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topiramate 50 MG Oral Tablet

1 INDICATIONS AND USAGE Topiramate tablets USP are an antiepileptic (AED) agent indicated for: ā€¢ Monotherapy epilepsy: Initial monotherapy in patients ā‰„10 years of age with partial onset or primary generalized tonic-clonic seizures (1.1) ā€¢ 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 ā‰„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 10 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)].

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4 months ago ROUND YELLOW 50 G topiramate 50 MG Oral Tablet

ROUND YELLOW 50 G

4 months ago ROUND YELLOW 50 G topiramate 50 MG Oral Tablet

50 G ROUND YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

TOPIRAMATE Tablets USP are available as circular, biconvex, film coated, tablets in the following strengths and colors: 50 mg yellow (engraved ā€œGā€ on one side; ā€œ50ā€ on the other) 100 mg yellow (engraved ā€œGā€ on one side; ā€œ100ā€ on the other) They are supplied as follows: 50 mg Tablets-bottles of 30 count with desiccant (NDC 63187-479-30) 50 mg Tablets-bottles of 60 count with desiccant (NDC 63187-479-60) 50 mg Tablets-bottles of 90 count with desiccant (NDC 63187-479-90) 100 mg tablets ā€“ bottles of 30 count with desiccant (NDC 63187-283-30) 100 mg tablets ā€“ bottles of 60 count with desiccant (NDC 63187-283-60) 100 mg tablets ā€“ bottles of 60 count with desiccant (NDC 63187-283-90) Storage and Handling

TOPIRAMATE Tablets USP should be stored in tightly-closed containers at 20Ā° to 25 o C (68Ā° to 77Ā°F) [See USP Controlled Room Temperature]. Protect from moisture.


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