constipation (12.9%)

    Monotherapy

    • Acne (3.4%)
    • Anxiety (5.2%)
    • Constipation (6.9%)
    • Diarrhea (5.2%)
    • Diplopia (3.4%)
    • Dyspepsia (8.6%)
    • Face edema (3.4%)
    • Fatigue (6.9%)
    • Headache (6.9%)
    • Insomnia (8.6%)
    • Intramenstrual bleeding (3.4%)
    • Otitis media (3.4%)
    • Rash (3.4%)
    • Urinary tract infection (3.4%)
    • Vomiting (8.6%)

    Increased risk of suicidal behavior reported with anticonvulsant use; monitor patients for changes in behavior that might indicate suicidal behavior

    Associated with increased incidence of aplastic anemia and acute hepatic failure , use only when alternative therapy is unsuitable and benefits outweigh risks

    Use caution in renal impairment

    Not for use as first line therapy in epilepsy; for use when benefits outweigh risks

    Do not discontinue therapy abruptly

    Pregnancy Category: C

    Lactation: Excreted in milk; not recommended

    Adults

    3600 mg/day PO.

    Elderly

    3600 mg/day PO.

    Adolescents

    3600 mg/day PO.

    Children

    >= 2 years: 3600 mg/day PO.
    < 2 years: Safety and efficacy have not been established.

    Felbamate

    tablets

    • 400 mg
    • 600 mg

    oral suspension

    • 600 mg/5 mL