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.

Children under 18 years:

Oxeltra should not be used in patients under 18 years of age.

Patients with renal or hepatic impairment:

The plasma concentration in this population may be increased. The dose initiation should follow a conservative approach in these patients. 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.

Use in non-malignant pain:

Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease.

Treatment goals and discontinuation Before initiating treatment with Oxycodone a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4).

Duration of treatment:

Oxycodone should not be used for longer than necessary. Method of administration Oxeltra tablets must be swallowed whole, and not broken, chewed or crushed.

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.

Respiratory, thoracic and mediastinal disorders:

Common: dyspnoea, bronchospasm, cough decreased Uncommon: respiratory depression, hiccups Gastrointestinal disorders: Very common: constipation, nausea, vomiting. Common: abdominal pain, diarrhoea, dry mouth, dyspepsia. Uncommon: dysphagia, flatulence, eructation, ileus, gastritis Frequency not known: dental caries.

Hepato-biliary disorders:

Uncommon: increased hepatic enzymes, biliary colic Frequency not known: cholestasis, spasm of sphincter of Oddi Skin and subcutaneous tissue disorders: Very common: pruritus. Common: rash, hyperhidrosis. Uncommon: dry skin, exfoliative dermatitis Rare: urticaria.

Renal and urinary disorders:

Uncommon: urinary retention, ureteral spasm Reproductive system and breast disorders: Uncommon: erectile dysfunction, hypogonadism Frequency not known: amenorrhoea.

General disorders and administration site conditions:

Common: asthenia, fatigue Uncommon: chills, malaise, oedema, peripheral oedema, thirst, pyrexia Frequency not known: drug withdrawal syndrome neonatal, opioid tolerance, opioid withdrawal syndrome. g. 8). ‘Not known’ should be interpreted as an indication of the rarity of the occurrence of opioid tolerance and opioid withdrawal syndrome, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency.

Drug dependence The frequency above regarding drug dependence reflects the current evidence, including cumulative data from clinical trials and additional post marketing sources, and indicates that the risk of drug dependence with opioids is highly variable depending upon: definition of drug dependence; duration of treatment; dose; individual patient risk factors; and clinical settings.

‘Not known’ should be interpreted as an indication of the rarity of the occurrence of drug dependence, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency. Repeated use of Oxycodone can lead to drug dependence, even at therapeutic doses.

4 for monitoring and risk reduction interventions). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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 patients 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.

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.

2 for additional information on treatment goals and discontinuation. Oxeltra tablets must be swallowed whole, and not broken, chewed or crushed. 9). Concomitant use of alcohol and Oxeltra may increase the undesirable effects of Oxeltra; concomitant use should be avoided.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, which may be fatal.

60 mg). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Empty matrix (tablets) may be seen in the stools. Opioids such as oxycodone hydrochloride may influence the hypothalamic-pituitary- adrenal or – gonadal axes.

Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Tolerance, Dependence and Opioid Use Disorder Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone.

Repeated use of Oxeltra may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Oxeltra may result in overdose and/or death.

g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact […]

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.