topiramate 50 MG Oral Tablet
1 INDICATIONS AND USAGE Topiramate is an antiepileptic (AED) agent 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 )] .
Sun Pharmaceutical Industries Limited
ROUND YELLOW S 710
S 710 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
TOPIRAMATE tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 25 mg tablets Bottles of 30’s with Child Resistant Cap…………...NDC 62756-707-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-707-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-707-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-707-08 Bottles of 500’s with Non Child Resistant Cap ……NDC 62756-707-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-707-18 50 mg tablets Bottles of 30’s with Child Resistant Cap…..............NDC 62756-710-83 Bottles of 60’s with Child Resistant Cap…………..NDC 62756-710-86 Bottles of 100’s with Child Resistant Cap …...........NDC 62756-710-88 Bottles of 100’s with Non Child Resistant Cap …...NDC 62756-710-08 Bottles of 500’s with Non Child Resistant Cap …...NDC 62756-710-13 Bottles of 1000’s with Non Child Resistant Cap ….NDC 62756-710-18 100 mg tablets Bottles of 30’s with Child Resistant Cap…..............NDC 62756-711-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-711-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-711-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-711-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-711-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-711-18 200 mg tablets Bottles of 30’s with Child Resistant Cap…...............NDC 62756-712-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-712-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-712-88 Bottles of 100’s with Non Child Resistant Cap …....NDC 62756-712-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-712-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-712-18 Storage and Handling Store
TOPIRAMATE tablets 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. Dispense in a tight container.
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