Loading…
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 post- operative pain. For the treatment of severe pain requiring the use of a strong opioid.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Subcutaneous injection or infusion. Intravenous injection or infusion.
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. v. 9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over one to two minutes.
Doses should not be administered more frequently than every four hours. v. 9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended. v. 9% saline, 5% dextrose or water for injections. 03 mg/kg should be administered with a minimum lock-out time of five minutes.
c. 9% saline, 5% dextrose or water for injection. A starting dose of 5 mg is recommended, repeated at four-hourly intervals as required. c. 9% saline, 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.
Conversion from morphine:
Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio. It must be emphasised that this is a guide to the dose of Oxycodone injection required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Elderly:
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: Term Frequency 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 Frequency 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. 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.
Vascular disorders:
Uncommon: vasodilatation, facial flushing. Rare: hypotension, orthostatic hypotension.
5). The primary risk of opioid excess is respiratory depression. Concomitant use of oxycodone 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). 5). Oxycodone injection should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Oxycodone injection should be discontinued immediately.
Oxycodone injection 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.
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.
2 for additional information on treatment goals and discontinuation. Tolerance, Dependence and Opioid Use Disorder 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.
1. Oxycodone must not be used in any situation where opioids are contraindicated: • severe respiratory depression with hypoxia • paralytic ileus • acute abdomen • severe chronic obstructive lung disease • cor pulmonale • severe bronchial asthma • elevated carbon dioxide levels in the blood • chronic constipation
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Oxycodone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. 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.
Children under 18 years:
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.
Method of administration Subcutaneous injection or infusion Intravenous injection or infusion Treatment goals and discontinuation Before initiating treatment with Oxycodone 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.
4). Duration of treatment Oxycodone should not be used for longer than necessary.
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.
Hepato-biliary 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: syndrome, malaise, oedema, peripheral oedema, , thirst, pyrexia, chills. Frequency not known: drug withdrawal syndrome neonatal, opioid tolerance, opioid withdrawal syndrome. 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.
Description of selected adverse reactions 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 occurrence of drug dependence, but a reflection of the limitations in available evidence that do not support a precise estimate of frequency. 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.
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). The prescriber should conduct a 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.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. A withdrawal syndrome may occur upon abrupt cessation of therapy following prolonged use of this product.
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. Hyperalgesia that will not respond to a further dose increase of oxycodone may occur, particularly in high doses.
An oxycodone dose reduction or change to an alternative opioid may be required. As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth. Concomitant use of alcohol and Oxycodone injection may increase the undesirable effects of Oxycodone injection; concomitant use should be avoided.
e. essentially ‘sodium-free’. Opioids, such as oxycodone hydrochloride, 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 manifest from these hormonal changes. Sleep-related breathing disorders […]