D. H. E. 45

DRUG DESCRIPTION

D.H.E. 45 (dihydroergotamine) ® is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45 (dihydroergotamine) ® is known chemically as ergotaman-3',6',18-trione,9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl) (5'a)-, monomethanesulfonate. Its molecular weight is 679. 80 and its empirical formula is C₁₃H₃₇N₅O₅ · CH₄O₃S. Its chemical structure is:

D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is a clear, colorless solution supplied in sterile ampuls for I.V., I.M. , or subcutaneous administration containing per mL:

dihydroergotamine mesylate, USP .................................. 1 mg
methanesulfonic acid/sodium hydroxide, qs to ..................pH 3.6 ± 0. 4
alcohol USP ...................................................................6.1 % by vol.
glycerin, UP ...................................................................15% by wt.
water for injection, USP , qs to ...................................... 1 ml .

What are the possible side effects of dihydroergotamine injection (D.H.E. 45)?

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;


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


• sudden numbness or weakness, especially on one side of the body;


• sudden...

Read All Potential Side Effects and See Pictures of D. H. E. 45 »

What are the precautions when taking dihydroergotamine (D. H. E. 45)?

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...

Read All Potential Precautions of D. H. E. 45 »

D. H. E. 45 Consumer (continued)

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 (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.

This medication may harm an unborn baby. Therefore, it must not be used during pregnancy. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pill) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.

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.

D. H. E. 45 Patient Information Including Side Effects

Brand Names: D.H.E. 45

Generic Name: dihydroergotamine (injection) (Pronunciation: dye HYE droe er GOT a meen)

• What is dihydroergotamine injection (D. H. E. 45)?


• What are the possible side effects of dihydroergotamine injection (D. H. E. 45)?


• What is the most important information I should know about dihydroergotamine injection (D. H. E. 45)?


• What should I discuss with my healthcare provider before using dihydroergotamine injection (D. H. E. 45)?


• How should I use dihydroergotamine injection (D. H. E. 45)?


• What happens if I miss a dose (D. H. E. 45)?


• What happens if I overdose (D. H. E. 45)?


• What should I avoid while using dihydroergotamine injection (D. H. E. 45)?


• What other drugs will affect dihydroergotamine injection (D. H. E. 45)?


• Where can I get more information?

What is dihydroergotamine injection (D. H. E. 45)?

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

What are the possible side effects of dihydroergotamine injection (D. H. E. 45)?

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;


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


• sudden numbness or weakness, especially on one side of the body;


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


• muscle pain in your arms or legs;


• leg weakness;


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


• swelling or itching in any part of your body;


• 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, uneven heartbeats, seizure).

Less serious side effects may include:

• headache, dizziness, feeling anxious;


• diarrhea;


• warmth, redness, or tingly feeling under your skin; or


• sweating, mild skin rash.

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.

What is the most important information I should know about dihydroergotamine injection (D. H. E. 45)?

This medication can harm an unborn baby or a nursing baby. Do not use dihydroergotamine injection if you are pregnant or breast-feeding.

Do not use this medication if you are allergic to dihydroergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, a serious infection, if you have recently had heart or blood vessel surgery.

Using certain medications together with dihydroergotamine can cause even greater decreases in blood flow than dihydroergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, ischemic bowel disease, liver or kidney disease, or risk factors for coronary artery disease (such as 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).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

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. An overdose of dihydroergotamine can be fatal.

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