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rizatriptan 10 MG Disintegrating Oral Tablet

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. 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. 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


4 years ago ROUND WHITE 468 rizatriptan 10 MG Disintegrating Oral Tablet

ROUND WHITE 468

16 HOW SUPPLIED/STORAGE AND HANDLING

RIZATRIPtan BENZOATE orally disintegrating tablets, USP 5 mg (equivalent to 7.265 mg

RIZATRIPtan BENZOATE) are white to off‑white, round, flat beveled edged, uncoated orally disintegrating tablets engraved with ‘467’ on one side and plain on the other side with a peppermint flavor. They are supplied as follows: Carton of 12 (2 x 6 unit-dose), NDC 68462-467-74 Carton of 18 (3 x 6 unit-dose), NDC 68462-467-06

RIZATRIPtan BENZOATE orally disintegrating tablets, USP 10 mg (equivalent to 14.53 mg

RIZATRIPtan BENZOATE) are white to off‑white, round, flat beveled edged, uncoated orally disintegrating tablets engraved with ‘468’ on one side and plain on the other side with a peppermint flavor. They are supplied as follows: Carton of 12 (2 x 6 unit-dose), NDC 68462-468-74 Carton of 18 (3 x 6 unit-dose), NDC 68462-468-06 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]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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