GENERIC NAME: DIHYDROERGOTAMINE - NASAL (dye-HI-dro-er-GOT-uh-meen)
BRAND NAME(S): Migranal
WARNING: This medication has rarely caused a very serious lack of blood flow to the hands and feet (peripheral ischemia) or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of dihydroergotamine from your body. Examples include azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV protease inhibitors (such as ritonavir, nelfinavir, indinavir), among others. See also Drug Interactions section.
USES: This medication is used to treat migraine headache attacks. It helps relieve headache pain and other symptoms such as sensitivity to light or sound. Prompt treatment allows you to get back to your normal routine sooner and may decrease your need for other pain medications. This medication is not used to prevent migraines from occurring.Dihydroergotamine belongs to a class of drugs known as ergot alkaloids. It may work by narrowing the blood vessels in the brain. It may also block other pain pathways in the brain.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using dihydroergotamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.This medication comes in individual nasal spray vials. Each vial contains enough medication to treat a single migraine attack. Do not use more than 4 sprays for a single attack. Before using each nasal spray vial, prime the pump by spraying 4 times into the air, away from the face.The US and Canadian manufacturers recommend: at the first sign of a migraine, spray this medication into the nostrils. Do not inject this medication. Use 1 spray into each nostril. Do not tilt your head back, sniff through your nose, or blow your nose while spraying or immediately after. Use another spray into each nostril 15 minutes after the first sprays, or use as directed by your doctor. After using the medication, you should lie down and relax in a quiet, darkened room. Therefore, the maximum number of sprays you can use for a single attack is 4 sprays (two in each nostril).The Canadian manufacturer further recommends to not use more than 8 sprays in 24 hours or 24 sprays in 1 week. Your condition will not improve any faster, and your risk of side effects will increase.The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed.This medication works best if it is used as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well. Use only as needed to treat migraine attacks when they occur. It is not meant for long-term daily use.If you have never used this medication before and you have risk factors for heart disease (see Precautions), you may need to be monitored for rare but serious side effects (such as chest pain) when you take the first dose. Your doctor may ask you to take the first dose in the office.If you also take "triptan" or other ergot medications (such as sumatriptan, methysergide), wait 24 hours before and after taking dihydroergotamine. Consult your doctor or pharmacist for more details and for advice on how to time your doses of these medications.You should feel some relief within 30 minutes. Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section.Sore nose/throat, stuffy/runny nose, changes in taste, dizziness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely cause a very serious lack of blood flow. Stop using dihydroergotamine and tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast heartbeat, weakness in the legs, muscle pain in the arms/legs, tingling/numbness, feeling of coldness in the hands/feet, blue fingers/toes, severe stomach/abdominal pain.Seek immediate medical attention if any of these rare but very serious side effects occur: jaw/left arm pain, chest pain/pressure, sudden tiredness, weakness on one side of the body, slurred speech, vision changes, mental/mood changes (such as confusion).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using dihydroergotamine, tell your doctor or pharmacist if you are allergic to it; or to other ergot alkaloids (such as ergotamine, methysergide, bromocriptine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially: heart disease (such as chest pain/angina, heart attack), stroke, high blood pressure, blood circulation disease (such as peripheral arterial disease, Raynaud's syndrome), a certain severe blood infection (sepsis), bowel disease (such as ischemic bowel syndrome), kidney disease, liver disease, headaches with unusual symptoms or certain types of headache (hemiplegic/basilar), recent blood vessel surgery, nasal problems (such as chronic congestion, nasal allergies).Tell your doctor if you have the following risk factors for heart disease: high blood pressure, high blood cholesterol, obesity, diabetes, smoking/tobacco use, family history of heart disease.If you are at high risk for heart disease, your doctor may want to check your heart before prescribing dihydroergotamine and give your first dose in the office.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (such as chest pain, fast/slow/irregular heartbeat) and decreased blood supply to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.This medication passes into breast milk and may harm a nursing infant. Do not breast-feed while using this drug.
DRUG INTERACTIONS: See also Warning and How to Use sections.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: bronchodilators/decongestants/stimulants (such as epinephrine, pseudoephedrine, methylphenidate, amphetamine).Other medications can affect the removal of dihydroergotamine from your body, which may affect how dihydroergotamine works. Examples include boceprevir, mifepristone, telaprevir, HIV NNRTIs (such as delavirdine, efavirenz), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir), certain antidepressants (such as nefazodone, SSRIs such as fluoxetine/paroxetine/fluvoxamine), among others.Check the labels on all your medicines (such as cough-and-cold products, diet aids, other migraine medications) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.
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OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe/sudden numbness, blue or purple hands/feet, slow/difficult breathing, confusion, seizures.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as EKG) may need to be performed to monitor your progress or check for side effects. Consult your doctor for more details.Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (such as irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.
STORAGE: Store at room temperature at 59-77 degrees F (15-25 degrees C) away from heat, light, and moisture. Do not freeze or refrigerate. Do not store in the bathroom. Discard opened nasal spray vials 8 hours after opening. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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