Topiramate topiramate 100 MG Oral Tablet
1. INDICATIONS AND USAGE Topiramate is indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ). Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 ) 1.1 Monotherapy Epilepsy Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [ see Clinical Studies ( 14.1 ) ]. 1.2 Adjunctive Therapy Epilepsy Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [ see Clinical Studies ( 14.2 ) ].
Camber Pharmaceuticals, Inc.
ROUND YELLOW IG 280
IG 280 ROUND YELLOW
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Camber Pharmaceuticals
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16. HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Topiramate tablets, USP are available containing 25 mg, 50 mg, 100 mg or 200 mg of topiramate USP. The 25 mg tablets are white, film coated, round, biconvex tablets debossed with IG on one side and 278 on other. They are available as follows: NDC 31722-278-60 bottles of 60 tablets NDC 31722-278-05 bottles of 500 tablets NDC 31722-278-10 bottles of 1000 tablets The 50 mg tablets are yellow, film coated, round, biconvex tablets debossed with IG on one side and 279 on other. They are available as follows: NDC 31722-279-60 bottles of 60 tablets NDC 31722-279-05 bottles of 500 tablets NDC 31722-279-10 bottles of 1000 tablets The 100 mg tablets are light yellow, film coated, round, biconvex tablets debossed with IG on one side and 280 on other. They are available as follows: NDC 31722-280-60 bottles of 60 tablets NDC 31722-280-05 bottles of 500 tablets NDC 31722-280-10 bottles of 1000 tablets The 200 mg tablets are pink, film coated, round, biconvex tablets debossed with IG on one side and 281 on other. They are available as follows: NDC 31722-281-60 bottles of 60 tablets NDC 31722-281-05 bottles of 500 tablets NDC 31722-281-10 bottles of 1000 tablets 16.2 Storage and Handling Topiramate tablets Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from moisture.
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