Caffeine and ergotamine oral / rectal

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.

Caffeine and ergotamine is a combination medicine 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 purposes not listed in this medication guide.

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.

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:

• weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes;

• painful sores on your rectum after using the rectal suppositories;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• fast or slow heart rate;

• leg weakness, muscle pain in your arms or legs;

• severe pain in your stomach or lower back;

• little or no urinating;

• chest discomfort, dry cough or hack, feeling short of breath on exertion; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• dizziness, spinning sensation;

• weakness;

• nausea, vomiting; or

• mild itching or swelling.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Swelling.
• Dizziness or passing out.
• Muscle pain or weakness.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.

The manufacturers of ergotamine preparations consider ergotamine to be contraindicated in the setting of "impaired renal and/or hepatic function".

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).