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Indications/Uses
For the relief of moderate to severe pain.
Dosage/Direction for Use
MORPHINE SULPHATE (MST CONTINUS) tablets 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: A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. tramadol) 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 MORPHINE SULPHATE (MST CONTINUS) tablets but in divided doses at 12-hourly intervals.
Increasing severity of pain will require an increased dosage of the tablets. Increase incrementally by 30-50% 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 higher strengths be reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations.
Patients receiving MORPHINE SULPHATE (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 100%. In such patients individual dose adjustments are required.
Children: 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: MORPHINE SULPHATE (MST CONTINUS) tablets are 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: MORPHINE SULPHATE (MST CONTINUS) tablets 20 mg 12 hourly to patients under 70 kg.
MORPHINE SULPHATE (MST CONTINUS) tablets 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 prolonged release formulation.
Administration: Oral.
The tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed modified release morphine tablets leads to a rapid release and absorption of a potentially fatal dose of morphine (see Overdosage).
Adults: A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. tramadol) 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 MORPHINE SULPHATE (MST CONTINUS) tablets but in divided doses at 12-hourly intervals.
Increasing severity of pain will require an increased dosage of the tablets. Increase incrementally by 30-50% 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 higher strengths be reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations.
Patients receiving MORPHINE SULPHATE (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 100%. In such patients individual dose adjustments are required.
Children: 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: MORPHINE SULPHATE (MST CONTINUS) tablets are 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: MORPHINE SULPHATE (MST CONTINUS) tablets 20 mg 12 hourly to patients under 70 kg.
MORPHINE SULPHATE (MST CONTINUS) tablets 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 prolonged release formulation.
Administration: Oral.
The tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed modified release morphine tablets leads to a rapid release and absorption of a potentially fatal dose of morphine (see Overdosage).
Overdosage
Acute overdosage with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis progressing to renal failure, skeletal muscle flaccidity, bradycardia, hypotension and death.
A patent airway must be maintained. The pure opioid antagonists are specific antidotes against the effects of opioid overdose. Other supportive measures should be employed as needed.
Crushing and taking the contents of a modified release dosage form leads to the release of the morphine in an immediate fashion; this might result in a fatal dose.
A patent airway must be maintained. The pure opioid antagonists are specific antidotes against the effects of opioid overdose. Other supportive measures should be employed as needed.
Crushing and taking the contents of a modified release dosage form leads to the release of the morphine in an immediate fashion; this might result in a fatal dose.
Administration
May be taken with or without food: Swallow whole, do not break/chew/crush to avoid rapid release & absorption of a potentially fatal dose of morphine.
Contraindications
Known hypersensitivity to morphine or any of the excipients (see Description).
Paralytic ileus.
Paralytic ileus.
Special Precautions
History of substance abuse, raised intracranial pressure, hypotension with hypovolemia, biliary tract disorders, pancreatitis, severe renal dysfunction, severely impaired hepatic function, severe chronic obstructive lung disease, severe cor pulmonale, severe bronchial asthma, respiratory depression.
The major risk of opioid excess is respiratory depression.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product 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 an abuse profile similar to other strong agonist opioids. Morphine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opioid analgesics, including morphine. MORPHINE SULFATE (MST CONTINUS) should be used with particular care in patients with a history of alcohol and drug abuse.
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.
Hyperalgesia that will not respond to a further dose increase of morphine sulfate may occur in particular in high doses. A morphine sulfate dose reduction or change in opioid may be required.
Drug product is not recommended preoperatively or within the first 24 hours postoperatively.
Effects on Ability to Drive and Use Machines: Morphine may impair the ability to drive and use machines.
The major risk of opioid excess is respiratory depression.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product 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 an abuse profile similar to other strong agonist opioids. Morphine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opioid analgesics, including morphine. MORPHINE SULFATE (MST CONTINUS) should be used with particular care in patients with a history of alcohol and drug abuse.
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.
Hyperalgesia that will not respond to a further dose increase of morphine sulfate may occur in particular in high doses. A morphine sulfate dose reduction or change in opioid may be required.
Drug product is not recommended preoperatively or within the first 24 hours postoperatively.
Effects on Ability to Drive and Use Machines: Morphine may impair the ability to drive and use machines.
Use In Pregnancy & Lactation
Use of this medicinal product should be avoided to the extent possible in patients who are pregnant or nursing.
Adverse Reactions
The undesirable effects listed as follows are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of ≥1% and uncommon undesirable effects have an incidence of <1%. (See Table.)
Drug Interactions
Morphine should be used with caution in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, gabapentin 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. Morphine should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy.
Caution For Usage
Special Precautions For Disposal and Other Handling: Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
MST CONTINUS 10 mg and 60 mg: Store at temperatures not exceeding 25°C.
MST CONTINUS 30 mg: Store at temperatures not exceeding 30°C.
Shelf-Life: Three years.
MST CONTINUS 30 mg: Store at temperatures not exceeding 30°C.
Shelf-Life: Three years.
