zolmitriptan 2.5 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Zolmitriptan orally disintegrating tablets are 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 ) Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan have not been established for cluster headache.
Zydus Pharmaceuticals (USA) Inc.
ROUND WHITE 715
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLMITRIPtan Orally Disintegrating Tablets USP, 2.5 mg are white/mottled white to cream white, round, flat-faced, uncoated tablet, debossed with '715' on one side and plain on the other side and are supplied as follows: NDC 68382-715-06 in bottle of 30 tablets with child-resistant closure NDC 68382-715-16 in bottle of 90 tablets with child-resistant closure NDC 68382-715-01 in bottle of 100 tablets NDC 68382-715-10 in bottle of 1000 tablets NDC 68382-715-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets NDC 68382-715-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets
ZOLMITRIPtan Orally Disintegrating Tablets USP, 5 mg are white/mottled white to cream white, round, biconvex, beveled, uncoated tablet, debossed with '717' on one side and plain on the other side and are supplied as follows: NDC 68382-717-06 in bottle of 30 tablets with child-resistant closure NDC 68382-717-16 in bottle of 90 tablets with child-resistant closure NDC 68382-717-01 in bottle of 100 tablets NDC 68382-717-10 in bottle of 1000 tablets NDC 68382-717-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets NDC 68382-717-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant closed container.
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