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Migranal Generic Name & Formulations
Legal Class
Rx
General Description
Dihydroergotamine mesylate 4mg/mL (0.5mg/spray); nasal spray; contains caffeine.
Pharmacological Class
Ergot alkaloid.
How Supplied
Nasal spray—8 units (vial + sprayer)
Manufacturer
Generic Availability
YES
Migranal Indications
Indications
Acute treatment of migraine.
Migranal Dosage and Administration
Adult
1 spray in each nostril, repeat 15mins later; max 6 sprays/24hrs and 8 sprays/wk.
Children
Not established.
Migranal Contraindications
Contraindications
Ischemic heart disease. Coronary artery vasospasm (eg, Prinzmetal's angina) or myocardial ischemia. Peripheral artery disease. Sepsis. Post-vascular surgery. Uncontrolled hypertension. Other significant cardiovascular disease. Severely impaired hepatic or renal function. Basilar or hemiplegic migraine. Concomitant potent CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) or other vasoconstrictors. Within 24 hours of other ergot-type drugs or 5-HT1 agonists.
Migranal Boxed Warnings
Boxed Warning
Peripheral ischemia following coadministration with potent CYP3A4 inhibitors.
Migranal Warnings/Precautions
Warnings/Precautions
Confirm diagnosis. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary disease (eg, postmenopausal women, men over age 40, hypercholesterolemia, hypertension, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Compromised circulation. Medication overuse headache. Elderly. Pregnancy: avoid. Nursing mothers: not recommended (during and for 3 days after the last dose).
Migranal Pharmacokinetics
See Literature
Migranal Interactions
Interactions
Other ergots, 5-HT1 agonists, potent CYP3A4 inhibitors, other vasoconstrictors: see Contraindications. Potentiated by CYP3A4 inhibitors (eg, protease inhibitors, macrolides, azole antifungals, saquinavir, nefazodone, fluoxetine, fluvoxamine, grapefruit juice, zileuton), propranolol, nicotine.
Migranal Adverse Reactions
Adverse Reactions
Rhinitis, pharyngitis, dysgeusia, local reactions (congestion, burning sensation, dryness, paresthesia, epistaxis, pain), nausea, vomiting, dizziness, somnolence; myocardial and peripheral vascular ischemia or vasoconstriction (ergotism: discontinue if occurs).
Migranal Clinical Trials
See Literature
Migranal Note
Not Applicable
Migranal Patient Counseling
See Literature
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