carbamazepine 400 mg
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.
amneal pharmaceuticals ny llc
ROUND BROWN A 4
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HOW SUPPLIED
CARBAMAZEPINE extended-release tablets USP, 100 mg, are available as light yellow, round, biconvex coated tablets, imprinted “A” over “2” on both sides and a release portal on one of the sides*. They are supplied as follows: Bottles of 100 with child-resistant closure NDC 69238-1213-1
CARBAMAZEPINE extended-release tablets USP, 200 mg, are available as light pink, round, biconvex coated tablets, imprinted “A” over “3” on one side and a release portal on one of the sides*. They are supplied as follows: Bottles of 100 with child-resistant closure NDC 69238-1214-1
CARBAMAZEPINE extended-release tablets USP, 400 mg, are available as light brown, round, biconvex coated tablets, imprinted “A” over “4” on one side and a release portal on one of the sides*. They are supplied as follows: Bottles of 100 with child-resistant closure NDC 69238-1215-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP. *Print markings on the release portal side might be partially absent due to the orifice. Thorazine ® , Trileptal ® and Mellaril ® are the registered trademarks of their respective owners and are not trademarks of Amneal Pharmaceuticals LLC. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2023-01 Dispense with Medication Guide available at: documents.amneal.com/mg/
CARBAMAZEPINE-er-tablets.pdf
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