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topiramate 25 mg

1 INDICATIONS AND USAGE Topiramate tablets are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.

Unichem Pharmaceuticals (USA), Inc.


4 years ago ROUND YELLOW U 115 topiramate 25 mg

ROUND YELLOW U 115

4 years ago ROUND YELLOW U 115 topiramate 25 mg

U 115 ROUND YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied.

TOPIRAMATE Tablets, USP are available as: 25 mg Tablet: Light yellow, round, biconvex, film-coated tablets with 'U' debossed on one side and '115' debossed on other side. Bottles of 60: NDC 29300-115-16 Bottles of 100: NDC 29300-115-01 Bottles of 500: NDC 29300-115-05 Bottles of 1,000: NDC 29300-115-10 50 mg Tablet: white to off-white, round, bevel edged, biconvex, film-coated tablets with 'U' debossed on one side and '116' debossed on other side. Bottles of 60: NDC 29300-116-16 Bottles of 100: NDC 29300-116-01 Bottles of 500: NDC 29300-116-05 Bottles of 1,000: NDC 29300-116-10 100 mg Tablet: salmon, round, bevel edged, biconvex, film-coated tablets with 'U' debossed on one side and '117' debossed on other side. Bottles of 60: NDC 29300-117-16 Bottles of 100: NDC 29300-117-01 Bottles of 500: NDC 29300-117-05 Bottles of 1,000: NDC 29300-117-10 200 mg Tablet: yellow, round, bevel edged, biconvex, film-coated tablets with 'U' debossed on one side and '118' debossed on other side. Bottles of 60: NDC 29300-118-16 Bottles of 100: NDC 29300-118-01 Bottles of 500: NDC 29300-118-05 Bottles of 1,000: NDC 29300-118-10 16.2 Storage and Handling. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.


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