Pharmaceutical form Prolonged release, round, convex tablet. 15 mg tablet contains 13.5 mg of oxycodone as 15 mg of oxycodone hydrochloride. For a full list of excipients see section 6.1. The 40 mg tablets are yellow, marked OC on one side and 40 on the other. 10 mg tablet contains 9.0 mg of oxycodone as 10 mg of oxycodone hydrochloride. 40 mg tablet contains 36.0 mg of oxycodone as 40 mg of oxycodone hydrochloride. The 20 mg tablets are pink, marked OC on one side and 20 on the other. Qualitative and quantitative composition 5 mg tablet contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride. 120 mg tablet contains 108 mg of oxycodone as 120 mg of oxycodone hydrochloride. The 5 mg tablets are light blue, marked OC on one side and 5 on the other. The 10 mg tablets are white, marked OC on one side and 10 on the other. Also contains lactose monohydrate. OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg 120mg prolonged release tablets 2. 3. 60 mg tablet contains 54 mg of oxycodone as 60 mg of oxycodone hydrochloride. 20 mg tablet contains 18.0 mg of oxycodone as 20 mg of oxycodone hydrochloride. Clinical particulars 4.1 Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and post-operative pain. 80 mg tablet contains 72.0 mg of oxycodone as 80 mg of oxycodone hydrochloride. 4. 4.2 Posology and method of administration OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. The 30 mg tablets are brown, marked OC on one side and 30 on the other. Adults over 18 years:. The 120 mg tablets are purple, marked OC on one side and 120 on the other. The 60 mg tablets are red, marked OC on one side and 60 on the other. The 15 mg tablets are grey, marked OC on one side and 15 on the other. 30 mg tablet contains 27 mg of oxycodone as 30 mg of oxycodone hydrochloride. For the treatment of severe pain requiring the use of a strong opioid. The 80 mg tablets are green, marked OC on one side and 80 on the other.
Psychiatric disorders: Common : anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams Uncommon : agitation, affect lability, euphoric mood, hallucinations, decreased libido, drug dependence (see section 4.4), disorientation, mood altered, restlessness, dysphoria Frequency unknown : aggression. Common : rash, hyperhidrosis. Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn. 4.7 Effects on ability to drive and use machines Oxycodone may impair the ability to drive and use machines. Vascular disorders: Uncommon : vasodilatation, facial flushing, hypotension, orthostatic hypotension. Hepato-biliary disorders: Uncommon : increased hepatic enzymes, cholestasis, biliary colic. Nervous system disorders: Very common : somnolence, dizziness, headache. When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive. Uncommon : dental caries, dysphagia, flatulence, eructation, ileus, gastritis. Eye disorders: Uncommon : visual impairment, miosis. Renal and urinary disorders: Uncommon : urinary retention, ureteral spasm. Uncommon : amnesia, convulsion, hypertonia, hypoaesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia. Reproductive system and breast disorders: Uncommon : amenorrhoea, erectile dysfunction. Metabolism and nutrition disorders: Common : decreased appetite. 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 unknown Cannot be estimated from the available data Immune system disorders: Uncommon : hypersensitivity, anaphylactic responses. Frequency unknown : hyperalgesia. Uncommon : respiratory depression, hiccups. Tolerance and dependence may occur (see Section 4.4). Common : tremor, sedation. Common : abdominal pain, diarrhoea, dry mouth, dyspepsia. OxyContin tablets should, therefore, not be used in breast-feeding mothers. Ear and labyrinth disorders: Uncommon : vertigo. Gastrointestinal disorders: Very common : constipation, nausea, vomiting. Uncommon : dry skin, exfoliative dermatitis, urticaria. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. Therefore patients should not drive or operate machinery if affected. • Do not drive until you know how the medicine affects you. • This defence applies when: • The medicine has been prescribed to treat a medical or dental problem; and • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine. Uncommon : dehydration. Cardiac disorders: Uncommon : palpitations (in the context of withdrawal syndrome), supraventricular tachycardia. Oxycodone may modify patients' reactions to a varying extent depending on the dosage and individual susceptibility. Skin and subcutaneous tissue disorders: Very common : pruritus. Reporting of suspected adverse reactions. This medicine can impair cognitive function and can affect a patient's ability to drive safely. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic. your ability to drive is being affected). Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law 4.8 Undesirable effects Adverse drug reactions are typical of full opioid agonists. • Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. • It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the 'statutory defence'). Respiratory, thoracic and mediastinal disorders: Common : dyspnoea, bronchospasm, cough decreased. General disorders and administration site conditions: Common : asthenic conditions, chills. Constipation may be prevented with an appropriate laxative. Uncommon : drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, pyrexia.
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OxyContin tablets are not recommended for use in pregnancy nor during labour. Breastfeeding. There are limited data from the use of oxycodone in pregnant women. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression.
OxyContin should not be used in patients under 18 years of age. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals. The dose initiation should follow a conservative approach in these patients. Patients with renal or hepatic impairment : The plasma concentration in this population may be increased. Duration of treatment. Use in non-malignant pain : Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. 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.
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OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets (PIL).
