Adult Dosing
Migraine headaches
- 1 spray/nostril every q15 mins
- Max: 4 sprays/attack, 6 sprays/day, 8 sprays/wk
Note: Before use, pump must be primed (i.e., squeezed 4 times). Once the nasal spray applicator has been prepared, it should be discarded after 8 hrs
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy should only be used where a clear diagnosis of migraine headache has been established
- Serious and/or life-threatening peripheral ischemia may occur when co-administered with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics; avoid using CYP3A4 inhibitors with dihydroergotamine [US Black Box Warning]
- Prolonged daily use of injectable dihydroergotamine may cause pleural and retroperitoneal fibrosis; also rare cases of cardiac valvular fibrosis have been reported. Hence, do not exceed the dosing guidelines
- Avoid using therapy in patients in whom unrecognized coronary artery disease (CAD) is predicted by presence of risk factors such as hypertension, hypercholesterolemia, smokeing, diabetes, obesity, and strong family history of CAD
- First dose of dihydroergotamine should always be administered in the physician's office or similar medically staffed and equipped facility for patients with risk factors predictive of CAD
- In long-term users of this therapy and who have or acquire risk factors predictive of CAD, periodic interval cardiovascular evaluation should be performed as they continue to use the nasal spray
- Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported during therapy
- Patients treated with dihydroergotamine injections have reported cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events
- Patients with migraine are at an increased risk of certain cerebrovascular events such as stroke, hemorrhage, transient ischemic attack
- Therapy may cause vasospastic reactions other than coronary artery vasospasm. Myocardial, peripheral vascular, and colonic ischemia have been reported during therapy
- Therapy-associated vasospastic phenomena may cause muscle pains, numbness, coldness, pallor, and cyanosis of the digits; discontinue the therapy if signs or symptoms of vasoconstriction develops
- Rare cases of markedly increased blood pressure have been reported in patients with and without a history of hypertension treated with dihydroergotamine
- Irritation in the nose, throat, and/or disturbances in taste may occur during therapy; these symptoms resolve within 4 hrs after dosing with dihydroergotamine nasal spray
- Therapy may cause coronary artery vasospasm; patients should be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses
Cautions: Use cautiously in
- Elderly patients
- Cardiac disease risk
- Less potent CYP3A4 inhibitors
Supplemental Patient Information
- Advise patients to promptly report to their physicians if they experience any numbness or tingling in the fingers and toes, muscle pain in the arms and legs, temporary speeding or slowing of the heart rate, chest pain, weakness in the legs, swelling, or itching
Pregnancy Category:X
Breastfeeding: It inhibits prolactin; this drug is likely to be excreted in human milk, but there are no data on the concentration of dihydroergotamine in human milk. Ergotamine is excreted in breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. Because of the potential for these serious adverse events in breastfed infants exposed to dihydroergotamine, nursing should be avoided.
Pricing data from www.DrugStore.com in U.S.A.
- Migranal 4 MG/ML SOLN [Glass Cont] (VALEANT)
6 ml = $636.01
18 ml = $1833.77
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
