zolmitriptan
zolmitriptan is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including zolmiptriptan, zolmitriptan, ZOMIG. Available dosage forms: tablet, orally disintegrating, spray, powder, tablet, film coated.
Drug Details
- Generic Name
- zolmitriptan
- Brand Names
- zolmiptriptan, zolmitriptan, ZOMIG
- Application Number
- ANDA202560
- Sponsor
- Glenmark Pharmaceuticals Inc., USA
- NDC Codes
- 9
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, SPRAY, POWDER, TABLET, FILM COATED
- Routes
- ORAL, NASAL
- Active Ingredients
- ZOLMITRIPTAN
Indications and Usage
1 INDICATIONS AND USAGE ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. Not recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.2) ] . ZOMIG Nasal Spray is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older (1) Limitations of Use: Use only after a clear diagnosis of migraine has been established (1) Not intended for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1) Not recommended in patients with moderate to severe hepatic impairment (1)