qudexy xr topiramate 25 mg
1 INDICATIONS AND USAGE QUDEXY XR is 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 QUDEXY XR is 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 QUDEXY XR is 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 QUDEXY XR is indicated for the preventive treatment of migraine in patients 12 years of age and older.
upsher-smith laboratories, llc
CAPSULE PINK UPSHER SMITH 25 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied QUDEXY ® XR (
TOPIRAMATE) extended-release capsules contain beads of
TOPIRAMATE in a capsule and are available in the following strengths and colors: 25 mg: light pink and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "25 mg" on the body in black ink. 25 mg capsules are supplied in the following package configurations: Bottles of 30 with desiccant and a child-resistant closure, NDC 0245-1071-30 Bottles of 90 with desiccant and a child-resistant closure, NDC 0245-1071-90 50 mg: golden yellow and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "50 mg" on the body in black ink. 50 mg capsules are supplied in the following package configurations: Bottles of 30 with desiccant and a child-resistant closure, NDC 0245-1072-30 Bottles of 90 with desiccant and a child-resistant closure, NDC 0245-1072-90 100 mg: reddish brown and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "100 mg" on the body in black ink. 100 mg capsules are supplied in the following package configurations: Bottles of 30 with desiccant and a child-resistant closure, NDC 0245-1074-30 Bottles of 90 with desiccant and a child-resistant closure, NDC 0245-1074-90 150 mg: pale yellow and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "150 mg" on the body in black ink. 150 mg capsules are supplied in the following package configurations: Bottles of 30 with desiccant and a child-resistant closure, NDC 0245-1075-30 Bottles of 90 with desiccant and a child-resistant closure, NDC 0245-1075-90 200 mg: brown and grey capsules, printed with "UPSHER-SMITH" on the cap in white ink and "200 mg" on the body in black ink. 200 mg capsules are supplied in the following package configurations: Bottles of 30 with desiccant and a child-resistant closure, NDC 0245-1073-30 Bottles of 90 with desiccant and a child-resistant closure, NDC 0245-1073-90 16.2 Storage and Handling QUDEXY XR (
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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