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CARDIOVASCULAR SYSTEM › LIPID MODIFYING AGENTS › LIPID MODIFYING AGENTS, COMBINATIONS › Combinations of various lipid modifying agents
rosuvastatin, ezetimibe and fenofibrate
C10BA15
Forms & Strengths
- Fixed-dose combination products containing rosuvastatin, ezetimibe, and fenofibrate in various strengths (e.g., Rosuvastatin 5mg/Ezetimibe 10mg/Fenofibrate 67mg, Rosuvastatin 10mg/Ezetimibe 10mg/Fenofibrate 160mg)
- Oral capsules
Adult Dosing
- One capsule daily, individualized based on baseline lipid profile, treatment goals, and patient tolerability
- Switching to combination therapy is typically reserved for patients already stabilized on the individual components
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Not recommended for use in children and adolescents under 18 years of age
Indications
- Adjunct to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia in adults
- Reduction of elevated total cholesterol, LDL-C, ApoB, non-HDL-C, triglycerides, and increasing HDL-C
Mechanism of Action
- Rosuvastatin: Selective and competitive inhibitor of HMG-CoA reductase, decreasing hepatic cholesterol synthesis and upregulating LDL receptors
- Ezetimibe: Inhibits intestinal absorption of cholesterol and plant sterols at the brush border of the small intestine via the NPC1L1 transporter
- Fenofibrate: Peroxisome proliferator-activated receptor alpha (PPAR-alpha) agonist, reducing serum triglycerides by upregulating lipoprotein lipase and decreasing VLDL production
Contraindications
- Hypersensitivity to rosuvastatin, ezetimibe, fenofibrate, or any component of the formulation
- Active liver disease or unexplained persistent elevations of serum transaminases
- Pre-existing gallbladder disease
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Nursing mothers and pregnancy
Adverse Reactions
- Myalgia, arthralgia, and risk of rhabdomyolysis
- Elevated liver transaminases
- Gastrointestinal disturbances (diarrhea, abdominal pain, nausea)
- Headache and nasopharyngitis
- Cholelithiasis and cholecystitis (due to fenofibrate component)
Drug Interactions
- Coumarin anticoagulants (e.g., warfarin): Increased risk of bleeding; monitor INR closely
- Cyclosporine: Significantly increases systemic exposure of rosuvastatin and ezetimibe
- Bile acid sequestrants: Decrease absorption of ezetimibe and statins; administer at least 2 hours before or 4 hours after
- Colchicine: Increased risk of myopathy and rhabdomyolysis
- Strong CYP2C9 and OATP1B1 inhibitors may alter rosuvastatin exposure
Curated Content: Needs Vetting Before Put to Clinical Use