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|D.H.E 45

D.H.E 45

D.H.E 45 is used for:

Preventing or treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots) and cluster headaches.

D.H.E 45 is an ergot derivative. It works by constricting blood vessels in the brain, which helps to relieve migraine headaches.

Do NOT use D.H.E 45 if:

• you are allergic to any ingredient in D.H.E 45 or to other ergot derivatives (eg, ergotamine)
• you are pregnant, planning to become pregnant, or are breast-feeding
• you are taking delavirdine, efavirenz, an HIV protease inhibitor (eg, indinavir), an imidazole (eg, ketoconazole), a macrolide (eg, erythromycin), a ketolide (eg, telithromycin), sumatriptan, or voriconazole
• you have used other migraine medications (eg, ergot-containing medications, another 5-HT₁ agonist) within the last 24 hours
• you have a history of heart disease, heart attack, or chest pain, or you have recently had heart surgery
• you have severely impaired kidney or liver function, uncontrolled high blood pressure, or other types of migraine headaches (hemiplegic or basilar)
• you have brain, heart, or peripheral blood vessel disease, blood circulation problems, or a blood disease, or you have had vascular surgery
• you have an infection of blood or tissues

Contact your doctor or health care provider right away if any of these apply to you.

Before using D.H.E 45 :

Some medical conditions may interact with D.H.E 45 . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have high blood pressure, high cholesterol, diabetes, liver or kidney disease, porphyria, a strong family history of heart disease, or a history of shortness of breath
• if you smoke or are overweight
• if you are a woman past menopause or have had a hysterectomy
• if you are a man older than 40 years of age
• if your migraine headache is different from previous migraines

Some MEDICINES MAY INTERACT with D.H.E 45 . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), delavirdine, efavirenz, HIV protease inhibitors (eg, indinavir), imidazoles (eg, ketoconazole), ketolides (eg, telithromycin),macrolides (eg, erythromycin), sumatriptan, or voriconazole because side effects, such as pain or weakness in the arms or legs or heart problems, may occur
• Droxidopa, sumatriptan, or sympathomimetics (parenteral) (eg, ephedrine) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if D.H.E 45 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use D.H.E 45 :

Use D.H.E 45 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Avoid eating grapefruit or drinking grapefruit juice while taking D.H.E 45 .
• D.H.E 45 comes with an additional patient leaflet. Read it carefully and reread it each time you get D.H.E 45 refilled.
• The first dose of D.H.E 45 may be given to you by your health care provider.
• Carefully follow the injection procedures taught to you by your health care provider. If you have any questions about how to properly use D.H.E 45 , contact your health care provider.
• D.H.E 45 is to be injected into a large muscle (in the middle of your thigh) as directed by your health care provider.
• Do not use daily on a regular basis.
• Do not use more than 6 doses per week, unless otherwise directed by your doctor.
• If D.H.E 45 contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If a dose is missed, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised to by your health care provider. If more than one dose is missed, contact your health care provider.

Ask your health care provider any questions you may have about how to use D.H.E 45 .

Important safety information:

• D.H.E 45 may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to D.H.E 45 . Using D.H.E 45 alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Additional monitoring of your condition may be needed if you are taking sumatriptan, nefazodone, fluconazole, fluoxetine, fluvoxamine, zileuton, clotrimazole, or other mild CYP3A4 enzyme inhibitors.
• Use D.H.E 45 with caution in the ELDERLY because they may be more sensitive to its effects.
• D.H.E 45 is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: D.H.E 45 has been shown to cause harm to the fetus. Do not use D.H.E 45 if you are pregnant. If you suspect that you could be pregnant, contact your immediately. D.H.E 45 is excreted in breast milk. Do not breast-feed while taking D.H.E 45 .

Possible side effects of D.H.E 45 :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; anxiety; diarrhea; dizziness; flushing; headache; increased sweating; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; itching; muscle pain or weakness in the arms and legs; numbness, coldness, loss of color, or tingling in the fingers and toes; swelling; swelling or itching at the injection site; temporary speeding or slowing of the heart rate.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; confusion; fainting; fast heartbeat; flushing; lightheadedness; numbness, tingling, or bluish discoloration in the fingers or toes; seizures; slow heartbeat; slowed breathing; stomach pain; weakness of the legs.

Store at or below 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat and light. Do not refrigerate or freeze. Do not use if the solution is discolored. Keep D.H.E 45 out of the reach of children and away from pets.

General information:

• If you have any questions about D.H.E 45 , please talk with your doctor, pharmacist, or other health care provider.
• D.H.E 45 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about D.H.E 45 . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.