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RELTEBON is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe pain, which can be adequately managed only with opioid analgesics. Reltebon is indicated in adults and adolescents aged 12 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment.
The following general dosage recommendations apply:
Adults and adolescents 12 years of age 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 side effects.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. For doses not realisable/practicable with these strengths, other strengths are available. According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation.
Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Reltebon prolonged-release tablets after conversion from other opioids, with 50- 75% of the calculated oxycodone dose.
Some patients who take Reltebon prolonged-release tablets following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Reltebon 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 Reltebon prolonged-release tablets. Use of the rescue medication more than twice daily indicates that the dose of Reltebon 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.
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 mornings and evenings) following a fixed schedule (every 12 hours) is appropriate for the majority of the patients.
Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic. The following frequency categories form the basis for classification of the undesirable effects: Term Frequency Very common Common Uncommon Rare Very rare Frequency not known ≥ 1/10 ≥ 1/100 to <1/10 ≥ 1/1,000 to <1/100 ≥ 1/10,000 to <1/1,000 <1/10,000 Cannot be estimated from the available data Body System Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Frequency unknown (Cannot be estimated from the available data) Blood and lymphatic system disorders lymphadenopathy Immune system disorders hypersensitivity anaphylactic reaction, anaphylactoid reaction.
Endocrine disorders syndrome of inappropriate antidiuretic hormone secretion Metabolism and nutrition disorders decreased appetite dehydration Psychiatric disorders anxiety, confusional state, depression, insomnia, nervousness. g. g.
8). 'Not known' should not be interpreted as an indication of the rarity of the occurrence of opioid tolerance and opioid withdrawal syndrome, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency.
Drug dependence The frequency above regarding drug dependence reflects the current evidence, including cumulative data from clinical trials and additional post marketing sources, and indicates that the risk of drug dependence with opioids is highly variable depending upon: definition of drug dependence; duration of treatment; dose; individual patient risk factors; and clinical settings.
'Not known' should not be interpreted as an indication of the rarity of the occurrence of drug dependence, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency. Repeated use of Reltebon can lead to drug dependence, even at therapeutic doses.
Paediatric population Reltebon prolonged-release tablets have not been studied in children younger than 12 years of age. The safety and efficacy of the tablets have not been demonstrated and the use in children younger than 12 years of age is therefore not recommended.
5). Hepatobiliary disorders Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, oxycodone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Respiratory depression The primary 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. 8). 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 Reltebon prolonged-release tablets 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. 2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). Reltebon prolonged-release tablets must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks. Reltebon prolonged-release tablets should not be used where there is a possibility of paralytic ileus occurring.
Should paralytic ileus be suspected or occur during use, Reltebon prolonged-release tablets should be discontinued immediately. Pre-operative use Reltebon prolonged release tablets are not recommended for pre-operative use or within the first 12-24 hours post operatively.
1. 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.
- Elevated carbon dioxide levels in the blood. - Paralytic ileus. - Acute abdomen, delayed gastric emptying. - Moderate to severe hepatic impairment - Chronic constipation
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 individual balancing efficacy with the tolerance and risk of undesirable effects.
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.
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.
Treatment goals and discontinuation Before initiating treatment with Reltebon, 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 Reltebon prolonged-release tablets should not be taken longer than necessary. Paediatric population There have been no studies in patients under 12 years of age, therefore oxycodone hydrochloride should not be used in patients under 12 years.
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.
Elderly patients A dose adjustment is not usually necessary in elderly patients. 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 their clinical situation.
Risk patients Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially receive half the recommended adult dose if they are opioid naïve. Dose titration should be performed in accordance with the individual clinical situation.
6. Method of administration For oral use. Reltebon prolonged-release tablets should be taken twice daily […]
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients undergoing abdominal surgery 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 physician is assured of normal bowel function.
g. surgery, plexus blockade) should not receive Reltebon prolonged-release tablets for 12 hours prior to the intervention. If further treatment with Reltebon prolonged- release tablets is indicated then the dosage should be adjusted to the new post- operative requirement.
Post-operative use Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). Initial and long-term use Reltebon prolonged-release tablets should not be used in patients not previously exposed to opioids.
These tablet strengths may cause fatal respiratory depression when administered to opioid naïve patients. 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. 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.
Drug dependence, tolerance and potential for abuse 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 Reltebon 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 Reltebon 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. Patients will […]