oxycodone + naloxone




Concise Prescribing Info
Per 5 mg/2.5 mg Oxycodone HCl 5 mg, naloxone HCl 2.5 mg. Per 10 mg/5 mg Oxycodone HCl 10 mg, naloxone HCl 5 mg. Per 20 mg/10 mg Oxycodone HCl 20 mg, naloxone HCl 10 mg. Per 40 mg/20 mg Oxycodone HCl 40 mg, naloxone HCl 20 mg
Management of moderate to severe chronic pain unresponsive to non-opioid analgesics.
Dosage/Direction for Use
Adult & opioid-naive patient Initially 10 mg/5 mg 12 hrly. Max: 160 mg/80 mg daily. Dose titration when initiating opioid therapy & individual dose adjustment: 5 mg/2.5 mg. Patients requiring higher dosage Max: 400 mg of oxycodone HCl daily. Non-malignant pain therapy 40 mg/20 mg daily.
May be taken with or without food: Swallow whole, do not break/chew/crush. Taking broken, chewed or crushed tab leads to rapid release & absorption of a potentially toxic dose of oxycodone.
Hypersensitivity. Severe resp depression (w/ hypoxia &/or hypercapnoea), severe COPD & severe bronchial asthma; cor pulmonale; non-opioid-induced paralytic ileus; moderate to severe hepatic impairment.
Special Precautions
Risk of resp depression. Opioid-induced paralytic ileus, severely impaired pulmonary function, myxoedema, hypothyroidism, Addison's disease, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, pancreatitis, hypotension, HTN, preexisting CV disease, head injury (due to increased intracranial pressure), epileptic disorder or predisposition to convulsions; diarrhoea. Concomitant use w/ MAOIs. Mild hepatic or renal impairment. Severe renal impairment. W/drawal symptoms may occur upon abrupt cessation of therapy. History of alcohol & drug abuse. Not recommended for use in patients w/ cancer associated to peritoneal carcinomatosis or w/ subocclusive syndrome in advanced stages of digestive & pelvic cancers. Pre-op use or w/in 1st 12-24 hr post-op. May produce +ve results in doping controls. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Pregnancy & lactation. Not recommended for use in childn & adolescents <18 yr. Elderly or infirm patients.
Adverse Reactions
Decreased appetite up to loss of appetite; restlessness; dizziness, headache; vertigo; decreased BP; abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, vomiting, nausea, flatulence; increased hepatic enzymes; pruritus, skin reactions, hyperhidrosis; drug w/drawal syndrome, hot & cold feeling, chills, asthenic conditions. Altered mood & personality change, decreased activity, psychomotor hyperactivity, agitation; hiccups; dysuria.
Drug Interactions
May enhance CNS-depressant effect (eg, resp depression) w/ substances w/ CNS-depressant effects (eg, alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines, anti-emetics). May enhance pharmacodynamic effect w/ alcohol, concomitant use should be avoided. Coumarin anti-coagulants; paracetamol, acetylsalicylic acid or naltrexone. May increase plasma conc of oxycodone w/ CYP3A4 inhibitors eg, macrolide antibiotics (eg, erythromycin), azole-antifungals (eg, ketoconazole) & PIs (eg, ritonavir). May induce teh metabolism of oxycodone w/ CYP450 inducers (eg, rifampin, carbamazepine & phenytoin).
MIMS Class
ATC Classification
N02AA55 - oxycodone and naloxone ; Belongs to the class of natural opium alkaloids. Used to relieve pain.
Targin 20 mg/10 mg PR tab
Targin 10 mg/5 mg PR tab
Targin 5 mg/2.5 mg PR tab
Targin 40 mg/20 mg PR tab
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