Classes
DEA Class; Rx
Common Brand Names; Felbatol
- Anticonvulsants, Other
Description
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.
Indications
Indicated for the treatment of partial seizures with or without generalization in adults.
Contraindications
Hypersensitivity to carbamates; history of blood dyscrasia, hepatic impairment
Adverse Effects
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%)
Warnings
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 and Lactation
Pregnancy Category: C
Lactation: Excreted in milk; not recommended
Maximum Dosage
3600 mg/day PO.
3600 mg/day PO.
3600 mg/day PO.
>= 2 years: 3600 mg/day PO.
< 2 years: Safety and efficacy have not been established.
How supplied
Felbamate
tablets
- 400 mg
- 600 mg
oral suspension
- 600 mg/5 mL