Rizatriptan Benzoate rizatriptan 10 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)
Citron Pharma LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIZATRIPtan BENZOATE Tablets USP, 5 m g are a pale pink-colored, circular, flat, beveled-edge uncoated tablets debossed with ‘X’ on one side and ‘13’ on other side. The tablets may be mottled. 18 (3 x 6) Unit-dose Tablets NDC 57237-087-63 12 (4 x 3) Unit-dose Tablets NDC 57237-087-34
RIZATRIPtan BENZOATE Tablets USP, 10 m g are a pale pink-colored, circular, flat, beveled-edge uncoated tablets debossed with ‘X’ on one side and ‘14’ on other side. The tablets may be mottled. 18 (3 x 6) Unit-dose Tablets NDC 57237-088-63 12 (4 x 3) Unit-dose Tablets NDC 57237-088-34 Storage Store
RIZATRIPtan BENZOATE tablets USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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