OXYCODONE HYDROCHLORIDE

Posology Adults (over 18 years of age) Opioids should be individually dose titrated due to large differences between different patients in terms of pharmacokinetics, pain intensity, pain origin, possible tolerance, and age.

The usual starting dose for opioid naïve patients:

The dose should be adjusted individually according to the patient's condition and any previous pain treatment. The starting dose for opioid naïve patients is 5 mg every 6 hours, but a higher initial dose may be required for pain control, depending on the patient’s need.

If the pain responds to opioid, the dose may be increased daily until the required effect is achieved or unacceptable side effects occur. Conversion from oral morphine For patients who have received oral morphine before Oxycodone Hydrochloride treatment, the daily dose should be based on the following ratio: 5 mg oral oxycodone is equivalent to 10 mg of oral morphine.

It must be emphasised that this is a guide to the required dose of Oxycodone Hydrochloride. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. At treatment initiation it might be advisable to use a lower dose than the equivalent dose.

Patients already receiving opioids may start with a higher dose of Oxycodone Hydrochloride, depending on previous experience. When Oxycodone Hydrochloride is used to treat breakthrough pain in patients treated with a prolonged-release formulation of oxycodone, Oxycodone Hydrochloride 1/8 to 1/6 of the daily dose of the prolonged-release formulation should be administered.

Particular attention should be paid to the treatment of opioid related adverse effects. After initiating treatment, patients should be regularly checked for pain relief and other opioid adverse effects. The dose should be adjusted to achieve the most effective pain control with minimal adverse effects.

Transferring patients between oral and parenteral oxycodone The dose should be based on the following ratio: 2 mg oral oxycodone is equivalent to 1 mg parenteral oxycodone. It must be emphasised that this is a guide to the required dose.

Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Duration of treatment Oxycodone should not be used longer than necessary. Children under 18 years of age Oxycodone Hydrochloride is not recommended for children under 18 years of age as the safety and efficacy has not been established.

The most commonly reported adverse reactions are nausea and constipation, both occurring in approximately 25 to 30% of patients. Nausea and vomiting are usually temporary, but may be treated with an antiemetic. As with any strong opioid, constipation may occur and should be treated with appropriate laxatives.

If the opioid related adverse effects continue, they should be investigated for an alternative cause. The adverse drug reactions typical for full opioid agonists tend to reduce with time, except for constipation. 9). Respiratory depression is most likely to occur in elderly, debilitated or opioid-naïve patients.

The following frequency categories form the basis for classification of adverse reactions: 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).

System Organ Class 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) Frequency not known Immune system disorders hypersensitivity anaphylactic reaction, anaphylactoid reaction. 4) aggression, drug System Organ Class 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) Frequency not known Nervous system disorders somnolence, dizziness, headache tremor, lethargy, amnesia, convulsion, hypertonia, involuntary muscle contractions; hypaesthesia; speech disorder, syncope, paraesthesia, dysgeusia Hyperalgesia, Central sleep apnea syndrome Eye disorders visual impairment, miosis Ear and labyrinth disorders vertigo Cardiac disorders palpitations (in the context of withdrawal syndrome) Vascular disorders vasodilatation, hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders dyspnoea, respiratory depression Central sleep apnoea syndrome Gastrointestinal disorders constipation, nausea, vomiting abdominal pain, diarrhoea, dry mouth, dyspepsia dysphagia, flatulence, eructation, ileus dental caries Hepato-biliary disorders increased hepatic enzymes Cholestasis, biliary colic, sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders pruritus rash, hyperhidrosis dry skin urticaria Renal and urinary disorders urinary retention System Organ Class 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) Frequency not known Reproductive system and breast disorders erectile disfunction, hypogonadism amenorrhoea General disorders and administration site conditions asthenia, fatigue drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, chills drug withdrawal syndrome neonatal Drug Dependence Repeated use of Oxycodone Hydrochloride can lead to drug dependence, even at therapeutic doses.

Respiratory depression The major risk of opioid excess is respiratory depression. The respiratory depression effect of oxycodone is due to inhibition of the carbon dioxide stimulating effect on the respiratory centres in the medulla oblongata.

5) Sleep-related breathing disorders Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner in some patients.

8). In patients who present with CSA, consider decreasing the total opioid dosage. 8). Should paralytic ileus be suspected or occur during use, this medicinal product should be discontinued immediately. 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.

Oxycodone Hydrochloride is not recommended for pre-operative use or within the first 12-24 hours post-operatively. The post-operative treatment initiation with Oxycodone Hydrochloride must be evaluated for each individual patient based on the type and extent of surgery, the method of anaesthesia, concomitant use of other drugs and the patient's condition.

Increased smooth muscle tone also causes pressure increase in the biliary and urinary tracts, hence oxycodone is less suitable for biliary or urinary tract spasms. 5). 2). 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. Oxycodone and sedatives Concomitant use of oxycodone and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

1. 4) • paralytic ileus