Composition: Oxycodone hydrochloride 10mg, 20mg, 40mg and 80mg.
Presentation: Film coated, modified release tablets, 10mg white, 20mg pink, 40mg yallow, 80mg green.
Storage and stability: Do not store above 25C.
Action: Full opioid agonist with no antagonist properties.
Indications: Treatment of moderate to severe pain in patients with cancer and postoperative pain.
Contraindications: As for other opioids, see SPC for details. Known hypersensitivity to oxycodone. Also, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10ml/min), hypercarbia, chronic constipation. Pregnancy and breast-feeding.
Dosage and administration:
Adults over 18 and elderly, take at 12-hourly intervals. The dosage is dependent on the severity of the pain and the patient's previous analgesic requirements. The correct dosage is that which controls the pain, and is well tolerated for a full 12 hours. Usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10mg 12-hourly. The dose should then be titrated, as frequently as once daily if necessary, to achieve pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made, where possible, in 25-50 per cent increments. The maximum dose is 200mg 12-hourly for most patients. A few patients may require higher doses and doses in excess of 1,000mg have been reported.
Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10mg oral oxycodone equivalent to 20mg oral morphine. Tablets must be swallowed whole.
Mild to moderate renal and mild hepatic impairment, the plasma concentration in this population may be increased. Opioid naïve patients should be started on Oxynorm liquid (see below) six-hourly and transferred to Oxycontin tablets when appropriate dose established.
Children under 18 years, should not be used as no studies have been carried out.
Overdosage: See SPC for treatment of oxycodone overdosage.
Precautions: As for other opioids, see SPC.
Drug interactions: As for other opioids. Concurrent administration of quinidine (cytochrome P450-2D6 inhibitor) resulted in an increase in plasma levels of oxycodone and noroxycodone. This interaction may also be observed with other potent inhibitors of cytochrome P450-2D6. Inhibitors of cytochrome P450-3A, such as ketoconazole and erythromycin may inhibit the metabolism of oxycodone.
Side effects: As for other opioids. Anorexia, nervousness, insomnia, fever, confusion, diarrhoea, abdominal pain, vasodilatation, dyspepsia, paraesthesia, rash, depression, anxiety, euphoria, dyspnoea, postural hypotension, chills, abnormal dreams, thought abnormalities, hiccups.
Net price: 56 tablets 10mg £21.43, 20mg £42.86, 40mg £85.73, 80mg £171.46.
Supplier: Napp Pharmaceuticals, Cambridge Science Park, Milton Road, Cambridge CB4 0GW. Tel 01223 424444, fax 01223 424441.
Legal class: POM.
| Correction The legal category of Oxycontin tablets is CD(Sch 2) POM. |