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Dihydroergotamine mesylate injection
DIHYDROERGOTAMINE - INJECTABLE

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DIHYDROERGOTAMINE - INJECTABLE

(dye-HI-dro-er-GOT-uh-meen)

COMMON BRAND NAME(S): D.H.E.45

WARNING: Infrequently, a very serious, life-threatening decrease in the amount of blood supply to the hands and feet (peripheral ischemia) and rarely to the brain can occur when this medication is taken with drugs that affect liver metabolism (e.g., potent CYP 3A4 enzyme inhibitors). Do not take this medication with macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin), protease inhibitors (e.g., ritonavir, nelfinavir, indinavir, amprenavir, saquinavir), azole antifungals (e.g., ketoconazole, itraconazole).

Uses

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

OTHER

Uses

This drug may also be used to prevent blood clots (e.g., thromboembolism, pulmonary embolism) or to treat low blood pressure (postural hypotension).

How To Use

Learn how to prepare and inject this drug and review the dihydroergotamine Patient Information Sheet with your doctor or pharmacist. Inject this medication into a vein (IV), into a muscle (IM), or under the skin (SC), as directed by your doctor. The dosage is based on your medical condition and response to therapy. If your headache returns or you have no relief from the first dose, the dose may be repeated 1 hour after the first dose; but only if instructed to do so by your doctor. If giving this medication by the IM or SC route, a third dose may be given, if needed, 1 hour after the second dose. If any of the dosing information is unclear, consult your doctor or pharmacist. If given IM or SC, do not exceed 3 ml of this medication in a 24-hour time period. If given IV, do not exceed 2 ml of this medication in a 24-hour time period. Do not use daily on a regular basis. Do not exceed giving 6 ml of this medication in a one-week time period. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

Dizziness, drowsiness, headache, nausea, vomiting, diarrhea, flushing, or increased sweating may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling, itching, trouble breathing, mental/mood changes (e.g., anxiety), tingling or numbness of the hands/feet, rash, stomach pain. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: muscle pain, chest pain, muscle weakness, unusually fast or slow heartbeat, one-sided weakness, vision problems, slurred speech, confusion. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication is not recommended for use if you have the following medical conditions: certain types of heart problems (e.g., ischemic heart disease including angina and heart attacks), uncontrolled high blood pressure, severe blood infections (sepsis), recent blood vessel surgery, blood vessel/circulation problems (e.g., coronary artery disease, peripheral artery disease), severe liver or kidney disease. Tell your doctor your medical history, especially of: liver problems, kidney problems, stroke, high blood pressure, diabetes, high cholesterol, stomach/intestinal problems (e.g., ischemic bowel syndrome), family history of heart disease, tobacco use, any allergies (especially to ergot migraine drugs such as ergotamine). This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages; alcohol may also make your headaches worse. This medication must not be used in pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk and has had undesirable effects on nursing infants. Breast-feeding while using this drug is not recommended.

Drug Interactions

This drug is not recommended for use with: weight loss medicine (e.g., fenfluramine, sibutramine), "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), efavirenz. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: decongestants (e.g., pseudoephedrine), nitrate heart medicine (e.g., isosorbide, nitroglycerin), dopamine, certain asthma medications (e.g., albuterol, salmeterol), beta blockers (e.g., metoprolol, propranolol), nicotine-containing products (e.g., tobacco or nicotine patches), SSRI antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline), nefazodone, fluconazole, zileuton, clotrimazole, other mild CYP 3A4 enzyme inhibitors. Also see Warning section for additional drug interaction information. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: vomiting, slow or shallow breathing, cold/pale or blue-colored hands/feet, seizures.

Notes

Do not share this medication with others. Laboratory and/or medical tests may be performed to monitor your progress.

Missed Dose

Not applicable.

Storage

Store at room temperature between 59 and 77 degrees F (15 and 25 degrees C) away from light and moisture. Do not refrigerate or freeze this product.