The FDA has approved Tegretol (carbamazepine) to help control certain types of seizures and to treat pain from trigeminal neuralgia, a condition that causes sudden, severe facial pain. For seizures, the drug works for partial seizures (also called psychomotor or temporal lobe seizures), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns that include these types. However, it does not control absence seizures (petit mal). For pain, Tegretol is specifically for true trigeminal neuralgia, and some patients with glossopharyngeal neuralgia have also benefited. This approval is based on studies that compared Tegretol to other active drugs. It is important to know that Tegretol is not a simple painkiller and should not be used for everyday aches or pains. Also, the liquid form of Tegretol should not be mixed with other liquid medicines or diluents because it can form a precipitate. If you or a loved one has one of these conditions, talk to your doctor about whether Tegretol might be a good treatment option. Your doctor can help you understand the benefits and risks based on your specific health needs.
FDA approved Tegretol (carbamazepine) for Epilepsy and Trigeminal NeuralgiaFDA approved Tegretol to treat seizures and nerve pain.
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The FDA has approved Tegretol (carbamazepine) for use as an anticonvulsant drug and for the treatment of pain associated with true trigeminal neuralgia. The approval covers partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns that include these or other partial or generalized seizures. Evidence supporting efficacy came from active drug-controlled studies. Notably, absence seizures (petit mal) do not appear to be controlled by Tegretol. For trigeminal neuralgia, beneficial results have also been reported in glossopharyngeal neuralgia. The drug is not a simple analgesic and should not be used for trivial aches or pains. Clinicians should note that Tegretol suspension should not be administered simultaneously with other liquid medications or diluents due to potential precipitate formation.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Tegretol is indicated for use as an anticonvulsant drug in patients with partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns which include these or other partial or generalized seizures. It is also indicated for the treatment of pain associated with true trigeminal neuralgia. Absence seizures (petit mal) are not controlled by Tegretol.
For epilepsy in adults and children over 12 years: initial 200 mg twice daily (tablets or XR) or 1 teaspoon four times daily (suspension) (400 mg/day). Increase weekly by up to 200 mg/day. Maintenance: 800-1200 mg daily. For children 6-12 years: initial 100 mg twice daily or ½ teaspoon four times daily (200 mg/day). Increase weekly by up to 100 mg/day. Maintenance: 400-800 mg daily. For children under 6 years: initial 10-20 mg/kg/day. Maintenance: optimal response at doses below 35 mg/kg/day. For trigeminal neuralgia: initial 100 mg twice daily or ½ teaspoon four times daily (200 mg/day). Increase by up to 200 mg/day as needed. Maintenance: 400-800 mg daily. Do not exceed 1200 mg daily. Tegretol-XR tablets must be swallowed whole and never crushed or chewed. Tegretol suspension should not be administered simultaneously with other liquid medications or diluents.
Trial data not available in label.
Not reported in label.
Tegretol may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased.
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