Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Migranal

Descriptions


Dihydroergotamine nasal spray is used to treat acute migraine headaches with or without aura. Dihydroergotamine is not an ordinary pain reliever. It will not relieve pain other than from migraine headaches.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Spray

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dihydroergotamine nasal spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of dihydroergotamine nasal spray in geriatric patients.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Almotriptan
  • Amprenavir
  • Atazanavir
  • Azithromycin
  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Cocaine
  • Darunavir
  • Delavirdine
  • Dirithromycin
  • Dobutamine
  • Dopamine
  • Eletriptan
  • Ephedrine
  • Epinephrine
  • Erythromycin
  • Fosamprenavir
  • Frovatriptan
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Josamycin
  • Ketoconazole
  • Letermovir
  • Lidocaine
  • Lopinavir
  • Mepartricin
  • Midodrine
  • Mifepristone
  • Miokamycin
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Nirmatrelvir
  • Norepinephrine
  • Phenylephrine
  • Phenylpropanolamine
  • Posaconazole
  • Propylhexedrine
  • Pseudoephedrine
  • Ritonavir
  • Rizatriptan
  • Rokitamycin
  • Roxithromycin
  • Saquinavir
  • Saralasin
  • Spiramycin
  • Sumatriptan
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Troleandomycin
  • Vasopressin
  • Voriconazole
  • Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Alefacept
  • Asciminib
  • Avacopan
  • Belzutifan
  • Berotralstat
  • Bromocriptine
  • Ceritinib
  • Conivaptan
  • Crizotinib
  • Dexfenfluramine
  • Eluxadoline
  • Enzalutamide
  • Erdafitinib
  • Fedratinib
  • Fexinidazole
  • Fluconazole
  • Fluvoxamine
  • Fosnetupitant
  • Imatinib
  • Lanreotide
  • Lefamulin
  • Lorlatinib
  • Lumacaftor
  • Mitotane
  • Mobocertinib
  • Netupitant
  • Octreotide
  • Palbociclib
  • Pazopanib
  • Propatyl Nitrate
  • Ranolazine
  • Ribociclib
  • Selpercatinib
  • Sibutramine
  • Sotorasib
  • Taurursodiol
  • Tucatinib
  • Voxelotor

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Nitroglycerin
  • Propranolol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina pectoris (chest pain) or
  • Basilar or hemiplegic migraine or
  • Heart attack, history of or
  • Heart or blood vessel disease (eg, ischemic heart disease, peripheral vascular disease) or
  • Hypertension (high blood pressure), uncontrolled or
  • Infection (eg, sepsis), severe or
  • Kidney disease, severe or
  • Liver disease, severe—Should not be used in patients with these conditions.
  • Diabetes or
  • Heart disease (eg, coronary artery disease), family history of or
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Hypertension (high blood pressure) or
  • Obesity or
  • Postmenopausal women or
  • Smoker—Should not be used in patients with these unrecognized coronary artery disease symptoms.

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off with water and call your doctor right away.

Do not use this medicine for a regular headache that is different from your usual migraine. Talk to your doctor about what to do for regular headaches.

To use the spray:

  • 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.

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.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For nasal dosage form (spray):
    • For migraine headaches:
      • Adults—One spray in each nostril followed by another spray in each nostril after 15 minutes. Each spray contains 0.5 milligrams (mg) of dihydroergotamine.
      • Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw the medicine bottle away 8 hours after opening.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using this medicine could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Do not use this medicine together with clarithromycin (Biaxin®), erythromycin (Erythrocin®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nelfinavir (Viracept®), ritonavir (Norvir®), or troleandomycin (Tao®).

This medicine may cause brain problems (eg, cerebral ischemia). Check with your doctor right away if you have confusion, headache, sudden, severe, and continuing, or nausea and vomiting.

This medicine may cause stomach problems (eg, retroperitoneal fibrosis). Check with your doctor right away if you have continuing or severe stomach pain, increased frequency of urination, continuing loss of appetite, lower back pain, continuing or severe nausea and vomiting, or weakness.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: blurred vision, change in consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position, hallucinations, headache, holding false beliefs that cannot be changed by fact, nervousness, numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds, irregular, fast or slow, or shallow breathing, loss of consciousness, pale, clammy skin, pounding in the ears, seizures, stomach pain, sweating, trouble breathing, unusual excitement, nervousness, or restlessness, unusual tiredness or weakness, or vomiting.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Check with your doctor right away if you have chest pain or tightness, or trouble breathing. These may be symptoms of a lung problem (eg, pleural fibrosis).

This medicine may raise your risk of having a heart attack. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, slurred speech, trouble breathing, or weakness.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Using too much of this medicine or any other migraine medicines (eg, triptans, opioids, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

This medicine may cause irritation in the nose, throat, or problems in taste. Check with your doctor right away if you have bloody nose, burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings, or burning, stinging, itching, redness, or irritation.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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 immediately if any of the following side effects occur:

Less common

  1. Chest pain or tightness
  2. cough
  3. fever
  4. irregular heartbeat
  5. itching of the skin
  6. numbness and tingling of the face, fingers, or toes
  7. pain in the arms, legs, or lower back
  8. pain in the back, chest or left arm
  9. pale bluish-colored or cold hands or feet
  10. sneezing
  11. sore throat
  12. trouble breathing
  13. weak or absent pulses in legs

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Blurred vision
  2. change or loss of consciousness
  3. cold clammy skin
  4. confusion as to time, place, or person
  5. decreased awareness or responsiveness
  6. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  7. hallucinations
  8. headache
  9. holding false beliefs that cannot be changed by fact
  10. nausea
  11. nervousness
  12. numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds
  13. pale or blue lips, fingernails, or skin
  14. pounding in the ears
  15. seizures
  16. severe sleepiness
  17. slow or fast heartbeat
  18. stomach pain
  19. sweating
  20. unusual excitement, nervousness, or restlessness
  21. unusual tiredness or weakness
  22. vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Burning or tingling sensation, dryness, soreness, or pain in the nose
  2. change in sense of taste
  3. diarrhea
  4. dizziness
  5. dry mouth
  6. headache
  7. increased sweating
  8. muscle stiffness
  9. nausea and vomiting
  10. sudden sweating and feelings of warmth
  11. sensation of burning, warmth, or heat
  12. sore throat
  13. sleepiness
  14. stuffy or runny nose
  15. unexplained nose bleeds
  16. unusual tiredness or weakness

Less common

  1. Anxiety
  2. blurred vision
  3. cold clammy skin
  4. confusion
  5. decreased appetite
  6. depression
  7. difficulty swallowing
  8. dizziness or lightheadedness when getting up from a lying or sitting position
  9. ear pain
  10. eye pain
  11. heartburn
  12. increased watering of the eyes
  13. increased watering of the mouth
  14. increased yawning
  15. muscle weakness
  16. nervousness
  17. pinpoint red spots on skin
  18. pounding heartbeat
  19. red or irritated eyes
  20. ringing or buzzing in the ears
  21. skin rash
  22. stomach pain
  23. sudden fainting
  24. swelling of the face, fingers, feet, or lower legs
  25. trembling or shaking of the hands or feet
  26. trouble in sleeping
  27. unusual feeling of well being

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

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