Migranal

Dihydroergotamine is an ergot alkaloid medicine that is used to treat a migraine or cluster headache attack. This medicine will not prevent headaches or reduce the number of attacks.

This medicine is not for common tension headaches or daily use.

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

You should not use dihydroergotamine if you are allergic to it, or if you have:

• heart disease, chest pain (angina), coronary artery disease, a history of a heart attack or stroke;
• circulation problems such as peripheral vascular disease;
• uncontrolled high blood pressure;
• sepsis (a severe reaction to an infection).
• severe liver or kidney disease;
• if you are allergic to dihydroergotamine or other ergot medicine (ergonovine, ergotamine, methylergonovine); or
• if you have recently had heart or blood vessel surgery (such as bypass surgery).

Dihydroergotamine can affect blood circulation to your uterus. Do not use if you are pregnant. Ask your doctor for a safer medicine to use during pregnancy, since having migraine headaches may cause complications in the mother and the baby.

Do not breastfeed.

Some drugs should not be used with dihydroergotamine. Your treatment plan may change if you also use:

• an antibiotic such as clarithromycin or erythromycin;
• antifungal medicine such as itraconazole or ketoconazole; or
• antiviral medicine for HIV or hepatitis C.

Tell your doctor if you have ever had:

• blood circulation problems in your arms, hands, legs, or feet;
• chest pain, shortness of breath;
• liver or kidney disease;
• risk factors for coronary artery disease (high blood pressure, high cholesterol, diabetes, menopause, smoking, family history of coronary artery disease, being overweight, being over 40 and a man);

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Dihydroergotamine is injected under the skin or into a muscle. Dihydroergotamine is sometimes injected into a vein by a healthcare provider.

Use an injection as soon as you notice headache symptoms, or shortly after an attack has begun.

Prepare an injection only when you are ready to give it. Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

If you still have a headache after 1 injection, you may use up to 2 more injections (spaced 1 hour apart), until your headache goes away.

Call your doctor if you still have a headache after 3 injections.

If you have another headache in the same day, you may use the medicine again if at least 6 hours have passed since your last injection.

Do not use more than a total of 3 injections in 24 hours, or more than 6 injections in 1 week.

You may need medical tests to check your heart function.

Store at room temperature away from moisture, heat, and light. Do not use past the expiration date.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Dihydroergotamine is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Do not use more than 3 injections per day or 6 injections per week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Do not take dihydroergotamine within 24 hours before or after using another migraine headache medicine. This includes another ergot medicine (ergotamine, methylergonovine) or "triptan" medicine (such as Amerge, Imitrex, Maxalt,or Zomig).

Grapefruit may interact with dihydroergotamine and cause side effects. Avoid consuming grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• numbness or tingling in your fingers or toes;
• muscle pain in your arms or legs;
• leg weakness;
• fast or slow heartbeats;
• chest pain or tightness, shortness of breath;
• swelling or itching;
• stomach cramps, diarrhea that may be bloody;
• severe headache; or
• discoloration or skin changes in your hands or feet.

Common side effects may include:

• headache, dizziness, anxiety;
• diarrhea;
• numbness, tingling, burning pain;
• increased blood pressure;
• rash, increased sweating; or
• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can affect dihydroergotamine, especially:

• heart or blood pressure medication;
• nicotine gum or patches;
• an antidepressant; or
• medicine to treat an infection.

This list is not complete. Many drugs can affect dihydroergotamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Your pharmacist can provide more information about dihydroergotamine injection.