rizatriptan benzoate tablet orally disintegrating
1 INDICATIONS AND USAGE Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. 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 ) Limitations of Use Rizatriptan benzoate orally disintegrating 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 orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
breckenridge pharmaceutical, inc.
ROUND GREEN 5
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIZATRIPtan BENZOATE Orally Disintegrating Tablets are available in strengths of 5 mg and 10 mg containing 7.265 mg or 14.53 mg of
RIZATRIPtan BENZOATE, USP equivalent to 5 mg or 10 mg of rizatriptan, respectively. The 5 mg tablets are white to off-white, round, uncoated tablets, debossed "5" on one side and plain on the other side. They are supplied as follows: NDC 51991-362-78, Carton of 18 unit-dose tablets. The 10 mg tablets are white to off-white, round, uncoated tablets, debossed "10" on one side and plain on the other side. They are supplied as follows: NDC 51991-363-78, Carton of 18 unit-dose tablets. Storage Store at 20° – 25°C (68° – 77°F) [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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