rizatriptan 5 MG Oral 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 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 )
Jubilant Cadista Pharmaceuticals Inc.
OVAL PINK 414 C
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Jubilant Cadista Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Rizatriptan benzoate tablets 5 mg are pale pink to pink colored, biconvex, capsule-shaped, uncoated tablets, debossed with ‘414’ on one side and ‘C’ on the other side. Unit-dose blister pack of 12 (2 x 6) tablets, NDC 59746-414-14 Unit-dose child-resistant blister pack of 18 (3 x 6) tablets, NDC 59746-414-19 Rizatriptan benzoate tablets 10 mg are pale pink to pink colored, biconvex, capsule-shaped, uncoated tablets, debossed with ‘415’ on one side and ‘C’ on the other side. Unit-dose blister pack of 12 (2 x 6) tablets, NDC 59746-415-14 Unit-dose child-resistant blister pack of 18 (3 x 6) tablets, NDC 59746-415-19 Storage Store rizatriptan benzoate tablets 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].
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