Action
Pharmacotherapeutic Group: Natural opium alkaloid. ATC code: N02A A01.
Pharmacology: Pharmacodynamics: Morphine is an opioid agonist with no antagonistic action.
Central Nervous System: The principal actions of therapeutic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis). Morphine produces respiratory depression by direct action on brainstem respiratory centers.
Morphine depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.
Morphine causes miosis even in total darkness. Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose.
Gastrointestinal Tract and Other Smooth Muscle: Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.
Cardiovascular System: Morphine may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.
Endocrine System: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.
Other Pharmacologic Effects: In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.
Pharmacokinetics: Morphine is well absorbed from modified release tablets in the digestive tract, peak plasma concentrations are generally achieved 1-6 hours following administration. The availability is complete when compared to an equivalent dose of immediate release oral solution. Morphine is subject to a significant first-pass metabolism in the liver resulting in a lower bioavailability when compared to an equivalent intravenous or intramuscular dose. Morphine is also metabolized by the kidneys and the intestinal mucosa. The major metabolic transformation is glucuronidation to morphine-3-glucuronide and to a lesser extent to morphine-6-glucuronide. Both metabolites undergo renal excretion.
Toxicology: Preclinical Safety Data: Genotoxicity: No regulatory studies to assess the mutagenic potential of morphine have been conducted. In the published literature, morphine was found to be mutagenic in vitro increasing DNA fragmentation in human T-cells. Morphine was reported to be mutagenic in thein vivo mouse micronucleus assay and positive for the induction of chromosomal aberrations in mouse spermatids and murine lymphocytes. Mechanistic studies suggest that the in vivo clastogenic effects reported with morphine in mice may be related to increases in glucocorticoid levels produced by morphine in this species. In contrast to the positive findings, in vitro studies in the literature have also shown that morphine did not induce chromosomal aberrations in human leukocytes or translocations or lethal mutations in Drosophila.
Carcinogenicity: Regulatory studies in animals to evaluate the carcinogenic potential of morphine have not been conducted.
Reproductive Toxicity: A study reported in the literature in female rats treated i.p. with up to 15 mg/kg/day of morphine before mating, up to 30 mg/kg/day over pregnancy and up to 40 mg/kg/day postpartum showed reduced fertility of the mothers and an increase in stillborns, and in the live offspring reduced growth, morphine withdrawal symptoms, and suppression of sperm production.
Pharmacology: Pharmacodynamics: Morphine is an opioid agonist with no antagonistic action.
Central Nervous System: The principal actions of therapeutic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis). Morphine produces respiratory depression by direct action on brainstem respiratory centers.
Morphine depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.
Morphine causes miosis even in total darkness. Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose.
Gastrointestinal Tract and Other Smooth Muscle: Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.
Cardiovascular System: Morphine may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.
Endocrine System: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.
Other Pharmacologic Effects: In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.
Pharmacokinetics: Morphine is well absorbed from modified release tablets in the digestive tract, peak plasma concentrations are generally achieved 1-6 hours following administration. The availability is complete when compared to an equivalent dose of immediate release oral solution. Morphine is subject to a significant first-pass metabolism in the liver resulting in a lower bioavailability when compared to an equivalent intravenous or intramuscular dose. Morphine is also metabolized by the kidneys and the intestinal mucosa. The major metabolic transformation is glucuronidation to morphine-3-glucuronide and to a lesser extent to morphine-6-glucuronide. Both metabolites undergo renal excretion.
Toxicology: Preclinical Safety Data: Genotoxicity: No regulatory studies to assess the mutagenic potential of morphine have been conducted. In the published literature, morphine was found to be mutagenic in vitro increasing DNA fragmentation in human T-cells. Morphine was reported to be mutagenic in thein vivo mouse micronucleus assay and positive for the induction of chromosomal aberrations in mouse spermatids and murine lymphocytes. Mechanistic studies suggest that the in vivo clastogenic effects reported with morphine in mice may be related to increases in glucocorticoid levels produced by morphine in this species. In contrast to the positive findings, in vitro studies in the literature have also shown that morphine did not induce chromosomal aberrations in human leukocytes or translocations or lethal mutations in Drosophila.
Carcinogenicity: Regulatory studies in animals to evaluate the carcinogenic potential of morphine have not been conducted.
Reproductive Toxicity: A study reported in the literature in female rats treated i.p. with up to 15 mg/kg/day of morphine before mating, up to 30 mg/kg/day over pregnancy and up to 40 mg/kg/day postpartum showed reduced fertility of the mothers and an increase in stillborns, and in the live offspring reduced growth, morphine withdrawal symptoms, and suppression of sperm production.
MedsGo Class
Analgesics (Opioid) / Supportive Care Therapy
Features
Dosage
60 mg
Ingredients
- Morphine
Packaging
Modified-Release Tablet 60's
Generic Name
Morphine Sulfate
Registration Number
DR-XY13021
Classification
Prescription Drug (RX)
Product Questions
Questions
