Migranal nasal

Dihydroergotamine is an ergot medicine. It works by narrowing the blood vessels around the brain.

Dihydroergotamine nasal is used to a treat migraine headache attack.

Dihydroergotamine nasal will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Dihydroergotamine nasal should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Dihydroergotamine nasal may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Dihydroergotamine is not for daily use.

Dihydroergotamine nasal spray is absorbed quickly through your nasal passages and is for use only in the nose. The nasal spray liquid should not be injected into the body.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Dihydroergotamine nasal comes in a bottle (vial) with a nasal sprayer attachment. Do not open the vial and attach the sprayer until you are ready to use the medication. A new vial and sprayer should be used for each new headache episode.

Before using the medicine, prime the nasal spray by pumping exactly 4 sprays into the air.

Use the first dose of dihydroergotamine as soon as you notice headache symptoms, or after an attack has already begun. Use one spray in each nostril, and after 15 minutes use a second spray in each nostril, for a total of 4 sprays.

Do not tilt your head back while you are using the nasal spray, and do not sniff through your nose during use or just after use. Throw away the vial and sprayer after you finish using it to treat one headache episode, or no longer than 8 hours after opening the vial.

If you still have migraine symptoms after using a total of 4 sprays, call your doctor before using any more. Do not use more than 6 total sprays of dihydroergotamine nasal in any 24-hour period. Do not use more than 8 total sprays of this medication over a period of 7 days.

If you use dihydroergotamine nasal long-term, your doctor may want to check your heart function periodically using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart. This will help your doctor determine if it is still safe for you to use this medication. Do not miss any scheduled visits to your doctor.

Do not share this medication with another person, even if they have the same headache symptoms you have. Dihydroergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches.

Store at room temperature away from moisture and heat. Do not keep this medicine in a refrigerator or freezer.

Do not use dihydroergotamine nasal within 24 hours before or after using another migraine headache medicine, including:

• another ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert); or

• almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

Avoid using a cough or cold medicine that contains a decongestant (such as phenylephrine or pseudoephedrine), while you are using dihydroergotamine nasal.

Grapefruit and grapefruit juice may interact with dihydroergotamine nasal and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

See also Warning section.

Sore nose/throat, stuffy/runny nose, changes in taste, dizziness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a very serious lack of blood flow. Stop using dihydroergotamine and tell your doctor right away if any of these rare but very serious side effects occur: slow/fast heartbeat, weakness in the legs, muscle pain in the arms/legs, tingling/numbness, feeling of coldness in the hands/feet, blue fingers/toes, severe stomach/abdominal pain.

Seek immediate medical attention if any of these rare but very serious side effects occur: jaw/left arm pain, chest pain/pressure, sudden tiredness, weakness on one side of the body, slurred speech, vision changes, mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Common side effects of Migranal include: nausea and rhinitis. Other side effects include: application site reaction, vomiting, and altered sense of smell. See below for a comprehensive list of adverse effects.

Applies to dihydroergotamine: injectable solution, nasal spray

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and diarrhea have been reported to occur commonly.[Ref]

The most frequent side effect with the use of intravenous dihydroergotamine is nausea. Following intramuscular or intranasal administration, the incidence of nausea is low.[Ref]

Other

Other side effects including arterial spasm, sometimes with resulting limb necrosis, have been reported rarely. The incidence is believed to be about 1 to 3 per 100,000 patients treated for thromboprophylaxis.[Ref]

Musculoskeletal

Musculoskeletal side effects including muscle cramps and weakness have been reported.[Ref]

Nervous system

Nervous system side effects including drowsiness, restlessness, cerebral arteriopathy, and paresthesias have been reported.[Ref]

Local

Local side effects including pain, burning, itching, edemas, and hematomas at the site of parenteral administration have been reported to occur commonly.[Ref]

Cardiovascular

Cardiovascular side effects including hypertension, tachycardia, bradycardia, precordial distress, and chest pain have been reported. Myocardial ischemia and myocardial infarction have been reported rarely.[Ref]

Respiratory

Respiratory side effects including pleural fibrosis have been reported following long-term high dose treatment.[Ref]

Renal

Renal side effect including retroperitoneal fibrosis have been reported following long-term high dose treatment.[Ref]

Some side effects of Migranal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.