caffeine and ergotamine (oral/rectal)

What is the most important information I should know about caffeine and ergotamine?

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

Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection.

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal.

What is caffeine and ergotamine?

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.

The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using caffeine and ergotamine ?

Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:

• a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;
• coronary artery disease or "hardening of the arteries";
• uncontrolled high blood pressure;
• severe liver disease;
• severe kidney disease; or
• a serious infection called sepsis.

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:

• conivaptan (Vaprisol);
• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);
• an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
• an antidepressant such as nefazodone;
• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or
• HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:

• breathing problems;
• high blood pressure;
• liver disease;
• kidney disease; or
• coronary artery disease (or risk factors that include 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 cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine.

Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby.

How should I use caffeine and ergotamine?

Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.

To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.

If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.

To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.

For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days.

Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches.

Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed.

What happens if I miss a dose?

Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.

Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week.

Do not use more than 2 suppositories per headache or 5 suppositories per week.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.

Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).

What should I avoid while using caffeine and ergotamine?

Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:

• dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or
• almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of caffeine and ergotamine?

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

Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• fast or slow heart rate;
• muscle pain in your arms or legs;
• leg weakness;
• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
• severe pain in your stomach or lower back;
• urinating less than usual or not at all;
• painful sores on your rectum after using the rectal suppositories;
• swelling or itching in any part of your body;
• cough with stabbing chest pain and trouble breathing; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• dizziness, spinning sensation;
• weakness;
• nausea, vomiting; or
• mild itching.

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.

What other drugs will affect caffeine and ergotamine?

Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:

• birth control pills;
• zileuton (Zyflo);
• cold or allergy medications;
• nicotine (Nicoderm, Nicorette);
• diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);
• an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;
• nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or
• heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about caffeine and ergotamine.