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Drug Details

CAFERGOT

• Drug Class Description
  Ergot alkaloids / xanthines.
• Generic Name
  Ergotamine tartrate, caffeine
• Presentation
  Cafergot Tablets: Ergotamine tartrate 1mg, caffeine 100mg. Cafergot Suppositories: Ergotamine tartrate 2mg, caffeine 100mg.
• Description
  Cafergot Tablets: white s-c tablet. Cafergot Suppositories: off-white suppositories, 3cm in length, 1cm in diameter.
• Indications
  

  Acute attacks of migraine and migraine variants unresponsive to simple analgesics.

• Adult Dosage
  

  There is considerable inter-individual variation in the sensitivity of patients to ergotamine. Care should therefore be exercised in selecting the optimum therapeutic dose for an individual patient which will not give rise to unwanted effects, either acutely or chronically. The maximum recommended dosages should not be exceeded and ergotamine treatment should not be administered at intervals of less than 4 days.

  For maximum efficacy, the optimal dose (in the preferred presentation) should be administered immediately prodromal symptoms are experienced.

  One or two tablets taken at the first warning of an attack are normally sufficient to obtain migraine relief. Some individuals may require higher dosages which should never exceed 4 tablets (4mg ergotamine) in 24 hours. It is essential to use the minimum effective dose.

  The maximum recommended weekly dose of 8 tablets (8mg ergotamine) should not be exceeded.

• Child Dosage
  

  Not recommended.

• Elderly Dosage
  

  Whilst there is no evidence to suggest that the elderly require different dosages of Cafergot, the contra-indications of this drug are common in the elderly, e.g. coronary heart disease, renal impairment, hepatic impairment and severe hypertension. Caution should therefore be exercised when prescribing for this age group.

• Contra Indications
  

  Known hypersensitivity to ergot alkaloids, caffeine, or any other components of the formulation.

  Patients with impaired peripheral circulation, obliterative vascular disease, coronary heart disease, inadequately controlled hypertension, septic conditions or shock. Impaired hepatic or renal function, temporal arteritis and patients with hemiplegic or basilar migraine are also contraindicated.

  Pregnancy or nursing mothers.

  Concomitant treatment with macrolide antibiotics, HIV-protease or reverse-transcriptase inhibitors, azole antifungals.

  Concomitant treatment with vasoconstrictive agents (including ergot alkaloids, sumatriptan and other 5HT₁-receptor agonists.

• Special Precautions
  

  Cafergot is only indicated for the treatment of acute migraine attacks and not for prevention.

  Continued daily use of Cafergot or use in excess of the recommended doses must be avoided since this may cause vasospasm.

  Owing to its vasoconstrictor properties, ergotamine may cause myocardial ischaemia or, in rare cases, infarction, even in patients with no known history of coronary heart disease.

  Patients who are being treated with Cafergot should be informed of the maximum doses allowed and of the first symptoms of over dosage: hypoaesthesia, paraesthesia (eg numbness, tingling) in the fingers and toes, non-migraine-related nausea and vomiting, and symptoms of myocardial ischaemia (e.g. precordial pain). If symptoms such as tingling in the fingers or toes occur, the drug should be discontinued at once and the physician consulted.

  If contrary to recommendations ergotamine-containing drugs are used excessively over years, they may induce fibrotic changes, in particular of the pleura and retroperitoneum. There have also been rare reports of fibrotic changes of the cardiac valves.

  The occurrence of drug-induced headaches has been reported during prolonged and uninterrupted treatment with Cafergot.

• Interactions
  

  Ergotism (increased peripheral vasoconstriction)

  Several drugs increase the risk of ergotism (vasoconstriction, convulsions, other CNS and GI effects) and concomitant use of the following with Cafergot should be avoided.

  Antibacterials

  • Macrolides (eg erythromycin, azithromycin, clarithromycin, spiramycin) or telithromycin
  • quinupristin/dalfopristin
  • tetracycline

  Antifungals

  • lmidazoles (eg ketaconazole, miconazole)
  • Triazoles (eg itraconazole, posaconazole, voriconazole)
  • Antivirals (eg amprenavir, indinavir, nelfinavir, ritonavir, saquinavir. atazinavir, efavirenz)

  5HT₁ agonists

  • Avoid Cafergot for 6 hours after almotriptan, rizatriptan, sumatriptan or zolmitriptan. Avoid almotriptan, rizatriptan, sumatriptan or zolmitriptan for 24 hours after Cafergot.
  • Avoid Cafergot for 24 hours after eletriptan or frovatriptan. Avoid eletriptan or frovatriptan for 24 hours after Cafergot.

  Cimetidine

  Sympathomimetic agents

  Beta-blockers

  Other vasoconstrictors - excessive nicotine may enhance vasoconstriction

  Other

  Anaesthetics

  • Halothane reduces the effect of ergometrine on the parturient uterus

  Antidepressants

  • Reboxetine - possible increase in hypertension in association with ergot
• Adverse Drug Reactions
  

  The caffeine component of Cafergot may give rise to unwanted stimulant effects.

  Side effects of Cafergot are related in the main to the ergotamine component.

  The most common of all side-effects are nausea and vomiting. Depending on the dose of ergotamine, signs and symptoms of vasoconstriction may occur.

  Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (greater than or equal to 1 in 10); common (less than or equal to 1 in 100, less than 1 in 10); uncommon (greater than or equal to 1 in 1,000, less than 1 in 100); rare (greater than or less than 1 in 10,000, less than 1 in 1,000) very rare ( less than 1 in 10,000), including isolated reports.

  Table 1:

  Immune system disorders

  Rare: Hypersensitivity reactions¹

  Nervous system disorders

  Common: Dizziness

  Uncommon: Paraesthesia (e.g. tingling), hypoaesthesia (e.g numbness)

  Ear and labyrinth disorders

  Rare: Vertigo

  Cardiac disorders

  Uncommon: Cyanosis

  Rare: Bradycardia, tachycardia

  Very rare: Myocardial ischaemia, myocardial infarction

  Vascular disorders

  Uncommon: Peripheral vasoconstriction

  Rare: Increase in blood pressure

  Very rare: Gangrene

  Respiratory, thoracic and mediastinal disorders

  Rare: Dyspnoea

  Gastrointestinal disorders

  Common: Nausea and vomiting (not migraine related), abdominal pain

  Uncommon: Diarrhoea

  Skin and subcutaneous tissue disorders

  Uncommon: Pain in extremities

  Rare: Myalgia

  General disorders and administration site conditions

  Uncommon: Weakness in extremities

  Investigations

  Rare: Absence of pulse

  Injury, poisoning and procedural complications

  Rare: Ergotism²

  1. Hypersensitivity reactions such as skin rash, face oedema, urticaria and dyspnoea.

  2. Ergotism is defined as an intense arterial vasoconstriction, producing signs and symptoms of vascular ischemia of the extremities and other tissues (such as renal or cerebral vasospasm)

  Rare cases of intestinal ischaemia have been associated with chronic use and overuse of ergotamine-containing preparations. Rarely, headache may be provoked either by chronic overdosage or by rapid withdrawal of the product.

  Excessive use of ergotamine-containing products for prolonged periods may result in fibrotic changes, in particular of the pleura and retroperitoneum. Rare cases of fibrosis of cardiac valves have also been reported.

  The occurrence of drug induced headaches has been reported during prolonged and uninterrupted treatment with Cafergot.