Migranal (nasal)

Migranal (nasal)

Migranal (Nasal) Nasal route (solution)

Severe and/or life-threatening peripheral ischemia has been associated with coadministration of dihydroergotamine with strong CYP3A4 inhibitors, including protease inhibitors and macrolide antibiotics. Because inhibition of CYP3A4 increases serum levels of dihydroergotamine, the risk of vasospasm leading to cerebral ischemia and/or extremity ischemia is increased. Therefore, taking these medications together is contraindicated.

Possible uses for Migranal

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

Before using Migranal

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of dihydroergotamine nasal spray in children and adolescents. Safety and effectiveness have not been established.

geriatrics

There is no information on the relationship between age and the effects of dihydroergotamine nasal spray in geriatric patients.

Breastfeeding

Studies of breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed or you should stop breast-feeding while using this medication.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Almotriptan
• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Kokain
• Darunavir
• Delavirdin
• Dobutamin
• Dopamin
• Eletriptan
• Ephedrin
• Adrenalin
• Erythromycin
• Fosamprenavir
• Frovatriptan
• Idelalisib
• Indinavir
• Itraconazol
• Ketoconazol
• Letermovir
• Levoketoconazol
• Lidocain
• Lopinavir
• Midodrin
• Mifepriston
• Naratriptan
• Nefazodon
• Nelfinavir
• Nirmatrelvir
• Noradrenalin
• Phenylephrin
• Phenylpropanolamin
• Posaconazol
• Propylhexedrin
• Pseudoephedrin
• Ritonavir
• Rizatriptan
• Saquinavir
• Saralasin
• Sumatriptan
• Telaprevir
• Telithromycin
• Tipranavir
• Troleandomycin
• Vasopressin
• Voriconazol
• Zolmitriptan

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

• Abametapir
• Adagrasib
• Alefacept
• Asciminib
• Avacopan
• Azithromycin
• Belzutifan
• Berotralstat
• Bromocriptin
• Ceritinib
• Conivaptan
• Crizotinib
• Dabrafenib
• Daridorexant
• Dexfenfluramin
• Eluxadolin
• Enzalutamid
• Erdafitinib
• Fedratinib
• Fexinidazol
• Fluconazol
• Fluvoxamin
• Fosnetupitant
• Imatinib
• Ivacaftor
• Lanreotid
• Lefamulin
• Lenacapavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotan
• Mobocertinib
• Netupitant
• Octreotid
• Omaveloxolon
• Palbociclib
• Pazopanib
• Phenobarbital
• Pirtobrutinib
• Primidon
• Propatylnitrat
• Ranolazin
• Ribociclib
• Ritlecitinib
• Selpercatinib
• Sibutramin
• Sotorasib
• Taurursodiol
• Tocilizumab
• Trofinetid
• Tucatinib
• Voxelotor

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines 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 medicines.

• Nitroglycerin
• Propranolol

Interactions with food/tobacco/alcohol

Certain medicines should not be taken with or while eating or consuming certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Grapefruitsaft

Other medical problems

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

• Angina pectoris (Brustschmerzen) oder
• Basiläre oder hemiplegische Migräne oder
• Herzinfarkt, Geschichte von oder
• Herz- oder Blutgefäßerkrankung (z. B. ischämische Herzkrankheit, periphere Gefäßerkrankung) oder
• Hypertonie (Bluthochdruck), unkontrollierte oder
• Infektion (z. B. Sepsis), schwere oder
• Nierenerkrankung, schwere oder
• Schwere Lebererkrankung: Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Diabetes bzw
• Herzerkrankungen (z. B. koronare Herzkrankheit), Familiengeschichte von oder
• Hypercholesterinämie (hoher Cholesterinspiegel im Blut) oder
• Hypertonie (Bluthochdruck) bzw
• Fettleibigkeit bzw
• Postmenopausale Frauen bzw
• Raucher – Sollte bei Patienten mit diesen unerkannten Symptomen einer koronaren Herzkrankheit nicht angewendet werden.

Correct use of Migranal

Use this medicine only as directed by your doctor. Do not use more of it or use it more often than your doctor prescribed. This may increase the risk of side effects.

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

This medicine is for nasal use only. Do not let any of it get into your eyes or mouth. If it gets on these areas, rinse with water and call your doctor immediately.

Do not use this medicine for regular headaches that are different from your usual migraine. Talk to your doctor about what you can do if you have regular headaches.

How to use the spray:

• Wenn Sie die Sprühflasche zum ersten Mal verwenden, müssen Sie die Pumpe entlüften. Pumpen Sie dazu das Spray vor der Anwendung 4-mal auf.
• Neigen Sie beim Sprühen oder danach nicht den Kopf nach hinten und schnüffeln Sie nicht durch die Nase.

Tell your doctor if you are using other medicines to treat migraines, including sumatriptan. You should not take sumatriptan or other ergot medicines within 24 hours of using dihydroergotamine.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für die nasale Darreichungsform (Spray):
  • Bei Migränekopfschmerzen:
    • Erwachsene: Ein Sprühstoß in jedes Nasenloch, gefolgt von einem weiteren Sprühstoß in jedes Nasenloch nach 15 Minuten. Jeder Sprühstoß enthält 0,5 Milligramm (mg) Dihydroergotamin.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

storage

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

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Throw away the medicine bottle 8 hours after opening it.

Precautions when using Migranal

It is very important that your doctor closely monitors your progress while you are receiving this medicine. This is to determine whether the medicine is working properly and to allow the dose to be changed. Blood tests may be needed to check for adverse effects.

