Warnings:

This medication has rarely caused a very serious lack of blood flow to the hands and feet (peripheral ischemia) or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of dihydroergotamine from your body. Examples include azole antifungals (such as ketoconazole, itraconazole), cobicistat, mifepristone, certain antidepressants (such as nefazodone), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV NNRTIs (such as delavirdine), HIV protease inhibitors (such as ritonavir, nelfinavir, indinavir), SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.

Warnings:

This medication has rarely caused a very serious lack of blood flow to the hands and feet (peripheral ischemia) or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of dihydroergotamine from your body. Examples include azole antifungals (such as ketoconazole, itraconazole), cobicistat, mifepristone, certain antidepressants (such as nefazodone), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV NNRTIs (such as delavirdine), HIV protease inhibitors (such as ritonavir, nelfinavir, indinavir), SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.

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Uses

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 (such as ergotamine, methysergide), or "triptan-type" drugs (such as 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.

Side Effects

Dizziness, drowsiness, headache, nausea, vomiting, diarrhea, flushing, or increased sweating may occur. If any of these effects last or get worse, tell your doctor.

Remember that this medication has been prescribed because your doctor 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, signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: difficult/painful breathing, chest pain, confusion, trouble speaking, 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other ergot alkaloids (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation disease (such as peripheral arterial disease, Raynaud's disease), heart disease (such as coronary artery disease, angina, heart attack), stroke, diabetes, family history of heart disease, high blood pressure, high cholesterol, liver disease, kidney disease, severe blood infection (sepsis), recent blood vessel surgery, stomach/intestinal problems (such as 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dihydroergotamine. Dihydroergotamine may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This drug may pass into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 3 days after the last dose. Consult your doctor before breast-feeding.

Interactions

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 (such as 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).

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Overdose

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 (such as heart tests) may be performed to monitor your progress.

Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (such as 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.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.