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Australian Journal of Pharmacy : March 2005
RXC4260 AJP March Ad 2/14/05 1:52 PM Page 1 Losing weight is tough for your customers – but with healthy eating habits, exercise and your help, they can make it happen. By recommending Xenical to your overweight customers you can boost their diet by 70%.1 Only Xenical rewards your customers when they eat correctly and reminds them when they don’t. So if your customers have the will, show them the way with Xenical. IF YOU HAVE THE WILL, WE HAVE THE WAY. Pharmacist Only Medicine. Please review full Product Information before prescribing, available from the manufacturer on request. 1. Sjostrom L, Rissanen A, Anderson T, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet 1998;352:167-172. XENICAL® (orlistat) INDICATIONS: For the treatment of obese patients with a body mass index (BMI) = 30, and overweight patients with a BMI = 27 in the presence of other risk factors, in conjunction with a mildly hypocaloric diet. CONTRAINDICATIONS: Hypersensitivity to orlistat or any of the excipients, pancreatic enzyme deficiency or chronic pancreatitis, major gastrointestinal surgery, chronic malabsorption syndrome and cholestasis. PRECAUTIONS: Patients should be on a nutritionally balanced hypocaloric diet containing no more than 30% of calories as fat and should also have an adequate intake of fat-soluble vitamins. If XENICAL is taken with any one meal very high in fat, the likelihood of gastrointestinal effects may increase. XENICAL should be administered with caution in patients with active peptic ulcer disease, chronically treated psychiatric/neurologic disorders, symptomatic cholelithiasis, postsurgical adhesions, bulimia or laxative abuse, patients with significant cardiac, renal, hepatic, GI or endocrine disorders, nephrolithiasis (renal stones), patient with a deficiency of fat-soluble vitamins A, D, E and K. Pregnancy Category B1, avoid breast-feeding. Plasma concentrations of cyclosporin should be monitored when co-administered with Xenical. Coagulation parameters should be monitored when oral anti- coagulants are given concomitantly with Xenical. Dose reductions for oral hypoglycaemic agents may be required. Due to reduced absorption of vitamin A, E and beta-carotene supplements, these should be taken 2 hours pre- or post- XENICAL dose. Concomitant dosing with acarbose or any other anti-obesity agent is not recommended. *Amiodarone: In a pharmacokinetic study, oral administration of amidarone during orlistat treatment demonstrated a 25-30% reduction in the systemic exposure to amiodarone and desethylamiodarone. The pharmacokinetics of amiodarone are complex. The effect of commencing orlistat treatment in patients on stable amiodarone therapy has not been studied, but reduced systemic exposure to amidarone and desethylamiodarone is possible, especially after chronic dosage with orlistat. A reduced therapeutic effect of amiodarone is possible. ADVERSE EFFECTS: Commonly observed adverse events were mild and transient including oily spotting, flatus with discharge, faecal urgency, fatty/oily stool, flatulence, abdominal pain, oily evacuation, liquid stools, increased defecation, faecal incontinence, soft stools, nausea, dyspepsia, headache and asthenia. DOSAGE AND ADMINISTRATION: Recommended dose one 120 mg capsule with each meal (during or up to one hour after the meal). *Please note change in Product Information 10 March 2004. Roche Products Pty Limited, ABN 70 000 132 865. ACN 000 132 865. 4-10 Inman Road Dee Why NSW 2099. TM ® Registered Trademarks RXC4260