topiramate 50 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.
ROUND WHITE 116 U
116 U ROUND WHITE
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topiramate 50 mg
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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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