zolmitriptan

FDA Drug Profile — zolmitriptan, ZOMIG, zolmiptriptan

Drug Details

Generic Name
zolmitriptan
Brand Names
zolmitriptan, ZOMIG, zolmiptriptan
Application Number
ANDA212469
Sponsor
Bryant Ranch Prepack
NDC Codes
9
Dosage Forms
SPRAY, POWDER, TABLET, FILM COATED, TABLET, ORALLY DISINTEGRATING
Routes
NASAL, ORAL
Active Ingredients
ZOLMITRIPTAN

Indications and Usage

1 INDICATIONS AND USAGE Zolmitriptan is 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 is not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan 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)