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MHRA recommendations on simvastatin interactions: …

Conclusions The MHRA Drug Safety Update (August 2012) highlights changes to the simvastatin SmPC regarding interactions that can increase the risk of myopathy and/or rhabdomyolysis. When used with amlodipine, the maximum dose of simvastatin is now 20mg; higher doses are off-label . For patients taking amlodipine and simvastatin 40mg consider: 1. Reducing simvastatin dose to 20mg most patients can be managed this way as the interaction with amlodipine leads to an increase in simvastatin exposure that is similar to taking simvastatin 40mg alone. 2. Staying on simvastatin 40mg discuss the risks and benefits of this off-label option with the patient.

Why has the simvastatin dosing guidance changed? Myopathy is an adverse effect associated with statins. The risk of myopathy increases with higher plasma levels associated with high-dose therapy (simvastatin 80mg) or concurrent use of interacting drugs.Following changes to SmPCs,the MHRA . Drug Safety Update. August 2012 highlights

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