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  • M.I.R.
    / Rafa


    Active Ingredient
    Morphine Sulphate 15 mg, 30 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    20 X 15 mg

    full basket chart 8342 13464

    Tablets

    20 X 30 mg

    full basket chart 8343 13465

    Related information


    Dosage

    The dosage of M.I.R. tablets is dependent on the severity of pain and the patient’s previous history of analgesic requirements. One tablet to be taken every four to six hours or as directed by a physician. Increasing severity of pain or tolerance to morphine will require increased dosage of M.I.R. tablets alone or in combination to achieve the desired relief. Patients receiving M.I.R. 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.
    Elderly: A reduction in adult dosage may be advisable.
    Children 3 -12 years of age: 0.2-0.5 mg/kg/dose every 4-6 hours as needed.


    Indications

    Moderate to severe pain not responding to non-narcotics, pre-op sedative.


    Contra-Indications

    Hypersensitivity to any of the constituent. Respiratory depression, head injury, obstructive airways disease, paralytic ileus, acute abdomen, delayed gastric emptying, known morphine sensitivity, acute hepatic disease, concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use. Not recommended during pregnancy. Not recommended for children below 3 years of age.


    Special Precautions

    The major risk of opioid excess is respiratory depression. As with all narcotics a reduction in dosage may be advisable in the elderly, in hypothyroidism, in renal and chronic hepatic disease. Use with caution in patients with impaired respiratory function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, severe cor pulmonale, opioid dependent patients, patients with a history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency. M.I.R. tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, M.I.R tablets should be discontinued immediately.
    Morphine may lower the seizure threshold in patients with a history of epilepsy. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive M.I.R. tablets for 4 hours prior to the intervention . If further treatment with M.I.R. tablets is indicated then the dosage should be adjusted to new post-operative requirements. M.I.R. tablets should be used with caution pre-operatively and within the first 24 hours post-operatively. M.I.R. tablets should also be used with caution following abdominal surgery as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function. 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.
    Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required. 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. The product 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.


    Side Effects

    In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with M.I.R. tablets but should they occur the tablets can be readily combined with an anti-emetic if required. Constipation may be treated with appropriate laxatives.
    For full details see prescribing information.


    Drug interactions

    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 tranquilisers, 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. In a study involving healthy volunteers (N = 12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately. Mixed agonist/antagonist opioid analgesics (e.g. buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.
    Medicinal products that block the action of acetylcholine, for example antihistamines, anti-parkinsons and anti-emetics, may interact with morphine to potentiate the anticholinergic adverse effects. Cimetidine inhibits the metabolism of morphine. Monoamine oxidase inhibitors are known to interact with narcotic analgesics producing CNS excitation or depression with hyper- or hypotensive crisis. Morphine should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy. Plasma concentrations of morphine may be reduced by rifampicin. Although there are no pharmacokinetic data available for concomitant use of ritonavir with morphine, ritonavir induces the hepatic enzymes responsible for the glucuronidation of morphine, and may possibly decrease plasma concentrations of morphine.


    Pregnancy and Lactation

    M.I.R. tablets are not recommended during pregnancy and labour due to the 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 new born of mothers undergoing chronic treatment.


    Overdose

    Signs and symptoms of morphine overdose: Signs of morphine toxicity and overdose are pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression, hypotension, somnolence and central nervous system depression which can progress to stupor or coma. 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.
    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, (1g/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. 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.


    Manufacturer
    Rafa Laboratories Ltd.
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