rizatriptan benzoate 10 mg
1 INDICATIONS AND USAGE 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) 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 has not been established for cluster headache.
Cipla USA Inc.
OVAL PINK IG 463
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIZATRIPtan BENZOATE tablets, USP 5 mg, are pink, oval-shaped tablets debossed with '462' on one side and "IG" on the other side: NDC 69097-865-17, unit-of-use blister pack of 6 tablets; available in carton of 18 tablets (3 x 6 tablets) NDC 69097-865-85
RIZATRIPtan BENZOATE tablets, USP 10 mg, are pink, oval-shaped tablets, debossed with '463' on one side and "IG" on the other side: NDC 69097-866-17, unit-of-use blister pack of 6 tablets; available in carton of 18 tablets (3 x 6 tablets), NDC 69097-866-85 Storage Store
RIZATRIPtan BENZOATE tablets at 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
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