Drug Details
Drug Name(s) D.H.E. 45
FDA Application No. (NDA) 005929
Active Ingredient(s) DIHYDROERGOTAMINE MESYLATE
Company VALEANT
Original Approval or
Tentative Approval Date April 12, 1946
Drug Name(s) D.H.E. 45
FDA Application No. (NDA) 005929
Active Ingredient(s) DIHYDROERGOTAMINE MESYLATE
Company VALEANT
Original Approval or
Tentative Approval Date April 12, 1946
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 injection
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.
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.
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 injection
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.
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.
Side Effects
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.
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.
Precautions
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.
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.