Home' Australian Pharmacist : Australian Pharmacist April 2013 Contents Another Apotex Success
Rosuvastatin Injunction Lifted
PBS Information: This product is not listed on the PBS. Anticipated PBS listing: 1 June 2013.
Please review the full Product Information before prescribing. Full Product
Information is available on request from Apotex Pty Ltd (1800 195 055).
APO-Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg. Indications: Should be used as an adjunct to diet when the response to diet and exercise is inadequate; prevention of
major cardiovascular events in men > 50 years old and women > 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors
for cardiovascular disease (hypertension, low HDL-C, smoking or a family history of premature coronary heart disease), indicated to reduce the risk of nonfatal myocardial
infarction, nonfatal stroke and coronary artery revascularisation procedures; treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).
Contraindications: Known hypersensitivity to any of the ingredients; patients with active liver disease including unexplained, persistent elevations of serum transaminases
and any serum transaminase elevation exceeding 3 x ULN; during pregnancy, in nursing mothers and in women of childbearing potential, unless they are taking adequate
contraceptive precautions; concomitant use with fusidic acid; APO-Rosuvastatin 40 mg is contraindicated in patients pre-disposing factors for myopathy/rhabdomyolysis,
including hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate,
alcohol abuse, situations where an increase in rosuvastatin plasma levels may occur, severe renal impairment (Clcr < 30 mL/min), Asian patients, concomitant use of fibrates.
Precautions: Liver effects; myopathy/rhabdomyolysis; renal insufficiency; hepatic dysfunction; Asian patients; pregnancy; lactation; endocrine effects; caution in prevention of
cardiovascular events and use of CRP testing; diabetes mellitus; interstitial lung disease. Interactions: Warfarin and other coumarin anticoagulants; cyclosporin; gemfibrozil;
protease inhibitors; antacids; fusidic acid. Adverse effects: Dizziness; constipation; nausea; abdominal pain; myalgia; asthenia; headache; increased CPK; arthralgia; increased
hepatic transaminases; diabetes mellitus; increase in HbA1c; renal events; haematuria. See full Product Information for other adverse effects. Dosage: Tablets must not be
broken or crushed and must be swallowed whole with a glass of water. The dose should be individualised according to the goal of therapy and patient response and should take
into account the potential risk for adverse reactions. A dose of 20 mg once daily has been found to reduce the risk of major cardiovascular events. For hypercholesterolaemia,
the recommended starting dose is 5 mg or 10 mg once per day both in statin naïve patients and in those switched from another HMG-CoA reductase inhibitor. The choice of
starting dose should take into account the individual patient’s cholesterol level, special patient populations and future cardiovascular risk. A dose adjustment can be made after
4 weeks of therapy where necessary. The usual maximum dose is 20 mg once per day. A dose of 40 mg once per day should only be considered in patients who are still at high
cardiovascular risk after their response to a dose of 20 mg once per day is assessed. It is recommended that the 40 mg dose is used only in patients in whom regular follow-up is
planned. A dose of 40 mg must not be exceeded in any patient taking rosuvastatin. Specialist supervision should be considered when the dose is titrated to 40 mg. Based on PI
last amended : 15 August 2012. PBS dispensed price: Refer to the Schedule of Pharmaceutical Benefits on 1 June 2013. Apotex Pty Ltd. ABN 52 096 916 148. 16 Giffnock
Avenue, Macquarie Park, NSW 2113. Apotex is the licensee of the registered trade marks APO and APOTEX from the registered proprietor, Apotex Inc. PM -AU-502, March 2013.
*Decision of the Federal Court on 5 March 2013. May be subject to appeal.
Apotex is pleased to announce the success
of its litigation challenge to patents
of Apotex leading the way in the generic
pharmaceutical industry in litigation.
Images for illustrative
To find out more, call your local
Apotex Territory Manager or our
Customer Service Team on
1800 APOTEX (1800 276 839)
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