24 HR topiramate 25 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Topiramate extended-release capsules are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies ( 14.2 )] . 1.2 Adjunctive Therapy Epilepsy Topiramate extended-release capsules 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 6 years of age and older [see Clinical Studies ( 14.3 )] . 1.3 Migraine Topiramate extended-release capsules are indicated for the preventive treatment of in patients 12 years of age and older [see Clinical Studies ( 14.4 )].
Zydus Pharmaceuticals (USA) Inc.
CAPSULE WHITE 863
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Extended-Release capsules
TOPIRAMATE Extended-Release capsules are available in the following strengths: 25 mg capsules : Off white pellets filled in size '2' hard gelatin capsules with white opaque cap printed with '863' in black ink and a white opaque body and are supplied as follows: NDC 68382-863-06 in bottle of 30 capsules with child-resistant closure NDC 68382-863-16 in bottle of 90 capsules with child-resistant closure NDC 68382-863-01 in bottle of 100 capsules with child-resistant closure NDC 68382-863-05 in bottle of 500 capsules NDC 68382-863-77 in cartons of 100 (10 x 10) unit-dose capsules 50 mg capsules : Off white pellets filled in size '0' hard gelatin capsules with white opaque cap printed with '864' in black ink and a white opaque body and are supplied as follows: NDC 68382-864-06 in bottle of 30 capsules with child-resistant closure NDC 68382-864-16 in bottle of 90 capsules with child-resistant closure NDC 68382-864-01 in bottle of 100 capsules with child-resistant closure NDC 68382-864-05 in bottle of 500 capsules NDC 68382-864-77 in cartons of 100 (10 x 10) unit-dose capsules 100 mg capsules : Off white pellets filled in size '0el' hard gelatin capsules with white opaque cap printed with '769' in black ink and a white opaque body and are supplied as follows: NDC 68382-769-06 in bottle of 30 capsules with child-resistant closure NDC 68382-769-16 in bottle of 90 capsules with child-resistant closure NDC 68382-769-01 in bottle of 100 capsules with child-resistant closure NDC 68382-769-05 in bottle of 500 capsules NDC 68382-769-77 in cartons of 100 (10 x 10) unit-dose capsules 200 mg capsules: white to off-white pellets filled in size '00' hard gelatin capsules with white opaque cap printed with '358' in black ink and a white opaque body and are supplied as follows: NDC 68382-358-06 in bottle of 30 capsules with child-resistant closure NDC 68382-358-01 in bottle of 100 capsules with child-resistant closure NDC 68382-358-05 in bottle of 500 capsules NDC 68382-358-78 in cartons of 30 capsules (3 x 10 unit-dose) (Unit-dose blisters are child-resistant) 16.2 Storage and Handling
TOPIRAMATE extended-release capsules should be stored in well-closed containers at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light.
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