zolmitriptan 2.5 MG Oral Tablet
1 INDICATIONS AND USAGE Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache. Zolmitriptan tablets are serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1) Limitations of Use: Use only after a 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.
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zolmitriptan 5 MG Oral Tablet
Jubilant Cadista Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets: Light pink, round, film-coated tablets, debossed with ‘CB7’ on one side and scoreline on the other side. Carton of 3 (1 x 3) unit-dose tablets (child resistant) NDC 59746-432-13 Carton of 6 (2 x 3) unit-dose tablets (child resistant) NDC 59746-432-16 5 mg Tablets: Light pink, round, film-coated tablets, debossed with ‘CB8’ on one side and plain on the other side. Carton of 3 (1 x 3) unit-dose tablets (child resistant) NDC 59746-433-13 Carton of 6 (2 x 3) unit-dose tablets (child resistant) NDC 59746-433-16 Carton of 3 (1 x 3) unit-dose tablets NDC 59746-433-15 Carton of 6 (2 x 3) unit-dose tablets NDC 59746-433-17 Store at 20ºC to 25°C (68ºF to 77ºF), excursions permitted to 15°C to 30°C (59ºF to 86ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.
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