Cafergot is a fixed-dose combination of ergotamine and caffeine, paired in a single oral preparation for the management of migraine and certain headache disorders. Combination products of this kind reflect a long-established backbone in antimigraine therapy, where caffeine is included alongside the principal active ingredient as part of a co-formulation that has been in clinical use for many decades.
Ergotamine is classified in the antimigraine category, while caffeine is the familiar methylxanthine found in many other contexts. Within Cafergot the two ingredients are presented together rather than taken separately, formalising a pairing that has historically been considered useful in this therapeutic area. The structured indication block lower on this page also notes the product's listing in relation to hypotension in some markets.
Cafergot is registered in 16 countries, with a broad and geographically scattered footprint rather than a single regional cluster. Markets where the brand is available include Argentina, Australia, Egypt, Singapore, the Netherlands, and South Africa, among others. Travellers moving between these markets may encounter Cafergot under the same brand name, while in countries outside the registered list the same combination — or alternative antimigraine therapies — will typically be offered under different brand names.
Combination antimigraine products vary between countries even more than single-ingredient drugs, both in their formulations and in their regulatory status, so substitution is rarely a like-for-like exercise. A pharmacist in the destination country can confirm what is locally available, but any decision to begin, continue, or change Cafergot belongs with a healthcare provider who knows the patient's history.
The toxic effects of an acute overdosage of CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and caffeine tablets, USP) are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days.
Treatment consists of removal of the offending drug by induction of emesis, gastric lavage, and catharsis. Maintenance of adequate pulmonary ventilation, correction of hypotension and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.
Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension.
Gastrointestinal: Nausea and vomiting.
Neurological: paresthesias, numbness, weakness, and vertigo.
Allergic: Localized edema and itching.
Fibrotic Complications(see WARNINGS).
Drug Abuse And Dependence: There have been reports of drug abuse and psychological dependence in patients on CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and caffeine tablets, USP) therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism (see PRECAUTIONS).
CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors): Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine (see CONTRAINDICATIONS). While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with ergotamine.
Fibrotic Complications: There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION).
PRECAUTIONSGeneral: Although signs and symptoms of ergotism rarely develop even after long-term intermittent use of the orally administered drug, care should be exercised to remain within the limits of recommended dosage.
Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle. In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result.
While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug.
Pregnancy Teratogenic EffectsPregnancy Category X: There are no studies on the placental transfer or teratogenicity of the combined products of CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and caffeine tablets, USP). Caffeine is known to cross the placenta and has been shown to be teratogenic in animals. Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals (see CONTRAINDICATIONS).
Nonteratogenic Effects: CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and caffeine tablets, USP) is contraindicated in pregnancy due to the oxytocic effects of ergotamine (see CONTRAINDICATIONS).
Labor and Delivery: CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) is contraindicated in labor and delivery due to its oxytocic effect which is maximal in the third trimester (see CONTRAINDICATIONS).
Nursing Mothers: Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and caffeine tablets, USP). Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from CAFERGOT® (ergotamine tartrate and caffeine tablets, USP), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Cafergot is prescribed for the management of migraine and certain types of headache, and is also listed for use in hypotension. The combination pairs an antimigraine ingredient with caffeine, which is a long-established approach in this therapeutic area. The structured indication section below this introduction lists each registered use as recognised in the markets where Cafergot is sold.
Cafergot contains two active ingredients: ergotamine, classified within the antimigraine category, and caffeine. Both ingredients are well known individually, and their pairing in a single oral product reflects a long-standing combination used in headache and migraine therapy. Each ingredient is also available worldwide on its own under various other brand names, particularly caffeine in non-medicinal contexts.
Cafergot is registered in 16 countries, with a geographically broad footprint that spans several continents. Examples include Argentina, Australia, Egypt, Singapore, the Netherlands, and South Africa. If your country is not represented on the list shown on this page, a local pharmacist can usually confirm whether an ergotamine-caffeine combination is available in that market under a different brand name.
Ergotamine-caffeine combinations are sold under several brand names in different regional markets, and ergotamine itself appears in other antimigraine preparations as well. The broader antimigraine category also includes other molecule families used for the same therapeutic purpose, although they are not freely interchangeable. To identify a local equivalent, search the active ingredients on Pill2Trip or ask a pharmacist about available options in your country.
Yes. Combination antimigraine products vary between countries in their formulations, prescription status, and clinical positioning, and migraine therapy in general is highly individualised. Travellers and expatriates moving between regulatory regimes can find that the same brand is unavailable, that a different combination is offered, or that prescription requirements differ. Any decision to start, continue, or substitute Cafergot should be made with a healthcare provider familiar with the patient.
