Tegretol (carbamazepine) - 2 indications

Scroll down for information on each indication:

• for the treatment of epilepsy; approved in 1968
• for the treatment of trigeminal neuralgia; approved in 1968
• extended release formulation for epilepsy and trigeminal neuralgia; approved March 1996 as Tegretol XR

General Information

Tegretol (carbamazepine) is an anticonvulsant and specific analgesic for trigeminal neuralgia. 

Tegretol/Tegretol-XR is specifically indicated for the following conditions:

• Epilepsy
  • Partial seizures with complex symptomatology (psychomotor, temporal lobe)
  • 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 Tegretol
• Pain associated with true trigeminal neuralgia

Tegretol XR was approved as a new formulation to allow patients to switch from three or four daily doses to a more convenient twice-daily regimen. 

Tegretol/Tegretol XR is supplied as an oral suspension, tablets and extended-release tablets. Scroll down to see the recommended dosing/administration for each indication.

Mechanism of Action

Tegretol (carbamazepine) has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Tegretol greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats. Tegretol is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.

Side Effects

Adverse effects associated with the use of Tegretol may include, but are not limited to, the following:

• dizziness
• drowsiness
• unsteadiness
• nausea
• vomiting

Indication 1 - for the treatment of epilepsy

approved in 1968; extended release formulation approved March 1996

Dosing/Administration

Adults and children over 12 years of age:

• Initial: Either 200 mg twice a day for tablets and XR tablets, or 1 teaspoon four times a day for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances.
• Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Children 6 to 12 years of age:

• Initial: Either 100 mg twice a day for tablets or XR tablets, or ½ teaspoon four times a day for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily.
• Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Children under 6 years of age:

• Initial: 10 to 20 mg/kg/day twice a day or three times a day as tablets, or four times a day as suspension. Increase weekly to achieve optimal clinical response administered three times a day or four times a day.
• Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Combination Therapy:

• Tegretol may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased

Clinical Trial Results

In controlled clinical trials, Tegretol has been shown to be effective in the treatment of psychomotor and grand mal seizures, as well as trigeminal neuralgia.

Indication 2 - for the treatment of trigeminal neuralgia

approved in 1968; extended release formulation approved March 1996

Dosing/Administration

Initial: On the first day, either 100 mg twice a day for tablets or XR tablets, or ½ teaspoon four times a day for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or XR tablets, or 50 mg (½ teaspoon) four times a day for suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily.

Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

Clinical Trial Results

In controlled clinical trials, Tegretol has been shown to be effective in the treatment of psychomotor and grand mal seizures, as well as trigeminal neuralgia.