topiramate 25 mg
1. Indications and Usage 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: 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 30 NDC:80425-0195-01 Bottles of 60 NDC:80425-0195-02 Bottles of 90 NDC:80425-0195-03 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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