This information is intended for use by health professionals

1. Name of the medicinal product

Morphine Sulfate Injection BP 15mg in 1ml

2. Qualitative and quantitative composition

Morphine Sulfate BP 1.5 % w/v

3. Pharmaceutical form

Solution for Injection

4. Clinical particulars
4.1 Therapeutic indications

For the relief of severe pain.

4.2 Posology and method of administration

By intramuscular, subcutaneous or intravenous injection.

Adults

Initially 10 - 20mg, the dose may be repeated every 4-6 hours.

In cases of terminal pain higher doses may be required.

The Elderly

Caution is advised. A reduction of dose is advisable.

Children

Not recommended at this strength.

4.3 Contraindications

• Hypersensitivity to any of the products ingredients.

• Acute respiratory depression or Chronic Obstructive Airways Disease.

• Asthma attack.

• Acute alcoholism.

• Bilary 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.

• Phaeochromocytoma.

4.4 Special warnings and precautions for use

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:

• Hypotension.

• Hypothyroidism.

• Depressed respiratory reserve.

• Prostatic hypertrophy.

• Hepatic or renal impairment. ( Avoid or reduce dose).

• Convulsive disorders.

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol : Enhanced sedative and hypertensive effects.

Antidepressants: 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.

Ciprofloxacin: 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.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

• Hallucinations, confusion, mood changes, dysphoria and dependence.

• Headache, vertigo, dizziness and drowsiness.

• Sweating and postural hypotension.

• Miosis.

• 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.

• Hypothermia.

• Myoclonus with higher doses.

4.9 Overdose

Symptoms:

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.

Treatment:

Treat with intravenous Naloxone. Maintain fluid and electrolyte levels and provide assisted respiration if necessary.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

No relevant pre-clinical data is available which would be of value to the prescriber.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium Chloride, Sodium Metabisulphite and Water for Injection.

The pH of the product may be adjusted where necessary with 10% Sodium Hydroxide Solution or 10% Sulphuric Acid Solution.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C and protect from light.

6.5 Nature and contents of container

Clear, colourless ampoules of Ph.Eur type1 glass of a nominal 1ml capacity each containing sufficient of the Morphine Sulphate Injection to permit the removal of 1ml. 10 ampoules are packed into a cardboard outer.

6.6 Special precautions for disposal and other handling

None stated.

Administrative data
7. Marketing authorisation holder

Macarthys Laboratories Ltd T/A Martindale Pharmaceuticals,

Bampton Road,

Harold Hill,

Romford,

RM3 8UG

8. Marketing authorisation number(s)

PL 1883/6176R

9. Date of first authorisation/renewal of the authorisation

First authorised:

19th January, 1982

Last renewal:

19th August 2002

10. Date of revision of the text

24/07/2014