Carbamazepine

What it is and how it works

Mechanism class: Cytochrome P450 3A4 Inducers · Cytochrome P450 1A2 Inducers · Cytochrome P450 2B6 Inducers

Indications

INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release capsules are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ). Trigeminal Neuralgia Carbamazepine extended-release capsules are indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests ). Dosage should be adjusted to the needs of the individual patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Carbamazepine extended-release capsules may be taken with or without food. Carbamazepine extended-release capsules may be swallowed whole or may be opened and all the beads sprinkled on a teaspoon of soft food such as applesauce. Make sure all of the food and medicine mixture is swallowed.

Contraindications

CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended.

Warnings and precautions

WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine extended-release capsules should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related.

Pregnancy

Usage in Pregnancy (See WARNINGS )

Storage and supply

HOW SUPPLIED Carbamazepine extended-release capsules 200 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C200” in black ink with white to off-white granule fill. They are supplied as follows: NDC: 71335-3002-1: 120 Capsules in a BOTTLE Store at 20˚C to 25°C (68˚F to 77°F).

Source: Carbamazepine (Carbamazepine) — US FDA prescribing information, 2025-11-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.