WARNING
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 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. (See also CONTRAINDICATIONS and WARNINGS section)
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D.H.E. 45 SUMMARY
D.H.E. 45ฎ
(dihydroergotamine mesylate)
Injection, USP
Rx only
Prescribing Information
D. H. E. 45ฎ is ergotamine hydrogenated in the 9, 10 position as the mesylate salt.
D.H.E. 45ฎ (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
ethanol, 94% w/w
6.2% by vol.
glycerin
15% by wt.
water for injection, qs to
..1 mL
D.H.E. 45ฎ (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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NEWS HIGHLIGHTS
Published Studies Related to D.h.e. 45 (Dihydroergotamine)
The PROMISE study: PROphylaxis of MIgraine with SEglor (dihydroergotamine mesilate) in French primary care. [2004]
INTRODUCTION: Seglor capsules, a unique modified-release formulation of dihydroergotamine mesilate, have long been in clinical use in France for migraine prophylaxis. The aim of the PROMISE (PROphylaxis of MIgraine with SEglor) study was to establish the efficacy and tolerability of Seglor in the prevention of migraine in a general practice setting... CONCLUSION: These results support the effectiveness of Seglor in patients with migraine-related quality-of-life impairment. The findings of the PROMISE study also suggest that patients' quality of life should be assessed systematically before initiating a preventive treatment for migraine.
Comparison of intravenous valproate versus intramuscular dihydroergotamine and metoclopramide for acute treatment of migraine headache. [2001.11]
OBJECTIVE: To determine the effectiveness and tolerability of intravenous valproate for the acute treatment of migraine headache with or without aura (International Headache Society diagnostic criteria 1.1 and 1.2) compared with intramuscular metoclopramide 10 mg followed 10 minutes later by intramuscular dihydroergotamine 1 mg. BACKGROUND: Divalproex sodium is approved for prophylaxis of migraine headache. We studied the possible effectiveness of intravenous sodium valproate for the treatment of acute migraine headache. Valproate offers a treatment option for patients with migraine who recently have used a triptan or dihydroergotamine, theoretically avoiding the risk of drug interactions or cardiovascular complications... CONCLUSIONS: Intravenous valproate is similar in effectiveness to dihydroergotamine/metoclopramide as abortive therapy for prolonged moderate-to-severe acute migraine headache. Although the results were not statistically significant (P =.3635), intravenous valproate appears to offer a safe, effective, and well-tolerated treatment for patients with acute migraine. Relative to dihydroergotamine/metoclopramide, however, headache relief was not as likely to be sustained at 24 hours as with intravenous valproate.
Haemodynamic effects of three doses of dihydroergotamine during spinal anaesthesia. [2001.09]
We performed a randomized study comparing the haemodynamic effects of three doses of the vasopressor dihydroergotamine (DHE) (5, 10 and 15 microg x kg(-1)) in 30 ASA 1 and 2 patients, aged 53-87 yr, undergoing spinal anaesthesia. Non-invasive systolic arterial pressure (SAP), heart rate and central venous pressure (CVP) were recorded continuously for 25 min...
Dihydroergotamine: discrepancy between arterial, arteriolar and pharmacokinetic data. [2001.07]
AIMS: To investigate the peripheral vascular effects and pharmacokinetics of dihydroergotamine (DHE) 0.5 mg after a single subcutaneous administration in humans... CONCLUSIONS: DHE decreased diameter and compliance of the brachial artery whereas forearm vascular resistance remained unchanged. Thus, DHE acts on conduit arteries without affecting resistance arteries. Furthermore, a discrepancy was demonstrated between the plasma concentrations of DHE which rapidly reach peak levels and quickly decline, and its long lasting vasoconstrictor activity.
Effects of dihydroergotamine on intracranial pressure, cerebral blood flow, and cerebral metabolism in patients undergoing craniotomy for brain tumors. [2001.07]
In a search for a nonsurgical intervention to control intracranial hypertension during craniotomy, the authors studied the effects of dihydroergotamine on mean arterial blood pressure (MABP), intracranial pressure (ICP), cerebral perfusion pressure (CPP), cerebral blood flow (CBF), and cerebral metabolism in patients who underwent craniotomy for supratentorial brain tumors...
Clinical Trials Related to D.h.e. 45 (Dihydroergotamine)
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity [Completed]
This is a research study examinining a migraine medicine called DHE-45. It will be used to
treat two migraine attacks in subjects who have a history of skin sensitivity associated with
their headaches. This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us
al-o-din-ee-uh).It has been noted in several studies that in subjects with migraine, seventy
nine percent of the subjects experienced allodynia on the facial skin on the same side as the
headache. It has also been shown that that once allodynia develops, other migraine medicines
that would normally be very effective for migraine pain, become much less effective or
ineffective. This study will compare the differences,if any, in attacks treated early with
this study drug and treated later with the same study drug. It is hoped that that this trial
will provide information on the use of DHE-45 in subjects who have cutaneous allodynia.
Understanding more about allodynia may help us understand how the pain system works in
migraine.
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine [Recruiting]
This is a research study looking at Migranal (study drug) in the treatment of two migraine
attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us
al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a
headache. It has been noted in several studies that in patients with migraine, seventy nine
percent of the patients experienced allodynia on the facial skin on the same side as the
headache. Understanding more about allodynia may help us understand how the pain system
works in migraine.
This study will compare the differences, if any, in attacks treated early with study drug
(at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat
one attack early and one attack late for this study. If the first attack you treat is early
(at 1 hour following onset of throbbing pain) then the second attack you treat should be
late (at 4 hours following onset of throbbing pain).
It is hoped that this study will provide information on the use of Migranal in subjects who
have cutaneous allodynia. The results from this study may be used in the development of
larger clinical trials. The study drug is a medication that is taken in the form of nasal
spray.
A Research Study to Examine Cutaneous Allodynia and Cluster Headache [Recruiting]
This is a research study examining cutaneous (q-tan-ee-us) allodynia (all-o-din-ee-uh) and
cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation
when normally non-painful stimuli (e. g. light touch) are applied to the skin. Many studies
have been performed looking at the presence of cutaneous allodynia in patients with
migraine; however, few studies have examined it in cluster headache patients. There is
still much to be learned about the brain and how it functions if we are to understand the
underlying causes of cluster headache. It is important to explore cutaneous allodynia in
cluster headache as it may help guide physicians with the care of these individuals. Sixty
patients will be screened for this study, in order to enroll sixty subjects. Thomas
Jefferson University is the only center enrolling patients in this research study.
Phase 3 Study of MAP0004 in Adult Migraineurs [Not yet recruiting]
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in
adult migraineurs. Subjects will self administer study drug in the outpatient setting.
Continuous Fetal Monitoring During Vacuum Delivery [Not yet recruiting]
The investigators have added an additional electrode to the vacuum device for birth in which
they can monitor the fetus during delivery.
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Page last updated: 2008-08-10
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