Source: Υπουργείο Υγείας (CY) Revision Year: 2023 Publisher: Mundipharma Pharmaceuticals Ltd, 13, Othellos str., Dhali Industrial Zone, Nicosia, Cyprus Tel.: +357 22815656 Fax: +357 22487833 Email: info@mundipharma.com.cy
OxyNorm injection is indicated in adults and adolescents (from 12 years and older) 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.
The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient’s previous history of analgesic requirements, their body weight, and sex (higher plasma concentration are produced in females), should be taken into account when determining the dose.
Generally, the lowest effective dose for analgesia should be selected. If higher doses are necessary, increases should be made in 25% - 50% increments where possible.
The correct dosage per individual patients is that which controls the pain with no or tolerable side effects.
If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two “rescues” per day could be an indication that the prolonged-release dosage requires upward titration.
The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.
Intravenous bolus: Slow administration of a bolus dose of 1 to 10 mg slowly over 1-2 minutes is recommended. With acute pain the dose should be titrated gradually until optimum analgesic effect is achieved. Bolus doses can be repeated, usually every 4 hours. In adolescents, a maximum bolus dose of 5 mg oxycodone hydrochloride is recommended.
Intravenous Infusion: A starting dose of 2 mg/hour is recommended.
Intravenous patient-controlled analgesia: Administration of a bolus doses of 0.03 mg/kg should be administered with a minimum lock–out time of 5 minutes.
Subcutaneous bolus: Use as 10 mg/ml strength. A strong dose of 5 mg is recommended. With acute pain the dose should be titrated gradually until optimum analgesic effect is achieved. Bolus doses can be repeated, usually every 4 hours, if pain relief decreases.
Subcutaneous infusion: A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. In adolescents, a starting dose of 5 mg oxycodone hydrochloride per day is recommended.
Cancer patients transferring from oral oxycodone may require much higher doses (see below).
Before initiating treatment with OxyNorm injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
Oxycodone should not be used for longer than necessary. See section 4.4 Special warnings and precautions for use regarding the need for close monitoring for development of dependence and abuse.
It must be emphasized that this is a guide to the dose of oxycodone required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Initially, a lower-than-equivalent dose may be advisable.
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 emphasized that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio.
Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.
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. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.
Opioids must only be used for appropriate indications and prescribed by a specialist experienced in managing severe pain in children, with careful assessments of the benefits and risks.
The safety and efficacy of oxycodone in children below 12 years of age has not yet been established. There are no data on the use of OxyNorm injection in patients under 18 years of age.
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 osteoathritic pain and intervertebral disc disease.
OxyNorm injection is intended for subcutaneous or intravenous injection or infusion after dilution.
For instructions on dilution of the product before administration, see section 6.
Signs of oxycodone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. Toxic leukoencephalopathy has been observed with 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 overdosage, 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 two 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 overdosage, 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 overdosage. 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.
5 years unopened.
After opening use immediately.
For further information see Section 6.6.
No special precautions for storage prior to opening.
For further information on use after opening see Section 6.6.
Clear neutral glass ampoules: 1 ml and 2 ml.
Pack size: 5 ampoules.
For intravenous use OxyNorm injection concentrate for solution for infusion should be diluted to a concentration of 1 mg/ml oxycodone hydrochloride. The following solutions for infusion/injection can be used as diluents 0.9% saline, 5% dextrose or water for injections.
For subcutaneous use OxyNorm injection can be diluted with the following solutions for infusion/injection 0.9% saline, 5% dextrose or water for injections.
The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. 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.
The results from studies indicate that OxyNorm injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags, over a 24 hour period at ambient temperature.
The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and contained in the various assemblies, does not need to be protected from light.
The compatibility with representative brands of a range of drugs (hyoscine butylbromide, hyoscine hydrobromide, dexamethasone sodium phosphate, haloperidol, midazolam hydrochloride, metoclopramide hydrochloride, levomepromazine hydrochloride) likely to be co-administered with oxycodone hydrochloride injection was also assessed when stored in high and low dose combinations in polypropylene syringes over a 24·hour period at ambient temperature. No evidence of incompatibility between oxycodone hydrochloride injection 10 mg/ml and any of the solutions of the seven drugs tested was observed.
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 not be longer than 24 hours at 2 to 8 °C, unless reconstitution, dilution, etc has taken place in controlled and validated aseptic conditions.
Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.
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