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CARDIOVASCULAR SYSTEM › LIPID MODIFYING AGENTS › LIPID MODIFYING AGENTS, COMBINATIONS › Combinations of various lipid modifying agents
rosuvastatin and omega-3 fatty acids
C10BA07
Forms & Strengths
- Rosuvastatin/Omega-3-acid ethyl esters 5 mg/1000 mg capsule
- Rosuvastatin/Omega-3-acid ethyl esters 10 mg/1000 mg capsule
- Rosuvastatin/Omega-3-acid ethyl esters 20 mg/1000 mg capsule
Adult Dosing
- Hyperlipidemia and mixed dyslipidemia: 1 capsule orally once daily with meals
- Titrate dose based on efficacy and tolerability after 4 weeks
- Maximum recommended rosuvastatin dose is 40 mg daily (typically 20 mg in fixed combinations to limit adverse effects)
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
- Not recommended for use in children under 18 years of age
Indications
- Adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and triglycerides in patients with mixed dyslipidemia
- Adjunct to diet for the treatment of severe hypertriglyceridemia
Mechanism of Action
- Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, increasing hepatic LDL uptake and reducing hepatic synthesis of VLDL
- Omega-3-acid ethyl esters (EPA and DHA) reduce hepatic synthesis of triglycerides by inhibiting esterification and increasing beta-oxidation
Contraindications
- Hypersensitivity to rosuvastatin, fish/shellfish, or any component of the formulation
- Active liver disease, including unexplained persistent elevations of hepatic transaminases
- Pregnancy and lactation
Adverse Reactions
- Myalgia, arthralgia, and myopathy
- Elevated serum transaminases and creatine kinase
- Nasopharyngitis, headache, and dizziness
- Eructation, dyspepsia, and taste perversion (associated with omega-3 fatty acids)
- Increased risk of bleeding at high doses due to antiplatelet effects of omega-3s
Drug Interactions
- Cyclosporine: significantly increases rosuvastatin exposure
- Coumarin anticoagulants: omega-3 fatty acids may prolong bleeding times; monitor INR closely
- Gemfibrozil: increases risk of rosuvastatin-induced myopathy; avoid concurrent use
- Antacids containing aluminum and magnesium hydroxide: decrease rosuvastatin plasma concentrations
- Niacin: increases risk of skeletal muscle effects
Curated Content: Needs Vetting Before Put to Clinical Use