In the U.S.—

• Antimigraine agent

Dihydroergotamine ( dye-hye-droe-er-GOT-a-meen) belongs to the group of medicines called ergot alkaloids. It is a nasal solution used to help relieve migraine headaches. Nasal dihydroergotamine is not an ordinary pain reliever. It will not relieve any kind of pain other than throbbing headaches.

Nasal dihydroergotamine may cause blood vessels in the body to constrict (become narrower). This action can lead to serious effects that are caused by a decrease in the flow of blood (blood circulation) to many parts of the body. Be sure that you discuss with your doctor the risks of using this medicine as well as the good it can do.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Nasal
• Nasal solution (US)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nasal dihydroergotamine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dihydroergotamine or any other ergot alkaloid. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of nasal dihydroergotamine by pregnant women may cause serious harm to the fetus. Therefore, nasal dihydroergotamine should not be used during pregnancy.

Breast-feeding—Use of nasal dihydroergotamine is not recommended for nursing mothers. Nasal dihydroergotamine may pass into the breast milk and may cause unwanted effects, such as vomiting, diarrhea, weak pulse, changes in blood pressure, or convulsions (seizures) in nursing babies. Nasal dihydroergotamine may also decrease the flow of breast milk.

Children—There is no specific information comparing use of nasal dihydroergotamine in children with use in other age groups.

Older adults—There is no specific information comparing use of nasal dihydroergotamine in older adults with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nasal dihydroergotamine, it is especially important that your health care professional know if you are using any of the following:

• Cocaine or
• Epinephrine by injection [e.g., Epi-Pen] or
• Other ergot medicines (ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert] or
• Sumatriptan [e.g., Imitrex]—The chance of serious side effects caused by nasal dihydroergotamine may be increased.

• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Infection—The chance of serious side effects caused by nasal dihydroergotmine may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use nasal dihydroergotamine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

It is important to use this medicine properly. Make sure that you read the patient directions carefully before using this medicine.

Do not use nasal dihydroergotamine for a headache that is different from your usual migraine. Instead, check with your doctor.

To relieve your migraine as soon as possible, use nasal dihydroergotamine as soon as the headache begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using nasal dihydroergotamine.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you feel much better after a dose of nasal dihydroergotamine, but your headache comes back or gets worse after a while, you may use more nasal dihydroergotamine. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches should occur less often, and they should be less severe, and easier to relieve. This can reduce the amount of nasal dihydroergotamine or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing—

The dose of nasal dihydroergotamine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nasal dihydroergotamine. If your dose is different, do not change it unless your doctor tells you to do so.

• For nasal dosage form (nasal solution):
  • For migraine headaches:
    • Adults—One spray (0.5 mg) in each nostril. After 15 minutes, another spray (0.5 mg) in each nostril should be used.
    • Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine attack, or after taking nasal dihydroergotamine to relieve a migraine headache. As long as you are feeling drowsy or dizzy, do not drive, use machines or do anything else that could be dangerous if you are dizzy or are not alert.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common or rare
  • Chest pain;  cough, fever, sneezing, or sore throat;  feeling of heaviness in chest;  irregular heartbeat;  itching of the skin;  numbness and tingling of face, fingers, or toes;  pain in arms, legs, or lower back;  pain in back, chest or left arm;  pale bluish-colored or cold hands or feet;  shortness of breath or troubled breathing;  weak or absent pulses in legs 
  
  

• Symptoms of overdose
  • Confusion;  convulsions (seizures);  delirium;  dizziness;  headaches;  nausea and/or vomiting;  numbness, tingling, and/or pain in the legs or arms;  shortness of breath;  stomach pain 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Burning or tingling sensation, dryness, soreness, or pain in the nose;  change in sense of taste;  diarrhea;  dizziness;  dry mouth;  fatigue;  headache ;  increased sweating;  nausea and or vomiting;  muscle stiffness;  runny and or stuffy nose;  sudden sweatings and feelings of warmth;  sensation of burning, warmth, or heat ;  sore throat;  sleepiness ;  unexplained nose bleeds;  unusual tiredness or weakness 
  
  

• Less common
  • Anxiety;  blurred vision;  cold clammy skin;  confusion;  congestion in chest;  cough;  decreased appetite;  depression;  difficulty swallowing;  dizziness or lightheadedness when getting up from a lying or sitting position;  ear pain;  eye pain;  fever;  heartburn;  increased watering of eyes;  increased watering of the mouth ;  increased yawning;  muscle weakness;  nervousness;  pinpoint red spots on skin;  pounding heartbeat;  red or irritated eyes;  ringing or buzzing in ears;  skin rash;  stomach pain;  sudden fainting;  swelling of face, fingers, feet, or lower legs;  trembling or shaking of hands or feet;  trouble in sleeping;  unusual feeling of well being 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.