Using this medicine could harm your unborn baby. Use an effective form of birth control to prevent pregnancy. Tell your doctor immediately if you think you have become pregnant.

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

This medicine may cause brain problems (e.g. cerebral ischemia). Contact your doctor immediately if you experience confusion, sudden, severe, and persistent headaches, or nausea and vomiting.

This medicine may cause stomach problems (e.g. retroperitoneal fibrosis). Consult your doctor immediately if you experience persistent or severe stomach pain, increased urination, persistent loss of appetite, lower back pain, persistent 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 immediately. Signs of overdose include: blurred vision, changes in consciousness, confusion, dizziness, fainting or lightheadedness when standing up suddenly from lying down, hallucinations, headaches, false beliefs that cannot be changed by facts, nervousness, numbness, tingling, pain and bluish discoloration of the fingernails, lips, skin, palms or nail beds, irregular, fast or slow or shallow breathing, Unconsciousness, pale, clammy skin, pounding in the ears, seizures, stomach pain, sweating, difficulty breathing, unusual agitation, nervousness or restlessness, unusual tiredness or weakness, or vomiting.

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

Contact your doctor immediately if you have chest pain or tightness or difficulty breathing. These may be symptoms of lung disease (e.g. pleural fibrosis).

This medicine may increase your risk of a heart attack. This is more likely in people who already have heart disease. People who use this medicine for a long time may also be at higher risk. Contact your doctor immediately if you have chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, slurred speech, difficulty breathing, or weakness.

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

Taking too much of this medicine or other migraine medications (e.g., triptans, opioids, or a combination treatment 10 or more days per month) may make your headaches worse. Talk to your doctor about this risk. It may also be helpful to note how often your migraine attacks occur and how much medication you take.

This medicine may cause irritation in the nose, throat or taste disturbances. Consult your doctor immediately if you experience a bloody nose, burning, crawling, itching, numbness, tingling, “pins and needles,” or tingling or burning, stinging, itching, redness, or irritation.

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

Side effects of Migranal

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

Less common

• Schmerzen oder Engegefühl in der Brust
• Husten
• Fieber
• Herzrhythmusstörung
• Juckreiz der Haut
• Taubheitsgefühl und Kribbeln im Gesicht, in den Fingern oder Zehen
• Schmerzen in den Armen, Beinen oder im unteren Rücken
• Schmerzen im Rücken, in der Brust oder im linken Arm
• blass bläulich gefärbte oder kalte Hände oder Füße
• niesen
• Halsentzündung
• Atembeschwerden
• schwacher oder fehlender Puls in den Beinen

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

Symptoms of overdose

• Verschwommene Sicht
• Veränderung oder Bewusstseinsverlust
• kalte, feuchte Haut
• Verwirrung hinsichtlich Zeit, Ort oder Person
• vermindertes Bewusstsein oder Reaktionsfähigkeit
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• Halluzinationen
• Kopfschmerzen
• falsche Überzeugungen vertreten, die nicht durch Tatsachen geändert werden können
• Brechreiz
• Nervosität
• Taubheitsgefühl, Kribbeln, Schmerzen und bläuliche Verfärbung der Fingernägel, Lippen, Haut, Handflächen oder Nagelbetten
• blasse oder blaue Lippen, Fingernägel oder Haut
• in den Ohren hämmern
• Anfälle
• starke Schläfrigkeit
• langsamer oder schneller Herzschlag
• Magenschmerzen
• Schwitzen
• ungewöhnliche Aufregung, Nervosität oder Unruhe
• ungewöhnliche Müdigkeit oder Schwäche
• Erbrechen

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Brennendes oder kribbelndes Gefühl, Trockenheit, Schmerzen oder Schmerzen in der Nase
• Veränderung des Geschmackssinns
• Durchfall
• Schwindel
• trockener Mund
• Kopfschmerzen
• vermehrtes Schwitzen
• Muskelsteifheit
• Übelkeit und Erbrechen
• plötzliches Schwitzen und Wärmegefühl
• Gefühl von Brennen, Wärme oder Hitze
• Halsentzündung
• Schläfrigkeit
• verstopfte oder laufende Nase
• unerklärliches Nasenbluten
• ungewöhnliche Müdigkeit oder Schwäche

Less common

• Angst
• verschwommene Sicht
• kalte, feuchte Haut
• Verwirrung
• verminderter Appetit
• Depression
• Schluckbeschwerden
• Schwindel oder Benommenheit beim Aufstehen aus liegender oder sitzender Position
• Ohrenschmerzen
• Augenschmerzen
• Sodbrennen
• vermehrtes Tränen der Augen
• vermehrtes Wasser im Mund
• verstärktes Gähnen
• Muskelschwäche
• Nervosität
• Punktgenaue rote Flecken auf der Haut
• hämmernder Herzschlag
• rote oder gereizte Augen
• Klingeln oder Summen in den Ohren
• Hautausschlag
• Magenschmerzen
• plötzliche Ohnmacht
• Schwellung von Gesicht, Fingern, Füßen oder Unterschenkeln
• Zittern oder Zittern der Hände oder Füße
• Schlafstörungen
• ungewöhnliches Wohlbefinden

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Migranal
• Trudhesa

Available dosage forms:

• Sprühen

Therapeutic Class: Antimigraine

Chemical Class: Ergot Alkaloid

• Welche neuen Medikamente gibt es zur Behandlung von Migräne?

More information