Tegretol-XR (Carbamazepine) - Indications and Dosage

INDICATIONS AND USAGE

EPILEPSY

Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:

1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
2. Generalized tonic-clonic seizures (grand mal).
3. 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 (see PRECAUTIONS, General).

TRIGEMINAL NEURALGIA

Tegretol is 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.

HOW SUPPLIED

Chewable Tablets 100 mg - round, red-speckled, pink, single-scored (imprinted Tegretol on one side and 52 twice on the scored side)

Bottles of 100.............................. NDC 0083-0052-30

Unit Dose (blister pack)

Box of 100 (strips of 10)............... NDC 0083-0052-32

Do not store above 30°C (86°F). Protect from light and moisture. Dispense in tight, light-resistant container (USP). Meets USP Dissolution Test 1.

Tablets 200 mg - capsule-shaped, pink, single-scored (imprinted Tegretol on one side and 27 twice on the partially scored side)

Bottles of 100................................ NDC 0083-0027-30

Bottles of 1000.............................. NDC 0083-0027-40

Unit Dose (blister pack)

Box of 100 (strips of 10)................ NDC 0083-0027-32

Do not store above 30°C (86°F). Protect from moisture. Dispense in tight container (USP). Meets USP Dissolution Test 2.

XR Tablets 100 mg - round, yellow, coated (imprinted T on one side and 100 mg on the other), release portal on one side

Bottles of 100................................. NDC 0083-0061-30

XR Tablets 200 mg - round, pink, coated (imprinted T on one side and 200 mg on the other), release portal on one side

Bottles of 100................................. NDC 0083-0062-30

XR Tablets 400 mg - round, brown, coated (imprinted T on one side and 400 mg on the other), release portal on one side

Bottles of 100................................. NDC 0083-0060-30

Store at controlled room temperature 15°C-30°C (59°F-86°F). Protect from moisture. Dispense in tight container (USP).

Suspension 100 mg/5 mL (teaspoon) - yellow-orange, citrus-vanilla flavored

Bottles of 450 mL........................... NDC 0083-0019-76

Shake well before using.

Do not store above 30°C (86°F). Dispense in tight, light-resistant container, (USP).

*Thorazine® is a registered trademark of GlaxoSmithKline.

Tegretol Chewable Tablets Manufactured by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

Tegretol Tablets Manufactured by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

Tegretol Suspension Manufactured by:

Patheon Inc.

Whitby Operations

Whitby Ontario, Canada

L1N 5Z5

Tegretol-XR Tablets Manufactured by:

Novartis Pharma GmbH

D-79664 Wehr, Germany

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

REV: SEPTEMBER 2003 2337-25-03A T2003-70

89007010

©Novartis