Dihydroergotamine (dye-hye-droe-er-GOT-a-meen)

Treats migraine headaches with or without aura.

Brand Name(s):

Migranal, Trudhesa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use only when you have a migraine. Do not use this medicine for regular headaches.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• The first time you use the spray bottle you will need to prime the pump. To do this, pump the spray 4 times before use.
• Do not tilt head back or sniff through your nose while spraying or after.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Dihydroergotamine is used only when you have a migraine. It is not used on a regular schedule.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light. Do not refrigerate or freeze. Throw the medicine bottle away 8 hours after opening.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nelfinavir, ritonavir, or troleandomycin.
• Some medicines can affect how dihydroergotamine works. Tell your doctor if you are using clotrimazole, fluconazole fluoxetine, fluvoxamine, nefazodone, nicotine, paroxetine, propranolol, saquinavir, sertraline, or zileuton.
• Tell your doctor if you use other medicine to treat migraines, including sumatriptan. You should not use sumatriptan or other ergot medicines within 24 hours of using dihydroergotamine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment and for 3 days after the last dose.
• Tell your doctor if you have high blood pressure, high cholesterol, diabetes, a history of stroke, or a family history of heart disease. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Brain problems, including cerebral ischemia
  • Increased risk of stroke, heart attack, or heart rhythm problems
  • Stomach problems, including retroperitoneal fibrosis
  • Lung problems, including pleural fibrosis
  • Increased blood pressure
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your headaches may become worse if you use headache medicine for 10 or more days per month. This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change or loss of consciousness, drowsiness, lightheadedness, fainting, fast, slow, or uneven heartbeat, seizures, cold, clammy skin
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating
• Confusion, sudden or severe headache, trouble seeing, speaking, or walking
• Lightheadedness, dizziness, fainting
• Muscle pain or weakness
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Stomach pain, change in how much or how often you urinate, loss of appetite, lower back pain, nausea, vomiting, weakness

If you notice these less serious side effects, talk with your doctor:

• Change in taste, mild nausea
• Dryness, irritation, pain, or bleeding in your nose
• Runny or stuffy nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088