MORPHINE SULFATE Solution for injection Ref.[7718] Active ingredients: Morphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Macarthys Laboratories Ltd t/a Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Therapeutic indications

Morphine is used for the symptomatic relief of severe pain; relief of dyspnoea of left ventricular failure and pulmonary oedema; pre-operative use.

Posology and method of administration

Posology

Adults

The dosage should be based on the severity of the pain and the response and tolerance of the patient. The usual adult subcutaneous or intramuscular dose is 10 mg every 4 hours if necessary, but may range from 5 mg to 20 mg.

The usual adult intravenous dose is 2.5 mg to 15 mg not more than 4 hourly, where necessary, but dosage and dosing interval must be titrated against the patient’s response and adjustments made until analgesia is achieved.

Elderly

Because of the depressant effect on respiration, caution is necessary when giving morphine to the elderly. A reduction of dose is advisable.

Paediatric Population

Not recommended for children under 6 years.

For children 6-12 years (after risk/benefit assessment): 5-10 mg by subcutaneous or intramuscular routes only.

Hepatic impairment

A reduction in dosage should be considered in hepatic impairment.

Renal impairment

The dosage should be reduced in moderate to severe renal impairment.

For concomitant illnesses/conditions where dose reduction may be appropriate see section 4.4

Method of administration

By intramuscular, subcutaneous or intravenous injection.

The subcutaneous route is not suitable for oedematous patients.

The epidural or intrathecal routes must not be used as the product contains a preservative.

Overdose

Toxic doses vary considerably with the individual, and regular users may tolerate large doses.

The triad of respiratory depression, coma and constricted pupils is considered indicative of opioid overdosage with dilatation of the pupils occurring as hypoxia develops. Death may occur from respiratory failure

Other opioid overdose symptoms include hypothermia, confusion, severe dizziness, severe drowsiness, hypotension, bradycardia, circulatory failure pulmonary oedema, severe nervousness or restlessness, hallucinations, convulsions (especially in infants and children). Rhabdomyolysis, progressing to renal failure, has been reported in overdosage.

Treatment: The medical management of overdose involves prompt administration of the specific opioid antagonist naloxone if coma or bradypnoea are present using one of the recommended dosage regimens. Both respiratory and cardiovascular support should be given where necessary.

Shelf life

36 months.

Special precautions for storage

Do not store above 25°C.

Keep the ampoules in the outer carton in order to protect from light.

Nature and contents of container

Clear, colourless 1ml Ph.Eur type1 glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.

Special precautions for disposal and other handling

Any solution remaining should be discarded or returned to the pharmacy.

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