Caffeine and ergotamine (oral/rectal)

Caffeine is a stimulant that makes blood vessels narrow (vasoconstriction). Ergotamine is an ergot alkaloid (ER-got AL-ka-loid) that also narrows blood vessels around the brain.

Caffeine and ergotamine is a combination medicine used to treat or prevent a migraine headache.

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

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

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

Follow all instructions on your prescription label. Never take more than your recommended dose. Using migraine headache medicine too much can make headaches worse. Tell your doctor if the medicine seems to stop working well for your migraine attacks. This medicine 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 started.
• If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes.
• If you need more medication, 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 6 tablets in any 24-hour period. Do not take more than 10 tablets in 7 days.

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

Wash your hands before and after inserting the suppository.

To use caffeine and ergotamine rectal suppositories:

• Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already started.
• Remove the wrapper before inserting the suppository. Avoid handling the suppository for too long or it will melt.
• Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first.
• Stay lying down for a few minutes while the suppository melts. You should feel little or no discomfort. Avoid using the bathroom for at least an hour.
• If your headache does not completely go away, use 1 more suppository after at least 1 hour.

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

Do not share this medication with anyone else, even if they have the same symptoms.

Store tablets at room temperature away from moisture, heat, and light.

Store rectal suppositories in the refrigerator, do not freeze.

Some medicines can cause a serious drop in blood flow when taken with caffeine and ergotamine. A severe drop in blood flow to the brain and other parts of the body can lead to serious side effects.

You should not use this medicine if you have coronary heart disease, high blood pressure, circulation problems, liver or kidney disease, or sepsis.

Tell your doctor about all your current medicines and any that you start or stop using. Many drugs can interact, and some drugs should not be used together.

Do not use if you are pregnant or could become pregnant.

You should not use caffeine and ergotamine if you are allergic to caffeine or ergotamine, or if you have:

• coronary heart disease;
• high blood pressure;
• blood circulation problems;
• sepsis (a severe reaction to an infection);
• liver disease;
• kidney disease; or
• if you are pregnant or could become pregnant.

Many drugs can cause a dangerous decrease in blood flow when used with caffeine and ergotamine. A severe decrease in blood flow to the brain and other parts of the body can lead to serious side effects. Some drugs should not be used together with caffeine and ergotamine. Your doctor may change your treatment plan if you also use:

• zileuton;
• an antidepressant--fluoxetine, fluvoxamine, nefazodone;
• an antibiotic--clarithromycin, erythromycin, metronidazole, telithromycin;
• antifungal medicine--clotrimazole, fluconazole, itraconazole, ketoconazole; or
• antiviral medicine to treat HIV/AIDS--indinavir, nelfinavir, ritonavir, saquinavir.

Do not use caffeine and ergotamine if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and tell your doctor if you become pregnant.

You should not breastfeed while using this medicine.

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

Caffeine and ergotamine may cause serious side effects. Stop using caffeine and ergotamine and call your doctor right away if you have:

• severe pain in your stomach or back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• cramps in your hips or legs, leg pain or swelling;
• weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes;
• muscle pain or weakness in your arms or legs;
• fast or slow heart rate;
• severe headache, blurred vision, pounding in your neck or ears;
• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
• painful sores on your rectum after using the rectal suppositories.

Serious side effects are more likely with overuse of caffeine and ergotamine. Caffeine and ergotamine is not for daily use.

Common side effects of caffeine and ergotamine may include:

• numbness, tingling, burning pain;
• dizziness, spinning sensation;
• weakness;
• itching or swelling;
• nausea, vomiting; or
• (with suppository use) a rectal sore or ulcer.

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.

Usual Adult Dose for Migraine:

Oral: Ergotamine 1 mg-caffeine 100 mg per tablet: Initial dose: 2 tablets orally at first sign of an attack; 1 additional tablet every half-hour as needed not to exceed maximum doses Maximum doses: 6 tablets per attack; 10 tablets per 7-day periodRectal: Ergotamine 2 mg-caffeine 100 mg per suppository: Initial dose: 1 suppository rectally at first sign of a migraine attack; 1 additional suppository may be administered after 1 hour if needed for full reliefMaximum dose: 2 suppositories per attack; 5 suppositories per 7-day periodComments:-Early administration at onset provides maximum effectiveness. -This drug should not be used for chronic daily administration. Use: To abort or prevent vascular headaches, such as a migraine, migraine variants, or "histaminic cephalalgia".

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 in one day or more than 10 tablets in one week.

Do not use more than 2 suppositories for one headache or more than 5 suppositories in one week.

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

Overdose symptoms may include vomiting, blurred vision, a pounding feeling in your neck or ears, feeling drowsy or light-headed, having a seizure, or experiencing signs of decreased blood flow in your arms or legs (such as pain, numbness, tingling, weak pulses, or a blue appearance).

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

• dihydroergotamine, ergonovine, or methylergonovine; or
• almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, rizatriptan, or zolmitriptan.

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to unwanted side effects. Avoid the use of grapefruit products while taking caffeine and ergotamine.

Tell your doctor about all the medicines you are currently taking. Many drugs can interact with caffeine and ergotamine, especially:

• nicotine gum or skin patch;
• an antibiotic or antifungal medicine;
• diet pills, stimulants, or medicines for attention deficit hyperactivity disorder (ADHD);
• heart or blood pressure medicines; or
• medicines for asthma, colds, or allergies.

This list is not complete, and many other drugs may also affect caffeine and ergotamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.