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.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE tablets ,USP
TOPIRAMATE tablets, USP are available in the following strengths and colors: 25 mg, white colored, circular, biconvex film-coated tablets, debossed with "122" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-122-03) Bottles of 500's (NDC 69097-122-12) Bottles of 1000's (NDC 69097-122-15) 50 mg, Light orange colored, circular, biconvex, film-coated tablets, debossed with "123" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-123-03) Bottles of 500's (NDC 69097-123-12) Bottles of 1000's (NDC 69097-123-15) 100 mg, orange colored, circular, biconvex, film-coated tablets, debossed with "124" on one side and "Cipla" on the other side and are available in Bottles of 60's (NDC 69097-124-03) Bottles of 500's (NDC 69097-124-12) Bottles of 1000's (NDC 69097-124-15) 200 mg, pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "125" on one side and "Cipla" on other side and are available in Bottles of 60's (NDC 69097-125-03) Bottles of 500's (NDC 69097-125-12) Bottles of 1000's (NDC 69097-125-15) PHARMACIST: Dispense in a tight container as defined in the USP. Use child-resistant closure (as required). 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.
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