Drug: D. H. E. 45

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 .

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Serious cardiac events, including some that have been fatal, have occurred following use of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. ( See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS) Post-Introduction Reports The following events derive from postmarketing experience have been occasionally reported in patients receiving D.H.E. 45® (dihydroergotamine mesylate) Injection, USP vasospasm, paraesthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine. Extremely rare cases of myocardial infarction and stroke have been reported. A causal relationship has not been established. D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is not recommended for prolonged daily use. (See DOSAGE AND ADMINISTRATION) DRUG ABUSE AND DEPENDENCE Currently available data have not demonstrated drug abuse or psychological dependence with dihydroergotamine. However, cases of drug abuse and psychological dependence in patients on other forms of ergot therapy have been reported. That, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.
Read the D. H. E. 45 (dihydroergotamine) Side Effects Center for a complete guide to possible side effectsLearn More »

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D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL.

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Vasoconstrictors: D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should not be used with peripheral vasoconstrictors because the combination may cause synergistic elevation of blood pressure. Sumatriptan: Sumatriptan has been reported to cause coronary artery vasospasm, and its effect could be additive with D.H.E. 45® (dihydroergotamine mesylate) Injection, USP. Sumatriptan and D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should not be taken within 24 hours of each other. (See CONTRAINDICATIONS). Beta Blockers: Although the results of a clinical study did not indicate a safe problem associated with the administration of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP to subjects already receiving propranolol, there have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. Nicotine: Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy. Macrolide Antibiotics (e. g. erythromycin and troleandomycin): Agents of the ergot alkaloid class, of which D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is a member, have been shown to interact with antibiotics of the macrolide class, resulting in increased plasma levels of unchanged alkaloids and peripheral vasoconstriction. Vasospastic reactions have been reported with therapeutic doses of ergotamine-containing drugs when co-administered with these antibiotics. SSRI's: Weakness hyperreflexia, and incoordination have been reported rarely when 5-HT1 agonists have been co-administered with SSRI's (e. g. fluoxetine, fluvoxamine, paroxetine, sertraline). There have been no reported cases from spontaneous reports of drug interaction between SSRI's and D.H.E. 45® (dihydroergotamine mesylate) Injection, USP. Oral Contraceptives: The effect of oral contraceptives on the pharmacokinetics of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP has not been studied. Read the D. H. E. 45 Drug Interactions Center for a complete guide to possible interactions Learn More »

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D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.

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D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina. (See WARNINGS) Because D.H.E. 45® (dihydroergotamine mesylate) Injection, USP may increase blood pressure , it should not be given to patients with uncontrolled hypertension. D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, 5-HT1 agonists (e.g., sumatriptan) ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other. D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should not be administered to patients with hemiplegic or basilar migraine. In addition to those conditions mentioned above, D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery and severely impaired hepatic or renal function. D.H.E. 45® (dihydroergotamine mesylate) Injection USP may cause fetal harm when administered to a pregnant woman. Dihydroergotamine possesses oxytocic properties and therefore, should not be administered during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. There are no adequate studies of dihydroergotamine in human pregnancy, but developmental toxicity has been demonstrated in experimental animals. In embryo-fetal development studies of dihydroergotamine mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses of 0.16 mg/day (associated with maternal plasma dihydroergotamine exposures [AUC] approximately 0.4-1.2 times the exposures in humans receiving the MADE of 4 mg) or greater. A no effect level for embryo-fetal toxicity was not established in rats. Delayed skeletal ossification was also noted in rabbit fetuses following intranasal administration of 3.6 mg/day (maternal exposures approximately 7 times human exposures at the MRDD) during organogenesis. A no effect level was seen at 1.2 mg/day (maternal exposures approximately 2.5 times human exposures at the MRDD). When dihydroergotamine mesylate nasal spray was administered intranasally to female rats during pregnancy and lactation, decreased body weights and impaired reproductive function (decreased mating indices) were observed in the offspring at doses of 0.16 mg/day or greater. A no effect level was not established. Effects on development occurred at doses below those that produced evidence of significant maternal toxicity in these studies. Dihydroergotamine-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone. D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids. Dihydroergotamine mesylate should not be used by nursing mothers. (See PRECAUTIONS) Dihydroergotamine mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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To date, there have been no reports of acute overdosage with this drug. Due to the risk of vascular spasm exceeding the recommended dosages of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is to be avoided. Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators and nursing care to prevent tissue damage. In general, the symptoms of an acute D.H.E. 45® (dihydroergotamine mesylate) Injection, USP overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with D.H.E. 45® (dihydroergotamine mesylate) Injection USP. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression, an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions and coma; and/or some degree of nausea, vomiting and abdominal pain. In laboratory animals significant lethality occurs when dihydroergotamine is given at I.V. doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits. Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physician's Desk Reference® (PDR).

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D.H.E. 45® (dihydroergotamine mesylate) Injection, USP Available as a clear, colorless, sterile solution in single 1 mL sterile ampuls containing 1 mg of dihydroergotamine mesylate per mL, in packages of 10 (NDC 0078-0041-01). Store below 77° F(25° C), in light-resistant containers. Do not refrigerate or freeze. To assure constant potency, protect the ampuls from light and heat. Administer only if clear and colorless. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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General D.H.E. 45® (dihydroergotamine mesylate) Injection, USP may cause coronary artery vasospasm; patients who experience signs or symptoms suggestive of angina following its administration should, therefore, be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud's syndrome following the use of any 5-HT agonist are candidates for further evaluation. (See WARNINGS) Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Assessment of the carcinogenic potential of dihydroergotamine mesylate in mice and rats is ongoing. Mutagenesis: Dihydroergotamine mesylate was clastogenic in two in vitro chromosomal aberration assays, the V79 Chinese hamster cell assay with metabolic activation and the cultured human peripheral blood lymphocyte assay. There was no evidence of mutagenic potential when dihydroergotamine mesylate was tested in the presence or absence of metabolic activation in two gene mutation assays (the Ames test and the in vitro mammalian Chinese hamster V79/HGPRT assay) and in an assay for DNA damage (the rat hepatocyte unscheduled DNA synthesis test). Dihydroergotamine was not clastogenic in the in vivo mouse and hamster micronucleus tests. Impairment of Fertility: Impairment of fertility was not evaluated for D.H.E. 45® (dihydroergotamine mosylate) Injection, USP. There was no evidence of impairment of fertility in rats given intranasal doses of Migranal® Nasal Spray up to 1.6 mg/day (associated with mean plasma dihydroergotamine mesylate exposures [AUC] approximately 9 to 11 times those in humans receiving the MADE of 4 mg). Pregnancy Pregnancy Category X: See CONTRAINDICATIONS. Nursing Mothers Ergot drugs are known to inhibit prolactin. It is likely that D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is excreted in human milk, but there are no data on the concentration of dihydroergotamine in human milk. It is known that ergotamine is excreted in breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. Because of the potential for these serious adverse events in nursing infants exposed to D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, nursing should not be undertaken with the use of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP. (See CONTRAINDICATIONS) Pediatric Use Safety and effectiveness in pediatric patients have not been established. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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