Introducing Oxeltra Prolonged-Release Tablets (oxycodone hydrochloride) Reduce your spending on oxycodone hydrochloride prolonged-release tablets... prescribe Oxeltra Prolonged-Release Tablets by brand Save 75% when compared to the use of the originator brand or a generically written script (Drug Tariff price) 1,2 Save 50% when compared to the use of the leading branded generic 1 Extensive dose range 75% Fixed prices until 2020 at the earliest less than Drug Tariff Price 2 National distribution via two UK whol esalers, Alliance Healthcare & Celesio UK 50% less than leading branded generic 1 Oxeltra Prolonged-Release Tablets: Indicated for the treatment of moderate to severe pain with cancer and postoperative pain; for severe pain requiring strong opioid 3 Available as 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg tablets Tablets colour-matched to originator brand for patient recognition and compliance Prescribing Information for Acidex Advance Oral Suspension (sodium alginate, potassium hydrogen carbonate) Abbreviated Prescribing Information: Oxeltra 5 mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg Prolonged-Release Tablets (Oxycodone hydrochloride 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg). Please refer to the Summary of Product Characteristics (SmPC) before prescribing PRESENTATION: Prolonged-release film- coated tablets in different colours, round biconvex marked OX 5, OX10, OX15, OX20, OX30, OX40, OX60 or OX80 on one side. INDICATIONS: For treatment of moderate to severe pain with cancer and postoperative pain; for severe pain requiring strong opioid. DOSAGE AND ADMINISTRATION: Dosage depends on the severity of pain and patient’s previous history of analgesic requirements. Increasing severity of pain will require increased dosage. The correct dosage for any patient is that which controls pain and is tolerated for 12 hours. Patients should be titrated to pain relief with dose increments of 25- 50%. Usual starting dose for opioid naïve patient is 10 mg 12 hourly which should be carefully titrated once a day to achieve full pain relief. Patients switching from oral morphine should have their dose adjusted in a ratio of 10mg oral oxycodone for 20 mg oral morphine. No dosage adjustment is required in elderly patients. Oxeltra should not be used in patients under 18 years of age. In patients with hepatic or renal impairment the recommended starting dose should be reduced by 50% and patients should be titrated to achieve pain relief. Oxeltra should not be used longer than necessary and discontinuation should be gradual to prevent withdrawal symptoms. CONTRAINDICATIONS: Hypersensitivity to oxycodone or any of the excipients in the product, any situation where opioids are contraindicated, severe respiratory depression with hypoxia, elevated serum carbon dioxide levels (hypercarbia), paralytic ileus, acute abdomen, delayed gastric emptying, chronic constipation, COPD, cor pulmonale, severe asthma, moderate to severe hepatic impairment, hereditary galactose intolerance Lapp lactase deficiency or glucose-galactose malabsorption. WARNINGS AND PRECAUTIONS: Opioid excess can cause respiratory depression. It should be used with caution in debilitated elderly, in patients with severely impaired pulmonary hepatic or renal function, in patients with myxoedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, disease of the biliary tract, IBD, pancreatitis, hypotension, hypovolemia, increased intracranial pressure, head injury or in patients taking benzodiazepines, other CNS depressants or MAO inhibitors. Concomittant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death and should be reserved for those patients for whom alternative treatment is not possible. In this case the lowest effective dose should be used and the patients should be followed closely for signs of respiratory depression.. Oxeltra should not be used in paralytic ileus and as it impairs intestinal motility it should not be used following abdominal surgery. Oxeltra is not recommended for preoperative use and within 12-24 hours postoperatively. Oxeltra 60mg and 80mg should not be used in opioid naïve patients since this strength may cause fatal respiratory depression. In patients suffering from non-malignant pain, opioids should be used as part of a comprehensive treatment programme with the involvement of other non-opioid pain medication. Oxeltra has an abuse profile similar to other strong opioids and should be used in particular care in patients with history and drug abuse. The patients may develop tolerance to the drug and chronic use may require higher doses