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Australian Journal of Pharmacy : November 2006
Only a Norspan patch covers pain ® for an entire week at a time. Moderate to severe osteoarthritis and back pain.1 Norspan® is a transdermal buprenorphine matrix patch, that has been clinically proven to treat moderate to severe pain associated with osteoarthritis or back pain.1 One Norspan® patch provides 7 days of continuous analgesia.1 available in 3 patch strengths: 5, 10 and 20 micrograms/hr.1 PBS Information: Restricted benefit. Chronic severe disabling pain not responding to non-narcotic analgesics. Authority required for increased maximum quantities and/or repeats. Refer to PBS Schedule for full Authority Required information. (buprenorphine) TRANSDERMAL PATCH MINIMUM PRODUCT INFORMATION. INDICATIONS: Management of moderate to severe pain. CONTRAINDICATIONS: Hypersensitivity to buprenorphine and components, severely impaired respiratory function, concurrent non-selective MAO inhibitors within 14 days of administration and treatment of narcotic dependence. PRECAUTIONS: Convulsive disorders, head injury, shock, reduced consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, severe hepatic impairment, hypotension, hypovolaemia, biliary tract disease, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, chronic renal and hepatic disease, following abdominal surgery, in debilitated patients, drug or alcohol abuse problems, serious mental illness, intravenous abuse of buprenorphine. Do not use in immediate post-operative period, within 24 hours of cordotomy or other pain-relieving surgery. Exercise caution in congenital or medication-induced QT prolongation, driving, pregnancy, lactation, reduce dosage in hypothyroidism, monitor severely febrile patients for enhanced drug absorption. Physical dependence and withdrawal syndrome may develop. Do not substitute for agonist opioids, as antagonist activity can induce withdrawal. INTERACTIONS: CNS depressants may cause respiratory depression, hypotension and profound sedation or coma. Some general anaesthetics and other drugs can decrease hepatic elimination. Antiarrythmics can enhance QT interval prolongation. Metabolised by CYP450 3A4, and CYP3A4 inhibitors can increase buprenorphine levels. Enzyme-inducers can increase clearance and reduce efficacy. Non-selective MAO inhibitors contraindicated. Selective MAO inhibitor effects unknown. Potentially increased aminotransferase levels, weight decrease, and increased INR levels (with concurrent warfarin). ADVERSE REACTIONS: GI: constipation, dry mouth, nausea, vomiting, anorexia, diarrhoea, dyspepsia. CNS: dizziness, somnolence, confusion, anxiety, depression, insomnia, nervousness, paraesthesia. Other: vasodilation, oedema, dyspnoea, pruritus, application site rash and erythema, sweating, taste perversion, headache, asthenia, abdominal and chest pain. DOSAGE AND ADMINISTRATION: Transdermal use over 7 days. Adults: 5mcg/hr starting dose, especially opioid-naïve patients and those converting from other opioids. Titrate to pain relief, use supplemental analgesics as required, and increase dose after 3-day intervals. If adequate pain relief not achieved at maximum dosage regime, convert to around-the-clock opioids. Apply new patch to intact, non- irritated, non-scarred, hairless skin of upper arm, back and chest at different site from removed patch. Do not reuse site for 3-4 weeks. Clean skin with water, dry before applying patch and press down for 30 seconds. Do not expose application site to heat. Fold adhesive sides together after removal and dispose safely. Serum concentrations will decrease gradually, and opioids should not be administered for 24 hours. No dosage adjustment required in renal impairment, mild to moderate hepatic impairment or the elderly, but use with extreme caution in severe hepatic impairment. Not for children under 18 years. Please review Product Information and review State and Federal regulations before prescribing. Full disclosure Product Information is available from Mundipharma Pty Limited, 26/6 O’Connell Street, Sydney, NSW 2000. Phone 1800 188 009. ® Norspan is a registered trademark. Reference: 1. Norspan Product Information (August 2005) W61004 1006 NORSPAN® Norspan® is 7-DAY CONTINUOUS PAIN RELIEF1 PBS LISTED