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Dihydroergotamine Nasal Spray
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  • FDA PI

Dihydroergotamine Nasal Spray

Generic name: dihydroergotamine mesylate
Dosage form: nasal spray, metered
Drug class:Antimigraine agents

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

The solution used in dihydroergotamine mesylate nasal spray (4 mg/mL)is intended for intranasal use and must not be injected.

Rx Only

WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.

(See also CONTRAINDICATIONS and WARNINGS section)

Dihydroergotamine Nasal Spray Description

Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5•CH4O3S.

The chemical structure is:

Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to faintly yellow solution in an amber glass vial containing:

dihydroergotamine mesylate……………4 mg

caffeine, anhydrous……………………. 10 mg

dextrose, anhydrous…………………… 50 mg

carbon dioxid...