Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden
Eudemine Tablets are used orally in the treatment of intractable hypoglycaemia.
Diazoxide also causes salt and water retention.
Hypoglycaemia: Eudemine administered orally is indicated for the treatment of intractable hypoglycaemia with severe symptoms from a variety of causes including: idiopathic hypoglycaemia in infancy, leucine-sensitive or unclassified; functional islet cell tumours both malignant and benign if inoperable, extra-pancreatic neoplasms producing hypoglycaemia; glycogen storage disease; hypoglycaemia of unknown origin.
Hypoglycaemia: In hypoglycaemia, the dosage schedule of Eudemine tablets is determined according to the clinical needs and the response of the individual patient. For both adults and children a starting oral dose of 5mg/kg body weight divided into 2 or 3 equal doses per 24 hours will establish the patient’s response and thereafter the dose can be increased until the symptoms and blood glucose level respond satisfactorily. Regular determinations of the blood glucose in the initial days of treatment are essential. The usual maintenance dose is 3-8mg/kg/day given in two or three divided doses.
Reduced doses may be required in patients with impaired renal function.
In children with leucine-sensitive hypoglycaemia, a dosage range of 15-20mg/kg/day is suggested.
In adults with benign or malignant islet-cell tumours producing large quantities of insulin, high dosages of up to 1,000mg per day have been used.
Excessive dosage of Eudemine can result in hyperglycaemia. Severe hyperglycaemia may be corrected by giving insulin and less severe hyperglycaemia may respond to oral hypoglycaemics. Hypotension may be managed with intravenous fluids and in severe cases may require sympathomimetics.
36 months.
None.
Plastic containers with tamper evident closure containing 100 tablets.
None stated.
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