एम्लोडिपिन और एटोरवास्टेटिन और फेनोफाइब्रिक एसिड का इंटरैक्शन

Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (> 1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir [see Adverse Reactions (6.1) ] .

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

Intervention: Consider if the benefit of using fibrates concomitantly with atorvastatin outweighs the increased risk of myopathy and rhabdomyolysis.

Fibrates (other than Gemfibrozil) Clinical Impact: Fibrates may cause myopathy when given alone.

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 fenofibric acid delayed-release capsules concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis.