MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION MS CONTIN ® (MORPHINE SULFATE PENTAHYDRATE) TABLETS MS CONTIN ® SUSPENSION (MORPHINE SULFATE PENTAHYDRATE) MODIFIED RELASE GRANULES WARNINGS Limitations of use Because of the risks associated with the use of opioids, MS CONTIN tablets or suspension should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special warnings and precautions for use). Hazardous and harmful use MS CONTIN tablets or suspension poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4. Special warnings and precautions for use). Life threatening respiratory depression Serious, life-threatening or fatal respiratory depression may occur with the use of MS CONTIN tablets or suspension. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special warnings and precautions for use). Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking MS CONTIN tablets or suspension. 1 NAME OF THE MEDICINE Morphine sulfate pentahydrate
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AUSTRALIAN PRODUCT INFORMATION MS CONTIN (MORPHINE … · CONTIN tablets at the same total daily morphine dosage, equally divided into two 12-hourly MS CONTIN tablet doses. For patients
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MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
MS CONTIN® (MORPHINE SULFATE PENTAHYDRATE) TABLETS
MS CONTIN® SUSPENSION (MORPHINE SULFATE PENTAHYDRATE)
MODIFIED RELASE GRANULES
WARNINGS
Limitations of use
Because of the risks associated with the use of opioids, MS CONTIN tablets or suspension should
only be used in patients for whom other treatment options, including non-opioid analgesics, are
ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain
(see Section 4.4 Special warnings and precautions for use).
Hazardous and harmful use
MS CONTIN tablets or suspension poses risks of hazardous and harmful use which can lead to
overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing
and monitor the patient regularly during treatment (see Section 4.4. Special warnings and
precautions for use).
Life threatening respiratory depression
Serious, life-threatening or fatal respiratory depression may occur with the use of MS CONTIN
tablets or suspension. Be aware of situations which increase the risk of respiratory depression,
modify dosing in patients at risk and monitor patients closely, especially on initiation or
following a dose increase (see Section 4.4 Special warnings and precautions for use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants,
including alcohol
Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor patients for signs and
symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while
taking MS CONTIN tablets or suspension.
1 NAME OF THE MEDICINE Morphine sulfate pentahydrate
MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 2 of 22
2. Dextromoramide - a single 5mg dose is equivalent to morphine 15mg (diamorphine* 10mg) in terms of peak effect but is shorter acting. The overall potency ratio has been adjusted accordingly.
*Not currently available in Australia.
IM – intramuscular; PO – oral administration
Dose titration
Dose titration is the key to success with morphine therapy. PROPER OPTIMISATION OF DOSES
SCALED TO THE RELIEF OF THE INDIVIDUAL'S PAIN SHOULD AIM AT THE REGULAR
ADMINISTRATION OF THE LOWEST DOSE OF MORPHINE WHICH WILL CONTROL THE PAIN
WITH NO OR TOLERABLE SIDE EFFECTS. Dose adjustments should be based on the patient's
clinical response. Higher doses may be justified in some patients to cover periods of physical
activity.
Because of the sustained release properties of MS CONTIN tablets, dosage adjustments should
generally be separated by 48 hours. If dose increments are required, they should be
proportionately greater at the lower dose level (in terms of percentage of previous dose), than
when adjusting a higher dose.
The usual recommended dose (12-hourly) increments are 5, 10, 15, 20, 30, 40, 60, 90, 120, 150,
180, 200 mg. Above the 200 mg/dose (400 mg/day), increments should be by 30 to 60 mg
morphine.
MS CONTIN tablets are designed to allow 12-hourly dosing. If "breakthrough" pain repeatedly
occurs at the end of a dose interval, it is generally an indication for a dosage increase, not more
frequent administration. However, where judged necessary for optimisation of drug effects, MS
CONTIN tablets may be administered 8-hourly. More frequent (than 8-hourly) administration
of MS CONTIN tablets is neither rational nor recommended.
Adjustment or reduction of dosage
During the first two or three days of effective pain relief, the patient may exhibit drowsiness or
sleep for prolonged periods. This can be misinterpreted as the effect of excessive analgesic
dosing rather than the first sign of relief in a pain-exhausted patient. The dose, therefore, should
MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 5 of 22
be maintained for at least three days before reduction, provided the sedation is not excessive or
associated with unsteadiness and confusional symptoms, and respiratory activity and other
vital signs are adequate. If excessive sedation persists, the reason(s) for such an effect must be
sought (see Section 4.8 Adverse effects (Undesirable effects): Sedation).