to maintain pain control. Prolonged use may lead to physical dependence and a withdrawal syndrome may occur following an abrupt discontinuation. Infants born to dependent mothers may exhibit withdrawal symptoms and may present with respiratory depression at birth. Concomitant use of alcohol and Oxeltra may increase the undesirable effects of oxycodone and should be avoided. The abuse of oral dosage form of oxycodone via parenteral administration can result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury which may be fatal. Opioids may influence the hypothalamic-pituitary-adrenal or – gonadal axis increasing serum prolactin or decreasing plasma cortisol and testosterone DRUG INTERACTIONS: Concomitant use of sedative agents such as benzodiazepines with opioids can increase the risk of sedation, repiratory depression, coma and death. Oxeltra potentiates the effects of alcohol, tranquillisers, anaesthetics, hypnotics, antidepressants, sedatives, phenotiazides, neuroleptic drugs, other opioids, muscle relaxants and antihypertensives. MAIs in combination with narcotic analgesics can produce CNS excitation or depression associated with hypertensive or hypotensive crisis. Alcohol may enhance the effect of oxycodone. Anticholinergic agents (e.g. psychotropic drugs, antihistamines, antiemetics, anti- Parkinson’s agents) may intensify the anticholinergic reactions of oxycodone such as constipation, dry mouth of urinary excretion dysfunction. Oxycodone is metabolized by CYP3A4 and by CYP2D6. Inhibitors of CYP3A4 such as macrolide antibiotics (clarithromycin, erythromycin) antifungals (ketoconazole, voriconazole, itriconazole, posaconazol) References 1. MIMS – October 2018 edition 2. Drug Tariff June 2018 (England & Wales) 3. Oxeltra 5mg Prolonged-Release Tablets Summary of Product Characteristics Wockhardt UK Ltd Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF, UK Tel: 01978 661261, Web: www.costsavingbrands.co.uk CSB35/18 October 2018 protease inhibitors (boceprevir, ritonavir, indinavir, nelfinavir, saquinavir), cimetidine and grapefruit juice may reduce clearance and increases the plasma concentration of oxycodone. CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin and St John’s Wort) may induce the metabolism and increase the clearance of oxycodone, reducing its plasma concentration. CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine) may decrease the clearance of oxycodone leading to increased plasma concentration of Oxeltra. PREGNANCY AND LACTATION: The product should be avoided during pregnancy and lactation. Withdrawal syndrome and respiratory depression may be observed in the new-born of mothers treated with oxycodone. Oxeltra can be secreted in breast milk and may cause respiratory depression therefore it should not be used in breast-feeding mothers. UNDESIRABLE EFFECTS: The following adverse events were reported in clinical practice: Very common (≥ 1/10): somnolence, dizziness, headache, constipation, nausea, vomiting and pruritus. Common (≥ 1/100 to < 1/10): decreased appetite, anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, tremor, dyspnoea, bronchospasm, abdominal pain diarrhoea, dry mouth, dyspepsia, rash, hyperhidrosis and aesthetic conditions. Uncommon (≥ 1/1,000 to < 1/100): hypersensitivity, dehydration, agitation, affect liability, euphoric mood, hallucinations, decreased libido, drug dependence, amnesia, convulsion, hypertonia, hypoesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, visual impairment, miosis, vertigo, palpitations, vasodilatation, respiratory depression, dysphagia, flatulence, eructation, ileus, increased hepatic enzymes, dry skin, urinary retention, erectile dysfunction, chills, drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance and thirst. Rare (≥ 1/10,000 to < 1/1,000): hypotension, orthostatic hypotension and urticaria. Frequency unknown: anaphylactic responses, aggression, hyperalgesia, dental caries, cholestasis, biliary colic and amenorrhea. For further information on adverse effects please refer to the SmPC. LEGAL CATEGORY: POM MARKETING AUTHORIZATION NUMBER AND HOLDER: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. MARKETING AUTHORIZATION NUMBER: PL 29831/0631 PACKAGE QUANTITIES AND BASIC NHS PRICE: 28 x 5mg £3.13: 56 x 10mg £6.26: 56 x 15mg £9.53: 56 x 20mg £12.52: 56 x 30mg £19.06: 56 x 40mg £25.05: 56 x 60mg £38.12: 56 x 80mg £50.10 DATE OF API PREPARATION: 26/09/2018 Adverse reactions should be reported. Reporting forms and information can be found at www. mhra.gov.uk/yellowcard. Adverse events should also be reported to Wockhardt UK Ltd (01978 661261).