Drug Profiles:
dihydroergotamine (injectable)
DHE 45®

CAUTION: Federal law prohibits dispensing without prescription.

Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. Before using DHE, be sure to consider and discuss with your doctor:

Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to atropine, belladonna, pentobarbital or other barbiturates, caffeine, cyclizine, dimenhydrinate, diphenhydramine, or an ergot medicine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-
Do not take dihydroergotamine if your are pregnant. Dihydroergotamine can induce uterine contractions, and it can restrict blood flow to the fetus.

Breast-feeding-
Dihydroergotamine passes into breast milk and can cause vomiting and diarrhea in a nursing infant. Do not take dihydroergotamine if you are breast-feeding a baby.

Children-
DHE 45 are used to relieve severe, throbbing headaches in children 6 years of age or older. They have not been shown to cause different side effects or problems in children than they do in adults. However, these medicines can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Older adults-
The chance of serious side effects caused by decreases in blood flow is increased in elderly people receiving these medicines.

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. You should tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. This is especially important if any medicine you take causes excitement, trouble in sleeping, dryness of the mouth, dizziness, or drowsiness.:

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. When you are taking dihydroergotamine or ergotamine, it is especially important that your health care professional know if you are taking any of the following:

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 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 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 dihydroergotamine for a headache that is different from your usual migraine
• Use dihydroergotamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Use your first dose of dihydroergotamine at the first sign of a headache.

Dosing-
The dose of DJE 45 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.

• Inject up to 1 mg (1 mL) as directed at the first sign of a headache. Two additional doses can be given at 1 hour intervals up to a total of 3 mg (3 mL). Doses smaller than 3 mg may be effective.
• Do not use more than 3 mg in any 24-hour period. Do not use more than 6 mg in any 7 days. If your symptoms are not being adequately treated, see 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
Check with your doctor:

• If your Migraines are worse than they were before you started using this medicine, or if DHE stops working as well as it did when you first started using it. Do not try to get better relief by increasing the dose.
• If your Migraines are occurring more often than they did before you started using this medicine. This is especially important if a new Migraines occurs within 1 day after you took your last dose of DHE, or if you are having Migraines every day. This may mean that you are experiencing rebound headaches. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.
• Drinking alcoholic beverages can make Migraines worse or cause new Migraines to occur. People who suffer from Migraines should probably avoid alcoholic beverages, especially during a Migraine.
• Smoking may increase some of the harmful effects of dihydroergotamine. It is best to avoid smoking for several hours after taking DHE.
• Dihydroergotamine may make you more sensitive to cold temperatures, especially if you have blood circulation problems. It tends to decrease blood flow in the skin, fingers, and toes. Dress warmly during cold weather and be careful during prolonged exposure to cold temperatures. This is especially important for older patients, who are more likely than younger adults to already have problems with their circulation.
• If you have a serious infection or illness of any kind, check with your doctor before using this medicine, since you may be more sensitive to its effects.

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:
    • anxiety or confusion (severe)
    • change in vision
    • chest pain
    • increase in blood pressure
    • pain in arms, legs, or lower back, especially if pain occurs in your calves or heels while you are walking
    • pale, bluish-colored, or cold hands or feet (not caused by cold temperatures and occurring together with other side effects listed in this section)
    • red or violet-colored blisters on the skin of the hands or feet
• 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:
  • nausea or vomiting
  • coldness, weakness, pain, numbness, or tingling in your hands, feet, arms, or legs
  • muscle pain
  • irregular heartbeats
  • chest pain
  • itching

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