OXELTRA

Posology Adults over 18 years:

Oxeltra tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements. 4). Oxeltra is not intended for use as a prn analgesic. Generally, the lowest effective dose for analgesia should be selected.

Increasing severity of pain will require an increased dosage of Oxeltra tablets, using the different tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours.

Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary increases should be made in 25% - 50% increments. The need for escape medication more than twice a day indicates that the dosage of Oxeltra tablets should be increased.

The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects.

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. However, a few patients may require higher doses. Doses in excess of 1000 mg have been recorded.

Conversion from oral morphine:

Patients receiving oral morphine before Oxeltra therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of Oxeltra tablets required.

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. 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.

Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic. 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 Very rare ≥1/10,000 to <1/1,000 <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.

Psychiatric disorders:

Common: anxiety, confusional state, depression, insomnia, nervousness. 4).

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, sleep apnoea syndrome.

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.

Do not use for acute post-operative pain owing to the increased risk of persistent post- operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). 5). The primary risk of opioid excess is respiratory depression. 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. 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 patient should be followed closely for signs and symptoms of respiratory depression and sedation.

5). Oxeltra tablets must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks. Oxeltra tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Oxeltra tablets should be discontinued immediately.

Oxeltra is not recommended for pre-operative use or within the first 12-24 hours post- operatively. As with all opioid preparations, Oxeltra tablets 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.

g. surgery, plexus blockade) should not receive Oxeltra tablets for 12 hours prior to the intervention. If further treatment with Oxeltra tablets is indicated then the dosage should be adjusted to the new post-operative requirement. 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.

1. Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation.