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OXYLAN is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oxylan is indicated in adults and adolescents (from 12 years and older) for the treatment of severe pain, which can be adequately managed only with opioid analgesics.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage depends on the pain intensity and the patient’s individual susceptibility to the treatment. For doses not realisable/practicable with this strength, other strengths of this medicinal product are available.
The following general dosage recommendations apply:
Adults and adolescents 12 years and older Dose titration and adjustment In general, the initial dose for opioid-naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimize the incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. Switching from morphine to oxycodone The inter-patient variability requires that each patient be carefully adjusted to the dose that is appropriate for them.
At the beginning of the change, a dose that is lower than the dose equivalent may be recommended. Patients who received oral morphine prior to oxycodone therapy should receive their daily dose based on the following ratio: 10 mg oral oxycodone is equivalent to 20 mg oral morphine Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Oxycodone hydrochloride prolonged-release tablets after conversion from other opioids, with 50-75% of the calculated oxycodone dose.
Some patients who take Oxycodone hydrochloride prolonged-release tablets following a fixed schedule need rapid-release analgesics as rescue medication in order to control breakthrough pain. Oxycodone hydrochloride prolonged-release tablets are not indicated for the treatment of acute pain and/or breakthrough pain.
The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Oxycodone hydrochloride prolonged-release tablets. Use of the rescue medication more than twice daily indicates that the dose of Oxycodone hydrochloride prolonged-release tablets needs to be increased.
The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved. Following a dose increase from 10 mg to 20 mg, taken every 12 hours, dose adjustments should be made in steps of approximately one third of the daily dose.
Oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of the smooth muscles and can suppress the cough reflex. Drug dependence Repeated use of Oxylan prolonged-release tablets can lead to drug dependence, even at therapeutic doses.
4). The most frequently reported undesirable effects are nausea (especially at the beginning of treatment) and constipation. Respiratory depression is the chief hazard of an opioid overdose and occurs predominantly in elderly or debilitated patients.
Opioids may cause severe hypotension in susceptible individuals. The adverse reactions considered at least possibly related to treatment are listed below by system organ class and absolute frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
g. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
g. 5). With the occurrence or suspicion of paralytic ileus, oxycodone should be immediately discontinued. Respiratory depression The major risk of opioid excess is respiratory depression. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Oxylan and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Oxylan concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). MAOIs Oxycodone should be administered with caution to patients taking MAOIs or who have received MAOIs within the last two weeks.
Tolerance, physical dependence, withdrawal symptoms and tapering off The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Oxylan prolonged-release tablets have a primary dependence potential.
Prolonged use of Oxylan prolonged-release tablets may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent withdrawal symptoms.
hypersensitivity to oxycodone hydrochloride, soya, peanut, or to any of the excipients Oxycodone must not be used in any situation where opioids are contraindicated: • severe respiratory depression with hypoxia and/or hypercapnia • severe chronic obstructive pulmonary disease • cor pulmonale • severe bronchial asthma • paralytic ileus • acute abdomen, delayed gastric emptying
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The aim is a patient-specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed. Even distribution (the same dose in the morning and in the evening) following a fixed schedule (every 12 hours) is appropriate for the majority of the patients.
For some patients it may be advantageous to distribute the doses unevenly. In general, the lowest effective analgesic dose should be chosen. For the treatment of non-malignant pain a daily dose of 40 mg is generally sufficient; but higher dosages may be necessary.
Patients with cancer-related pain may require dosages of 80 to 120 mg, which in individual cases can be increased to up to 400 mg. If even higher doses are required, the dose should be decided individually balancing efficacy against tolerance and the risk of undesirable effects.
Elderly patients Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments. Patients with renal or hepatic impairment The dose initiation should follow a conservative approach in these patients.
The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to his/her clinical situation.
e. 10 mg, is not suitable as a starting dose. In these cases Oxylan 5 mg prolonged-release tablets can be used. Other risk patients In patients with low body weight or slow metabolism of drugs who are also opioid- naive, the recommended starting dose should be reduced to half the normally recommended starting dose for adults.
e. 10 mg, is not suitable as a starting dose. In these cases Oxylan 5 mg prolonged-release tablets can be used. Paediatric population 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.
Children below the age of 12 years The safety and efficacy of oxycodone in children below 12 years of age has not yet been established. No data are available. METHOD OF ADMINISTRATION Oral use. Oxylan prolonged-release tablets should be taken twice daily based on a fixed schedule at the dosage determined.
The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of liquid. Oxylan prolonged-release tablets must be swallowed whole, and they must not be chewed, divided or crushed. Treatment goals and discontinuation Before initiating treatment with Oxylan prolonged-release tablets, 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.
4). Duration of administration Oxylan prolonged-release tablets should not be taken longer than necessary.
Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions, insomnia, and myalgia. Hyperalgesia Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses.
An oxycodone dose reduction or change to an alternative opioid may be required. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone.
Repeated use of Oxylan may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Oxylan may result in overdose and/or death. g.
major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g.
too early requests for refills). This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Parenteral abuse Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal. Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment.
Opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities. Patients with chronic non-malignant pain should be monitored for signs of dependence or substance abuse. The attainment of treatment goals should be regularly checked in accordance with pain management guidelines.
If appropriate, the dose is to be adjusted. In case the treatment objectives are not met, discontinuation of therapy should be considered. The prolonged-release tablets must be swallowed whole, and not broken, crushed or chewed. 9). Surgical procedures As with all opioid preparations, oxycodone products should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the […]