topiramate 50 MG Oral Tablet
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.
Glenmark Generics Inc., USA
ROUND YELLOW G 50
G 50 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Tablets, USP are available as circular, biconvex, film-coated tablets in the following strengths and colors: 25 mg white tablets with ‘G’ engraved on one side and ‘25’ on the other side. Bottles of 60 count with desiccant (NDC 68462-108-60) Bottles of 500 count with desiccant (NDC 68462-108-05) Bottles of 1000 count with desiccant (NDC 68462-108-10) 50 mg yellow tablets with ‘G’ engraved on one side and ‘50’ on the other side. Bottles of 60 count with desiccant (NDC 68462-153-60) Bottles of 500 count with desiccant (NDC 68462-153-05) Bottles of 1000 count with desiccant (NDC 68462-153-10) 100 mg yellow tablets with ‘G’ engraved on one side and ‘100’ on the other side. Bottles of 60 count with desiccant (NDC 68462-109-60) Bottles of 500 count with desiccant (NDC 68462-109-05) Bottles of 1000 count with desiccant (NDC 68462-109-10) 200 mg pink tablets with ‘G’ engraved on one side and ‘200’ on the other side. Bottles of 60 count with desiccant (NDC 68462-110-60) Bottles of 500 count with desiccant (NDC 68462-110-05) Bottles of 1000 count with desiccant (NDC 68462-110-10) 16.2 Storage and Handling
TOPIRAMATE tablets should be stored in tightly-closed containers at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
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