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  • Oxycod Syrup
    / Rafa


    Active Ingredient
    Oxycodone HCl 10 mg / 5 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Syrup

    50 ml

    partial basket chart 35564 15104

    Related information


    Dosage

    Elderly and adults over 18 years: This syrup should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. Increasing severity of pain will require an increased dosage of this drug. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses. Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose ofit required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.2 Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate. Adults with mild to moderate renal impairment and mild hepatic impairment The plasma concentration in this patient population may be increased. Therefore, dose initiationshould follow a conservative approach. The starting dose for opioid naïve patients is 2.5 mg 6-hourly.
    Children: This drug should not be used in patients under 6 years. Doses should be titrated to appropriate effect. 0.05-0.15mg/kg/dose every 4-6 hours as needed.
    Use in non-malignant pain: Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the
    only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals.
    Cessation of Therapy: When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
    For full details see prescribing information.


    Indications

    For the relief of moderate to severe pain.


    Contra-Indications

    Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, chronic bronchial asthma, hypercarbia, known oxycodone sensitivity or in any situation where opioids are contraindicated, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10 ml/min), chronic constipation, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use, pregnancy and lactation, hypersensitivity to any of the constituents of the product.


    Special Precautions

    The major risk of opioid excess is respiratory depression. Use with caution in opioid-dependent patients and in patients with raised intracranial pressure, hypotension, hypovolemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, acute alcoholism, delirium tremens, history of alcohol and drug abuse , chronic renal and hepatic disease, or severe pulmonary disease, and debilitated elderly and infirm patient. Reduction in dosage may be advisable in hypothyroidism. Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive Oxycod Forte syrup for 6 hours prior to the intervention. Contains Sunset yellow and sodium benzoate.
    See prescribing information for full details.


    Side Effects

    Common (incidence of >1%): Anorexia, anxiety, confusional state, insomnia, nervousness, thinking disturbances, abnormal dreams, headache, dizziness, sedation, somnolence, bronchospasm, dyspnea, cough decreased, constipation, nausea, vomiting, dry mouth, dyspepsia, abdominal pain, diarrhea, hyperhidrosis, pruritus, rash, asthenia, chills.
    See prescribing information for full details.


    Drug interactions

    Oxycodone potentiates the effects of tranquillisers, anesthetics, hypnotics, anti-depressants, sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression with hypertensive or hypotensive crisis. Interaction may be observed for potent inhibitors of cytochrome P450-2D6 enzyme. Cimetidine and inhibitors of cytochrome P450-3A4 such as ketoconazole and erythromycin may inhibit the metabolism of oxycodone.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: This drug is not recommended for use in pregnancy nor during labour. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression.
    Lactation: Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn. Therefore, not be used in breast-feeding mothers.


    Overdose

    Signs of oxycodone toxicity and overdose are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases.
    Treatment of oxycodone overdose: primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation. In the case of massive overdose, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient’s clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients.
    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 oxycodone overdose. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
    Additional/other considerations: Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.


    Manufacturer
    Rafa Laboratories Ltd.
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