Dihydroergotamine

Dihydroergotamine Mesylate Injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.

• Dihydroergotamine Mesylate Injection 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
• Dihydroergotamine Mesylate Injection should not be used for chronic daily administration

• Safety and effectiveness
• In pediatric patients have not been established

• The text of a patient information sheet is printed at the end of this insert
• To assure safe and effective use of Dihydroergotamine Mesylate Injection the information and instructions provided in the patient information sheet should be discussed with patients
• Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest, temporary speeding or slowing of the heart rate, swelling, or itching. …

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. …

Vasoconstrictors Dihydroergotamine Mesylate Injection 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 Dihydroergotamine Mesylate Injection. Sumatriptan and Dihydroergotamine Mesylate Injection should not be taken within 24 hours of each other. …

Dihydroergotamine Mesylate Injection should only be used where a clear diagnosis of migraine headache has been established. CYP3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection 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 and ischemia of the extremities. The use of potent CYP3A4 inhibitors with dihydroergotamine should therefore be avoided (see CONTRAINDICATIONS ). …

Serious cardiac events, including some that have been fatal, have occurred following use of Dihydroergotamine Mesylate Injection 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 .). Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate (See WARNINGS: Fibrotic Complications ). …

Pregnancy Risk Summary Available data from published literature indicate an increased risk of preterm delivery with Dihydroergotamine Mesylate Injection use during pregnancy. Avoid use of Dihydroergotamine Mesylate Injection during pregnancy (see WARNINGS ) . Data collected over decades have shown no increased risk of major birth defects or miscarriage with the use of dihydroergotamine mesylate during pregnancy. …

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 Dihydroergotamine Mesylate Injection 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. …

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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.