Cholib

Adjunctive therapy to diet & exercise in high CV risk adult w/ mixed dyslipidemia to reduce triglycerides & increase HDL-C levels when LDL-C levels are adequately controlled w/ the corresponding dose of simvastatin monotherapy.

1 tab daily.

May be taken with or without food: Swallow whole w/ a glass of water, do not chew/crush. Avoid intake w/ grapefruit juice.

Hypersensitivity to fenofibrate, simvastatin, peanut or soya. Photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen. Active liver disease or unexplained persistent elevations of serum transaminases. Gallbladder disease. Chronic or acute pancreatitis w/ exception of acute pancreatitis due to severe hypertriglyceridemia. History of myopathy &/or rhabdomyolysis w/ statins &/or fibrates or confirmed creatine phosphokinase elevation >5 times ULN under previous statin treatment. Concomitant administration of fibrates, statins, danazol, ciclosporin, potent CYP450 inhibitors or glecaprevir/pibrentasvir. Moderate to severe renal insufficiency (estimate GFR <60 mL/min/1.73 m²). Pregnancy & lactation. Childn <18 yr. 145 mg/40 mg: Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem.

Skeletal muscle toxicity. Cases of de novo or aggravated pre-existing myasthenia gravis or ocular myasthenia are observed. Reduced function of transport proteins. Immune-mediated necrotizing myopathy. Do not administer w/ fusidic acid. Carefully monitor patients for any signs & symptoms of muscle pain, tenderness or weakness particularly during the initial mth of therapy. Patients w/ predisposing factors for rhabdomyolysis. Discontinue in case of myopathy. Temporarily stop few days prior to elective major surgery & when major medical or surgical condition supervenes. Patients who consume substantial quantities of alcohol. Pancreatitis. ILD. DM. Veno-thromboembolic events. Patients w/ history of pulmonary embolism. Hepatic disorders. Mild renal insufficiency w/ GFR 60-89 mL/min/1.73 m². Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; fructose intolerance or sucrase-isomaltase insufficiency. Rare reports of dizziness; may impair ability to drive or operate machinery. Simvastatin: Concomitant use w/ BCRP inhibitors (eg, elbasvir & grazoprevir). Creatine kinase increase (>5 times ULN). Reports of myopathy &/or rhabdomyolysis w/ daptomycin. Consider temporary suspension of treatment in patients taking daptomycin particularly those w/ pre-disposing factors for myopathy or rhabdomyolysis. 145 mg/20 mg: Sunset yellow FCF (E110) content may cause allergic reactions.

Increased blood creatinine. URTI, gastroenteritis; increased platelet count; increased ALT.

Enhanced effects of vit K antagonists & increased risk of bleeding. Fenofibrate: Reversible paradoxical reduction of HDL-C w/ glitazones. Simvastatin: Increased risk of myopathy & rhabdomyolysis w/ CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV PIs (eg, nelfinavir), cobicistat, nefazodone; fluconazole; danazol; ciclosporin; amiodarone, amlodipine, diltiazem, verapamil; gemfibrozil, other fibrates, statins; daptomycin; niacin (≥1 g daily); fusidic acid; colchicine. Increased plasma conc & risk of myopathy w/ BCRP inhibitors (eg, elbasvir & grazoprevir). Increased plasma exposure w/ grapefruit juice. Loss of efficacy of simvastatin w/ long-term rifampicin therapy.

Dyslipidaemic Agents

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.

Rx