Nomi Nasal Spray2.5mcg/Spray

Indicated for the acute treatment of migraines with or without aura in adults. Not used for migraine prevention or to reduce the frequency of attacks.

Tablet: The recommended starting dose is 2.5 mg. Maximum single dose is 5 mg. If the migraine has not resolved 2 hours after taking the dose, or returns after transient improvement, a second dose may be taken at least 2 hours after the first. Maximum daily dose is 10 mg in any 24-hour period. Nasal Spray: Administer one dose of 5 mg nasal spray for acute migraine. If headache returns, the dose may be repeated after 2 hours. Maximum daily dose should not exceed 10 mg in any 24-hour period. A single 5 mg dose administered into one nostril has been shown effective for acute migraine in adults. Doses lower than 5 mg can only be achieved with the oral formulation; choice of dose and route should be individualized. Safety of treating an average of more than 4 headaches in a 30-day period has not been established.

The most common adverse reactions were: Neck/throat/jaw pain or pressure Dizziness Paresthesia Asthenia (weakness) Somnolence Warm/cold sensation Nausea Heaviness sensation Dry mouth

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration. Sensations of tightness, pain, and pressure may occur in the chest, throat, neck, and jaw after treatment - these are usually not cardiac in origin, but should be evaluated promptly if they occur. Overuse (more than 10 days/month) may lead to medication-overuse headache. Before treating patients with atypical migraine symptoms, exclude other potentially serious neurological conditions. Clearance is reduced in patients with severe renal impairment (CrCl 5-25 mL/min); use with caution. Use with caution and adjusted dosing in moderate to severe hepatic impairment.