Ergotamine-Caffeine

Ergotamine/Caffeine is a combination prescription medication used for aborting or preventing vascular headaches.

• Ergotamine/Caffeine is available under the following different brand names: Cafergot, Migergot

Adult dosage

Oral tablet (Cafergot)

• 1mg/100mg

Rectal suppository (Migergot)

• 2mg/100mg

Vascular Headache

Adult dosage

Oral

• 2 tablets (ergotamine 2 mg/Caffeine 200 mg) orally at the first sign of attack; may take 1 tablet (ergotamine 1 mg/Caffeine 100 mg) every 30 minutes or as needed
• Not to exceed 6 tablets/attack
• Not to exceed 10 tablets/week

Rectal

• Insert 1 suppository rectally at the first sign of attack; may repeat once after 1 hr
• Not to exceed 2 suppositories/attack
• Not to exceed 5 suppositories/week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ergotamine/Caffeine include:

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

Serious side effects of Ergotamine/Caffeine include:

• severe pain in the 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 the arms and legs, numbness and tingling or pain in the hands or feet, blue-colored fingers or toes;
• muscle pain or weakness in the arms or legs;
• fast or slow heart rate;
• severe headache, blurred vision, pounding in the 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 the rectum after using the rectal suppositories.

Rare side effects of Ergotamine/Caffeine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ergotamine/Caffeine has severe interactions with at least 32 other drugs.
• Ergotamine/Caffeine has serious interactions with at least 119 other drugs.
• Ergotamine/Caffeine has moderate interactions with at least 249 other drugs.
• Ergotamine/Caffeine has minor interactions with at least 43 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Potent CYP3A4 inhibitors owing to the risk of acute ergot toxicity
• Pregnancy
• Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, sepsis
• Hypersensitivity to any of the ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ergotamine/Caffeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ergotamine/Caffeine?”

Cautions

• Ergotism
  • Although ergotism rarely develops even after long-term intermittent use of orally administered ergotamine, do not exceed dosage recommendations
  • Ergotism manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia
  • Headache, intermittent claudication, muscle pains, numbness, or coldness and pallor of the digits may occur with chronic intoxication; if the condition is allowed to progress untreated, gangrene can result
  • While most cases result from frank overdosage, some cases involve hypersensitivity
  • There are few reports among patients taking doses within recommended limits or for brief periods
  • Withdrawal symptoms (eg, rebound headache) upon discontinuation are rare; typically reported with long, indiscriminate use
• Fibrotic complications
  • Retroperitoneal and/or pleuropulmonary fibrosis reported
  • Rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term, continuous use of ergotamine tartrate and Caffeine
  • Do not use it for the chronic daily administration
• Drug interaction overview
  • Ergotamine is a CYP3A substrate and inhibitor
  • CYP3A inhibitors
  • Potent inhibitors: Contraindicated owing to risk for acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities
  • Less potent inhibitors: Although not contraindicated, avoid them if possible owing to the risk for vasospasm

Pregnancy and Lactation

• Contraindicated; ergotamine elicits oxytocic effects
• There are no studies on placental transfer or teratogenicity of the combination of ergotamine and Caffeine
• Labor and delivery
• Contraindicated in labor and delivery owing to ergotamine’s oxytocic effect, which is maximal in the third trimester
• Lactation
  • Ergot drugs are known to inhibit prolactin, but there are no reports of decreased lactation with ergotamine/Caffeine
  • Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants
  • Owing to the potential serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother