24 hr trokendi 100 mg extended release capsule
1 INDICATIONS AND USAGE TROKENDI XR ® is 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 TROKENDI XR ® is 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 TROKENDI 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 6 years of age and older [see Clinical Studies (14.3) ] . 1.3 Migraine TROKENDI XR ® is indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4) ] .
supernus pharmaceuticals
CAPSULE GREEN SPN 100
SPN 100 CAPSULE GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TROKENDI XR ® (
TOPIRAMATE) extended-release capsules are available in the following strengths and colors: 25 mg (light green opaque body/yellow opaque cap with black print "SPN" and "25"): bottles of 7 count (NDC-17772-101-70), 30 count (NDC-17772-101-30) and 100 count (NDC-17772-101-01) blister packages of 30-count (NDC-17772-101-15) 50 mg (light green opaque body/orange opaque cap with black print "SPN" and "50"): bottles of 7 count (NDC-17772-102-70), 30 count (NDC-17772-102-30) and 100 count (NDC-17772-102-01) blister packages of 30-count (NDC-17772-102-15) 100 mg (green opaque body/blue opaque cap with black print "SPN" and "100"): bottles of 7 count (NDC-17772-103-70), 30 count (NDC-17772-103-30) and 100 count (NDC-17772-103-01) blister packages of 30-count (NDC-17772-103-15) 200 mg (pink opaque body/blue opaque cap with black print "SPN" and "200"): bottles of 7 count (NDC-17772-104-70), 30 count (NDC-17772-104-30) and 100 count (NDC-17772-104-01) blister packages of 30-count (NDC-17772-104-15) 16.2 Storage and Handling TROKENDI XR ® (
TOPIRAMATE) extended-release capsules should be stored in well closed containers at controlled room temperature [25°C (77°F); excursions 15°C-30°C (59°F-86°F)]. Protect from moisture and light.
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