Description
Dihydroergotamine injection is used to treat migraine headaches with or without aura and cluster headaches. 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:
- Solution
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 injection 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 injection 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
- Boceprevir
- Ceritinib
- Clarithromycin
- Cobicistat
- Darunavir
- Delavirdine
- Dopamine
- Droxidopa
- Eletriptan
- Ephedrine
- Epinephrine
- Erythromycin
- 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
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
- Aprepitant
- Asciminib
- Avacopan
- Azithromycin
- Berotralstat
- Carbamazepine
- Cilostazol
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Clotrimazole
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Daridorexant
- Dexfenfluramine
- Diltiazem
- Dronedarone
- Duvelisib
- Enasidenib
- Enzalutamide
- Fedratinib
- Fexinidazole
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Fosaprepitant
- Fosnetupitant
- Imatinib
- Ivacaftor
- Lanreotide
- Larotrectinib
- Lazertinib
- Lefamulin
- Lenacapavir
- Lomitapide
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 (chest pain) or
- Basilar migraine (migraine with vision and hearing problems), history of or
- Heart attack, history of
- Heart or blood vessel disease (eg, coronary artery disease, ischemic heart disease) or
- Hemiplegic migraine (migraine with some paralysis), history of 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
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into one of your muscles, under your skin (usually in the middle of the thighs), or through a needle placed in one of your vein.
You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
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.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:
- How to prepare the injection.
- The proper use of disposable syringes.
- How to give the injection.
- How long the injection can be stored at home.
Check the liquid in the vial. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.
If you feel much better after a dose of this medicine, but your headache comes back or gets worse after a while, wait at least 1 hour before using another dose.
If you get another migraine headache after you have used this medicine, do not use a second dose unless it has been more than 6 hours from the last dose.
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 injection dosage form (solution):
- For migraine or cluster headaches:
- Adults—1 milliliters (mL) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. However, the dose should not be more than 6 mL per week.
- Children—Use and dose must be determined by your doctor.
- For migraine or cluster headaches:
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 vial away 1 hour after opening. Do not save unused medicine from an opened vial.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
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.
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.
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.
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.
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.
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 increase your risk of having heart rhythm problems, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech.
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 some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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:
Rare
- Dizziness
- headache
- numbness or tingling in the arms or legs
- trouble thinking, speaking, or walking
- weakness
Incidence not known
- Chest pain, discomfort, or tightness
- confusion
- continuing or severe abdominal or stomach pain
- continuing or severe nausea and vomiting
- increased frequency of urination
- lower back or side pain
- pain or discomfort in the arms, jaw, back, or neck
- stroke
- sweating
- trouble breathing
- vomiting
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
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.
CON-XXXXXXXX
