Dihydroergotamine

The recommended dose of dihydroergotamine is one spray in each nostril (total of 2 sprays) at the first sign or symptom of a migraine headache, or as early as possible after the onset of migraine headache pain. If the migraine has not improved sufficiently after about 15 minutes, one additional spray can be used in each nostril (total of 2 more sprays).

One bottle of dihydroergotamine nasal spray contains 4 sprays. No more than 4 sprays (2 in each nostril, i.e., one bottle) should be used for any migraine attack. No more than 8 sprays (2 bottles) should be used in any 24-hour period. No more then 24 sprays (6 bottles) should be used in any 7-day period.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Dihydroergotamine exactly as prescribed by your doctor.

The spray should be used in the following manner (see package insert for illustrated details):

• Start to prepare the sprayer only when you have a migraine attack.
• Slowly lift and bend back the lip of the blue seal to show the rubber stopper. Try not to break the blue seal.
• Completely remove the seal and metal collar in one piece, if possible. If the two should break apart, carefully continue removing the metal collar. The collar has a sharp edge - handle it with care.
• Gently pull the rubber stopper out of the bottle. Be careful not to spill the contents.
• Gently remove the transparent plastic protective cover from the bottom of the sprayer. Insert the sprayer into the bottle and tighten firmly onto the bottle in a clockwise direction.
• Holding the bottle upright, gently remove the blue plastic protective cap from the top of the sprayer.
• Prior to use, the sprayer must be primed (pumped 4 times in the air).
• Hold your head straight.
• Insert the sprayer into one nostril and pump the sprayer once to release the medication. Repeat in the other nostril (a total of 2 sprays).
• Don't blow your nose.
• Wait about 15 minutes. If you have not already experienced sufficient relief, or to obtain optimal efficacy and long-lasting relief, repeat the spray once in each nostril. Discard the bottle and sprayer after use or within 8 hours of preparation.
• Lie down in a quiet, dark room for a while after you use Dihydroergotamine. This may help with your treatment.

Store the product at room temperature.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause numbness; it may cause drowsiness or dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea and vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each mL of sterile injectable solution contains dihydroergotamine mesylate 1 mg. Nonmedicinal ingredients: anhydrous ethyl alcohol 47 mg, glycerol, methanesulfonic acid to adjust pH and water for injection.

Do not use dihydroergotamine if you:

• are allergic to any of the ingredients
• are pregnant
• are a breast-feeding mother
• are taking the following medications
  • protease inhibitors (e.g., ritonavir, nelfinavir, indinavir)
  • macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin)
  • antifungal agents (e.g., ketoconazole, itraconazole)
• have Coronary Artery Disease
• have diseases of blood circulation
• have uncontrolled high blood pressure
• have severely impaired liver function
• have severely impaired kidney function

There may be other conditions where the doctor may not want you to use Dihydroergotamine. Be sure to tell all health care professionals involved in your care about all your medical conditions.

There may be an interaction between dihydroergotamine and any of the following:

• antifungal agents (e.g., ketoconazole, itraconazole)
• cocaine
• Epinephrine by injection
• macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin)
• Naratriptan
• Nicotine
• other ergot medications (e.g., methysergide, ergonovine, ergoloid mesylates)
• protease inhibitors (e.g., ritonavir, nelfinavir, indinavir)
• Rizatriptan
• Sumatriptan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Dihydroergotamine. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Dihydroergotamine.

Dependence: If you take dihydroergotamine for extended periods of time you may become dependent upon it and require progressively increasing doses for relief of headaches or to prevent the increasing unpleasant effects which may follow withdrawal of the medication.

Drowsiness/reduced alertness: You should not undertake activities requiring mental alertness, such as operating equipment or driving a vehicle, until you determine your response and sensitivity to Dihydroergotamine.

Overdose: It is important to stay within the limits of the recommended dosage of Dihydroergotamine and avoid excessive or prolonged use. An overdose of ergotamine is dangerous, and may cause the following effects:

• cold and pale skin
• confusion
• depression
• diarrhea
• dizziness
• drowsiness
• headache
• itching
• muscle pain
• nausea
• pain like that of Angina
• rapid and weak pulse
• rise and/or fall of blood pressure (usually in that order)
• slow or fast heart rate
• thirst
• tingling and numbness of the extremities
• unconsciousness
• vomiting

If an overdose is suspected, seek medical help immediately.

Pregnancy: Dihydroergotamine may cause harm when taken during pregnancy. If you become pregnant while using Dihydroergotamine, contact your doctor immediately.

Breast-feeding: Dihydroergotamine passes into breast milk and may cause symptoms of vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. If you are a breast-feeding mother you should not take Dihydroergotamine.

Children: The safety and effectiveness of Dihydroergotamine for children less than 16 years of age have not been established. It is not recommended for use by children.

This product must be injected under the skin (subcutaneously). Do not shake the container before use. To use: If in an ampoule, break off the tip. if in a vial, clean the top with alcohol. Measure the prescribed dose carefully with a syringe. Clean the skin at the injection site with an alcohol swab. Pinch the skin and inject the medication into the fold. Wait at least one week before injecting the same site again. For greater effectiveness and faster relief, use this product at the first sign of a migraine. Generally, this medication is used only as needed.