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RAPID LONG-LASTING RELIEF

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INDICATION

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is used to treat an active migraine headache with or without aura. Do not use it to try to prevent a migraine if you have no symptoms, to treat a common tension headache, or to treat a migraine that is not typical of your usual migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Migranal Nasal Spray) and protease inhibitors and macrolide antibiotics have been reported rarely. As a result, these medications should not be taken together.

Do not use Migranal Nasal Spray if you:

  • Are pregnant or nursing
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors
  • Are taking a macrolide antibiotic such as troleandomycin, clarithromycin, or erythromycin
  • Have taken other medications for the treatment or prevention of migraine within the last 24 hours
  • Have severe liver or kidney disease
  • Experience hemiplegic or basilar migraines, which often cause paralysis or impairment of speech

Before taking Migranal Nasal Spray, tell your doctor if:

  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements
  • You have or had any disease of the liver or kidney
  • This headache is different from your usual migraine attacks

The use of Migranal Nasal Spray should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following use of injectable dihydroergotamine, the active ingredient in Migranal Nasal Spray, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Migranal Nasal Spray. Contact your doctor immediately if you experience:

  • Numbness or tingling in your fingers and toes
  • Pain, tightness, or discomfort in your chest
  • Muscle pain or cramps in your arms and legs
  • Weakness in your legs
  • Temporary speeding or slowing of your heart rate
  • Swelling or itching
Please click here for full Prescribing Information, including Boxed Warning and Patient Information.
You are encouraged to report adverse side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch
or call 1-800-FDA-1088.

 
 
 

REFERENCES

  • 1.MIGRANAL [package insert]. Aliso Viejo, CA: Valeant Pharmaceuticals North America; 2014.
  • 2.Gallagher RM; Dihydroergotamine Working Group. Acute treatment of migraine with dihydroergotamine nasal spray. Arch Neurol. 1996;53(12):1285-1291.
  • 3.Malik SN, Hopkins M, Young WB, Silberstein SD. Acute migraine treatment: patterns of use and satisfaction in a clinical population. Headache. 2006;46(5):773-780.
  • 4.Symphony Health Solutions, current as of August 2015.
  • 5.Center for Drug Evaluation and Research. Migranal approval letter. December 8, 1997. http://www.accessdata.fda.gov/drugsatfda_docs/NDA/97/20148_Migranal_apprltr.pdf. Accessed May 27, 2016.

MIG.0023.USA.16

INDICATION

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is used to treat an active migraine headache with or without aura. Do not use it to try to prevent a migraine if you have no symptoms, to treat a common tension headache, or to treat a migraine that is not typical of your usual migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Migranal Nasal Spray) and protease inhibitors and macrolide antibiotics have been reported rarely. As a result, these medications should not be taken together.

Do not use Migranal Nasal Spray if you:

  • Are pregnant or nursing
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors
  • Are taking a macrolide antibiotic such as troleandomycin, clarithromycin, or erythromycin
  • Have taken other medications for the treatment or prevention of migraine within the last 24 hours
  • Have severe liver or kidney disease
  • Experience hemiplegic or basilar migraines, which often cause paralysis or impairment of speech

Before taking Migranal Nasal Spray, tell your doctor if:

  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements
  • You have or had any disease of the liver or kidney
  • This headache is different from your usual migraine attacks

The use of Migranal Nasal Spray should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following use of injectable dihydroergotamine, the active ingredient in Migranal Nasal Spray, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Migranal Nasal Spray. Contact your doctor immediately if you experience:

  • Numbness or tingling in your fingers and toes
  • Pain, tightness, or discomfort in your chest
  • Muscle pain or cramps in your arms and legs
  • Weakness in your legs
  • Temporary speeding or slowing of your heart rate
  • Swelling or itching
Please click here for full Prescribing Information, including Boxed Warning and Patient Information.
You are encouraged to report adverse side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch
or call 1-800-FDA-1088.