Generic Name and Formulations:
Dihydroergotamine mesylate 4mg/mL (0.5mg/spray); nasal spray; contains caffeine.
Valeant Pharmaceuticals, Inc
Indications for MIGRANAL:
Acute treatment of migraine.
1 spray in each nostril, repeat 15 minutes later; max 6 sprays/24 hrs and 8 sprays/wk.
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. Pregnancy (Cat.X). Nursing mothers.
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. Elderly.
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.
Rhinitis, pharyngitis, dysgeusia, local reactions (congestion, burning sensation, dryness, paresthesia, epistaxis, pain), GI disturbances, dizziness, somnolence; myocardial and peripheral vascular ischemia or vasoconstriction (ergotism: discontinue if occurs).
Nasal spray—8 units (vial + sprayer)
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