MST CONTINUS Prolonged release granules for oral suspension Ref.[27739] Active ingredients: Morphine

Posology

Adults

A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. dihydrocodeine) should normally be started on 30 mg 12 hourly. Patients previously on normal release oral morphine should be given the same total daily dose as MST CONTINUS suspension but in divided doses at 12-hourly intervals.

Increasing severity of pain will require an increased dosage of the suspension. Higher doses should be made, where possible in 30-50% increments as required. The correct dosage for any individual patient is that which is sufficient to control pain with no, or tolerable, side effects for a full 12 hours. It is recommended that the 200-mg strength is reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations.

Patients receiving MST CONTINUS suspension in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration. Usually such increased requirement is of the order of 100%. In such patients, individual dose adjustments are required.

Paediatric Population

The use of MST CONTINUS suspension in children has not been extensively evaluated. For children with severe cancer pain, a starting dose in the range of 0.2 to 0.8 mg morphine per kg bodyweight 12 hourly is recommended. Doses should then be titrated as for adults.

Post-operative pain

MST CONTINUS suspension is not recommended in the first 24 hours post-operatively or until normal bowel function has returned; thereafter it is suggested that the following dosage schedule be observed at the physician’s discretion:

• MST CONTINUS suspension 20 mg 12 hourly to patients under 70 kg
• MST CONTINUS suspension 30 mg 12 hourly to patients over 70 kg
• Elderly – a reduction in dosage may be advisable in the elderly
• Children – not recommended

Supplemental parenteral morphine may be given if required but with careful attention to the total dosages of morphine, and bearing in mind the prolonged effects of morphine in this controlled release formulation.

Method of Administration

20, 30 & 60 mg strengths: The contents of one sachet should be mixed with at least 10 ml water or sprinkled on to soft food, for example yogurt.

100 mg strength: The contents of one sachet should be mixed with at least 20 ml water or sprinkled on to soft food, for example yogurt.

200 mg strength: The contents of one sachet should be mixed with at least 30 ml water or sprinkled on to soft food, for example yogurt.

The prolonged release granules must be suspended whole and ingested immediately, but not be broken, chewed or crushed. The administration of broken, chewed or crushed morphine granules leads to a rapid release and absorption of a potentially fatal dose of morphine (see section 4.9, Overdose).

MST CONTINUS suspension should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain, the patient’s age and previous history of analgesic requirements.

Discontinuation of therapy

An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore, the dose should be gradually reduced prior to discontinuation

Signs of morphine toxicity and overdose are drowsiness, pin-point pupils, skeletal muscle flaccidity, bradycardia, hypotension, pneumonia aspiration, respiratory depression, somnolence and central nervous system depression which can progress to stupor or coma. Death may occur from respiratory failure. Circulatory failure and deepening coma may occur in more severe cases. Overdose can result in death. Rhabdomyolysis progressing to renal failure has been reported in opioid overdose.

Crushing and taking the contents of a prolonged release dosage form leads to the release of the morphine in an immediate fashion; this might result in a fatal overdose.

Treatment of morphine overdose:

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

Oral activated charcoal (50g for adults, 1 g/kg for children) may be considered if a substantial amount has been ingested within one hour, provided the airway can be protected.

The pure opioid antagonists are specific antidotes against the effects of opioid overdose. Other supportive measures should be employed as needed.

In the case of massive overdose, administer naloxone 0.8 mg intravenously. Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).

The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response. However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. MST CONTINUS suspension will continue to release and add to the morphine load for up to 12 hours after administration and the management of morphine overdose should be modified accordingly.

For less severe overdose, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose.

Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on morphine. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

2 years.

Do not store above 25°C.

Pack type: surlyn lined, laminated aluminium foil sachets coated with polyethylene and clay coated Kraft paper.

Pack size: Boxboard cartons of 10, 20, 30, 60 sachets or medical sample packs of up to 14 sachets.

Not all pack sizes may be marketed.

The contents of the sachet should be added to water or sprinkled onto soft food, e.g. yoghurt (see 4.2 Posology and Method of Administration).