Ergotamine, Oral/Rectal

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KEY POINTS

• This medicine is taken by mouth or given by suppository to prevent or relieve the pain of migraine headaches and other types of throbbing headaches in progress. Use it exactly as directed. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches.
• Do not use this medicine if you are pregnant. It may cause birth defects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. If you take this medicine with certain drugs that affect the liver, it can have very serious effects on blood supply to the hands, feet, and brain.

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What are other names for this medicine?

Type of medicine: antimigraine

Generic and brand names: ergotamine and caffeine, oral; ergotamine and caffeine, rectal; ergotamine, oral; ergotamine, rectal; ergotamine, sublingual; Cafergot; Ergomar; Migergot

What is this medicine used for?

This medicine is taken by mouth or given by suppository to prevent or relieve the pain of migraine headaches and other types of throbbing headaches in progress.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Angina
• Heart disease or a heart attack
• High blood pressure
• Kidney or liver problems
• Problems with circulation or blood vessel disease
• Problems with substance abuse
• Risk factors for heart disease such as smoking, family history of heart disease, diabetes, or high cholesterol

If you take this medicine with certain drugs that affect the liver, it can have very serious effects on blood supply to the hands, feet, and brain. This medicine may interact with many other medicines. Tell your provider all prescription and nonprescription medicines you take. Do not start or stop any medicine unless you check with your healthcare provider or pharmacist first.

Females of childbearing age: Do not use this medicine if you are pregnant. This medicine has been reported to cause birth defects. Use an effective birth control method while you are taking this medicine. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while you are using this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed. It is not taken on a regular schedule.

Check with your healthcare provider before using this medicine in children under age 18.

If you have the sublingual tablets, place a tablet under the tongue and let it dissolve slowly. Do not chew or swallow the tablets whole. Do not use more than 3 tablets in 24 hours. Do not take more than 5 sublingual tablets during a 7-day period unless your healthcare provider specifically tells you to do so.

If you have the suppository form, first remove the foil wrapper and moisten the suppository with water. If the suppository is too soft to insert easily, run cold water over it or put it in ice water until it is firm. If it is too dry or hard, moisten it with warm water. Lie on your left side and bend your right knee up toward your chest. Gently push the suppository into your rectum (pointed end first) deep enough so that it will not come out. Keep lying down for about 5 minutes. This lets the medicine dissolve and keeps the suppository from coming out. Do not use more than 2 suppositories during one migraine attack and no more than 5 suppositories during a 7-day period unless your healthcare provider specifically tells you to do so.

If you have the tablets that you swallow whole, do not take more than 6 tablets during one migraine attack and no more than 10 tablets during a 7-day period unless your healthcare provider specifically tells you to do so.

Do not use any other medicine for migraines within 24 hours of using this medicine.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, weakness, muscle pain, numbness or tingling in your fingers or toes, drowsiness, confusion, seizures.

What should I watch out for?

You should not use this medicine for more than 10 days per month. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches. Tell your healthcare provider if you need to use the medicine more often, if the medicine is not working as well, if you have headaches more often, or if your headaches get worse.

Do not smoke while using this medicine. Smoking may increase your risk of side effects.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make you more sensitive to cold temperatures. Dress warmly during cold weather and avoid prolonged exposure to cold temperatures.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

This medicine may contain caffeine. You may want to limit the use of other medicines, foods, or drinks that contain caffeine while taking this product.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Vision problems, numbness or tingling of fingers or toes, cold hands or feet, muscle pain or weakness in arms or legs, unexplained swelling, skin blisters, chest pain, fast or slow heartbeat.

Other: Dizziness, diarrhea, nausea, vomiting, rectal irritation (with use of suppositories).

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), metronidazole, and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), sotalol (Betapace, Sorine), and timolol
• Ephedrine, epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), phenylephrine (Neo-Synephrine, Sudafed PE), or pseudoephedrine (Sudafed)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as feverfew, green tea, and guarana
• Nicotine replacement products such as Habitrol, NicoDerm, Nicorette, Nicotrol
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Phentermine (Adipex-P, Suprenza)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), dextroamphetamine (Dexedrine), and methamphetamine (Desoxyn)
• Zileuton (Zyflo)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

If suppositories are too soft, you may store them in the refrigerator.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.