EUDEMINE Sugar coated tablet Ref.[9315] Active ingredients: Diazoxide

In the treatment of hypoglycaemia it is necessary that the blood pressure be monitored regularly.

Retention of sodium and water is likely to necessitate therapy with an oral diuretic such as frusemide or ethacrynic acid. The dosage of either of the diuretics mentioned may be up to 1g daily. It must be appreciated that if diuretics are employed then both the hypotensive and hyperglycaemic activities of diazoxide will be potentiated and it is likely that the dosage of diazoxide will require adjustment downwards. In patients with severe renal failure it is desirable to maintain, with diuretic therapy, urinary volumes in excess of 1 litre daily. Hypokalaemia should be avoided by adequate potassium replacement.

Diazoxide should be used with caution in patients with cardiac failure or impaired cardiac reserve in whom sodium and water retention may worsen or precipitate congestive heart failure. A direct effect on myocardium and cardiac function cannot be excluded.

Diazoxide should be used with care in patients with impaired cardiac or cerebral circulation and in patients with aortic coarctation, aortic stenosis, arteriovenous shunt, heart failure or other cardiovascular disorders in which an increase in cardiac output could be detrimental.

Diazoxide should be administered with caution to patients with hyperuricaemia or a history of gout, and it is advisable to monitor serum uric acid concentration.

Whenever Eudemine is given over a prolonged period regular haematological examinations are indicated to exclude changes in white blood cell and platelet counts.

Also in children there should be regular assessment of growth, bone and psychological maturation.

The very rapid, almost complete protein binding of diazoxide requires cautious dosage to be used in patients whose plasma proteins may be lower than normal.

Drugs potentiated by diazoxide therapy include: oral diuretics, antihypertensive agents and anticoagulants.

Phenytoin levels should be monitored as increased dosage may be needed if administered concurrently with diazoxide.

The risk of hyperglycaemia may be increased by concurrent administration of corticosteroids or oestrogen-progestogen combinations.

Eudemine Tablets are only to be used in pregnant women when the indicated condition is deemed to put the mother’s life at risk.

Side Effects

Prolonged oral therapy of Eudemine during pregnancy has been reported to cause alopecia in the newborn.

Eudemine should not be given to nursing mothers as the safety of Diazoxide during lactation has not been established.

None known.

With oral therapy, nausea is common in the first two or three weeks and may require relief with an anti-nauseant. Prolonged therapy has given rise to reports of hypertrichosis lanuginosa, anorexia and hyperuricaemia.

Extra-pyramidal side-effects have been reported with oral diazoxide. It was found that extra-pyramidal effects such as parkinsonian tremor, cogwheel rigidity and oculogyric crisis could be easily suppressed by intravenous injection of an antiparkinsonian drug such as procyclidine and that they could be prevented by maintenance therapy with such a drug given orally.

Other adverse effects of Eudemine which have been reported are listed below.

Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, decreased haemoglobin and/or haematocrit, eosinophilia, bleeding

Immune system disorders: Hypogammaglobulinaemia, hypersensitivity reactions such as rash, fever and leucopenia, decreased immunoglobulins (IgG) in infants,

Endocrine disorder: Hirsutism, galactorrhoea, pancreatitis, increased serum androgens

Metabolism and nutrition disorders: Hyperuricaemia (after prolonged therapy), hyperosmolar non-ketotic coma, inappropriate hyperglycaemia including ketoacidosis

Psychiatric disorders: Anorexia (after prolonged therapy), decreased libido

Nervous system disorders: Extra-pyramidal side-effects such as parkinsonian tremor, cogwheel rigidity and oculogyric crisis, headache, dizziness

Eye disorders: Blurred vision, transient cataracts, subconjunctival haemorrhage, ring scotoma, diplopia, lacrimation

Ear and labyrinth disorders: Tinnitus

Cardiac disorders: Cardiomegaly, cardiac failure, arrhythmias

Vascular disorders: Inappropriate hypotension

Respiratory, thoracic and mediastinal disorders: Dysponea, pulmonary hypertension

Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, ileus, constipation, dysgeusia

Hepatobiliary disorders: Increased AST and alkaline phosphate

Skin and subcutaneous tissue disorders: Pruritis, dermatitis, lichenoid eruption

Musculoskeletal and connective tissue disorders: Musculoskeletal pain

Renal and urinary disorders: Azotemia, decreased creatinine clearance, reversible nephritic syndrome, haematuria and albuminuria

Congenital, familial and genetic disorders: Hypertrichosis lanuginose (after prolonged therapy)

General disorders and administration site disorders: Voice changes and abnormal faces in children (on long term therapy), sodium retention, fluids retention.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard).

None stated.