Dihydroergotamine Mesylate, Inhalation

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KEY POINTS

• This medicine, in the form of a nasal spray, is used to treat migraine headaches. It will not relieve the pain of tension headaches. Use it exactly as directed. Using too much of this medicine, or using it too often, can cause overuse or rebound headaches.
• Do not use this medicine if you are pregnant. It may cause birth defects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. If you take this medicine with certain drugs that affect the liver, it can have very serious effects on blood supply to the hands, feet, and brain.

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What are other names for this medicine?

Type of medicine: antimigraine

Generic and brand names: dihydroergotamine mesylate, inhalation; Migranal

What is this medicine used for?

This medicine, in the form of a nasal spray, is used to treat migraine headaches. It does not prevent migraines, and will not relieve the pain of tension headaches or headaches that are not like your usual migraines.

This medicine is not for injection.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Angina
• Heart disease or a heart attack
• High blood pressure
• Kidney or liver problems
• Problems with circulation or blood vessel disease
• Problems with substance abuse
• Risk factors for heart disease such as smoking, family history of heart disease, diabetes, or high cholesterol

If you take this medicine with certain drugs that affect the liver, it can have very serious effects on blood supply to the hands, feet, and brain. This medicine may interact with many other medicines. Tell your provider all prescription and nonprescription medicines you take. Do not start or stop any medicine unless you check with your healthcare provider or pharmacist first.

Females of childbearing age: Do not use this medicine if you are pregnant. This medicine has been reported to cause birth defects. Use an effective birth control method while you are taking this medicine. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while you are using this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed. It is not taken on a regular schedule. Ask your healthcare provider or pharmacist to explain anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine comes in single-dose vials with a nasal sprayer. Do not open a vial until needed. Once opened, you must use the medicine within 8 hours. Discard any spray you haven't used within 8 hours after you prepared it.

Wash your hands before using this medicine. Before using this medicine, clear your nasal passages by gently blowing your nose.

Take this medicine at the first sign of a migraine. Assemble the vial and sprayer according to package directions. Pump the sprayer 4 times to prime it with medicine. Spray once in each nostril. While spraying, do NOT tilt your head back or inhale through your nose. Wait 15 minutes, then spray once in each nostril again. After the second spray, discard the sprayer and the vial's cap.

Do not sniff the spray. It must stay in your nose so that it can be absorbed into your bloodstream through the lining of your nose.

You may still use this medicine if you have a stuffy nose, a cold, or allergies. However, do not take any medicines for your stuffy nose, cold, or allergies, including those you can buy without a prescription, unless you talk to your healthcare provider first.

Do not use any other medicine for migraines within 24 hours of using this medicine.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: numbness, tingling, chills, bluish coloring in your hands or feet, nausea, vomiting, stomach pain, confusion, unusual thoughts or behavior, severe headache, blurred vision, trouble concentrating, chest pain, lightheadedness, fainting, slow or shallow breathing, seizures.

What should I watch out for?

You should not use this medicine for more than 10 days per month. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches. Tell your healthcare provider if you need to use the medicine more often, if the medicine is not working as well, if you have headaches more often, or if your headaches get worse.

Do not smoke while using this medicine. Smoking may increase your risk of side effects.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make you more sensitive to cold temperatures. Dress warmly during cold weather and avoid prolonged exposure to cold temperatures.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Cold hands or feet; muscle pain or weakness in arms or legs; chest pain, irregular heartbeat.

Other: Runny or stuffy nose, sore nose or throat, nausea, vomiting, diarrhea, change in taste sensation, dizziness, flushing, sweating, drowsiness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), metronidazole, and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), sotalol (Betapace, Sorine), and timolol
• Ephedrine, epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), phenylephrine (Neo-Synephrine, Sudafed PE), or pseudoephedrine (Sudafed)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as feverfew, green tea, and guarana
• Nicotine replacement products such as Habitrol, NicoDerm, Nicorette, Nicotrol
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Phentermine (Adipex-P, Suprenza)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), dextroamphetamine (Dexedrine), and methamphetamine (Desoxyn)
• Zileuton (Zyflo)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.