Rosuvastatin & Fenofibrate Tablet Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: (10mg + 160mg),(20mg + 160mg)

Reference Brands: -

Category: Heart Disorder

Fenofibrate+Rosuvastatin is a combination of two lipid (fat) lowering medicines. It is used to lower the levels of lipids known as cholesterol and triglycerides in the blood when lifestyle changes (eg. low-fat diet) on their own have failed. This medicine helps to reduce the risk of heart disease.-

Product Description:

This tablet combines rosuvastatin, a high-intensity statin, with fenofibrate, a PPAR-alpha agonist. Rosuvastatin inhibits cholesterol synthesis in the liver and raises LDL receptor activity, lowering LDL cholesterol substantially. Fenofibrate works on a different pathway, increasing lipoprotein lipase activity and fatty acid oxidation, which mainly lowers triglycerides and modestly raises HDL. The combination targets mixed dyslipidaemia — high LDL together with high triglycerides — which is common in metabolic syndrome and type 2 diabetes.

The rationale is sound, but the evidence for adding a fibrate to a statin is qualified: large trials found no overall reduction in cardiovascular events from that addition, with possible benefit limited to patients with high triglycerides and low HDL. The main safety concern is muscle toxicity, which is higher when a statin and a fibrate are combined; fenofibrate is preferred over gemfibrozil for that reason. Fenofibrate also causes a reversible rise in creatinine. Liver enzymes and muscle symptoms are monitored.

Sourcing notes. This fixed-dose combination is registered mainly in India and a few other markets; regulated markets generally expect the two agents prescribed separately. Confirm the destination regulator accepts the combination, which needs its own bioequivalence data.