Product Description.:
Aerosol , clear , clear
Colorless to faintly yellow
Migranal? (dihydroergotamine mesylate, USP) is indicated for the acute treatment of migraine headaches with or without aura.
Description
Migranal? Nasal Spray provides relief at any time during a migraine, whether early or late in the attack. Migranal's broad receptor coverage in both the peripheral and central brain components may allow it to provide relief when other migraine medications that work merely in the periphery do not. Migranal? is classified by the American Headache Society - US Headache Consortium as a Group 1 treatment option which demonstrates proven, pronounced statistical and clinical benefit. This fast-acting nasal spray is generally well tolerated.
Product Availability
* United States
Important Safety Information
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 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. Migranal? Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina. Migranal? also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine. Migranal? Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Migranal? Nasal Spray should not be administered to pregnant women or nursing mothers.
Serious cardiac events, including some that have been fatal, have occurred following use of DHE 45 but are extremely rare. During clinical studies and the foreign postmarketing experience with Migranal? Nasal Spray, there have been no fatalities due to cardiac events. The most commonly reported adverse events in clinical trials for Migranal? Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
