Zolmitriptan 5 mg
1 INDICATIONS AND USAGE Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan orally disintegrating tablets are if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan orally disintegrating tablets are treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan orally disintegrating tablets are administered to treat any subsequent attacks. Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan orally disintegrating tablets have not been established for cluster headache. Zolmitriptan is a 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.
ROUND WHITE C K
C K ROUND WHITE
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Jubilant Cadista Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLMITRIPtan Orally Disintegrating Tablets, USP 2.5 mg: white, round, flat faced, beveled edged tablets, debossed with ‘C’ on one side and ‘J’ on the other side. Carton of 6 (2 × 3) unit-dose tablets NDC 59746-461-16
ZOLMITRIPtan Orally Disintegrating Tablets, USP 5 mg :white, round, flat faced, beveled edged tablets, debossed with ‘C’ on one side and ‘K’on the other side. Carton of 3 (1 × 3) unit-dose tablets NDC 59746-462-13 Store at 20ºC-25°C (68ºF-77ºF), excursions permitted to 15°C -30°C (59ºF-86ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.
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