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CAREXIL 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. Carexil® 10 mg Prolonged-release Tablets are indicated in adults and adolescents aged 12 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. For doses not practicable with this medicinal product other strengths are available. Adults and adolescents (12 years of age and older) Carexil® prolonged-release tablets should be taken twice daily based on a fixed schedule at the dose determined.
Starting dose The usual starting dose for an opioid-naïve patient is 10 mg oxycodone hydrochloride per dose at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher doses of Carexil® 10 mg Prolonged-release Tablets taking into account their experience with former opioid therapies. 10 to 13 mg oxycodone hydrochloride correspond to approximately 20 mg of morphine sulphate, both in the prolonged-release formulation.
Dose adjustment Some patients who take Carexil® 10 mg Prolonged-release Tablets following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Carexil® 10 mg Prolonged-release Tablets is not intended for therapy of breakthrough pain.
The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Carexil® 10 mg Prolonged-release Tablets. Use of the rescue medication more than twice daily indicates that the dose of Carexil® 10 mg Prolonged-release Tablets needs to be increased.
The dose should not be adjusted more often than once every 1-2 days until a stable 12-hourly administration has been achieved. Following a dose increase from 10 mg to 20 mg oxycodone hydrochloride taken every 12 hours dose adjustments should be made in steps of approximately one third of the daily dose until the desired effect is obtained.
The aim is a patient specific 12-hourly dose that will maintain adequate analgesia with acceptable undesirable effects and as little rescue medication as possible as long as pain control is necessary. Even administration (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 beneficial to arrange 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 oxycodone hydrochloride is generally sufficient; but higher doses may be necessary.
Due to its pharmacological properties oxycodone can cause respiratory depression, miosis, bronchial spasm and spasm of the smooth muscles and may suppress the cough reflex. 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 most commonly in elderly or debilitated patients. Opioids may cause severe hypotension in susceptible individuals. 4) Not known: aggression Nervous system disorders Very common: somnolence, sedation, dizziness, headache Common: tremor, lethargy Uncommon: amnesia, convulsion (especially in persons with epileptic disorder or predisposition to convulsions), concentration impaired, migraine, hypertonia, involuntary muscle contractions, hypoaesthesia, coordination disturbances, speech disorder, syncope, paraesthesia, dysgeusia Not known: hyperalgesia Eye disorders Uncommon: visual impairment, miosis Ear and labyrinth disorders Uncommon: hearing impaired,vertigo Cardiac disorders Uncommon: tachycardia, palpitations (in the context of withdrawal syndrome) Vascular disorders Uncommon: vasodilatation.
Rare: hypotension, orthostatic hypotension. g. chest pain), malaise, oedema, peripheral oedema, drug tolerance, thirst Rare: weight increase, weight decrease Not known: drug withdrawal syndrome neonatal Injury, poisoning and procedural complications Uncommon: injuries from accidents Drug dependence Repeated use of Carexil can lead to drug dependence, even at therapeutic doses.
4). Paediatric population The frequency, type and severity of adverse reactions in patients under 12 years of age is expected to be no different to those in adults and adolescents aged 12 years and above. 6. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
The major risk of opioid excess is respiratory depression. 5) With the occurrence or suspicion of paralytic ileus, oxycodone should be immediately discontinued. 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. Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products: Concomitant use of oxycodone and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe oxycodone concomitantly with sedative medicinal products, 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). Tolerance and dependence The patient may develop tolerance to the active substance with chronic use and require progressively higher doses to maintain pain control.
Prolonged use of this medicinal product 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 symptoms of withdrawal.
Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions, insomnia or myalgia. Hyperalgesia that will not respond to a further dose increase of oxycodone may occur particularly in high doses.
1 • severe respiratory depression with hypoxia • elevated carbon dioxide levels in the blood (hypercarbia) • severe chronic obstructive lung disease • cor pulmonale • severe bronchial asthma • paralytic ileus
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with cancer-related pain may require doses of 80 to 120 mg oxycodone hydrochloride, which in individual cases can be increased to up to 400 mg. Duration of administration Carexil® 10 mg Prolonged-release Tablets should not be used for longer than necessary.
Special populations Elderly A dose adjustment is usually not necessary in elderly patients without clinically manifest impairment of hepatic or renal function. 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 of oxycodone hydrochloride orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.
In such cases Carexil® 10 mg Prolonged- release Tablets can be used. Other patients at risk Patients with low body weight or slow metabolisers, who are opioid-naïve should initially receive half the dose usually recommended for adults.
Therefore, 10 mg of oxycodone hydrochloride per dose at intervals of 12 hours may not be suitable as a starting dose and in such cases Carexil® 10 mg Prolonged-release Tablets can be used. Paediatric population Carexil® 10 mg Prolonged-release Tablets are not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.
Method of administration Oral use. The prolonged-release tablets may be taken with or without food with sufficient liquid. Carexil® 10 mg Prolonged-release Tablets must not be divided, broken, crushed or chewed. Treatment goals and discontinuation Before initiating treatment with Carexil, 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).
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.
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 Carexil® 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 Carexil® 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.
Abuse of oral pharmaceutical forms by parenteral administration can be expected to result in serious adverse events, which may be fatal. To avoid damage to the controlled-release properties of the prolonged-release tablets, the Carexil® 10 mg Prolonged-release Tablets must be swallowed whole and must not be divided, broken, crushed or chewed.
9). 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.
Surgical procedures Carexil® 10 mg Prolonged-release Tablets are not recommended for pre- operative use or within the first 12-24 hours post-operatively. Depending on the type and extent of surgery, the anaesthetic procedure selected, other co- medication and the individual condition of the patient, the exact timing for initiating postoperative treatment with Carexil® 10 mg Prolonged-release Tablets depends on a careful risk-benefit assessment for each individual patient.
Oxycodone-containing medicinal 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. Alcohol Concomitant use of alcohol and Carexil® 10 mg Prolonged-release Tablets may increase the undesirable effects of oxycodone; concomitant use […]