DIAMORPHINE HYDROCHLORIDE Tablet Ref.[9781] Active ingredients: Diamorphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG

Therapeutic indications

Diamorphine hydrochloride is indicated for the relief of severe pain associated with terminal illness, acute myocardial infarction, left ventricular pain and acute pulmonary oedema.

Posology and method of administration

It is important that dosage be suited to the individual patient, taking into account the properties of the drug, the nature of the pain, the total condition of the patient and previous or concurrent medication.

Adults and Children Over 12 Years

5-10mg by mouth. The dosage should not normally be repeated more than four hourly. The dose may be increased according to need.

Children Under 12 Years

Not Recommended.

Elderly

Mainly because of its respiratory depressant effect caution should be exercised when giving to the elderly and a reduced dose should be used.

Overdose

Symptoms of severe overdosage are respiratory depression, coma or stupor, muscle flaccidity, cold clammy skin, constricted pupils and occasionally bradycardia and hypotension.

Circulatory failure and pulmonary oedema may occur in severe cases.

Treatment

Treat with intravenous Naloxone is the antidote if coma or bradypnoea are present. It should be administered by subcutaneous, intramuscular or intravenous injection at a dose of 0.4 to 2 mg repeated at two or three minutes intervals up to maximum of 10mg if the respiratory function does not improve. The dosage for overdose in children is 10 mcg/kg bodyweight. Alternatively, naloxone may be given by continuous infusion, 2mg in 500ml solution, at a rate adjusted to the patient’s response. Maintain fluid and electrolyte levels and provide assisted respiration if necessary.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store below 30°C.

Keep the glass bottle in the outer carton in order to protect from light.

Keep this medicine out of the sight and reach of children.

Nature and contents of container

Tablet container: Amber glass bottle containing 100 tablets.

Special precautions for disposal and other handling

Not applicable.

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