topiramate 200 mg
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 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 extended-release capsules 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 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 2 years of age and older. 1.3 Migraine Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older .
Glenmark Pharmaceuticals Inc., USA
CAPSULE BROWN G 371
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Extended-Release capsules contain pellets of
TOPIRAMATE in a capsule and are available in the following strengths and colors: 25 mg: Flesh colored cap printed with “G” in black ink and light grey body printed with “367” in black ink. 25 mg capsules are supplied in the following package configurations: • Bottles of 30 with desiccant and a child-resistant closure, NDC 68462-372-30 • Bottles of 90 with desiccant a child-resistant closure, NDC 68462-372-90 • Bottles of 500 with desiccant, NDC 68462-372-05 50 mg: light orange cap printed with “G” in black ink and light grey body printed with “368” in black ink. 50 mg capsules are supplied in the following package configurations: • Bottles of 30 with desiccant and a child-resistant closure, NDC 68462-373-30 • Bottles of 90 with desiccant and a child-resistant closure, NDC 68462-373-90 • Bottles of 500 with desiccant, NDC 68462-373-05 100 mg: reddish orange cap printed with “G” in black ink and light grey body printed with “369” in black ink. 100 mg capsules are supplied in the following package configurations: • Bottles of 30 with desiccant and a child-resistant closure, NDC 68462-374-30 • Bottles of 90 with desiccant and a child-resistant closure, NDC 68462-374-90 • Bottles of 500 with desiccant, NDC 68462-374-05 150 mg: grey cap printed with “G” in black ink and light grey body printed with “370” in black ink. 150 mg capsules are supplied in the following package configurations: • Bottles of 30 with desiccant and a child-resistant closure, NDC 68462-370-30 • Bottles of 90 with desiccant and a child-resistant closure, NDC 68462-370-90 • Bottles of 500 with desiccant, NDC 68462-370-05 200 mg: brown cap printed with “G” in black ink and light grey body printed with “371” in black ink. 200 mg capsules are supplied in the following package configurations: • Bottles of 30 with desiccant and a child-resistant closure, NDC 68462-371-30 • Bottles of 90 with desiccant and a child-resistant closure, NDC 68462-371-90 • Bottles of 500 with desiccant, NDC 68462-371-05 16.2 Storage and Handling
TOPIRAMATE Extended-Release capsules should be stored in a tightly-closed container at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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