Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Laboratoire HRA Pharma, 15 rue Béranger, 75003, Paris, France
A diagnostic aid in the differential diagnosis of ACTH-dependent Cushing’s syndrome. The management of patients with Cushing’s syndrome.
In conjunction with glucocorticosteroids in the treatment of resistant oedema due to increased aldosterone secretion in patients suffering from cirrhosis, nephrosis and congestive heart failure.
The capsules should be taken with milk or after a meal, to minimise nausea and vomiting, which can lead to impaired absorption.
For use as a diagnostic aid: the patient must be hospitalised. Urinary 17-oxygenic steroid excretion is measured over 24 hours on each of 4 consecutive days. The first 2 days serve as a control period. On the third day, 750mg Metopirone (3 capsules) must be given at four-hourly intervals to give a total of 6 doses (ie 4.5g). Maximum urine steroid excretion may occur on the fourth day. If urinary steroid excretion increases in response to Metopirone, this suggests the high levels of circulatory cortisol are due to adrenocortical hyperplasia following excessive ACTH production rather than a cortisolproducing adrenal tumour.
For therapeutic use: for the management of Cushing’s syndrome, the dosage must be adjusted to meet the patient’s requirements; a daily dosage from 250mg to 6g may be required to restore normal cortisol levels.
For the treatment of resistant oedema: The usual daily dose of 3g (12 capsules) should be given in divided doses in conjunction with a glucocorticoid.
Children should be given a smaller amount based upon 6 four hourly doses of 15mg/kg, with a minimum dose of 250mg every four hours.
Clinical evidence would indicate that no special dosage regimen is necessary.
The clinical picture of acute Metopirone poisoning is characterised by gastrointestinal symptoms and acute adrenocortical insufficiency. Laboratory findings: hyponatraemia, hypochloraemia, hyperkalaemia. In patients under treatment with insulin or oral antidiabetics, the signs and symptoms of acute poisoning with Metopirone may be aggravated or modified.
There is no specific antidote. Gastric lavage and forced emesis should be employed to reduce the absorption of the drug. In addition to general measures, a large dose of hydrocortisone should be administered at once, together with iv saline and glucose. This should be repeated as necessary in accordance with the patient’s clinical condition. For a few days, blood pressure and fluid and electrolyte balance should be monitored.
Shelf life: 3 years.
Protect from moisture and heat. Store below 30°C.
High density polyethylene bottles of 100 capsules with child resistant polypropylene closure.
None stated.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
