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Australian Journal of Pharmacy : November 2006
A POSITIVE STEP IN PA IN* RELIEF PBS Information: Restricted benefit. Chronic severe disabling pain not responding to non-narcotic analgesics. Authority required for increased maximum quantities and/or repeats. Refer to PBS Schedule for full Authority Required information. *For the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. Please review full Product Information and refer to state and federal regulations before prescribing. Full Product Information is available on request from Mundipharma. Composition: Oxycodone hydrochloride USP. Indications: The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. Contraindications: Hypersensitivity to opioids, acute respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma, other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment (creatinine < 10mL/min), delayed gastric emptying, acute alcoholism, brain tumour, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens,hypercarbia, pre-operative use, breast-feeding, concurrent monoamine oxidase inhibitors (MAOIs) or within 14 days of their use. Precautions: The major risk of opioid excess is respiratory depression. Hypothyroidism, myxedema, raised intracranial pressure, hypotension, hypovolaemia, biliary tract disease, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, toxic psychosis, chronic pulmonary, renal or hepatic disease, following abdominal surgery, debilitated patients. Tolerance and physical dependence, parenteral administration may be fatal, non-malignant pain, substance abuse. Reduce dosage in elderly debilitated patients and in patients with renal impairment or hepatic impairment (half to one-third of usual starting dose). Driving or operating machinery. Do not use within 6 hours of cordotomy or other pain relieving surgery. Pregnancy Category C. Interactions: Anticholinergic agents, antihypertensives, CNS depressants (sedatives, hypnotics, general anaesthetics, phenothiazines or other tranquilizers, alcohol, other opiates and neuroleptic drugs etc), coumarin derivatives, metoclopramide, non-selective MAOIs, neuromuscular blocking agents, opioid agonists and mixed agonist/antagonists, drugs that affect the P450 enzyme system (CYP3A4, CYP2D6). Adverse reactions: Typical of full opioid agonists and tend to reduce with time, except constipation. GI effects, including nausea, vomiting, dry mouth, gastritis, hiccup, dyspepsia, abdominal pain, constipation, diarrhoea, anorexia. CNS effects, including headache, confusion, asthenia, faintness, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, thought abnormalities, somnolence and twitching. Other: orthostatic hypotension, bronchospasm, dyspnoea, pharyngitis, voice alteration, rash, sweating, pruritus, fever and chills. Dosage and administration: Must be swallowed whole and not broken, chewed or crushed. Taking broken, chewed or crushed OxyContin tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone. Adults:Dose at 12 hourly intervals. Usual starting dose (opioid naïve patients): 12 mg 12 hourly or 5 mg 12 hourly for patients with renal or hepatic impairment. Titrate carefully (24 hourly if required) to achieve pain relief. 10 mg oral oxycodone is equivalent to 20 mg oral morphine. The 80 mg tablet should only be used in opioid-tolerant patients. Children:Not recommended in patients under 12 years of age. Presentation: OxyContin Tablets 5 mg (pale blue), 10 mg (white), 20 mg (pink), 40 mg (yellow), 80 mg (green): blister packs of 20s and 60s. Sponsor: Mundipharma Pty Limited, Level 26, 6 O’Connell Street, SYDNEY NSW 2000. TGA approval date: 15 July 1999. Date of most recent amendment: 4 March 2005. Full Product Information available from sponsor (phone 1800 188 009). ® OXYCONTIN is a Registered Trademark. ™PARTNERS AGAINST PAIN is a Trademark. W61003 10/06