This information is intended for use by health professionals
Morphine Sulfate Injection BP 20mg in 1ml
Morphine Sulfate BP 2.0 % w/v
For the relief of severe pain.
By intramuscular, subcutaneous or intravenous injection.
Initially 10 - 20mg, the dose may be repeated every 4-6 hours.
In cases of terminal pain higher doses may be required.
Caution is advised. A reduction of dose is advisable.
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
• Hypersensitivity to any of the products ingredients.
• Acute respiratory depression or Chronic Obstructive Airways Disease.
• Asthma attack.
• Acute alcoholism
• Biliary colic.
• Head injuries or increased intracranial pressure.
• Heart failure secondary to lung disease.
• Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
• Risk of paralytic ileus.
Repeated use can cause tolerance and dependence. Caution in use should be excercised and a reduction in dose may be advisable in the elderly and in the following cases:
• Depressed respiratory reserve.
• Prostatic hypertrophy.
• Hepatic or renal impairment. ( Avoid or reduce dose).
• Convulsive disorders.
: Enhanced sedative and hypertensive effects.
: The use of morphine should be avoided or used with caution in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
Anxiolytics, Hypnotics and other CNS Depressants
: Sedative effects may be enhanced by simultaneous use of morphine.
: Morphine Sulfate should not be used as a premedication when ciprofloxacin is used for surgical prophylaxis as serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery.
Morphine should not be used during pregnancy or lactation as it crosses the placenta and is secreted in breast milk and can cause respiratory depression in the neonate.
May cause drowsiness, if affected patients should not drive or operate machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
• Hallucinations, confusion, mood changes, dysphoria and dependence.
• Headache, vertigo, dizziness and drowsiness.
• Sweating and postural hypotension.
• Bradycardia, palpitations, tachycardia and facial flushing.
• Respiratory depression.
• Constipation, nausea, vomiting and a dry mouth.
• Ureteric or biliary spasm.
• Rashes, pruritis and urticaria.
• Anaphylaxis and bronchospasm.
• Decrease in libido or potency.
• Difficulty with micturition.
• Myoclonus with higher doses.
|| Pin point pupils, respiratory depression and hypotension. Convulsions, especially in children and rhabdomyolysis leading to renal failure. Circulatory failure and coma may occur in severe cases.
|| Treat with intravenous Naloxone. Maintain fluid and electrolyte levels and provide assisted respiration if necessary.
Morphine is a powerful analgesic and narcotic and has central stimulant action. It depresses the thalamus, sensory cortex , respiratory and cough centres but stimulates the vomiting centre. Morphine increases the tone of involuntary muscles especially the sphincters of the gastro-intestinal tract.
Morphine is distributed throughout the body but mainly in the kidneys, liver, lungs and spleen. It crosses the placenta and traces are found in sweat and milk.
It is about 35% plasma protein bound. The plasma half life is 2 - 3 hours and about 60% of the dose is excreted in the urine after 24 hours. A small proportion of this is free morphine (higher in alkaline urine) and about 60 - 70% is conjugated. A small amount may be excreted in the bile.
No additional pre-clinical data of relevence to the prescriber.
Sodium Chloride , Sodium Metabisulphite and Water for Injection.
The pH may be adjusted with Sodium Hydroxide or Sulphuric Acid Solution.
Do not store above 25°C and protect from light.
Clear, colourless 1ml glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.
Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals,
Bampton Road, Harold Hill, Romford RM3 8UG
| First authorised:
|| 19th January, 1982
| Last renewal:
|| 19th August 2002