Dihydroergotamine nasal

You should not use this medicine if you are allergic to dihydroergotamine or similar medicines (ergotamine, ergonovine, methylergonovine, methysergide, Cafergot, Ergomar, Methergine, Sansert, and others), or if you have:

• a history of heart disease, angina (chest pain), blood circulation problems, coronary artery disease (hardening of the arteries), or history of a heart attack or stroke;

• uncontrolled high blood pressure;

• severe liver or kidney disease;

• a serious infection called sepsis; or

• if you have recently had heart or blood vessel surgery (such as bypass surgery).

This medication can harm an unborn baby or a nursing baby. Do not use dihydroergotamine nasal if you are pregnant or breast-feeding.

Some medicines can cause severe decreases in blood flow and dangerous side effects when used with dihydroergotamine. Your doctor may need to change your treatment plan if you use any of the following drugs:

• an antibiotic--clarithromycin, erythromycin;

• antifungal medicine--itraconazole, ketoconazole; or

• HIV or AIDS medication--indinavir, nelfinavir, ritonavir.

To make sure dihydroergotamine nasal is safe for you, tell your doctor if you have:

• breathing problems;

• high blood pressure;

• ischemic bowel disease;

• liver or kidney disease; or

• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use dihydroergotamine nasal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

Dihydroergotamine nasal can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking dihydroergotamine nasal.

Since dihydroergotamine is used on an as-needed basis, you are not likely to miss a dose.

Do not use more than 6 sprays of dihydroergotamine nasal per day or more than 8 sprays per week.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using dihydroergotamine nasal and call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

• muscle pain in your arms or legs, leg weakness;

• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

• swelling or itching in any part of your body;

• stomach cramps, diarrhea that may be bloody; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• dizziness;

• nausea, vomiting;

• runny nose;

• altered sense of taste; or

• soreness or irritation in your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with dihydroergotamine nasal. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with dihydroergotamine nasal, especially:

• an antibiotic such as telithromycin;

• antifungal medicine such as fluconazole; or

• nefazodone (an antidepressant).

This list is not complete and many other drugs can interact with dihydroergotamine nasal. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Dihydroergotamine 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 dihydroergotamine as well as the good it can do.

dihydroergotamine is available only with your doctor's prescription.

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 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 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

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

Geriatric

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

Pregnancy

Breast Feeding

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

Interactions with 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 dihydroergotamine, 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 dihydroergotamine 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
• Amifampridine
• Amprenavir
• Atazanavir
• Azithromycin
• Boceprevir
• Clarithromycin
• Cobicistat
• Cocaine
• Darunavir
• Delavirdine
• Dirithromycin
• Eletriptan
• Epinephrine
• Erythromycin
• Fosamprenavir
• Frovatriptan
• Idelalisib
• Indinavir
• Itraconazole
• Josamycin
• Ketoconazole
• Lidocaine
• Lopinavir
• Mepartricin
• Midodrine
• Mifepristone
• Miokamycin
• Naratriptan
• Nefazodone
• Nelfinavir
• Norepinephrine
• Phenylpropanolamine
• Posaconazole
• Propylhexedrine
• Pseudoephedrine
• Ritonavir
• Rizatriptan
• Rokitamycin
• Roxithromycin
• Saquinavir
• Saralasin
• Spiramycin
• Sumatriptan
• Telaprevir
• Tipranavir
• Troleandomycin
• Voriconazole
• Zolmitriptan

Using dihydroergotamine 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.

• Alefacept
• Blinatumomab
• Bromocriptine
• Ceritinib
• Conivaptan
• Crizotinib
• Dexfenfluramine
• Eluxadoline
• Enzalutamide
• Fluconazole
• Fluvoxamine
• Golimumab
• Guselkumab
• Imatinib
• Lumacaftor
• Netupitant
• Pazopanib
• Pitolisant
• Propatyl Nitrate
• Ranolazine
• Ribociclib
• Secukinumab
• Sibutramine
• Telithromycin

Using dihydroergotamine 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

Interactions with Food/Tobacco/Alcohol

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 dihydroergotamine 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 dihydroergotamine, 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 dihydroergotamine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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 dihydroergotamine properly. Make sure that you read the patient directions carefully before using dihydroergotamine.

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 dihydroergotamine 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 dihydroergotamine 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 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 dihydroergotamine. 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 (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

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.

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:

• 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

• 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

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:

• 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

• 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 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.