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Australian Journal of Pharmacy : November 2006
Two Proven Stars. One Take. Caduet is available as 5mg or 10mg doses of Norvasc combined with 10mg, 20mg, 40mg or 80mg doses of Lipitor. NEW CADUET. THE POWERFUL COMBINATION TO TARGET CV RISK. 1,2,3 CADUET PBS information: This product is not listed on the PBS. NORVASC PBS Information: This product is listed on the PBS as a Calcium Channel Blocker with mainly vascular effects. LIPITOR PBS Information: Restricted benefi t. For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs. Before prescribing, please review full Product Information available from Pfi zer Pty Ltd. CADUET®: A combination of amlodipine besylate and atorvastatin calcium. INDICATIONS: CADUET (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented. These include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolaemia and in hypertensive patients with multiple risk factors for CHD to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. DOSAGE AND ADMINISTRATION: The starting dose and maintenance doses of CADUET should be individualised according to goals consistent with current treatment guidelines and patient response. CADUET is available in eight strengths ranging from amlodipine besylate/atorvastatin calcium 5mg/10mg to amlodipine besylate/atorvastatin calcium 10mg/80mg. CADUET is to be taken once daily and may be taken at any time of the day with or without food. After initiation, lipid levels should be analysed and blood pressure measured after approximately 4-6 weeks with dosage adjusted accordingly. In patients requiring additional blood pressure lowering and/or angina treatment, CADUET may be added to existing therapies. SPECIAL PATIENT POPULATIONS: Small, Fragile or Elderly: Can be used once titration to 5mg of amlodipine has been achieved; Children: No current studies available; Renal Insufficiency: No dosage adjustment is necessary; Hepatic Insuffi ciency: Administer with caution in patients with impaired liver function or history of liver disease, and in patients who consume substantial quantities of alcohol. CONCOMITANT MEDICATIONS: May be administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin. May be used with a bile acid binding resin for additive effect. Avoid use with fi brates. CONTRAINDICATIONS: Patients with a known hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases, pregnancy (Category D), breastfeeding,women of child-bearing potential, unless on an effective contraceptive and highly unlikely to conceive. PRECAUTIONS: Rare increased frequency, duration and severity of angina upon initiation or increased dosage, particularly in patients with severe obstructive coronary artery disease; Aortic stenosis; Does not protect against beta-blocker withdrawal; Can cause peripheral oedema which should be differentiated from the effects of increasing left ventricular dysfunction. Calcium channel blockers should be used cautiously in patients with congestive heart failure (CHF); May cause hypotension in small, fragile or elderly patients. Titrate these patients to amlodipine 5mg prior to use of CADUET. Monitor liver function at start of treatment and periodically thereafter; Patients who consume substantial quantities of alcohol and/or have a history of liver disease; Myopathy – promptly report muscle weakness, tenderness, or aching (monitor CK); Risk factors predisposing to development of renal failure secondary to rhabdomyolysis; Concomitant use with medicines that increase the activity of steroid hormones e.g. ketoconazole, spironolactone and cimetidine; Signifi cant decreases in circulating ubiquinone levels the clinical signifi cance of which is not known; Variable effects on lipoprotein (a). Interactions with other medicines: inhibitors of cytochrome P450 3A4, other HMG-CoA reductase inhibitors, antacid, colestipol, erythromycin/clarithromycin, protease inhibitors, digoxin, oral contraceptives. Use not established in children. ADVERSE REACTIONS: The safety profi le of the combination product is consistent with the adverse events previously reported for amlodipine and/or atorvastatin. These include headache, oedema, fatigue, dizziness, nausea, abdominal pain, somnolence, fl ushing, palpitations, asthenia, dyspepsia, fl atulence, constipation, diarrhoea, insomnia, myalgia. Refer to Product Information before prescribing. Full disclosure Product Information is available on request from Pfi zer Australia Pty Ltd. ABN 50 008 422 348. 38-42 Wharf Road, WEST RYDE, NSW 2114. Based on the full disclosure Product Information approved by the TGA on 14 July 2005. ®Registered trademarks. PBS Dispensed Price: Lipitor $41.19 (10mg x 30); $58.32 (20mg x 30); $80.03 (40mg x 30); $112.19 (80mg x 30). Norvasc $29.32 (5mg x 30); $44.94 (10mg x 30) References: 1. Hypertension Management Guide for Doctors 2004 (National Heart Foundation). 2. Lipid Management Guidelines 2001 (National Heart Foundation). 3. New Zealand Cardiovascular Risk Calculator accessed via Hypertension Management Guide for Doctors 2004 (National Heart Foundation). Grey HC PFI0086 10/06