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

Therapeutic indications

Diazoxide is a benzothiadizine analogue. It is used intravenously for the acute treatment of severe hypertension associated with renal disease.

Hypertensive emergencies

Eudemine injection is used particularly for the emergency treatment of acute hypertensive crises, especially those occurring in association with acute hypertensive encephalopathy, congestive heart failure, acute glomerular nephitis, eclampsia or pre-eclampsia.

Severe hypertension

It is also indicated for the control of severe hypertension associated with renal disease. In hypertensive patients requiring such diagnostic procedures as renal biopsy, arteriography or cardiac catheterisation, Eudemine injection may be given to facilitate the procedure and reduce the danger of haemorrhage due to hypertension. Eudemine injection is also indicated in patients who have failed to respond to other hypotensive agents.

Posology and method of administration

Diazoxide should never be mixed with other drugs and should not be diluted.

Hypertensive emergencies ans severe hypertension

In the treatment of hypertension, Eudemine injection is administered by the intravenous route only and it should never be given intramuscularly or subcutaneously.

Adults: A full dose of 300 mg in 20 ml will be required by most patients. However, an adequate fall in blood pressure in some patients may be obtained with as little as 150 mg. Patients must be recumbent during the injection which must be rapid and not exceed 30 seconds. Eudemine injection should not be administered in a bolus dose of 300 mg since single intravenous doses of 300 mg have been associated with myocardial and cerebral infarction.

Children: On the rare occasions that Eudemine injection is indicated for hypertension in children, the dosage should be based on a level of 5 mg per Kg body weight.

A response occurs within five minutes and usually persists for a least four hours. One injection is usually effective, but further injections may be required, particularly in hypertensive crises or in accelerating disease refractory to other hypotensive agents. Up to four ampoules may be given in 24 hours.

An initial dose of 600 mg is recommended only in life-threatening situations. Once the blood pressure is controlled by Eudemine injection, treatment with anti-hypertensive agents designed for maintenance can be initiated. It appears that if hypertensive patients treated with Eudemine injection are allowed an unrestricted sodium intake then the subsequent response to oral hypotensive agents will be improved.

Route of administration

Intravenous injection.

Overdose

Excessive dosage of Eudemine injection can result in hyperglycaemia which will respond to insulin and/or to hypotension which will necessitate maintenance of blood volume with intravenous fluids.

Shelf life

36 months.

Special precautions for storage

Protect from light.

Store below 25°C.

Nature and contents of container

20 ml One Point Cut (OPC) clear glass ampoule, Type I Ph.Eur. Borosilicate glass, with white snap ring, in packs of 5, containing 300 mg Diazoxide BP.

Special precautions for disposal and other handling

It is particularly important that Eudemine ampoules are protected from light. Eudemine injection must never be mixed with other drugs, and must not be diluted.

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