12 HR Carbamazepine 100 MG Extended Release Oral Capsule
INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release capsules are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine 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 improvements 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 (see PRECAUTIONS, General ). Trigeminal Neuralgia Carbamazepine extended-release capsules 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.
apotex corp.
CAPSULE BLUE APO C100
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HOW SUPPLIED
CARBAMAZEPINE extended-release capsules 100 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C100” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2805-3) Bottles of 120s (NDC 60505-2805-7) Bottles of 1000s (NDC 60505-2805-8)
CARBAMAZEPINE extended-release capsules 200 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C200” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2806-3) Bottles of 120s (NDC 60505-2806-7) Bottles of 1000s (NDC 60505-2806-8)
CARBAMAZEPINE extended-release capsules 300 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C300” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2807-3) Bottles of 120s (NDC 60505-2807-7) Bottles of 500s (NDC 60505-2807-5) Store at 20˚C to 25°C (68˚F to 77°F); excursions permitted to 15˚C to 30°C (59˚F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp APOTEX INC.
CARBAMAZEPINE EXTENDED-RELEASE capsuleS 100 mg, 200 mg and 300 mg Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida USA 33326 Rev. 11
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