D.H.E. 45 injection

Dihydroergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain and affects blood flow patterns that are associated with certain types of headaches.

Dihydroergotamine injection is used to treat a migraine or cluster headache attack. This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Dihydroergotamine injection should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Dihydroergotamine is not for daily use.

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

Do not use this medication if you are allergic to dihydroergotamine or other ergot medicine such as Ergomar, Cafergot, Migergot, Migranal, or Methergine. Do not use dihydroergotamine injection if you are pregnant or breast-feeding, or if you have:

• a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;

• coronary artery disease or "hardening of the arteries";

• uncontrolled high blood pressure;

• severe liver or kidney disease;

• a serious infection called sepsis; or

• if you have recently had heart or blood vessel surgery (such as bypass surgery).

Using certain medications together with dihydroergotamine can cause even greater decreases in blood flow than dihydroergotamine used alone, which can lead to dangerous side effects. Do not use dihydroergotamine if you are also using any of the following medications:

• conivaptan (Vaprisol), imatinib (Gleevec), isoniazid (for treating tuberculosis), or nefazodone (an antidepressant);

• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

• clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

• clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan); or

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

Dihydroergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. To make sure you can safely take dihdroergotamine, tell your doctor if you have any of these other conditions:

• breathing problems;

• high blood pressure;

• ischemic bowel disease;

• liver or kidney disease; or

• coronary heart disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category X. Dihydroergotamine can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Dihydroergotamine can pass into breast milk and may harm a nursing baby. Dihydroergotamine may also decrease milk production. Do not use if you are breast-feeding a baby.

Use exactly as prescribed by your doctor. Never use more than your prescribed dose of dihydroergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Dihydroergotamine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

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

If your headache does not completely go away, you may use a second injection after 1 hour has passed, and a third injection if needed after another hour has passed (a total of 3 injections).

If you still have migraine symptoms after using 3 injections, call your doctor before using any more. If your headache goes away and then comes back, you may use the medication again if it has been at least 6 hours since your last injection.

Do not use more than a total of 3 injections of this medication in any 24-hour period. Do not use more than a total of 6 injections over a period of 7 days.

Dihydroergotamine injection should be clear and colorless. Do not use if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

If you use dihydroergotamine 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.

Store at room temperature away from moisture, heat, and light. Do not use if the expiration date on the label has passed.

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

Stop using dihydroergotamine and call your doctor at once if you have a serious side effect such as:

• fast or slow heart rate, swelling or itching in any part of your body;

• chest pain spreading to the arm or shoulder, and nausea, sweating, or general ill feeling;

• sudden numbness or weakness, sudden headache, confusion, or problems with vision, speech, or balance;

• leg weakness, muscle pain in your arms or legs;

• numbness, tingling, and a pale or blue-colored appearance in your fingers or toes;

• stomach cramps, diarrhea that may be bloody;

• cough with stabbing chest pain and trouble breathing; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath).

Less serious side effects may include:

• headache, dizziness, feeling anxious;

• diarrhea;

• sweating, mild skin rash, redness or tingly feeling under your skin.

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.

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.

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (such as chest pain, fast/slow/irregular heartbeat) and decreased blood supply to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

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.

Dihydroergotamine is used to treat migraine headaches and cluster headaches. It is not recommended for migraines that affect only one side of the brain (hemiplegic migraine) or the base of the brain/neck area (basilar migraine), or to prevent migraines from occurring.

Dihydroergotamine is an ergot medication that helps narrow widened blood vessels in the head, thereby reducing the throbbing effects of these headaches.

How to use D.H.E.45 Ampul

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. The solution is normally clear and colorless. 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.

If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.

See also Warning and How to Use sections.

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: bronchodilators/decongestants/stimulants (such as epinephrine, pseudoephedrine, methylphenidate, amphetamine).

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.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or other migraine medications).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can 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.

Notes

Do not share this medication with others.

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.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Do not refrigerate or freeze. Do not store in the bathroom. 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.Information last revised May 2017. Copyright(c) 2017 First Databank, Inc.