Classes
DEA Class; Rx
Common Brand Names; D.H.E. 45, Migranal, Trudhesa
- Ergot Derivatives
Description
Parenteral and nasally administered ergotamine derivative
Used for the treatment of acute migraine with or without aura and cluster headache
Associated with serious adverse cardiac and cerebrovascular events; cardiovascular evaluation recommended prior to starting therapy
Indications
Indicated for the acute treatment of migraine with or without aura.
Indicated for acute treatment of migraine headaches with or without aura, and acute treatment of cluster headache episodes
Contraindications
Coadministration with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole)
Patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal’s variant angina
Uncontrolled hypertension
Within 24 hours of 5-HT 1 agonists (eg, sumatriptan), ergotamine-containing or ergot-type medications or methysergide
Patients with hemiplegic or basilar migraine
Patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function
During pregnancy
Documented hypersensitivity to drug or excipients
Nursing mothers
Coadministration with peripheral and central vasoconstrictors
Adverse Effects
Common
Dizziness
Paresthesia
Nausea
Vomiting
Taste sense altered, Nasal spray
Nasal irritation
Throat irritation
Serious
Peripheral ischemia (rare)
Vasospasm
Tachycardia
Cerebrovascular disease
Ergotism (rare)
Warnings
Only for use where a clear diagnostic of migraine has been established
Pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable dihydroergotamine mesylate reported; prolonged daily use of other ergot alkaloid drugs associated with cardiac valvular fibrosis (rare); therapy should not exceed dosing guidelines and should not be used for chronic daily administration
Potential for adverse cardiac events exists; serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death reported to have occurred following administration of dihydroergotamine mesylate injection; considering the extent of use of dihydroergotamine mesylate in patients with migraine, the incidence of these events is extremely low
Significant elevation in blood pressure reported on rare occasions in patients with and without a history of hypertension treated with this drug; therapy is contraindicated in patients with uncontrolled hypertension
Therapy may cause coronary artery vasospasm; patients who experience signs or symptoms suggestive of angina following its administration should be evaluated for presence of CAD or a predisposition to variant angina before receiving additional doses
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
Pregnancy and Lactation
Available data from published literature indicate an increased risk of preterm delivery with use during pregnancy
There are no data on presence of this drug in human milk; however, ergotamine, a related drug, is present in human milk
Maximum Dosage
3 mg/day IM or subcutaneous or 2 mg/day IV and 6 mg/week IV/IM/subcutaneous; 3 mg/day and 4 mg/week intranasal (Migranal and generic equivalents) or 2.9 mg/day and 4.35 mg/week intranasal (Trudhesa).
3 mg/day IM or subcutaneous or 2 mg/day IV and 6 mg/week IV/IM/subcutaneous; 3 mg/day and 4 mg/week intranasal (Migranal and generic equivalents) or 2.9 mg/day and 4.35 mg/week intranasal (Trudhesa).
Safety and efficacy have not been established; however, doses up to 1 mg/dose IV or 3 mg/day IV have been used off-label.
10 to 12 years weighing 25 kg or more: Safety and efficacy have not been established; however, doses up to 1 mg/dose IV or 3 mg/day IV have been used off-label.
10 to 12 years weighing less than 25 kg: Safety and efficacy have not been established; however, doses up to 0.5 mg/dose IV or 1.5 mg/day IV have been used off-label.
6 to 9 years: Safety and efficacy have not been established; however, doses up to 0.5 mg/dose IV or 1.5 mg/day IV have been used off-label.
1 to 5 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
