Ergotamine Tartrate – Cyclizine HCl – Caffeine Hydrate
Indications And Clinical Uses: The treatment of vascular headache, migraine and related conditions where distention of cranial vessels appears to be the cause.
Contra-Indications: Sepsis, occlusive vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, coronary artery disease, thrombophlebitis, Raynaud’s disease), thyrotoxicosis, anemia, renal or hepatic disease, hypertension, angina pectoris, peptic ulcer, infectious states, malnutrition, severe pruritus, pregnancy, lactation. Hypersensitivity to any of the components. Ergotamine should not be used prophylactically.
Precautions: Avoid prolonged administration or dosage in excess of that recommended, because of the danger of ergotism and gangrene. Use the minimum effective dosage of ergotamine necessary since individual sensitivity to the arterial effects of ergotamine varies considerably. Doses of ergotamine as small as 2 mg have caused signs of arterial insufficiency, but this is a very rare occurrence. Discontinue use if symptoms of arterial insufficiency develop.
Megral should be used with caution in patients with infective hepatitis because of an increased risk of precipitating peripheral ischemia.
Repeated doses of ergotamine have occasionally been associated with renal artery spasm and loss of renal function.
Occupational Hazards: Caution patients not to operate vehicles or hazardous machinery until their response to the drug has been determined.
Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, caution patients against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.
In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting primarily of headache upon discontinuation of the product.
Drug Interactions: The concomitant use of ergot alkaloids and beta-blocking agents increases the risks of peripheral vasoconstriction.
Vomiting and peripheral ischemia have been reported after concomitant use of ergot alkaloids and the antibiotics erythromycin and oleandomycin.
Adverse Reactions: Unpleasant adverse effects which may occur include nausea and vomiting, weakness in the legs, muscle pains in the extremities, numbness and tingling of fingers and toes, precordial distress and pain, and transient tachycardia or bradycardia. Localized edema and itching may occur in the rare sensitive patient.
Many of these effects are the result of reduced arteriolar blood flow and are usually relieved by withdrawing therapy. Failure to recognize the early symptoms of arterial insufficiency has on rare occasions led to irreversible vascular change after therapeutic use of ergotamine.
Symptoms And Treatment Of Overdose: Symptoms: Nausea, tachycardia, hypotonia, peripheral ischemia, vomiting, salivation, weakness, tremor, fall of blood pressure, convulsions, peripheral vascular spasms, abdominal colic, respiratory depression, stupor and coma.
Treatment: Gastric lavage, fluids, diuretics, cathartics (sodium sulfates), amyl nitrite inhalation. Some success has been reported with sodium nitroprusside, starting at a rate of 25 Âµg/minute and increasing at 15 minute intervals to 100 Âµg/minute. Peritoneal dialysis and forced diuresis may help to eliminate ergotamine from the body.
Dosage: Initially, 1/4 to 1 tablet with a little water at the first warning of an attack, then 1/2 to 1 tablet every half-hour; not more than 3 tablets should be taken for any single attack. No more than 6 tablets should be taken per week. Children, 1/4 to 1/2 tablet.
Availability And Storage: Each white, biconvex, press-coated tablet with code number WELLCOME A4A on same side as score mark, contains: ergotamine tartrate 2 mg, cyclizine HCl 50 mg, caffeine hydrate 100 mg. Nonmedicinal ingredients: amaranth, cornstarch, dextrose, docusate sodium, gelatin, lactose, liquid glucose, magnesium stearate and sodium metabisulfite. When cut in half, the tablet reveals a pink core. Bottles of 50. Store at 15 to 25°C and keep dry. (Shown in Product Recognition Section)
MEGRAL® Glaxo Wellcome Ergotamine Tartrate – Cyclizine HCl – Caffeine Hydrate Migraine Therapy