topiramate 25 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.
Aurobindo Pharma Limited
ROUND WHITE E 22
E 22 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Tablets USP, 25 mg are white, circular, biconvex, film-coated tablets debossed with ‘E’ on one side and ‘22’ on the other side. Bottles of 60 NDC 65862-171-60 Bottles of 500 NDC 65862-171-05 Bottles of 1,000 NDC 65862-171-99
TOPIRAMATE Tablets USP, 50 mg are light yellow colored, circular, biconvex, film-coated tablets debossed with ‘E’ on one side and ‘33’ on the other side. Bottles of 60 NDC 65862-172-60 Bottles of 500 NDC 65862-172-05 Bottles of 1,000 NDC 65862-172-99
TOPIRAMATE Tablets USP, 100 mg are dark yellow colored, circular, biconvex, beveled edge, film-coated tablets debossed with ‘E’ on one side and ‘23’ on the other side. Bottles of 60 NDC 65862-173-60 Bottles of 500 NDC 65862-173-05 Bottles of 1,000 NDC 65862-173-99
TOPIRAMATE Tablets USP, 200 mg are pink colored, circular, biconvex, beveled edge, film-coated tablets debossed with ‘E’ on one side and ‘24’ on the other side. Bottles of 60 NDC 65862-174-60 Bottles of 500 NDC 65862-174-05 Bottles of 1,000 NDC 65862-174-99 16.2 Storage and Handling Store
TOPIRAMATE tablets in tightly-closed containers 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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