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Migranal

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Migranal

Migranal

INDICATIONS

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

DOSAGE AND ADMINISTRATION

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

In clinical trials, Migranal® (dihydroergotamine mesylate, USP) 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 spray) ® (dihydroergotamine mesylate, USP) Nasal Spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of Migranal (dihydroergotamine mesylate spray) ® (dihydroergotamine mesylate, USP) Nasal Spray should be administered in each nostril, for a total dosage of four sprays (2.0 mg) of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray. Studies have shown no additional benefit from acute doses greater than 2.0 mg for a single migraine administration. The safety of doses greater than 3.0 mg in a 24 hour period and 4.0 mg in a 7 day period has not been established.

Migranal® (dihydroergotamine mesylate, USP) 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).

HOW SUPPLIED

Migranal®(dihydroergotamine mesylate, USP) Nasal Spray is available (as a clear, colorless to faintly yellowsolution) in 3.5 mL amber glass vials containing 4 mg of dihydroergotamine mesylate, USP.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is provided as a package of 8 units, administration instruction sheet, and one package insert. Each unit consists of one vial and one sprayer. (NDC 0187-0245-03)

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

Manufactured by: MiPharm S.p.A, Milan, Italy. Distributed by: Valeant Pharmaceuticals North America, One Enterprise, Aliso Viejo, CA 92656. www.migranal (dihydroergotamine mesylate spray) .com. June 2007.

Last reviewed on RxList: 5/11/2009
This monograph has been modified to include the generic and brand name in many instances.

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