MST Continus

MST Continus

morphine

Manufacturer:

Mundipharma

Distributor:

DKSH
Full Prescribing Info
Contents
Morphine sulfate.
Action
MST Continus tablets have been specifically developed in order to treat severe pain. Treatment with MST Continus tablets at 12-hrly intervals ensures relief from severe pain. The simplicity of 12-hrly dosing makes MST Continus tablets suitable as a treatment both in hospital and in the patient's home.
Pharmacokinetics: Morphine sulfate is readily absorbed from the gastrointestinal tract following oral administration. The patented prolonged-release system maintains plasma levels of morphine over a period of up to 12 hrs and reduces the likelihood of morphine-associated side effects.
Indications/Uses
Prolonged relief of severe pain.
Dosage/Direction for Use
MST Continus tablets should be used twice daily, at 12-hrly intervals. The dosage is dependent upon the severity of the pain, the patient's age and previous history of analgesic requirements.
A patient presenting with severe pain should normally be started on a dosage of 1 or 2 MST Continus tablets 10 mg twice daily.
Persisting or increasing severity of pain will require increased dosage of MST Continus tablets using 10-mg, 30-mg and 60-mg tablets alone or in combination to achieve the desired pain relief. Increases of the dosage should be made in 25-50% increments.
A patient transferred from immediate-release oral morphine preparations should normally receive the same total 24-hr morphine dosage divided between morning and evening administration.
Patients receiving MST Continus tablets 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 50-100%. In such patients, individual dose adjustments are required.
Postoperative Pain: MST Continus tablets are not recommended in the first 24 hrs postoperatively; thereafter it is suggested that the following dosage schedule be observed at the physician's discretion: a) MST Continus tablets 20 mg 12-hrly to patients <70 kg. b) MST Continus tablets 30 mg 12-hrly to patients >70 kg.
Supplemental parenteral morphine may be given if required but with careful attention to the total dosage of morphine and bearing in mind the prolonged effects of morphine in the MST Continus formulation.
As with oral morphine preparations, MST Continus tablets should be used with caution postoperatively and particularly in "acute abdomen" and following abdominal surgery.
Transferability: It is not possible to ensure bioequivalence between different prolonged-release morphine products. Therefore, it should be emphasized that patients, once titrated to an effective dose, should not be changed from MST Continus tablet to other slow, sustained-release or prolonged-release morphine preparations without re-titration and clinical assessment.
Administration: MST Continus tablets must be swallowed whole and not chewed.
Overdosage
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventillation.
Symptoms: Pinpoint pupils, respiratory depression, somnolence progressing to stupor and coma, skeletal muscle flaccidity, bradycardia, hypotension and death.
Crushing and taking the contents of a prolonged-release dosage form leads to the release of morphine in an immediate fashion; this might result in a fatal overdose.
Treatment: Administer naloxone 0.4 mg IV. Repeat at 2-min to 3-min 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 to the patient's response. Empty the stomach. A 0.02% aqueous solution of potassium permanganate may be used for lavage. Assist respiration if necessary. Maintain fluid and electrolyte levels. In the case of MST Continus tablets, the physician should be aware that tablets remaining in the intestine will continue to release morphine sulfate and add to the morphine load for up to 12 hrs after administration and the management of morphine overdosage should be modified accordingly.
Contraindications
Respiratory depression, head injury, paralytic ileus, biliary colic, delayed gastric emptying, obstructive airways disease, cardiac arrhythmias, known morphine sensitivity, acute hepatic disease, concurrent administration of monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuation of their use (see Interactions).
Should paralytic ileus be suspected or occur during use, MST Continus tablets should be discontinued immediately.
MST Continus tablets are not recommended for paediatric use or in pregnancy.
Preoperative administration of MST Continus tablets is not recommended and is not an approved indication.
Not recommended for preoperative use or for the first 24 hrs postoperatively.
Use in pregnancy & lactation: Use of MST Continus should be avoided during pregnancy and labour due to risk of neonatal respiratory depression. Administration to nursing mothers is not recommended as morphine is excreted in breast milk.
Withdrawal symptoms may be observed in the newborn of mothers undergoing chronic treatment.
Special Precautions
As with all narcotics, a reduction in dosage may be advisable in the elderly, in hypothyroidism, in renal and chronic hepatic disease.
