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|Migranal Spray

Migranal Spray

Migranal Spray is used for:

Treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots).

Migranal Spray is an ergot derivative. It works by constricting blood vessels in the brain, which helps to relieve migraine headaches.

Do NOT use Migranal Spray if:

• you are allergic to any ingredient in Migranal Spray or to other ergot derivatives (eg, ergotamine)
• you are pregnant, planning to become pregnant, or are breast-feeding
• you are taking delavirdine, efavirenz, an HIV protease inhibitor (eg, indinavir), an imidazole (eg, ketoconazole), a macrolide (eg, erythromycin), a ketolide (eg, telithromycin), sumatriptan, or voriconazole
• you have used other migraine medications (eg, ergot-containing medications, another 5-HT₁ agonist) within the last 24 hours
• you have a history of heart disease or heart attack, or you have recently had heart surgery
• you have severely impaired kidney or liver function, uncontrolled high blood pressure, or other types of migraine headaches (hemiplegic or basilar)
• you have brain, heart, or peripheral blood vessel disease, blood circulation problems, or a blood disease, or you have had vascular surgery
• you have an infection of blood or tissues

Contact your doctor or health care provider right away if any of these apply to you.

Before using Migranal Spray:

Some medical conditions may interact with Migranal Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have high blood pressure, high cholesterol, diabetes, liver or kidney disease, porphyria, a strong family history of heart disease, or a history of chest pain or shortness of breath
• if you smoke or are overweight
• if you are a woman past menopause or have had a hysterectomy
• if you are a man older than 40 years of age
• if your migraine headache is different from previous migraines

Some MEDICINES MAY INTERACT with Migranal Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), delavirdine, efavirenz, HIV protease inhibitors (eg, indinavir), imidazoles (eg, ketoconazole), ketolides (eg, telithromycin), macrolides (eg, erythromycin), sumatriptan, or voriconazole because side effects, such as pain or weakness in the arms or legs or heart problems, may occur
• Droxidopa, sumatriptan, or sympathomimetics (parenteral) (eg, ephedrine) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Migranal Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Migranal Spray:

Use Migranal Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Avoid eating grapefruit or drinking grapefruit juice while taking Migranal Spray.
• Migranal Spray comes with an additional patient leaflet. Read it carefully and reread it each time you get Migranal Spray refilled.
• Migranal Spray is for use in the nose only. It is not to be injected.
• Assemble the device according to the instructions provided with Migranal Spray.
• Pump the applicator 4 times before using. Do not prime the applicator more than 4 times.
• Do not sniff, tilt your head back, or inhale while using Migranal Spray.
• A usual dose of Migranal Spray is 1 spray in each nostril as soon as possible after a migraine headache has started. If more than 1 spray per nostril is to be used, wait 15 minutes before between sprays. Do not exceed the recommended dose.
• Do not breathe in deeply during or immediately after spraying.
• Do not use daily on a regular basis.
• After using, carefully throw away the sprayer containing the ampule and the breaker cap containing the top of the ampule. Load a new unit dose tray into the assembly case. Keep the assembly case for up to 4 treatments. Throw it away along with the unit dose tray after 4 treatments.
• Once the nasal spray ampule has been opened, it must be thrown away after 8 hours.
• If you miss a dose of Migranal Spray and you still have a headache, follow your doctor"s dosing instructions. Contact your doctor if you are unsure what to do if you miss a dose. Do not take Migranal Spray more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Migranal Spray.

Important safety information:

• Migranal Spray may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Migranal Spray. Using Migranal Spray alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Additional monitoring of your condition may be needed if you are taking nefazodone, fluconazole, fluoxetine, fluvoxamine, zileuton, clotrimazole, or other mild CYP3A4 enzyme inhibitors.
• Use this medicine with caution in the ELDERLY because they may be more sensitive to its effects.
• Migranal Spray is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Migranal Spray has been shown to cause harm to the fetus. Do not use Migranal Spray if you are pregnant. If you suspect that you could be pregnant, contact your immediately. Migranal Spray is excreted in breast milk. Do not breast-feed while taking Migranal Spray.

Possible side effects of Migranal Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning sensation; changes in taste; diarrhea; dizziness; drowsiness; dry mouth; hot flashes; irritation; nasal congestion or dryness; nasal discharge; nausea; pain; reaction at the application site; runny nose; sinus inflammation; sore nose or throat; stiffness; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; chest pain; itching; muscle pain or weakness in the arms and legs; numbness, coldness, loss of color, or tingling in the fingers and toes; swelling; temporary speeding or slowing of the heart rate.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately. Symptoms may include coma; confusion; fainting; fast heartbeat; flushing; headache; lightheadedness; nausea; numbness, tingling, or pain in the fingers or toes; seizures; slow heartbeat; slowed breathing; vomiting; weakness of the legs.

Store Migranal Spray at or below 77 degrees F (25 degrees C). Protect from heat and light. Do not refrigerate or freeze. Keep in the original tray until ready to assemble. Discard any remaining medicine 8 hours after the spray applicator has been prepared. Do not use after the expiration date. Keep Migranal Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Migranal Spray, please talk with your doctor, pharmacist, or other health care provider.
• Migranal Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Migranal Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.