Home' Australian Pharmacist : Australian Pharmacist December 2014 Contents Before prescribing, please refer to Product Information
and to State and Federal regulations. The Product
Information for OxyContin® tablets can be accessed
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 restricted
benefit and authority information.
MINIMUM PRODUCT INFORMATION OxyContin® modified release tablets 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
80 mg NAME OF THE MEDICINE: Oxycodone hydrochloride. INDICATIONS: The management of moderate
to severe chronic pain unresponsive to non-narcotic analgesia. CONTRAINDICATIONS: Hypersensitivity
to opioids or to any of the constituents of OxyContin® tablets, acute respiratory depression, cor pulmonale,
cardiac arrhythmias, acute asthma or other obstructive airways disease, suspected mechanical gastrointestinal
obstruction (e.g. bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g. ileus
of any type), suspected surgical abdomen, severe renal impairment (creatinine clearance <10 mL/min), severe
hepatic impairment (refer to Special Risk Groups), delayed gastric emptying, acute alcoholism, brain tumour,
increased cerebrospinal or intracranial pressure, head injury (due to risk of raised intracranial pressure), severe
CNS depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of MAOIs or
within two weeks of discontinuation of their use. Not recommended for pre-operative use or for the first 24 hours
post-operatively. Pregnancy. PRECAUTIONS: The major risk of opioid excess is respiratory depression. Use
with caution in patients with hypothyroidism (may need to reduce dose), debilitated elderly or infirm patients,
opioid-dependent patients, hypotension, hypovolaemia, diseases of the biliary tract, pancreatitis, inflammatory
bowel disorders, prostatic hypertrophy, adrenocortical insufficiency (Addison’s disease), toxic psychosis, chronic
pulmonary, renal or hepatic disease, myxedema, following abdominal surgery (discontinue use if paralytic ileus
is suspected or occurs), underlying gastro-intestinal disorders, chronic non-malignant pain, a prior history of
alcohol or substance abuse. OxyContin® tablets should not be taken by patients with swallowing difficulties.
Oxycodone should not be used during pregnancy or lactation unless clearly needed (Category C). Tolerance
and physical dependence tend to develop upon repeated administration. Withdraw gradually. Parenteral
venous injection of the tablet constituents may be fatal. Reduce dosage in the elderly, debilitated patients and in
patients with renal or hepatic impairment (one-third to one-half of usual starting dose). Reduce dose or change
to another opioid in hyperalgesia that will not respond to an increase dose of oxycodone. May affect driving or
operating machinery. Do not use in immediate pre-operative period, or within 24 hours of cordotomy or other
pain-relieving surgery. INTERACTIONS WITH OTHER MEDICINES: Anticholinergic agents, antihypertensives,
CNS depressants (sedatives, hypnotics, general anaesthetics, phenothiazines, other tranquillisers, alcohol, other
opioids, neuroleptic drugs, etc.), coumarin derivatives, metoclopramide, non-selective MAOIs or within 14 days
of stopping such treatment (caution is advised with selective MAOIs), neuromuscular blocking agents, opioid
agonist analgesics and mixed agonist/antagonist analgesics, drugs and dietary elements (grapefruit juice) that
affect the P450 enzyme system (CYP3A4, CYP2D6). ADVERSE EFFECTS: Adverse reactions are typical of full
opioid agonists and tend to reduce with time, with the exception of constipation. Very common side effects
(incidence ≥1/10) include constipation, dizziness, headache, nausea, pruritus, somnolence and vomiting.
Common side effects (incidence ≥1/100 to <1/10) include abdominal pain, abnormal dreams, anxiety, asthenic
conditions, bronchospasm, chills, confusional state, decreased appetite, depression, diarrhoea, dry mouth,
dyspepsia, dyspnoea, faintness, fever, gastritis, hiccup, hyperhidrosis, insomnia, nervousness, orthostatic
hypotension, pharyngitis, rash, sedation, thinking abnormal, tremor, twitching and voice alteration. DOSAGE
AND ADMINISTRATION Must be swallowed whole, and are not to be cut, broken, chewed, crushed
or dissolved. The tablets have been hardened to reduce the risk of being accidently or intentionally
broken, chewed or crushed. Taking cut, broken, chewed, crushed or dissolved OxyContin® tablets could
lead to the rapid release and absorption of a potentially fatal dose of oxycodone. OxyContin® tablets
should not be pre-soaked, licked or otherwise wetted prior to placing in the mouth and should be taken one
tablet at a time with enough water to ensure complete swallowing immediately after placing it in the mouth.
Rectal administration of OxyContin® tablets is not recommended. Do not administer OxyContin® tablets via
nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes. Alcohol should be
avoided while the patient is being treated with OxyContin® tablets. Adults, elderly and children over 12 years:
Dose at 12-hourly intervals. Usual starting dose (opioid-naïve patients or patients presenting with moderate to
severe pain uncontrolled by weaker opioids): one OxyContin® 10 mg tablet 12-hourly. Patients with renal or
hepatic impairment: Reduce starting dose by 1⁄3 to 1⁄2. Titrate carefully (as frequently as once a day if necessary)
to achieve pain relief. 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. OxyContin® 80 mg
tablets should only be used in opioid-tolerant patients. In opioid naïve patients, this tablet strength may
cause fatal respiratory depression. Children: Not recommended in patients under 12 years of age. DATE OF
FIRST INCLUSION IN THE ARTG: 22 October 2013. DATE OF MOST RECENT AMENDMENT: 28 May 2014.
Reference: 1. Analgesic Expert Group. Therapeutic Guidelines: Analgesic. Version 6.
Melbourne: Therapeutic Guidelines Limited, 2012. ®: OXYCONTIN is a Registered Trademark.
Mundipharma Pty Limited ABN 87 081 322 509, 50 Bridge Street, Sydney, NSW 2000.
Tel: 1800 188 009. Saatchi & Saatchi Health MOX0038/AP/DPS ORBIS AU-2364 Aug 14.
Following a comprehensive biopsychosocial assessment, opioid analgesics such
as OxyContin® tablets should not be prescribed in isolation, but only as part of a
multimodal pain management approach after all conservative non-pharmacological
and pharmacological approaches have been tried and are inadequate.1
COULD YOUR PHARMACY
BE SEEN AS A TARGET?
Think carefully before offering a
substitute for OxyContin® tablets.
MOX0038_APDPS_LHP - 1 2014- 09- 16T14: 27: 34+10: 00
modified release oxycodone tablets
MOX0038_AP_DPS_RHP - 1 2014- 09- 16T14: 31: 51+10: 00
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