Carbamazepine ER capsules
CARBATROL
What it isExtended-release sodium-channel-blocking anticonvulsant; focal and tonic-clonic seizures and trigeminal neuralgia.
Why this oneIts capsule contains mixed-release beads and can be opened and sprinkled, unlike many extended-release tablets.
What limits itAutoinduction and broad enzyme induction create major interactions; hyponatremia, cytopenias, serious rash, and teratogenicity require vigilance.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Epilepsy (partial with complex symptomatology, generalized tonic-clonic, mixed seizure patterns) | Adults & children >12 yr | 200 mg BID | 800–1200 mg/day | 1200 mg/day (>15 yr); 1000 mg/day (12–15 yr) |
| Epilepsy | Children <12 yr (converted from immediate-release at same total daily dose) | Same total daily dose as IR, given BID | <35 mg/kg/day | 35 mg/kg/day |
| Trigeminal neuralgia | Adults | 200 mg on Day 1, increase by <=200 mg/day every 12 h PRN | 400–800 mg/day | 1200 mg/day |
Titration Epilepsy: increase at weekly intervals; trigeminal neuralgia: increase every 12 hours as needed
Renal Undefined
Hepatic Undefined
Extended-release capsule for twice-daily administration
Instructions
- Twice-daily extended-release capsule; take with or without food
- Swallow whole, or open and sprinkle all beads on soft food (e.g., applesauce); do not crush or chew
- When converting from immediate-release, keep the same total daily mg dose
- Do not abruptly discontinue (risk of seizures/status epilepticus) — taper
- Screen for HLA-B*1502 before treatment in at-risk (Asian-ancestry) patients
Contraindications
- History of bone marrow depression
- Sensitivity to tricyclic compounds (e.g., amitriptyline, imipramine, nortriptyline)
- Use with monoamine oxidase inhibitors (label: discontinue MAOI >=14 days before)
- Coadministration with nefazodone (subtherapeutic nefazodone levels)
- Coadministration with delavirdine (loss of virologic response)
Cautions
- Serious dermatologic reactions (SJS/TEN) and HLA-B*1502
- Aplastic anemia and agranulocytosis
- Hepatic effects including vanishing bile duct syndrome
- Hypersensitivity/DRESS, anaphylaxis, angioedema
- Do not use with other carbamazepine-containing products
Adverse reactions
- Dizziness
- Drowsiness
- Unsteadiness
- Nausea/vomiting
- Serious: aplastic anemia, agranulocytosis, SJS/TEN
Pregnancy Can cause fetal harm; associated with congenital malformations including spina bifida; monotherapy preferable if therapy is continued.
Lactation Undefined
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Carbamazepine ER capsules ballicule