Following successful relief of severe pain, periodic attempts to reduce the opioid dose should be
made. Smaller doses or complete discontinuation of the opioid analgesic may become feasible
due to a change in the patient's condition or improved mental state.
MS CONTIN TABLETS SHOULD BE SWALLOWED WHOLE, NOT CHEWED, CRUSHED OR
BROKEN.
MS CONTIN SUSPENSION (modified release granules):
The entire contents of the sachet should be reconstituted in water as follows:
20 mg, 30 mg and 60 mg in 10 mL of water
100 mg in 20 mL of water
200 mg in 30 mL of water
Mix thoroughly and take immediately.
The pink granules with an odour of raspberries produce a uniform red dispersion when
reconstituted.
MS CONTIN SUSPENSION should be taken with food where possible.
The modified release granules in 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.
Adults
The most frequent initial dose is 30 mg MS CONTIN SUSPENSION every 12 hours.
Increasing severity of pain will require an increased dosage of MS CONTIN modified release
granules in suspension. A daily increase of 30-50% may be appropriate. The correct dosage for
any individual patient is that which is sufficient to control pain for a full 12 hours.
Because of the sustained release properties of MS CONTIN SUSPENSION, dosage adjustments
should generally be separated by 48 hours. If dose increments are required, they should be
proportionately greater at the lower dose level (in terms of percentage of previous dose), than
when adjusting a higher dose.
Patients receiving the 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 requirements are of the order of 100%. In such patients
individual dose adjustments are required.
MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 6 of 22
4.3 CONTRAINDICATIONS
MS CONTIN tablets or suspension 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 (see Section 4.5 Interactions with
other medicines and other forms of interactions); children under one year of age; pregnancy.
Not recommended for pre-operative use or for the first 24 hours post-operatively.
MS CONTIN tablets or suspension are contraindicated in patients with chronic pain not due to
malignancy, who have a prior history of substance and alcohol abuse.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hazardous and harmful use
MS CONTIN tablets or suspension contain the opioid morphine and is a potential drug of abuse,
misuse and addiction. Addiction can occur in patients appropriately prescribed MS CONTIN
tablets or suspension at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance
abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also
increases the longer the drug is used and with higher doses. Patients should be assessed for
their risks for opioid abuse or addiction prior to being prescribed MS CONTIN tablets or
suspension.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse.
Opioids are sought by people with addiction and may be subject to diversion. Strategies to
reduce these risks include prescribing the drug in the smallest appropriate quantity and
advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4
Special precautions for storage and Section 6.6 Special precautions for disposal). Caution
patients that abuse of oral or transdermal forms of opioids by parenteral administration can
result in serious adverse events, which may be fatal.
Patients should be advised not to share MS CONTIN tablets or suspension with anyone else.
Respiratory depression
Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even
when used as recommended. It can occur at any time during the use of MS CONTIN tablets or
suspension, but the risk is greatest during initiation of therapy or following an increase in dose.
Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated
patients, in patients with renal and hepatic impairment and in patients with existing
impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma).
Opioids should be used with caution and with close monitoring in these patients (see Section 4.2
MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 7 of 22
Dose and method of administration). The use of opioids is contraindicated in patients with
severe respiratory disease, acute respiratory disease and respiratory depression (see Section
4.3 Contraindications).
Morphine should be used with extreme caution in patients with substantially decreased
respiratory reserve, hypoxia or hypercapnia. Such patients are often less sensitive to the
stimulatory effects of carbon dioxide on the respiratory centre and the respiratory depressant
effects of morphine may reduce respiratory drive to the point of apnoea.
The risk of respiratory depression is greater with the use of high doses of opioids, especially
high potency and modified release formulations, and in opioid naïve patients. Initiation of
opioid treatment should be at the lower end of the dosage recommendations with careful
titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is
required when changing opioids or switching from immediate release to modified release
formulations, (see Section 4.2 Dose and method of administration), together with consideration
of pharmacological differences between opioids. Consider starting the new opioid at a reduced
dose to account for individual variation in response.
Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and
sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner
in some patients. Opioids may also cause worsening of pre-existing sleep apnoea (see section
4.8 Adverse effects (undesirable effects)). In patients who present with CSA, consider
decreasing the total opioid dosage.
Risks from concomitant use of benzodiazepines or other CNS depressants, including
alcohol
Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol,
may result in sedation, respiratory depression, coma and death. Because of these risks,
concomitant prescribing of MS CONTIN tablets or suspension with CNS depressant medicines,
such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives,