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.
Cipla USA Inc.
ROUND ORANGE 123 C
123 C ROUND ORANGE
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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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