FDA approved Tegretol-XR (carbamazepine) Extended-Release for Epilepsy and Trigeminal NeuralgiaFDA approved Tegretol-XR for seizures and nerve pain.

Not reported in label.

Tegretol is indicated for use as an anticonvulsant in patients with partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns including these or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol. It is also indicated for the treatment of pain associated with true trigeminal neuralgia; beneficial results have been reported in glossopharyngeal neuralgia. The drug is not a simple analgesic and should not be used for trivial aches or pains.

Tegretol-XR is an extended-release formulation for twice a day administration. When converting from conventional tablets to Tegretol-XR, the same total daily mg dose should be used. Tablets must be swallowed whole and never crushed or chewed. Inspect for chips or cracks; damaged tablets or tablets without a release portal should not be consumed. The tablet coating is not absorbed and is excreted in feces; coatings may be noticeable in stool. For epilepsy in adults and children over 12 years: initial 200 mg twice a day, increase weekly by up to 200 mg/day using a twice a day regimen. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years and 1200 mg daily in patients above 15 years; up to 1600 mg daily used rarely in adults. Maintenance: 800 to 1200 mg daily. For children 6 to 12 years: initial 100 mg twice a day, increase weekly by up to 100 mg/day; generally not exceed 1000 mg daily. Maintenance: 400 to 800 mg daily. For children under 6 years: initial 10 to 20 mg/kg/day twice a day; increase weekly; optimal response at doses below 35 mg/kg. For trigeminal neuralgia: initial 100 mg twice a day on first day, increase by up to 200 mg/day as needed; do not exceed 1200 mg daily. Maintenance: 400 to 800 mg daily; some patients may require as little as 200 mg or as much as 1200 mg daily. Attempt dose reduction every 3 months.

Trial data not available in label.

Not reported in label.

Tegretol-XR provides a twice-daily extended-release option for patients requiring carbamazepine for epilepsy or trigeminal neuralgia. It may improve adherence compared to more frequent dosing regimens. However, absence seizures are not controlled by Tegretol. The drug is not a simple analgesic and should not be used for trivial pain.