MS

What it is

MS MONO capsules are a range of modified release capsules containing a multi-particulate formulation of morphine sulfate pentahydrate. MS MONO modified release capsules are available in 30 mg, 60 mg, 90 mg and 120 mg strengths. The capsules are intended for once-daily oral administration and should be used at 24-hourly intervals.

Approved indications

MS MONO capsules are indicated for the management of severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long-term treatment. MS MONO capsules are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. MS MONO capsules are not indicated as an as-needed (PRN) analgesia.

Dosing overview

Patients presenting with severe pain uncontrolled by weaker opioids should normally be started on 60 mg daily. Patients previously on immediate release oral morphine or MS CONTIN tablets should be given the same total daily dose of morphine as MS MONO capsules. Increasing severity of pain will require an increased dosage of MS MONO capsules using 30 mg, 60 mg, 90 mg or 120 mg alone or in combination to achieve pain relief, with higher doses given in 30% to 50% increments as required. An initial dose for chronic severe pain in cancer in children over 25 kg in the range of 0.4 to 1.6 mg/kg daily is recommended, but will depend upon the degree of morphine tolerability and should be titrated in accordance with the patient's needs. As with all opioids, a reduction in dosage may be advisable in the elderly.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of MS MONO capsules. Patients should be aware of situations which increase the risk of respiratory depression, dosing should be modified in patients at risk and patients should be monitored closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Patients should be cautioned not to drink alcohol while taking MS MONO capsules. MS MONO capsules pose risks of hazardous and harmful use which can lead to overdose and death. Patients' risk of hazardous and harmful use should be assessed before prescribing and monitored regularly during treatment. Acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment, with most reactions occurring within the first 10 days of treatment. Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.

Contraindications

MS MONO capsules should not be given to patients with hypersensitivity to opioids or to any of the excipients; acute bronchial asthma or other obstructive airway disease, severe respiratory disease, acute respiratory disease and respiratory depression; cor pulmonale; cardiac arrhythmias; acute alcoholism; delirium tremens; severe CNS depression; convulsive disorders; increased cerebrospinal or intracranial pressure; head injury; brain tumour; paralytic ileus, delayed gastric emptying, suspected surgical and acute abdomen; severe liver disease, incipient hepatic encephalopathy; severe renal dysfunction; concomitant monoamine oxidase inhibitors (MAOIs), or within 14 days of such therapy; children under one year of age; pregnancy. MS MONO capsules are contraindicated in patients with chronic pain not due to malignancy, who have a prior history of substance and alcohol abuse.

Regulatory history

MS MONO morphine sulfate pentahydrate modified release capsules in 30 mg, 60 mg, 90 mg and 120 mg strengths were first listed on the ARTG on 26 September 2000.