12 HR Carbamazepine 400 MG Extended Release Oral Tablet

INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets 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 improvement 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 extended-release tablets (see PRECAUTIONS, General ). Trigeminal Neuralgia Carbamazepine extended-release tablets 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.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] dyspnoea` `[3] toxicity to various agents` `[4] off label use` `[5] gynaecomastia` `[6] completed suicide` `[7] fatigue` `[8] nausea` `[9] drug abuse` `[10] drug interaction`

4 years ago

ROUND WHITE 557

HOW SUPPLIED

CARBAMAZEPINE Extended-release Tablets, USP 100 mg are white to off white colored, round shaped, beveled edge, biconvex, coated tablets with release portal on one side and imprinted with '555' with black ink on any one side of the tablet and are supplied as follows: NDC 68382-555-06 in bottles of 30 tablets NDC 68382-555-16 in bottles of 90 tablets NDC 68382-555-01 in bottles of 100 tablets NDC 68382-555-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

CARBAMAZEPINE Extended-release Tablets, USP 200 mg are white to off white colored, round shaped, beveled edge, biconvex, coated tablets with release portal on one side and imprinted with '556' with black ink on any one side of the tablet and are supplied as follows: NDC 68382-556-06 in bottles of 30 tablets NDC 68382-556-16 in bottles of 90 tablets NDC 68382-556-01 in bottles of 100 tablets NDC 68382-556-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

CARBAMAZEPINE Extended-release Tablets, USP 400 mg are white to off white colored, round shaped, beveled edge, biconvex, coated tablets with release portal on one side and imprinted with '557' with black ink on any one side of the tablet and are supplied as follows: NDC 68382-557-06 in bottles of 30 tablets NDC 68382-557-16 in bottles of 90 tablets NDC 68382-557-01 in bottles of 100 tablets NDC 68382-557-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Protect from moisture. Dispense in a tight container (USP). *Trademarks are the property of their respective owners. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals ( USA) Inc. Pennington, NJ 08534 Rev.: 02/24

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