← Search & browse all drugs
CARDIOVASCULAR SYSTEM › LIPID MODIFYING AGENTS › LIPID MODIFYING AGENTS, COMBINATIONS › Combinations of various lipid modifying agents
simvastatin and fenofibrate
C10BA04
Forms & Strengths
- Simvastatin 20-80 mg and Fenofibrate 145 mg tablets
- Simvastatin 20-40 mg and Fenofibrate 88 mg tablets
- Simvastatin 10-20 mg and Fenofibrate 67.5 mg tablets
Adult Dosing
- Primary hypercholesterolemia: 1 tablet once daily in the evening
- Mixed dyslipidemia: 1 tablet once daily in the evening
- Hypertriglyceridemia: 1 tablet once daily in the evening
- Dosage adjustments should be made at intervals of 4 weeks or more
Pediatric Dosing
- Not recommended for use in children under 18 years
- Safety and efficacy have not been established in pediatric patients
Indications
- Treatment of primary hypercholesterolemia
- Treatment of mixed dyslipidemia
- Treatment of hypertriglyceridemia
- Adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL-C, and triglycerides
Mechanism of Action
- Simvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis
- Fenofibrate activates PPAR-alpha, increasing lipolysis and elimination of triglyceride-rich particles
Contraindications
- Liver disease, acute or severe
- Hypersensitivity to simvastatin, fenofibrate, or any component of the formulation
- Gallbladder disease
- Severe renal impairment
Adverse Reactions
- Myopathy, rhabdomyolysis
- Elevated liver enzymes, liver failure
- Gallstones, cholelithiasis
- Headache, dizziness, fatigue
- Muscle pain, muscle weakness
- Increased risk of pancreatitis
Drug Interactions
- Cyclosporine, increased risk of myopathy
- Gemfibrozil, increased risk of myopathy
- Warfarin, increased INR
- Amiodarone, increased risk of myopathy
- Verapamil, diltiazem, increased risk of myopathy
Curated Content: Needs Vetting Before Put to Clinical Use