EUDEMINE Solution for injection Ref.[2740] Active ingredients: Diazoxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Mercury Pharma Group Ltd, No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Contraindications

There are no absolute contraindications to Eudemine for the control of hypertension but it should be used with discretion. Agents which can be given by infusion, such as hydralazine or labetalol, should have been shown to be ineffective before a bolus injection of diazoxide is given.

Hypersensitivity to any component of the preparation or to other thiazides.

Special warnings and precautions for use

Eudemine injection may cause hyperglycaemia and therefore in the treatment of hypertension, therapy with Eudemine necessitates regular monitoring of the blood glucose levels.

Eudemine injection should be used with care in patients who have impaired cerebral or cardiac circulation, ie. in patients in whom abrupt reduction in blood pressure might be detrimental. Prolonged hypotension should be avoided so as not to aggravate pre-existing renal failure.

Diazoxide should be used with care in patients with coronary heart disease or ischaemic cerebrovascular disease.

Due to the haemodynamic effects of diazoxide it should also be used with caution in patients with aortic stenosis or other left ventricular outflow tract obstruction, and in patients with aortic coarctation or arteriovenous shunt.

Retention of sodium and water is likely to necessitate therapy with an oral diuretic such as furosemide 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 the 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.

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.

With Eudemine injection the high alkalinity of the solution necessitates that great care is taken to ensure that the injection is given directly into a vein without leakage into surrounding tissues.

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.

Interaction with other medicinal products and other forms of interaction

Drugs potentiated by diazoxide therapy include diuretics, anti-hypertensive agents and anticoagulants. Phenytoin may reduce the effects of diazoxide.

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

Pregnancy and lactation

Eudemine injection should only be used in pregnant women when the indicated condition is deemed to be life-threatening to the mother.

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

Effects on ability to drive and use machines

None stated.

Undesirable effects

In the treatment of hypertension the hyperglycaemia induced by diazoxide is generally inevitable. Each injection of diazoxide usually means a transient rise in blood sugar of about 10%. Fortunately the hyperglycaemia in hypertensive patients can be readily controlled with tolbutamide, or exceptionally with insulin.

A hypotensive effect in normotensive patients is of minor importance and rarely requires any specific therapy. An oral diuretic may be indicated to control sodium and water retention.

With Eudemine injection reflex tachycardia is not uncommon in the first few minutes after injection and is more frequent in digitalised patients. Orthostatic hypotension is unlikely but it may occur in those recently treated with adrenergic blocking agents. When it is used during labour for the treatment of toxaemia, the smooth muscle relaxant effect can cause delay in the second stage. This should be counteracted with oxytocic agents.

Other adverse effects of Eudemine injection which have been reported are hyperosmolar non-ketonic coma, cardiomegaly, leucopenia, thrombocytopenia, and hirsutism.

Incompatibilities

None stated.

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