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 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M 702
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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, unscored tablets debossed with M on one side of the tablet and 701 on one side of the tablet. They are available as follows: NDC 0378-3701-59 bottles of 9 tablets The 10 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 702 on one side of the table. They are available as follows: NDC 0378-3702-59 bottles of 9 tablets Store at 20º to 25ºC (68º to 77ºF). [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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