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Dihydroergotamine Mesylate (D.h.e. 45)

Trade Name : D.H.E. 45

Bausch Health US, LLC

INJECTION, SOLUTION

Strength 1 mg/mL

DIHYDROERGOTAMINE MESYLATE Ergotamines [CS],Ergotamine Derivative [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dihydroergotamine Mesylate (D.h.e. 45) which is also known as D.H.E. 45 and Manufactured by Bausch Health US, LLC. It is available in strength of 1 mg/mL per ml. Read more

Dihydroergotamine Mesylate (D.h.e. 45) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated n
  • D.H.E. 45 is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45 is known chemically as ergotaman-3u00b4,6u00b4,18-trione,9,10-dihydro-12u00b4-hydroxy-2u00b4-methyl-5u00b4-(phenylmethyl)-,(5u00b4u03b1)-, monomethanesulfonate. Its molecular weight is 679.80 and its empirical formula is CHNOu2022CHOS.
  • The chemical structure is:
  • Dihydroergotamine mesylateCHNOu2022CHOSu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Mol. Wt. 679.80
  • D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is a clear, colorless solution supplied in sterile ampuls for intravenous, intramuscular, or subcutaneous administration. Each mL contains 1 mg Dihydroergotamine Mesylate, USP; Alcohol, USP 6.1% by volume; Glycerin, USP 15% by weight; Water for Injection, USP; Methanesulfonic Acid and/or Sodium Hydroxide for pH adjustment (pH range is 3.4 to 4.9).
  • No data
  • 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.
  • There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP3A4 inhibitors (i.e., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore, contraindicated ().
  • D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should not be given to patients with ischemic heart disease (e.g., 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 ().
  • 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-HT 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 embryofetal 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 to 1.2 times the exposures in humans receiving the MRDD of 4 mg) or greater. A no effect level for embryofetal 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 ().
  • Dihydroergotamine mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.
  • D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should only be used where a clear diagnosis of migraine headache has been established.
  • No data
  • 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 , , and ). Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate ().
  • The following events derived 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 (s).
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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. Thus, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.
  • 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 (PDR).*
  • 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. D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should not be used for chronic daily administration.
  • No data
  • Information for the Patient
  • D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
  • Before self-injecting D.H.E. 45 (dihydroergotamine mesylate) Injection, USP by subcutaneous administration, you will need to obtain professional instruction on how to properly administer your medication. Below are some of the steps you should follow carefully. Read this leaflet completely before using this medication.
  • This leaflet does not contain all of the information on D.H.E. 45 (dihydroergotamine mesylate) Injection, USP. Your pharmacist and/or health care provider can provide more detailed information.
  • Purpose of your medication
  • D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is intended to treat an active migraine headache. Do not try to use it to prevent a headache if you have no symptoms. Do not use it to treat common tension headache or a headache that is not at all typical of your usual migraine headache. Administration of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should not exceed the dosing guidelines and should not be used for chronic daily administration. There have been reports of fibrosis (stiffening) in the lung or kidney areas in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs (the class of drugs to which D.H.E. 45 (dihydroergotamine mesylate) Injection, USP belongs) has been associated with heart valvular fibrosis.
  • Rare cases have also been reported in association with the use of injectable dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with heart valvular fibrosis.
  • Do not use D.H.E. 45 (dihydroergotamine mesylate) Injection, USP if you:
  • Important questions to consider before using n- D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
  • Please answer the following questions before you use your D.H.E. 45 (dihydroergotamine mesylate) Injection, USP.
  • If you answer YES to any of these questions or are unsure of the answer, you should talk to your doctor before using D.H.E. 45 (dihydroergotamine mesylate) Injection, USP.
  • Serious or potentially life-threatening reductions in blood flow to the brain or extremities have been reported rarely due to interactions between D.H.E. 45 (dihydroergotamine mesylate) Injection, USP and protease inhibitors or macrolide antibiotics.
  • REMEMBER TO TELL YOUR DOCTOR IF YOU HAVE ANSWERED u201cYESu201d TO ANY OF THESE QUESTIONS BEFORE YOU USE D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
  • Side effects to watch out for
  • Although the following reactions rarely occur, they can be serious and should be reported to your physician immediately:
  • Dosage
  • Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with D.H.E. 45 (dihydroergotamine mesylate) Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should be injected during a 1-week period. D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is not intended to be used on a prolonged daily basis.
  • Learn what to do in case of an Overdose
  • If you have used more medication than you have been instructed, contact your doctor, hospital emergency department, or nearest poison control center immediately.
  • How to use the D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
  • Check the expiration date printed on the ampul containing medication. If the expiration date has passed, do not use it.
  • Answers to Patients' Questions About D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
  • What if I need help in using my D.H.E. 45 (dihydroergotamine mesylate) Injection, USP?
  • If you have any questions or if you need help in opening, putting together, or using D.H.E. 45 (dihydroergotamine mesylate) Injection, USP, speak to your doctor or pharmacist.
  • How much medication should I use and how often?
  • Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with D.H.E. 45 (dihydroergotamine mesylate) Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should be injected during a 1-week period. Do not use more than this amount unless instructed to do so by your doctor. D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is not intended for chronic daily use.
  • If you have any other unanswered questions about D.H.E. 45 (dihydroergotamine mesylate) Injection, USP, consult your doctor or pharmacist.
  • *Trademark of PDR Network, LLC
  • Distributed by
  • Bausch Health US, LLC
  • Bridgewater, NJ 08807 USA
  • Manufactured by:
  • u00ae/u2122 are trademarks of Bausch Health Companies Inc. or its affiliates.u00a9 2019 Bausch Health Companies Inc. or its affiliates
  • NDC 66490-041-01n- Rx Only
  • D.H.E. 45n- (dihydroergotamine mesylate) injection, USP
  • 1 mg/mL
  • FOR INTRAVENOUS, INTRAMUSCULAR,n- AND SUBCUTANEOUS USE ONLY
  • 10 u00d7 1 mL ampulsn- Unit Dose Package
  • Bausch Health n

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