Morphine has to be administered with caution in patients with history of substance abuse, raised intracranial pressure, hypotension with hypovolemia, biliary tract disorders, pancreatitis, severe renal dysfunction, severe cor pulmonale, severe bronchial asthma, severe chronic obstructive lung disease, respiratory depression, inflammatory bowel disorders, prostatic hypertrophy and adrenocortical insufficiency.
The major risk of opioid excess is respiratory depression.
As with all oral morphine preparations, MST Continus should be used with caution postoperatively and following abdominal surgery, as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function.
MST Continus tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, MST Continus tablets should be discontinued immediately.
As with all morphine preparations, patients who are to undergo cordotomy or other pain relieving surgical procedures should not receive MST Continus tablets for 24 hrs prior to surgery. If further treatment with MST Continus tablets is then indicated, the dosage should be adjusted to the new postoperative requirements.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of MST Continus may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Morphine has a well recognised abuse and addiction profile similar to other strong opioids. Morphine may be sought and abused by people with latent or manifest addiction disorders. The development of psychological dependence to opioid analgesics in properly managed patients with pain has been reported to be rare. Tolerance to analgesic effects may develop upon repeated administration.
The controlled-release tablets must be swallowed whole and not broken, chewed or crushed. The administration of broken, chewed or crushed controlled-release morphine tablets leads to a rapid release and absorption of a potentially fatal dose of morphine. (See Overdosage.)
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
Morphine may lower the seizure threshold in patients with a history of epilepsy.
Effects on the Ability to Drive or Operate Machinery: Morphine may impair the ability to drive and use machines.
Use In Pregnancy & Lactation
Use of MST Continus should be avoided during pregnancy and labour due to risk of neonatal respiratory depression. Administration to nursing mothers is not recommended as morphine is excreted in breast milk. Withdrawal symptoms may be observed in the newborn of mothers undergoing chronic treatment.
Side Effects
The adverse experiences listed as follows are classified by body system according to their incidence (common or uncommon). Common ADE have an incidence of ≥1% and uncommon ADE have an incidence of <1%.
Gastrointestinal: Common: Abdominal pain, anorexia, constipation, dry mouth, dyspepsia, nausea, vomiting. Uncommon: Elevated hepatic enzymes, biliary pain, ileus, taste perversion.
Central Nervous System: Common: Asthenia, confusion, headache, insomia, involuntary muscle contractions, somnolence, thought abnormalities. Uncommon: Agitation, dysphoria, euphoria, hallucinations, malaise, mood changes, paresthesia, respiratory depression, seizure, vertigo, vision abnormalities, withdrawal syndrome.
Genitourinary: Uncommon: Amenorrhea, decreased libido, impotence, urinary retention.
Cardiovascular: Uncommon: Hypotension, syncope.
Metabolic and Nutritional: Uncommon: Peripheral and pulmonary edema.
Respiratory: Common: Bronchospasm, decreased cough.
Dermatological: Common: Rash. Uncommon: Urticaria.
General: Common: Chills, pruritus, sweating. Uncommon: Allergic reaction, anaphylactic/anaphylactoid reactions, drug dependence, facial flushing, hypertonia, miosis, tolerance.
When nausea and vomiting are troublesome, MST Continus tablets can be readily combined with antiemetics. If constipation occurs, it may be treated with appropriate laxatives.
Drug Interactions
Concurrent administration of monoamine oxidase inhibitors MAOIs or within 2 weeks of discontinuation of their use is contraindicated. MAIOs are known to interact with narcotic analgesics producing central nervous system excitation or depression with hypertensive or hypotensive crisis.
Morphine should be used with caution in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anaesthetics, phenothiazines, other tranquilizers, muscle relaxants, antihypertensives and alcohol. Interactive effects resulting in respiratory depression, hypotension, profound sedation or coma may result if these drugs are taken in combination with the usual doses of morphine.
Cimetidine inhibits the metabolism of morphine.
Storage
Do not store above 25°C.
MIMS Class
ATC Classification
N02AA01 - morphine ; Belongs to the class of natural opium alkaloids. Used to relieve pain.
Presentation/Packing
FC tab 10 mg (golden brown, biconvex and marked "10 mg" on one side) x 30's. 30 mg (dark purple, biconvex and marked "30 mg" on one side) x 30's. 60 mg (orange, biconvex and marked "60 mg" on one side) x 30's.
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