Astra Zeneca, has submitted a labelling amendment to update the package insert (PI) of rosuvastatin (Crestor®) to indicate information on the two-fold increase in median AUC after a single dose (40 mg) of rosuvastatin was given to the Chinese in Singapore compared to the western Causasian patients. This observation was similarly reported in the Japanese subjects residing in Japan. The label update was approved by HSA as follows:

Under Pharmacokinetic properties:

'Pharmacokinetic studies show an approximately two-fold elevation in median AUC compared with western Caucasians in Japanese subjects residing in Japan. Preliminary data from a pharmacokinetic study conducted in Chinese subjects living in Singapore suggests a similar response as seen with the Japanese subjects. However, limited studies in other Asian patients have been inconclusive. The contribution of environmental and genetic factors to these observed differences has not been determined. Crestor® 40 mg will only be required for patients who do not achieve their treatment goal on 20 mg and should be used with caution.'

Under Special warnings and precautions for use:

'Crestor® 40 mg will only be required for patients who do not achieve their treatment goal on 20 mg. Pharmacokinetic studies suggest an elevation in median exposure of approximately two-fold in Japanese subjects residing in Japan. Limited studies in other Asian patients have been inconclusive.'

It is advisable to start rosuvastatin at 10 mg daily. Rosuvastatin 40 mg will only be required for patients who do not achieve their treatment goal with lower doses.

Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as, renal impairment, advanced age and hypothyroidism, or situations where an increase in plasma levels may occur. Patients with renal or liver dysfunction should also be closely monitored. Patients who develop any signs or symptoms suggestive of myopathy should have their CK levels measured.