MIGRANAL Nasal spray Ref.[10876] Active ingredients: Dihydroergotamine

The solution used in MIGRANAL (dihydroergotamine mesylate) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.

In clinical trials, MIGRANAL (dihydroergotamine mesylate) Nasal Spray has been effective for the acute treatment of migraine headaches with or without aura. One spray (0.5 mg) of MIGRANAL (dihydroergotamine mesylate) Nasal Spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of MIGRANAL (dihydroergotamine mesylate) Nasal Spray should be administered in each nostril, for a total dosage of four sprays (2 mg) of MIGRANAL (dihydroergotamine mesylate) Nasal Spray. Studies have shown no additional benefit from acute doses greater than 2 mg for a single migraine administration. The safety of doses greater than 3 mg in a 24 hour period and 4 mg in a 7 day period has not been established.

MIGRANAL (dihydroergotamine mesylate) Nasal Spray, should not be used for chronic daily administration.

Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use (see administration instructions). Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial) after 8 hours.

Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use (See administration instructions).

Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial after 8 hours).

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 MIGRANAL (dihydroergotamine mesylate) Nasal Spray 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.

In general, the symptoms of an acute MIGRANAL (dihydroergotamine mesylate) Nasal Spray overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with MIGRANAL (dihydroergotamine mesylate) Nasal Spray. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain.

In laboratory animals, significant lethality occurs when dihydroergotamine is given at I.V. doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits.

Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians' Desk Reference (PDR).*

Store below 25°C (77°F). Do not refrigerate or freeze.