rizatriptan 5 MG Oral Tablet
1 INDICATIONS AND USAGE Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use • Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications ( 4 )]. • Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache. Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use: • Use only after clear diagnosis of migraine has been established ( 1 ) • Not indicated for the prophylactic therapy of migraine ( 1 ) • Not indicated for the treatment of cluster headache ( 1 )
glenmark pharmaceuticals inc., usa
ROUND PINK 465
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIZATRIPtan BENZOATE tablets USP, 5 mg (7.265 mg of
RIZATRIPtan BENZOATE, USP equivalent to 5 mg of rizatriptan) are light pink to reddish brown, mottled, round, uncoated tablets engraved with ‘465’ on one side and plain on the other side. Carton of 12 (2 x 6 unit-dose), NDC 68462-465-72 Carton of 18 (3 x 6 unit-dose), NDC 68462-465-99
RIZATRIPtan BENZOATE tablets USP, 10 mg (14.53 mg of
RIZATRIPtan BENZOATE, USP equivalent to 10 mg of rizatriptan) are light pink to reddish brown, mottled, round, uncoated tablets engraved with ‘466’ on one side and plain on the other side. Carton of 12 (2 x 6 unit-dose), NDC 68462-466-72 Carton of 18 (3 x 6 unit-dose), NDC 68462-466-99 Storage Store 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].
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