Morphine Oral Concentrate 100mg/5ml

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Product Summary

1. Trade Name of the Medicinal Product Morphine Oral Concentrate 100mg/5ml

2. Qualitative and Quantitative Composition

Morphine Sulphate EP 2.0 % w/v

3. Pharmaceutical Form

Oral Solution

Clinical Particulars

4.1. Therap euti c Indi cati ons

For the relief of severe pain.

4.2. Posology and Method of Administration

For oral use only. A calibrated dropper is supplied with this dosage form for accurate and convenient dose adjustment. The required dose may be added to a soft drink immediately prior to administration.

Adults

Usual dose 10 - 20mg, this may be repeated every 4 hours.

In certain cases higher doses may be required. Dosage can be increased under medical supervision according to the patients analgesic requirements and the severity of pain.

The Elderly and Debilitated Patients

Caution is advised. A reduction of dose may be appropriate. Children

Not recommended for children under 1 year.

For children 1 - 5 years, maximum dose 5mg every 4 hours.

For children 6 -12 years, maximum dose 5 - 10 mg every 4 hours.

When transferring from other morphine dosage forms dosage adjustment may be required.

4.3. Contra-indications

Known sensitivity to morphine, obstructive airways disease, respiratory depression, acute alcoholism, chronic hepatic or renal disease, head injuries, coma, increased intracranial pressure, convulsive disorders and bronchial asthma. Monoamine oxidase inhibitors (MAOI’s) or if MAOI’s have been withdrawn within the previous 2 weeks. Should not be given if a paralytic ileus is likely to occur.

4.4. Special Warnings and Precautions for Use

Repeated use can cause tolerance and dependence. A reduction in dose is advisable in the elderly, in cases of hypothyroidism, hyperthyroidism, renal disease and chronic hepatic disease. Also in cases of shock, adrenocortical insufficiency, myxoedema or prostatic hypertrophy. Exercise care if administered in the first 24 hours after an operation. Or in cases of severe obesity, emphysema or kyphoscoliosis.

4.5. Interactions with other Medicaments and other forms of Interaction

Morphine may potentiate the action of hypnotics and anxiolytics. The depressant effects of morphine are enhanced by alcohol, anaesthetics, hypnotics, phenothiazines, muscle relaxants, tricyclic antidepressants and sedatives.

4.6. Pregnancy and Lactation

Although there is insufficient evidence of safety during pregnancy or lactation, morphine has been in use for many years. Morphine is known to cross the placenta and to be present in breast milk and thus may cause respiratory depression in the new-born. Morphine should not be used during pregnancy, especially the first trimester, unless the expected benefit outweighs the potential risks.

May cause drowsiness. If affected patients should not drive or operate machinery.

4.8. Undesirable Effects

Nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, respiratory depression, bradycardia, palpitations and orthostatic hypotension. Micturition may be difficult, there may be biliary or ureteric spasm and an antidiuretic effect. Restlessness, changes in mood, miosis, vertigo and hypothermia may also occur. Raised intracranial pressure can occur in some patients and urticaria and or pruritis may occur due to histamine release.

4.9. Overdose

Symptoms: Pin point pupils, respiratory depression and hypotension. Circulatory failure and coma may occur in severe cases. Death can occur due to respiratory failure. Convulsions may occur in infants and children.

Treatment: Treat with intravenous naloxone. If no improvement is observed in 2 to 3 minutes consider naloxone infusion. Empty the stomach and maintain fluid and electrolyte levels. Provide assisted respiration if necessary.

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 additional pre-clinical data of relevance to the prescriber.

Pharmaceutical Particulars

6.1. List of Excipients

Sodium benzoate, carmoisine (E122), disodium edetate, hydrochloric acid and purified water.

6.2. Incompatibilities

None stated.

6.3. Shelf Life

2 years (24 months) unopened 180 days once opened

6.4. Special Precautions for Storage

Do not store above 25 °C.

Keep container in the outer container

6.5. Nature and Contents of Container

Round amber glass bottles with child proof and tamper evident caps. The carton contains a calibrated dropper for dose measurement. The dropper should replace the cap after first opening. The bottles and dropper are packed in a cardboard carton along with a patient leaflet.

Pack sizes: 30ml and 120ml.,

6.6. Instruction for Use/Handling