Dihydroergotamine Mesylate Nasal spray, solution

What is this medicine?

DIHYDROERGOTAMINE (dye hye droe er GOT a meen) is part of a group of medicines called ergot alkaloids. It is used to treat migraine headaches with or without aura. It should not be used to prevent migraine headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• chest pain or difficulty breathing

• heart or blood vessel disease

• high blood pressure

• infection

• kidney disease

• liver disease

• poor circulation

• risk factors for heart disease such as smoking, high cholesterol, a family history of heart disease, or if you are postmenopausal or a male over 40 years of age

• an unusual or allergic reaction to dihydroergotamine, ergot alkaloids, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for use in the nose. Follow the directions on the prescription label. This medicine is given at the first symptoms of a migraine. It is not for everyday use. You must prepare the nasal spray only when you are ready to use it. Follow the instructions that come with your prescription or contact your doctor or health care professional if you are unsure how to do this. Throw away the sprayer after completing the full dose. Each unit is only good for eight hours once opened. Do not use this medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply; this medicine is not for regular use.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• antifungal drugs like fluconazole, itraconazole, ketoconazole or voriconazole

• certain antibiotics like erythromycin, clarithromycin, and troleandomycin

• cocaine

• conivaptan

• dexfenfluramine

• ephedrine

• feverfew

• grapefruit juice

• imatinib

• isoproterenol

• medicines called nitrates like isosorbide and nitroglycerin

• medicines for colds, flu, or breathing difficulties like phenylephrine and pseudoephedrine

• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan

• midodrine

• nefazodone

• other ergot alkaloids like bromocriptine, cabergoline, dihydroergotamine, ergoloid mesylates, ergonovine, methylergonovine, and methysergide

• some medicines for HIV

This medicine may also interact with the following medications:

• clotrimazole

• fluoxetine

• fluvoxamine

• medicines for high blood pressure, especially beta-blockers

• metronidazole

• nicotine

• zileuton

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Check with your doctor or health care professional if you do not get relief from your headaches after using this medicine. You may need to be changed to a different kind of medicine to treat your migraines.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness, dizziness and flushing. Avoid alcoholic drinks.

This medicine decreases the circulation of blood to your skin, fingers, and toes. You may get more sensitive to the cold. Elderly patients are more likely to feel this effect. Dress warmly and avoid long exposure to the cold.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• chest pain

• cold hands or feet

• fast, irregular heartbeat

• leg or arm pain, cramps

• swelling of hands, ankles, or feet

• tingling, pain or numbness in feet or hands

• vomiting

• weakness in legs

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in the taste of food

• nasal congestion or sore throat

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 25 degrees C (77 degrees F). Protect from light, moisture, and heat. Do not refrigerate or freeze. Keep the parts of the nasal spray in the tray provided. Keep this tray loaded in the assembly case. Do not keep an opened nasal spray for more than 8 hours. Throw away any unopened medicine after the expiration date.

Dihydroergotamine Mesylate Solution for injection

What is this medicine?

DIHYDROERGOTAMINE (dye hye droe er GOT a meen) is used to treat migraine headaches with or without aura. It should not be used to prevent migraine headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel problems, or surgery on your arteries

• chest pain

• heart disease

• high blood pressure

• infection

• kidney disease

• liver disease

• risk factors for heart disease like smoking, high cholesterol, a family history of heart disease, or if you are a postmenopausal female or a male over 40 years of age

• an unusual or allergic reaction to dihydroergotamine, ergot alkaloids, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin, into a muscle, or into a vein. You will be taught how to prepare and give this medicine. Use exactly as directed. Do not take your medicine more often than directed. Do not use more than the maximum daily or weekly dose. This drug is not for daily use.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. Use this medicine only when you have a headache. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medicines:

• clarithromycin

• cocaine

• conivaptan

• dexfenfluramine

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ephedrine

• erythromycin

• feverfew

• grapefruit juice

• imatinib

• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• medicines used to treat colds or breathing difficulties

• medicines used to treat fungal infections like itraconazole, ketoconazole, posaconazole and voriconazole

• midodrine

• nefazodone

• nitrate medicines like nitroglycerin

• some medicines for HIV

• troleandomycin

This medicine may also interact with the following medications:

• medicines for blood pressure

• medicines for mental depression

• nicotine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness, dizziness and flushing. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast, irregular heartbeat

• muscle pain or cramps

• pain, tightness, or discomfort in your chest

• pain, tingling, numbness in the hands or feet

• weakness in legs

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in the taste of food

• cold hands or feet

• nasal congestion or sore throat

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light, moisture, and heat. Do not refrigerate or freeze. Throw away any unused medicine after the expiration date.