API

Fenofibrate (145mg) + Rosuvastatin (5mg)

Drug classification

Lipid-lowering agent; specific subclass: fibrate (fenofibrate) and statin (rosuvastatin) combination.

Dosage form

Film-coated oral tablet containing fenofibrate 145mg and rosuvastatin 5mg.

API strength per dosage

Dose

Rxtor-F 5 Tablet combines fenofibrate 145 mg and rosuvastatin 5 mg, typically taken once daily with or without food. Dose adjustments may be needed in renal impairment; avoid in severe hepatic dysfunction. Safety and efficacy in children have not been established. Always individualize therapy based on lipid goals and patient tolerability.

Mechanism of action

Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα), increasing lipolysis and elimination of triglyceride-rich particles. Rosuvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis and upregulating hepatic LDL receptors. Together, they lower triglycerides, total cholesterol, and LDL-C, and modestly raise HDL-C, improving overall lipid profile.

Indications

Treatment of High cholesterolPrevention of Heart attack

Side effects

Headache Muscle pain Constipation Abnormal liver function tests Joint pain Elevated creatine kinase Diabetes

Pregnancy category

Fenofibrate and rosuvastatin are contraindicated in pregnancy due to potential fetal harm; effective contraception is recommended during treatment and discontinuation if pregnancy occurs.

Precautions

Assess renal and hepatic function before and during therapy, monitor lipid levels, watch for myopathy or rhabdomyolysis symptoms, caution in patients with hypothyroidism or alcohol use, monitor for new-onset diabetes, avoid in active liver disease, assess for drug interactions, monitor creatine kinase if muscle symptoms occur.

Contraindications

Active liver disease, unexplained persistent liver enzyme elevations, severe renal impairment, gallbladder disease, breastfeeding, pregnancy, known hypersensitivity to fenofibrate, rosuvastatin, or any excipients, concurrent use with cyclosporine.