rizatriptan benzoate 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 tablets are 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.
OVAL PINK RN5
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rizatriptan benzoate tablet
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIZATRIPtan BENZOATE Tablets, USP are available 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 light pink, oval, unscored tablets debossed with RN5 on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-1403-96 bottles of 12 tablets The 10 mg tablets are light pink, oval, unscored tablets debossed with RN10 on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-1404-96 bottles of 12 tablets Storage: Store at 20° to 25°C (68° to 77°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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