Morphine Sulfate Injection Bp 20 Mg In 1 Ml
1.
NAME OF THE MEDICINAL PRODUCT
Morphine Sulfate Injection BP 20mg in 1ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Sulfate BP 2.0 % w/v PHARMACEUTICAL FORM Solution for Injection
CLINICAL PARTICULARS Therapeutic Indications
For the relief of severe pain.
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 for children under 6 years
For children 6 -12 years (after risk/benefit assessment)
5 - 10 mg by subcutaneous or intramuscular routes only
Contra-Indications
• 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.
• Phaeochromocytoma.
Special Warnings and Special Precautions for Use
4.4.
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. Interactions 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. Pre-clinical Safety Data
No additional pre-clinical data of relevence to the prescriber.
PHARMACEUTICAL PARTICULARS
6.
6.1. List of Excipients
Sodium Chloride , Sodium Metabisulphite and Water for Injection.
The pH may be adjusted with Sodium Hydroxide or 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 Content of Container
Clear, colourless 1ml glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.
6.6. Instructions for Use, Handling and Disposal
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
PL 1883/6177R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
First authorised: Last renewal: 19th January, 1982 19th August 2002
10 DATE OF REVISION OF THE TEXT
24/07/2014