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Indications and Dosage
Oral
Acute migraine attacks Adult: Each tablet contains ergotamine tartrate 2 mg, cyclizine hydrochloride 50 mg and caffeine hydrate 100 mg. Initially, 1 tablet, additional doses of ½-1 tablet may be taken at half-hrly intervals, if needed. To be taken as soon as possible at the 1st warning of a migraine attack. Max: 3 tablets in 24 hr, 4 tablets per attack, 6 tablets per wk and 2 courses of treatment per mth. Ensure an interval of at least 4 days between successive treatment courses.
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Contraindications
Not to be used with potent inhibitors of CYP3A4 and protease inhibitors. Hyperthyroidism, renal or hepatic impairment. Pre-existing vascular disease including coronary disease, obliterative vascular disease, angina, claudication, peripheral ischaemia, Raynaud's syndrome and hypertension. Not to be used when there is sepsis. Pregnancy and lactation.
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Special Precautions
Not to be taken regularly or used for migraine prophylaxis. Increased risk of arterial constriction and other symptoms of ergotism. Discontinue treatment when symptoms of arterial occlusion occur e.g. numbness and tingling of the extremities. Caution when used in patients with infective hepatitis, cardiac disease or anaemia. GI tract obstructive disease, glaucoma, prostatic hypertrophy or urinary retention may be worsened by cyclizine. May increase risk of retroperitoneal and/or pleuropulmonary fibrosis. Not recommended for use with other vasoconstrictors. Elderly.
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Adverse Reactions
Increased BP, hypotension, rapid and weak pulse, palpitations, arrhythmias, precordial pain, coronary infarction, fibrotic thickening of the heart valves. Cerebral ischaemia and thrombosis, blurred vision, sleep disturbances, urinary retention, muscle cramps and joint pains. GI symptoms such as nausea, vomiting, constipation, abdominal pain. Dysaesthesia, paraesthesia, formication, tremor, convulsions, headache, extrapyramidal effects. Anxiety, depression, confusion, hallucinations, psychomotor impairment.
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Overdosage
Acute overdosage: Symptoms: Nausea, vomiting, diarrhoea, extreme thirst, coldness, weakness, tingling and itching of the skin, rapid and weak pulse, hypotension, shock, confusion, convulsions and unconsciousness. BP may be difficult to measure; may result in fatalities. Further symptoms of peripheral vasoconstriction or CV disturbances may occur but be delayed. Treatment includes using activated charcoal to reduce absorption. General supportive measures should be instituted. IV vasodilators such as sodium nitroprusside infusion may be required to relieve vasospasm. Peritoneal dialysis and forced diuresis may be used to remove ergotamine from the body. Chronic overdosage: Symptoms: Peripheral ischaemia of the extremities, especially the feet and legs. Gangrene may develop in the toes and fingers. Anginal pain, tachycardia or bradycardia and BP fluctuations may occur. Excessive use may lead to pleural and peritoneal fibrosis. Rebound headache may occur and is a major withdrawal symptom following the development of ergotamine dependence. Treatment: IV vasodilators e.g. nitroprusside and nitroglycerin may be used to re-establish normal blood flow. Captopril may be used to reverse the effects of chronic overdosage with ergotamine.
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Drug Interactions
Increased sedative effect when used with alcohol. Caffeine may increase clearance of lithium. Clearance of caffeine may be reduced when used with oestrogens, progesterones, mexiletine, fluvoxamine, disulfiram or quinoline antibacterials. Serum levels of ergotamine-containing drugs may be increased when used with macrolide antibacterials. Concurrent use with MAOIs or TCAs may increase the sedative and antimuscarinic effects of cyclizine. Increased clearance of caffeine by phenytoin. Increased risk of arterial occlusion with methysergide and vasospasm with 5-HT1 agonists. Avoid ergotamine for 6 hr after almotriptan, sumatriptan, rizatriptan and zolmitriptan, and for 24 hr after eletriptan. Avoid almotriptan, eletriptan, sumatriptan and rizatriptan for 24 hr, and zolmitriptan for 6 hr, after ergotamine. Increased sedative effects when used with anxiolytics and hypnotics. Increased risk of vasoconstriction when used with β-blockers or nicotine. May reduce anti-anginal effects of glyceryl trinitrate. May increase plasma levels of theophylline.
Potentially Fatal: Concurrent use with HIV-proteases which are potent CYP3A4 inhibitors (e.g. amprenavir, indinavir, nelfinavir, ritonavir) is not recommended due to increased risk of ergotism. |
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Action
Description: Ergotamine is an α-adrenergic blocker with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels, it also depresses central vasomotor centers. Caffeine is also a cranial vasoconstrictor. Cyclizine is a sedative piperazine antihistamine with antimuscarinic activity. It is commonly used as an antiemetic.
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Storage
Store below 25°C.
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MIMS Class
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