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(dihydroergotamine mesylate, USP) Nasal Spray
Migranal (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches
with
or without aura. Migranal Nasal Spray is not intended for the prophylactic therapy of migraines or for the
management
of hemiplegic or basilar migraines. Migranal has the ability to relieve moderate to severe migraine pain long after
a
migraine has started.
Migranal contains the active ingredient dihydroergotamine mesylate (DHE). For more than 50 years, DHE has been used
to
treat both peripheral and central components of migraine pain.
| Peripheral Effects |
Central Effects |
Nausea
Sensitivity to light
Sensitivity to sound
Pain/throbbing
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Sensitivity
Increased pain
Pain from stimuli which are normally not painful
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It is believed that the effectiveness of Migranal stems from two distinct actions. The first occurs when the active
ingredient in Migranal, DHE, attaches to the receptors in the brain that are normally bound by substances called
"neurotransmitters". These include key serotonergic, adrenergic, and dopaminergic receptors. This interference can help
counteract the peripheral symptoms of a migraine attack such as sensitivity to light and nausea. The second action
occurs when Migranal helps to regulate the run-away pain response that makes 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.
A Phase 4 study with Migranal is investigating the use of Migranal in early versus delayed treatment of migraine headaches.
Migraine headaches can be classified into two main groups, those without Aura and those with Aura. Aura can be described
as a disturbance to their visual field before an attack occurs. Either of these types of migraines can be considered
chronic if they occur more than 15 times per month.
To properly diagnose a migraine, your doctor may look for the following symptoms:
Migraines without Aura (80% of migraine suffers)
Symptoms include:
- Headaches lasting 4 - 72 hours
- At least some of the following symptoms:
- Pain in one part of the head
- Pulsing/throbbing pain
- Moderate to severe intensity
- Sensitivity to motion, light, and/or sound
- Nausea
- Vomiting
Migraines with Aura
These migraines are rarer and typically have the following warning signs:
- Disturbance to vision up to 60 minutes before pain begins (the aura)
- Neurological disturbances that can include:
- Blind spots, flashing lights, blurred vision
- Tingling in the hands and/or feet
- Numbness
- Speech difficulties
- Weakness in half the body
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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.
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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 in 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 post-marketing 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
Please see full Prescribing Information, including BOXED WARNING at www.migranal.com. |
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