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warnings
WARNINGS Patients who are being treated with MEDIHALER ERGOTAMINE should be informed adequately of the symptoms of ergotism. Close medical supervision by the physician is recommended so that he may react appropriately should signs of ergotism develop. Six inhalations per day, if continued daily, entail the risk of vasospastic complications. Avoid prolonged administration or in excess of the recommended dosage because of the danger of ergotism and gangrene. Pediatric Patients : Since there is no experience in children who have received this drug, safety and efficacy in children have not been established. Nursing Mothers: Whether ergotamine tartrate is excreted in mothers' milk is not known. As a general rule, nursing should not be undertaken while a patient is on a drug (since many drugs are excreted in human milk).
ADVERSE REACTIONS Ergotamine tartrate may cause nausea and vomiting. Patients with headaches may become nauseated and drug induced distress may be difficult to evaluate. Ergotamine in large doses raises arterial pressure, produces coronary vasoconstriction and slows the heart both by direct action and its effect on the vagus. Under this condition, ergotamine also has oxytocic and spasmolytic properties. The above conditions are seen as a consequence of overdosage and may be manifested at the dosage recommended for control of headaches. Vasoconstrictive complications, at times of a serious nature, may occur. These include pulselessness, weakness, muscle pains and paresthesias of the extremities and precordial distress and pain. 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 adverse effects include transient tachycardia or bradycardia, nausea, vomiting, localized edema and itching.