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  • Oxycod Injection
    / Rafa


    Active Ingredient
    Oxycodone HCl 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    50 ×1 ml

    not in the basket chart 53815 15433

    Ampoule

    50 ×2 ml

    not in the basket chart 53816 15434

    Related information


    Dosage

    I.V. S.C.: The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.  Recommended starting doses in adults over 18 yrs: (A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases).
    I.V. (Bolus):  Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections.  Administer a bolus dose of 1 to10 mg slowly over 1-2 min.  Not to be administered more frequently than every 4 hours.
    I.V. (Infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections.  A starting dose of 2 mg/hour is recommended.
    I.V. (PCA): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections.  Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes.
    S.C. (Bolus):  Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required.
    S.C. (Infusion):  Dilute in 0.9% saline, 5% dextrose or water for injections if required.  Opioid naïve patients: starting dose of 7.5 mg/day, titrating gradually according to symptom control.  Cancer patients transferring from oral oxycodone may require much higher doses.
    Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio:  2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone.  It must be emphasised that this is a guide to the dose required.  Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
    Elderly: Elderly patients should be treated with caution.  The lowest dose should be administered with careful titration to pain control.
    Patients with renal and hepatic impairment: Patients with mild to moderate renal impairment and/or mild hepatic impairment should be treated with caution.  The lowest dose should be given with careful titration to pain control.
    Children under 18 years: There are no data on the use of Oxycod injection in patients under 18 years of age.
    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.


    Indications

    For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.   


    Contra-Indications

    Patients with known hypersensitivity to oxycodone or any of the other constituents, or in any situation where opioids are contraindicated; respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; 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.


    Special Precautions

    The major risk of opioid excess is respiratory depression. As with all opioids, a reduction in dosage may be advisable in hypothyroidism. Use with caution in patients with raised intracranial pressure, hypotension, hypovolaemia, toxic psychoses, diseases of the biliary tract, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, acute alcoholism, delirium tremens, pancreatitis, chronic renal and hepatic disease or severe pulmonary disease and debilitated, elderly and infirm patients. Oxycod injection should not be used where there is a possibility of paralytic ileus occurring.  Should paralytic ileus be suspected or occur during use, Oxycod injection should be discontinued immediately.
    The patient may develop tolerance to oxycodone with chronic use and require progressively higher doses to maintain pain control.  The patient may develop physical dependence, in which case an abstinence syndrome may be seen following abrupt cessation. For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities. A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and substance abuse history. There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone.  Oxycod injection, like all opioids, should be used with particular care in patients with a history of alcohol and drug abuse.
    If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects. Oxycodone has an abuse profile similar to other strong opioids and should be used with caution in opioid-dependent patients. Oxycodone may be sought and abused by people with latent or manifest addiction disorders.  As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth.
    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

    There is an enhanced CNS depressant effect with drugs such as tranquillisers, anaesthetics, 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. Oxycodone is metabolised in part via the CYP2D6 and CYP3A4 pathways. While these pathways may be blocked by a variety of drugs, such blockade has not yet been shown to be of clinical significance with this agent.
    See prescribing information for full details.


    Pregnancy and Lactation

    The effect of oxycodone in human reproduction has not been adequately studied. No studies on fertility or the post-natal effects of intrauterine exposure have been carried out. However, studies in rats and rabbits with oral doses of oxycodone equivalent to 3 and 47 times an adult dose of 160 mg/day, respectively, did not reveal evidence of harm to the foetus due to oxycodone. Oxycodone injection 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. Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn. Oxycodone should therefore not be used in breast-feeding mothers.  


    Overdose

    Symptoms of over dosage: Signs of oxycodone toxicity and overdose are pin-point pupils, respiratory depression, hypotension and hallucinations. Nausea and vomiting are common in less severe cases. Non-cardiac pulmonary oedema and rhabdomyolysis are particularly common after intravenous injection of opioid analgesics. Circulatory failure and somnolence progressing to stupor or coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. The effects of overdose will be potentiated by the simultaneous ingestion of alcohol or other psychotropic drugs.
    Treatment of over dosage:  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 2mg for an adult and 0.01mg/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.
    The patient should be observed for at least 6 hours after the last dose of naloxone. 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.


    Important notes

    Compatibility: This medicinal product must not be mixed with other medicinal products except: Hyoscine butylbromide, hyoscine hydrobromide, dexamethasone sodium phosphate, haloperidol, midazolam hydrochloride, metoclopramide hydrochloride, levomepromazine hydrochloride.
    Cyclizine at concentrations of 3 mg/ml or less, when mixed with this injection, either undiluted or diluted with water for injections, shows no sign of precipitation over a period of 24 hours storage at room temperature. Precipitation has been shown to occur in mixtures with this injection at cyclizine concentrations greater than 3 mg/ml or when diluted with 0.9% saline. It is recommended that water for injections be used as a diluent when cyclizine and oxycodone hydrochloride are co-administered either intravenously or subcutaneously as an infusion. Prochlorperazine is chemically incompatible with this injection.
    Storage:  Store below 30°C. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution, dilution, etc has taken place in controlled and validated aseptic conditions.
    See prescribing information for full details.


    Manufacturer
    Rafa Laboratories Ltd.
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