Monograph Details
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Pain & Pyrexia
> Migraine and headache
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D.H.E. 45 |
| Manufacturer |
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Valeant Pharmaceuticals, Inc |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Ergot alkaloid. |
| Generic Name |
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Dihydroergotamine mesylate 1mg/mL; for IM, IV, or SC inj. |
| Indications |
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Acute treatment of migraine headache or cluster headache episodes. |
| Children |
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Not recommended. |
| Adults |
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1mL IV at 1 hour intervals; max 2 doses/day. Or, 1 mL IM or SC at 1-hour intervals; max 3 doses/day. For all: max 6 doses/week. Do not use chronically. |
| Contraindications |
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Ischemic heart disease. Coronary artery vasospasm (eg, Prinzmetal's angina) or myocardial ischemia. Peripheral artery disease. Sepsis. Post-vascular surgery. Uncontrolled hypertension. Other significant cardiovascular disease. Severely impaired hepatic or renal function. Basilar or hemiplegic migraine. Concomitant potent CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandmycin, ketoconazole, itraconazole) or other vasoconstrictors. Within 24 hours of sumatriptan, zolmitriptan, other 5-HT1 agonists, or ergot-type drugs. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Confirm diagnosis. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary disease (eg, postmenopausal women, men over age 40, hypercholesterolemia, hypertension, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Compromised circulation. Elderly. |
| Interactions |
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See Contraindications. Potentiated by CYP3A4 inhibitors (eg, protease inhibitors, macrolides, azole antifungals, saquinavir, nefazodone, fluoxetine, fluvoxamine, grapefruit juice, zileuton), propranolol, nicotine. |
| Adverse Reactions |
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Numbness, pain, weakness of extremities, epigastric distress, tachycardia or bradycardia, nausea, vomiting, localized edema and itching, cardiac or cerebrovascular events; myocardial and peripheral vascular ischemia or vasoconstriction (ergotism: discontinue if occurs); rare: fibrotic complication. |
| How Supplied |
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Amps (1 mL)—10 |
| Additional Resources |
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• Related Prescribing Note |
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