Adjunctive therapy to diet & exercise in high CV risk adult patients w/ mixed dyslipidaemia to reduce triglycerides & increase HDL-C levels when LDL-C levels are adequately controlled w/ corresponding dose of simvastatin monotherapy.
View Cholib overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole w/ a glass of water, do not chew/crush. Avoid grapefruit juice.
Contraindications
Hypersensitivity to fenofibrate, simvastatin, peanut or soya. Known photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen; gallbladder disease. Active liver disease or unexplained persistent serum transaminases elevation. Chronic or acute pancreatitis except due to severe hypertriglyceridaemia. History of myopathy &/or rhabdomyolysis w/ statins &/or fibrates or confirmed creatine phosphokinase elevation >5 times ULN under previous statin treatment. Concomitant use of fibrates, statins, danazol, ciclosporin or potent CYP450 3A4 inhibitors. Hepatic impairment. Moderate to severe renal insufficiency (GFR <60 mL/min/1.73 m2). Pregnancy & lactation. Paed <18 yr.
Discontinue use if myopathy is suspected or ILD develops. Immune-mediated necrotizing myopathy; skeletal muscle toxicity. Predisposing factors for rhabdomyolysis. Pancreatitis; DM; history of pulmonary embolism. Monitor transaminase levels prior to, every 3 mth during 1st 12-mth & periodically thereafter. Temporarily w/draw therapy few days prior to elective major surgery. Substantial alcohol consumption. May cause allergic reactions due to sunset yellow FCF (E110). Galactose or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May affect ability to drive & use machines. Not to be used w/ fusidic acid. Avoid use w/ grapefruit juice. Concomitant use w/ niacin ≥1 g daily, CYP3A4 & BCRP inhibitors. Mild renal insufficiency (GFR 60-80 mL/min/1.73 m2). Elderly ≥65 yr.
C10BA04 - simvastatin and fenofibrate ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.
Sign Out
