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.
camber pharmaceuticals, inc.
ROUND YELLOW T 50
T 50 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Tablets
TOPIRAMATE tablets, USP are available in the following strengths and colors: 25 mg tablets: cream colored, round biconvex tablets debossed with ‘T’ on one side and ‘25’ on the other side. Bottles of 60’s NDC 31722-181-60 Bottles of 500’s NDC 31722-181-05 50 mg tablets: light yellow colored, round biconvex tablets debossed with ‘T’ on one side and ‘50’ on the other side. Bottles of 60’s NDC 31722-182-60 Bottles of 500’s NDC 31722-182-05 100 mg tablets: yellow colored, round biconvex tablets debossed with ‘T’ on one side and ‘100’ on the other side. Bottles of 60’s NDC 31722-183-60 Bottles of 500’s NDC 31722-183-05 200 mg tablets: salmon colored, round biconvex tablets debossed with ‘T’ on one side and ‘200’ on the other side. Bottles of 60’s NDC 31722-184-60 Bottles of 500’s NDC 31722-184-05 16.2 Storage and Handling
TOPIRAMATE Tablets
TOPIRAMATE tablets, USP should be stored in tightly-closed containers. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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