Dihydroergotamine Mesylate 1 mg/mL
Dihydroergotamine Mesylate · INJECTION · Hikma Pharmaceuticals USA Inc.
Dihydroergotamine Mesylate is a injection containing dihydroergotamine mesylate at 1 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Dihydroergotamine Mesylate
- Generic Name
- Dihydroergotamine Mesylate
- NDC Code (Product)
0143-9151- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA040453
- Marketing Start
- 03/31/2023
Recall History
Provepharm Inc.
Discoloration
JD & SN Inc., dba Moses Lake Professional Pharmacy
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Dihydroergotamine Mesylate Injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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.
Warnings
WARNINGS 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 ). Examples of some of the more potent CYP3A4 inhibitors include: anti-fungals ketoconazole and itraconazole, the protease inhibitors ritonavir, nelfinavir, and indinavir, and macrolide antibiotics erythromycin, clarithromycin, and troleandomycin. Other less potent CYP3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concom…
Contraindications
CONTRAINDICATIONS 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 (See WARNINGS: CYP3A4 Inhibitors ). Dihydroergotamine Mesylate Injection 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. (See WARNINGS .) Because Dihydroergotamine Mesylate Injection may increase blood pressure, it should not be given to patients with uncontrolled hypertension. Dihydroergotamine Mesylate Injection 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of …
Drug Interactions
Drug Interactions 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. (See CONTRAINDICATIONS .) Beta Blockers Although the results of a clinical study did not indicate a safety problem associated with the administration of Dihydroergotamine Mesylate Injection 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. CYP3 A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS . SSRI’s Weakness, hyperreflexia, and incoordination have been reported rarely when 5-HT 1 agonists have been co-administere…
Adverse Reactions
ADVERSE REACTIONS 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 ). Post-introduction Reports The following events derived from postmarketing experience have been occasionally reported in patients receiving Dihydroergotamine Mesylate Injection: 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. Dihydroergotamine Mesylate Injection is not recommended for prolonged daily use. (See DOSAGE AND ADMINISTRATION .) To report SUSPECTED ADVER…
Frequently Asked Questions
What is Dihydroergotamine Mesylate used for?
Dihydroergotamine Mesylate contains Dihydroergotamine Mesylate. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Dihydroergotamine Mesylate a controlled substance?
Dihydroergotamine Mesylate is not classified as a controlled substance by the DEA.
What is the generic name for Dihydroergotamine Mesylate?
The generic name for Dihydroergotamine Mesylate is Dihydroergotamine Mesylate. There are 6 other brand versions of Dihydroergotamine Mesylate.
What is the NDC code for Dihydroergotamine Mesylate 1 mg/mL?
The NDC (National Drug Code) for Dihydroergotamine Mesylate 1 mg/mL is 0143-9151, listed by Hikma Pharmaceuticals USA Inc..