Description
Dihydroergotamine nasal powder and spray are 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:
- Powder
- 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 powder and 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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Atzumi® nasal powder or Trudhesa™ nasal spray in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving this medicine.
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
- Boceprevir
- Ceritinib
- Clarithromycin
- Cobicistat
- Darunavir
- Delavirdine
- Dopamine
- Droxidopa
- Eletriptan
- Ephedrine
- Epinephrine
- Fosamprenavir
- Frovatriptan
- Idelalisib
- Indinavir
- Isoproterenol
- Itraconazole
- Ketoconazole
- Letermovir
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Midodrine
- Mifepristone
- Naratriptan
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Norepinephrine
- Paritaprevir
- Phenylephrine
- Phenylpropanolamine
- Posaconazole
- Propylhexedrine
- Pseudoephedrine
- Ribociclib
- Ritonavir
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
- Amiodarone
- Apalutamide
- Aprepitant
- Asciminib
- Avacopan
- Azithromycin
- Berotralstat
- Carbamazepine
- Cilostazol
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Clotrimazole
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Daridorexant
- Dexfenfluramine
- Diltiazem
- Dronedarone
- Duvelisib
- Enasidenib
- Enzalutamide
- Erythromycin
- Fedratinib
- Fexinidazole
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Fosaprepitant
- Fosnetupitant
- Gepotidacin
- Imatinib
- Ivacaftor
- Lanreotide
- Larotrectinib
- Lazertinib
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 or
- Vascular (blood vessel) surgery, history of—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
- Raynaud's syndrome or
- Smoking—Use with caution. May be at increased risk for certain side effects.
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 a Medication Guide and a 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 nasal powder:
- Remove the round blue tab from the blue nozzle. Insert the blue nozzle into one nostril.
- Squeeze the white air pump 3 separate times into one nostril while inhaling.
- Release the air pump to expand back to its original shape between squeezes.
- Use fast, complete, pulse-like squeezes to deliver the dose.
To use the Migranal® nasal 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 your head back or sniff through your nose while spraying or after.
To use the Trudhesa™ nasal spray:
- Remove the blue plastic cover from the glass vial. Slowly peel away all the metal foil from the gray rubber stopper in a circular motion. Pull the gray rubber stopper up and out of the vial.
- Hold the nasal spray upright. Pull down the plastic cover and remove it. Gently push the glass vial into the bottom of the nasal spray device and screw it on.
- If you are using the nasal spray for the first time, you will need to prime the spray. To do this, pump the bottle exactly 4 times until some of the medicine sprays out. Now it is ready to use.
- Make sure your head is straight. Insert the spray nozzle into your first nostril. Firmly press the finger grips down and press the glass vial up at the same time. Spray into your other nostril the same way.
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 migraine headaches:
- For nasal dosage form (powder):
- Adults—One spray in one nostril. Each spray contains 5.2 milligrams (mg) of dihydroergotamine. You may repeat a dose as long as it has been at least 1 hour since the last spray. Do not use more than 2 doses (10.4 mg) in a 24-hour period (one day).
- Children—Use and dose must be determined by your doctor.
- For nasal dosage form (Migranal® spray):
- 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.
- For nasal dosage form (Trudhesa™ spray):
- Adults—One spray in each nostril. Each spray contains 0.725 milligrams (mg) of dihydroergotamine. You may repeat a dose as long as it has been at least 1 hour since the last spray. Do not use more than 2 doses in a 24-hour period (one day) or 3 doses in a 7-day period.
- Children—Use and dose must be determined by your doctor.
- For nasal dosage form (powder):
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
- Chest pain or tightness
- cough
- fever
- irregular heartbeat
- itching of the skin
- numbness and tingling of the face, fingers, or toes
- pain in the arms, legs, or lower back
- pain in the back, chest or left arm
- pale bluish-colored or cold hands or feet
- sneezing
- sore throat
- trouble breathing
- weak or absent pulses in legs
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- change or loss of consciousness
- cold clammy skin
- confusion as to time, place, or person
- decreased awareness or responsiveness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hallucinations
- headache
- holding false beliefs that cannot be changed by fact
- nausea
- nervousness
- numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds
- pale or blue lips, fingernails, or skin
- pounding in the ears
- seizures
- severe sleepiness
- slow or fast heartbeat
- stomach pain
- sweating
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- 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
- Burning or tingling sensation, dryness, soreness, or pain in the nose
- change in sense of taste
- diarrhea
- dizziness
- dry mouth
- headache
- increased sweating
- muscle stiffness
- nausea and vomiting
- sudden sweating and feelings of warmth
- sensation of burning, warmth, or heat
- sore throat
- sleepiness
- stuffy or runny nose
- unexplained nose bleeds
- unusual tiredness or weakness
Less common
- Anxiety
- blurred vision
- cold clammy skin
- confusion
- decreased appetite
- depression
- difficulty swallowing
- dizziness or lightheadedness when getting up from a lying or sitting position
- ear pain
- eye pain
- heartburn
- increased watering of the 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 the ears
- skin rash
- stomach pain
- sudden fainting
- swelling of the face, fingers, feet, or lower legs
- trembling or shaking of the hands or feet
- trouble in sleeping
- 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.
DRG-20063447
