फेनोफाइब्रेट और रोसुवास्टेटिन का इंटरैक्शन

Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment, or hypothyroidism.

Pemafibrate did not reduce cardiovascular disease morbidity or mortality in a large, randomized, placebo - controlled trial of patients with type 2 diabetes mellitus on background statin therapy [see Clinical Studies (14.4) ].

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates, including fenofibrates, are co-administered with a statin.

The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins.

Intervention: Consider if the benefit of using fenofibrate concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis.

Fenofibrates (e.g., fenofibrate and fenofibric acid) Prevention or Management: Consider if the benefit of using fibrates concomitantly with rosuvastatin tablets outweighs the increased risk of myopathy and rhabdomyolysis.

Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions ( 7.1) ].

Mechanism and Clinical Effect(s): Fibrates may cause myopathy when given alone.