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treatment & management

Drug Profiles:
dihydroergotamine

Migranal® Nasal Spray

CAUTION: Federal law prohibits dispensing without prescription.

   
Description
Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, is for the acute treatment of Migraine with or without aura. Ergotamine preparations are non-triptan Migraine abortive medications. In clinical trials, self-administration of Migranal® Nasal Spray resulted in Migraine pain relief and a reduction in pain intensity. Over 50% of patients in pivotal clinical trials did not need additional medications during the 24-hour period following a single 2 mg Migranal® treatment. Developed by Novartis Pharmaceuticals Corporation, Migranal® was cleared for marketing by the U.S. Food and Drug Administration on December 8, 1997.

In clinical trials, Migranal® Nasal Spray was shown to produce a reduction in nausea and sensitivity to both light and sound at 2 and 4 hours compared with placebo. Over 50% of patients in all pivotal clinical trials did not need additional migraine medications during the 24-hour period following a single 2 mg Migranal treatment. In addition, the nasal spray formulation bypasses the gastrointestinal tract, making it appropriate for patients who suffer from nausea and vomiting as a result of migraine, and who may therefore have difficulty with oral treatments.
Migranal® Nasal Spray is a migraine-specific serotonin agonist. It attacks migraine at its source by selectively binding to receptors in the brain that regulate the release of serotonin, a chemical thought to play a major role in the development of migraine. Migranal® is also nonnarcotic, non-habit forming, and nonsedating.

Migranal® is available only with your doctor's prescription.

Before Using This Medicine
Nasal dihydroergotamine may cause blood vessels in the body to constrict (become narrower). This action can lead to serious effects that are caused by a decrease in the flow of blood (blood circulation) to many parts of the body. Be sure that you discuss with your doctor the risks of using this medicine as well as the good it can do. Before using Migranal, be sure to consider and discuss with your doctor:

Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to dihydroergotamine or any other ergot alkaloid. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-
Use of nasal dihydroergotamine by pregnant women may cause serious harm to the fetus. Therefore, nasal dihydroergotamine should not be used during pregnancy.

Breast-feeding-
Use of nasal dihydroergotamine is not recommended for nursing mothers. Nasal dihydroergotamine may pass into the breast milk and may cause unwanted effects, such as vomiting, diarrhea, weak pulse, changes in blood pressure, or convulsions (seizures) in nursing babies. Nasal dihydroergotamine may also decrease the flow of breast milk.

Children-
There is no specific information comparing use of nasal dihydroergotamine in children with use in other age groups.

Older adults-
There is no specific information comparing use of nasal dihydroergotamine in older adults with use in other age groups.

Other medicines-
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nasal dihydroergotamine, it is especially important that your health care professional know if you are using any of the following:

Do not take frovatriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) within the last 14 days. The combination could cause seizures, nausea, vomiting, sweating, flushing, and dizziness.

Do not take frovatriptan if you:

  • Cocaine
  • Epinephrine by injection [e.g., Epi-Pen]
  • Other ergot medicines (ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert]
  • Triptans: Imitrex/sumatriptan, Amerge/naratriptan, Maxalt/rizatriptan, Zomig/zolmitriptan, Axert/almotriptan, Frova/frovatriptan. The chance of serious side effects caused by nasal dihydroergotamine may be increased
  • beta-blockers (which are used to treat high blood pressure, irregular heartbeats, and other heart conditions) such as acebutolol (Sectral), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard), pindolol (Visken), propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren)
  • antibiotics, including erythromycin (Ery-Tab, E.E.S., E-Mycin, Eryc, PCE, and others), clarithromycin (Biaxin), and azithromycin (Zithromax).

Other medical problems-
The presence of other medical problems may affect the use of Migranal. Make sure you tell your doctor if you have any other medical problems, especially:

  • Heart or blood vessel disease
  • a peripheral vascular disease or poor circulation,
  • arteriosclerosis or "hardening of the arteries"
  • Hypertension (high blood pressure)
  • Kidney disease
  • Liver disease
  • Infection—The chance of serious side effects caused by nasal dihydroergotmine may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use nasal dihydroergotamine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of This Medicine
It is important to use this medicine properly:

  • Do not use nasal dihydroergotamine for a headache that is different from your usual migraine
  • To relieve your migraine as soon as possible, use nasal dihydroergotamine as soon as the headache begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using nasal dihydroergotamine.
  • Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.
  • If you feel much better after a dose of nasal dihydroergotamine, but your head pain comes back or gets worse after a while, you may use more nasal dihydroergotamine. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed.
  • Your doctor may direct you to take another medicine to help prevent Migraines. It is important that you follow your doctor's directions, even if your headaches continue to occur. Migraine-preventing medicines may take several weeks to start working. Even after they do start working, your headaches should occur less often, and they should be less severe, and easier to relieve. This can reduce the amount of nasal dihydroergotamine or other pain medicines that you need. If you do not notice any improvement after several weeks of Migraine-preventing treatment, check with your doctor.

Dosing-
The dose of nasal dihydroergotamine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nasal dihydroergotamine. If your dose is different, do not change it unless your doctor tells you to do so.

  • Adults—One spray (0.5 mg) in each nostril. After 15 minutes, another spray (0.5 mg) in each nostril should be used.
  • Children—Use and dose must be determined by your doctor.

Storage-
To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children..

Precautions While Using This Medicine
Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine attack, or after taking nasal dihydroergotamine to relieve a migraine headache. As long as you are feeling drowsy or dizzy, do not drive, use machines or do anything else that could be dangerous if you are dizzy or are not alert.

Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

  • Check with your doctor as soon as possible if any of the following side effects occur:
    • Less common or rare:
      • Chest pain; cough, fever, sneezing, or sore throat
      • feeling of heaviness in chest
      • irregular heartbeat
      • itching of the skin
      • numbness and tingling of face, fingers, or toes
      • pain in arms, legs, or lower back
      • pain in back, chest or left arm
      • pale bluish-colored or cold hands or feet
      • shortness of breath or troubled breathing
      • weak or absent pulses in legs
  • Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
    • More common
      • Burning or tingling sensation, dryness, soreness, or pain in the nose
      • change in sense of taste
      • diarrhea
      • dizziness
      • dry mouth
      • fatigue
      • headache
      • increased sweating
      • nausea and or vomiting
      • muscle stiffness
      • runny and or stuffy nose
      • sudden sweating and feelings of warmth
      • sensation of burning, warmth, or heat
      • sore throat
      • sleepiness
      • unexplained nose bleeds
      • unusual tiredness or weakness
    • Less common
      • Anxiety
      • blurred vision
      • cold clammy skin
      • confusion
      • congestion in chest
      • cough
      • decreased appetite
      • depression
      • difficulty swallowing
      • dizziness or lightheadedness when getting up from a lying or sitting position
      • ear pain
      • eye pain
      • fever
      • heartburn
      • increased watering of eyes
      • increased watering of the mouth
      • increased yawning
      • muscle weakness
      • nervousness
      • pinpoint red spots on skin
      • pounding heartbeat
      • red or irritated eyes
      • ringing or buzzing in ears
      • skin rash
      • stomach pain
      • sudden fainting
      • swelling of face, fingers, feet, or lower legs
      • trembling or shaking of hands or feet
      • trouble in sleeping
      • unusual feeling of well being.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
  

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Information offered at this Web site by either a lay person or a health professional should not be interpreted as giving a diagnosis or a treatment recommendation. These can only be provided by a physician who has had an opportunity to interact with a patient in person and at length, with access to the patient's previous records and appropriate follow-up.