The public is notified by the US FDA that the dose limitation for simvastatin has been revised
- PDF / 136,188 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 40 Downloads / 159 Views
1
■ The public is notified by the US FDA that the dose limitation for simvastatin has been revised from 10 mg/day to 20 mg/day, when used in conjunction with the cardiac drug amiodarone. The FDA previously recommended that the dose limitation for simvastatin be reduced from 20 mg/day to 10 mg/day,* and has now reconsidered that recommendation, as there were no pharmacokinetic or clinical trail data to support such a dose reduction when these drugs are used concurrently. Drug labels for simvastatin (Zocor and Vytorin) have been updated to reflect this correction. * see also Reactions 1215 p2; 801075343 US FDA. FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone. FDA Drug Safety Newsletter : 15 Dec 2011. Available from: URL: http:// 803064800 www.fda.gov
0114-9954/10/1383-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 7 Jan 2012 No. 1383
Data Loading...
