D.H.E. 45

Not applicable.

Read the Patient Information Leaflet provided by your pharmacist before you start using dihydroergotamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Inject this medication into a vein, into a muscle, or under the skin as directed by your doctor. Dosage is based on your medical condition and response to treatment. Usually, this medication should be used only as needed. It is not meant for long-term daily use. This medication works best if it is taken as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well. If your headache returns or you have no relief from the first dose, you may repeat the dose 1 hour after the first dose, but only if instructed to do so by your doctor. If this medication is given into a muscle or under the skin, a third dose may be given 1 hour after the second dose if needed. Do not use more than 3 milliliters in 24 hours or 6 milliliters in a week. If this medication is given into a vein, do not use more than 2 milliliters in 24 hours or 6 milliliters in a week. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Other "ergot" drugs (e.g., ergotamine, methysergide), or "triptan-type" drugs (e.g., sumatriptan) should not be used within 24 hours of this drug. Tell your doctor if you notice increased use of this medication, the medication not working as well, a worsening of headaches, an increase in the number of headaches, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

See also Warning section and How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: certain beta blockers (e.g., propranolol), decongestants (e.g., pseudoephedrine), delavirdine, dopamine, efavirenz, drugs affecting liver enzymes that remove ergotamine from your body (such as fluconazole, fluoxetine, fluvoxamine, clotrimazole, nefazodone, zileuton), drugs listed in Warning section, nicotine (e.g., nicotine gum, nicotine patches, tobacco), nitrates (e.g., isosorbide, nitroglycerin), other ergot alkaloids (e.g., methysergide), sibutramine. If you also take "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), you will need to separate your "triptan" dose from your dose of this medication to reduce the risk of serious side effects. Ask your doctor how long you should wait between your doses of these drugs. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, other migraine medications) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

Laboratory and/or medical tests (e.g., heart tests) may be performed to monitor your progress. Certain foods/beverages or food additives (e.g., red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (e.g., irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: severe dizziness/drowsiness, loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other ergot alkaloids (e.g., ergotamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood circulation disease (e.g., peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease), uncontrolled high blood pressure, heart/blood vessel disease (e.g., coronary artery disease, stroke, angina, heart attack), liver disease, kidney disease, severe blood infection (sepsis), recent blood vessel surgery. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family history of heart disease, high blood pressure (controlled), high cholesterol, stomach/intestinal problems (e.g., ischemic bowel syndrome), smoking/tobacco use, permanent ending of menstrual periods due to age/surgery/hormonal changes (post-menopausal). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Remember that alcohol may be a cause of headaches. This medication may harm an unborn baby. Therefore, it must not be used during pregnancy. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pill) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Dizziness, drowsiness, headache, nausea, vomiting, diarrhea, flushing, or increased sweating may occur. If any of these effects persist or worsen, tell your doctor. 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. Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, tingling/pain/coldness in the fingers/toes, whitish fingers/toes/nails, loss of feeling in the fingers/toes, bluish hands/feet, muscle pain/weakness in the arms/legs, severe stomach/abdominal pain, lower back pain, little or no urine. Get medical help right away if any of these rare but very serious side effects occur: difficult/painful breathing, chest pain, confusion, slurred speech, weakness on one side of the body, vision problems. A very serious allergic reaction to this drug is rare. However, get medical help right away 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This medication has infrequently caused a lack of blood flow to the hands and feet (peripheral ischemia). It has also rarely caused a lack of blood flow to the brain (cerebral ischemia). The chances of these effects are increased when this medication is taken with certain drugs. Do not take this medication with macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin, telithromycin), protease inhibitors (e.g., amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Consult your doctor or pharmacist for more details.