It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations; however there is no evidence to support this. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Intramuscular naloxone is an alternative in the event IV access is not possible. Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative. 5. Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken. Other supportive measures should be employed as needed. In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children), if the patient is in a coma or respiratory depression is present. It has an affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. • OxyContin tablets will continue to release and add to the oxycodone load for up to 12 hours after administration and management of oxycodone overdosage should be modified accordingly. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Natural opium alkaloids ATC code: NO2A AO5 Oxycodone is a full opioid agonist with no antagonist properties. Infusions are not a substitute for frequent review of the patient's clinical state. Additional/other considerations : • Consider activated charcoal (50 g for adults, 10 -15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. 4.9 Overdose Acute overdose with oxycodone can be manifested by miosis, respiratory depression, hypotension and hallucinations. The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or other psychotropic drugs. Endocrine system. The patient should be observed for at least 6 hours after the last dose of naloxone. Treatment of oxycodone overdosage: Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation. The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose. It allows continued monitoring of the benefit/risk balance of the medicinal product. Circulatory failure and somnolence progressing to stupor or deepening coma, hypotonia, bradycardia and death may occur in more severe cases. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. Oxycodone is similar to morphine in its action. Reporting suspected adverse reactions after authorisation of the medicinal product is important. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome. Repeat the dose at 2 minute intervals if there is no response.
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Oxycodone should not be used for longer than necessary. Discontinuation of treatment.
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The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12-hourly. The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg, 12-hourly. Patients receiving oral morphine before OxyContin therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. It must be emphasised that this is a guide to the dose of OxyContin tablets required. 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. OxyContin tablets should be taken at 12-hourly intervals. However, a few patients may require higher doses. The need for escape medication more than twice a day indicates that the dosage of OxyContin tablets should be increased. If higher doses are necessary, increases should be made, where possible, in 25% - 50% increments. Children under 18 years:. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Elderly patients : A dose adjustment is not usually necessary in elderly patients. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Increasing severity of pain will require an increased dosage of OxyContin tablets using individual tablet strengths, either alone or in combination, to achieve pain relief. OxyContin is not intended for use as a prn analgesic. Doses in excess of 1000 mg have been recorded. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.
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by 14%. Empty matrix (tablets) may be seen in the stools. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to the intervention. 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. An oxycodone dose reduction or change to an alternative opioid may be required. Some specific examples are provided below: • Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased the AUC of oral oxycodone. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. These tablet strengths may cause fatal respiratory depression when administered to opioid naïve patients. • Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the AUC of oral oxycodone. OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. MAO inhibitors cause CNS excitation or depression associated with hypertensive or hypotensive crisis (see section 4.4). • Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days, increased the AUC of oral oxycodone. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. The oxycodone dose may need to be adjusted accordingly. Oxycodone has an abuse profile similar to other strong opioids. 4.6 Fertility, pregnancy and lactation Pregnancy. On average, the AUC was approximay 2.4 times higher (range 1.5 - 3.4). If further treatment with OxyContin tablets is indicated then the dosage should be adjusted to the new post-operative requirement. Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses. CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin and St John´s Wort may induce the metabolism of oxycodone and cause an increased clearance of oxycodone that could cause a reduction of the plasma concentrations of oxycodone. Also an increase in noroxycodone level was observed, (C max by 50%; AUC by 85%, and t ½ elim. The administration of broken, chewed or crushed OxyContin tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see Section 4.9). Therefore the oxycodone dose may need to be adjusted accordingly. Some specific examples are provided below: • St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days, reduced the AUC of oral oxycodone. The pharmacodynamic effects of oxycodone were not altered. There is potential for development of psychological dependence to opioid analgesics, including oxycodone. On average, the AUC was approximay 3.6 times higher (range 2.7 - 5.6). The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. Patients about to undergo additional pain relieving procedures (e.g. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. • ithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the AUC of oral oxycodone. Abuse of oral dosage forms by parenteral administration can be expected to result in other serious adverse events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, which may be fatal. 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. OxyContin 60 mg, 80 mg and 120 mg tablets should not be used in patients not previously exposed to opioids. The physician and patient can then agree to discontinue treatment if these objectives are not met. Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin ; concomitant use should be avoided. Pregnancy. On average, the AUC was approximay 86% lower Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. 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. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements. Oxycodone may be sought and abused by people with latent or manifest addiction disorders. 4.3 Contraindications Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1. Concurrent administration of quinidine resulted in an increase in oxycodone C max by 11%, AUC by 13%, and t ½ elim. MAO inhibitors are known to interact with narcotic analgesics. On average, the AUC was approximay 1.7 times higher (range 1.1 2.1). 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. Alcohol may enhance the pharmacodynamic effects of OxyContin ; concomitant use should be avoided. 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. Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. It is strongly recommended that the physician defines treatment outcomes in accordance with pain management guidelines. OxyContin should be used with particular care in patients with a history of alcohol and drug abuse. clarithromycin, erythromycin and ithromycin), azole-antifungals (e.g. 4.5 Interaction with other medicinal products and other forms of interaction There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as tranquillisers, anaesthetics, hypnotics, anti-depressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and antihypertensives. Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, 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, and patients with raised intracranial pressure. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. On average, the AUC was approximay 50% lower (range 37-57%). CYP3A4 inhibitors, such as macrolide antibiotics (e.g. There must be frequent contact between physician and patient so that dosage adjustments can be made. Should paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued immediay. Oxycodone must not be used in any situation where opioids are contraindicated: respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, hypercarbia, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10 ml/min), chronic constipation, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. • Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg given as first two doses), increased the AUC of oral oxycodone. 4.4 Special warnings and precautions for use The major risk of opioid excess is respiratory depression. OxyContin tablets are not recommended for pre-operative use or within the first 12-24 hours post-operatively. On average, the AUC was approximay 1.8 times higher (range 1.3 2.3). When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth. by 42%).Oxycodone 30mg