Generic Name: dihydroergotamine (dye-HYE-droe-er-GOT-a-meen)
Brand Name: Migranal
A serious, life-threatening decrease in the amount of blood supply to the hands and feet (peripheral ischemia), and to the brain (cerebral ischemia) has been reported when Migranal spray was taken with certain other medicines. Do not take Migranal spray with macrolide antibiotics (eg, erythromycin, clarithromycin, troleandomycin), HIV protease inhibitors (eg, ritonavir, nelfinavir, indinavir), or azole antifungals (eg, ketoconazole, itraconazole, voriconazole).
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 shrinking blood vessels in the brain, which helps to relieve migraine headaches.
Do NOT use Migranal spray if:
- you are pregnant, planning to become pregnant, or are breast-feeding
- you are allergic to any ingredient in Migranal spray or to other ergot derivatives (eg, ergotamine)
- you have a history of certain heart problems (eg, coronary artery disease or vasospasm, heart attack, angina)
- you have severe kidney or liver problems, uncontrolled high blood pressure, or certain types of migraine headaches (hemiplegic or basilar)
- you have blood vessel problems (eg, in the brain or heart, or throughout the body; peripheral blood vessel disease) or blood circulation problems
- you have recently had blood vessel surgery (including blood vessels in the heart)
- you have a serious infection of the blood
- you have used certain other migraine medicines, such as methysergide, a 5-HT1 agonist (eg, sumatriptan), or other ergot derivatives (eg, ergotamine), within the last 24 hours
- you are taking delavirdine, efavirenz, an HIV protease inhibitor (eg, indinavir, nelfinavir, ritonavir), an imidazole antifungal (eg, itraconazole, ketoconazole, voriconazole), a ketolide antibiotic (eg, telithromycin), or a macrolide antibiotic (eg, clarithromycin, erythromycin, troleandomycin)
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 risk factors for heart disease (eg, high blood pressure, high cholesterol, diabetes, smoking, are overweight, a family history of heart disease, a woman past menopause or if you have had your uterus removed [eg, hysterectomy], a man older than 40 years)
- if you have a history of the blood disease porphyria, heart problems, liver or kidney problems, chest pain, or shortness of breath
- 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:
- Clotrimazole, delavirdine, efavirenz, fluoxetine, fluvoxamine, HIV protease inhibitors (eg, indinavir, nelfinavir, ritonavir, saquinavir), imidazole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, clarithromycin, erythromycin, troleandomycin), nefazodone, or zileuton because serious side effects may occur
- Beta blockers (eg, propranolol), delavirdine, efavirenz, 5-HT1 agonists (eg, sumatriptan), methysergide, or other ergot derivatives (eg, ergotamine) because they may increase the risk of Migranal spray's side effects
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:
An extra patient leaflet is available with Migranal spray. Talk to your pharmacist if you have questions about this information.
- Migranal spray comes with an additional patient leaflet. Read it carefully and reread it each time you get Migranal spray refilled.
- Check with your doctor before eating grapefruit or drinking grapefruit juice while taking Migranal spray.
- 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.
- Before you use Migranal spray, you will need to prime it. Remove the cap from the spray unit, hold the vial upright, and point the nasal sprayer away from your face. Pump the spray unit 4 times. Do not pump it more than 4 times.
- Spray 1 time into each nostril. Do NOT sniff or tilt your head back while spraying Migranal spray or immediately after.
- If more than 1 spray per nostril is to be used, wait 15 minutes between sprays. Do not exceed the recommended dose.
- After using Migranal spray, carefully throw away the nasal spray pump with the vial. Once a nasal spray vial has been opened, it must be thrown away after 8 hours.
- Do not assemble another vial of Migranal spray until you are ready to use it.
- 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 drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Migranal spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take Migranal spray before you receive any medical or dental care, emergency care, or surgery.
- Do not use more than the recommended dose without checking with your doctor. Do not use Migranal spray daily on a regular basis.
- Migranal spray is not intended to prevent migraine headaches. Discuss any questions or concerns with your doctor.
- Use Migranal spray with caution in the ELDERLY; they may be more sensitive to its effects.
- Migranal spray should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Migranal spray has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Migranal spray while you are pregnant. Migranal spray is found 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Changes in taste; dizziness; drowsiness; nasal discharge; nausea; nose or throat burning sensation, tingling, pain, soreness, or dryness; nosebleeds; runny or stuffy nose; sinus inflammation; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; fast, slow, or irregular heartbeat; itching; muscle pain, cramps, or weakness in the arms and legs; numbness, coldness, loss of color, bluish discoloration, or tingling in the fingers and toes; severe or persistent headache or dizziness; stomach pain, tenderness, or cramping; swelling; symptoms of heart attack (eg, chest, jaw, or left arm pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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, or emergency room immediately. Symptoms may include coma; confusion; fainting; light-headedness; nausea; numbness, coldness, loss of color, bluish discoloration, tingling, or pain in the fingers or toes; seizures; severe dizziness or headache; slow or shallow breathing; stomach pain; vomiting.Proper storage of Migranal spray:
Store Migranal spray below 77 degrees F (25 degrees C). Protect from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Discard any remaining medicine 8 hours after the nasal spray vial has been prepared. Do not use after the expiration date. Keep Migranal spray out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Migranal spray or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Migranal spray. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Migranal spray. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Migranal spray.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.