MIGRANAL® (dihydroergotamine mesylate) works in the brain to counteract
the effects of the two different kinds of migraine pain, known
as peripheral and central migraine pain.
Peripheral Effects
Central Effects
Nausea
Sensitivity to light
Sensitivity to sound
Pain/throbbing
Sensitivity
Increased pain
Pain from stimuli which are normally not painful
It is believed the effectiveness of MIGRANAL
comes from two distinct actions:
MIGRANAL attaches to receptors in the
brain that substances called "neurotransmitters"
normally bind to. This may help
to counteract a migraine attack’s peripheral symptoms,
such as sensitivity to light and nausea.
MIGRANAL helps to regulate the run–away
pain response that can make migraines so
painful.
Relief can begin within a half hour of taking
MIGRANAL, and 61% of MIGRANAL users experience total relief
of their symptoms within 2 hours. The active ingredient in
MIGRANAL, dihydroergotamine (DHE), has been used for 50 years
and has a long record of safe and effective use.
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.
