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OXYCODONE HYDROCHLORIDE is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of moderate to severe pain in patients with cancer and postoperative pain. For the treatment of severe pain requiring the use of a strong opioid. Oxycodone is indicated in adults only.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.
Adults over 18 years:
The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. 9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes.
Doses should not be administered more frequently than every 4 hours. 9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. A starting dose of 2 mg/hour is recommended. 9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections.
03 mg/kg should be administered with a minimum lock-out time of 5 minutes.
SC (Bolus):
Use as 10 mg/ml concentration. 9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required. 9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections if required.
5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).
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.
The patient should be monitored closely until stable when switching opioid medications.
Conversion of patients from IV morphine to IV oxycodone:
In patients who have received IV morphine prior treatment with IV oxycodone, the daily dosage should be based on 1:1 equivalence ratio. 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.
Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic. The following frequency categories form the basis for classification of the undesirable effects: 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 Very rare < 1/10 000 Not known Cannot be estimated from the available data Immune system disorders: Uncommon: hypersensitivity.
Frequency not known: anaphylactic reaction, anaphylactoid reaction.
Metabolism and nutrition disorders:
Common: decreased appetite. Uncommon: dehydration.
Psychiatric disorders:
Common: anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams. 4), disorientation, mood altered, restlessness, dysphoria. Frequency not known: aggression.
Nervous system disorders:
Very common: somnolence, dizziness, headache. Common: tremor, lethargy, sedation. Uncommon: amnesia, convulsion, hypertonia, hypoaesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.
Frequency not known: hyperalgesia.
Eye disorders:
Uncommon: visual impairment, miosis.
Ear and labyrinth disorders:
Uncommon: vertigo.
Cardiac disorders:
Uncommon: palpitations (in the context of withdrawal syndrome), supraventricular tachycardia.
The major risk of opioid excess is respiratory depression. Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia, raised intracranial pressure, head injury (due to risk of increased intracranial pressure) or patients taking MAO inhibitors.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids 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). Gastrointestinal disorders Oxycodone should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Oxycodone should be discontinued immediately.
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.
Surgical procedures Oxycodone should be used with caution pre- or intra-operatively and within the first 12-24 hours post-operatively. 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.
1. Oxycodone must not be used in any situation where opioids are contraindicated: − known sensitivity to morphine or other opioids; − severe respiratory depression with hypoxia; − severe chronic obstructive lung disease; − cor pulmonale; − severe bronchial asthma; − elevated carbon dioxide levels in the blood; − paralytic ileus; − acute abdomen; − chronic constipation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The patient should be monitored closely until stable when switching opioid medications.
Elderly patients:
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:
The dose initiation should follow a conservative approach in these patients. 2).
Paediatric population:
There are no data on the use of oxycodone 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.
Treatment goals and discontinuation:
Before initiating treatment with Oxycodone, 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 treatment:
Oxycodone should not be used for longer than necessary. 6. Method of administration Subcutaneous injection or infusion. Intravenous injection or infusion.
Vascular disorders:
Uncommon: vasodilatation, facial flushing. Rare: hypotension, orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea, bronchospasm, cough decreased. Uncommon: respiratory depression, hiccups. Frequency not known: central sleep apnoea syndrome.
Gastrointestinal disorders:
Very common: constipation, nausea, vomiting. Common: abdominal pain, diarrhoea, dry mouth, dyspepsia. Uncommon: dysphagia, flatulence, eructation, ileus, gastritis. Frequency not known: dental caries.
Hepatobiliary disorders:
Uncommon: increased hepatic enzymes, biliary colic. Frequency not known: cholestasis, sphincter of Oddi dysfunction.
Skin and subcutaneous tissue disorders:
Very common: pruritus. Common: rash, hyperhidrosis. Uncommon: dry skin, exfoliative dermatitis. Rare: urticaria.
Renal and urinary disorders:
Uncommon: urinary retention, ureteral spasm.
Reproductive system and breast disorders:
Uncommon: erectile dysfunction, hypogonadism. Frequency not known: amenorrhoea.
General disorders and administration site conditions:
Common: asthenia, fatigue. Uncommon: drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, pyrexia, chills. Frequency not known: drug withdrawal syndrome neonatal. Drug dependence Repeated use of Oxycodone can lead to drug dependence, even at therapeutic doses.
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.
Non-malignant pain 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. Endocrine system Opioids may influence the hypothalamic-pituitary-adrenal or gonadal axes.
Some changes that can be seen include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes. 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. 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 Oxycodone 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 Oxycodone 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.
Tolerance The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.
Withdrawal syndrome When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. The opioid abstinence or withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, respiratory rate or heart rate. As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth.
Hyperalgesia Hyperalgesia that will not respond to a further dose […]