Cholib

Fenofibrate 145 mg, simvastatin 20 mg

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.

1 tab daily.

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 w/ exception of acute pancreatitis due to severe hypertriglyceridaemia. History of myopathy &/or rhabdomyolysis w/ statins &/or fibrates or confirmed creatine phosphokinase elevation >5 times the upper limit of normal (ULN) under previous statin treatment. Concomitant administration of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin & nefazodone); gemfibrozil, ciclosporine, or danazol; glecaprevir/pibrentasvir. Hepatic impairment. Moderate to severe renal insufficiency (estimated GFR <60 mL/min/1.73 m²). Pregnancy & lactation. Childn <18 yr.

Skeletal muscle toxicity, including rare rhabdomyolysis cases w/ or w/o renal failure; reduced transport proteins function; immune-mediated necrotizing myopathy. Patients carrying SLCO1B1 gene allele (c.521T>C). Carefully monitor patients for signs & symptoms of muscle pain, tenderness, or weakness, particularly during initial mth of combined therapy w/ niacin. Concomitant use w/ potent CYP3A4 inhibitors, breast cancer resistant protein (BCRP) inhibitors. Do not co-administer w/ fusidic acid. Do not measure creatine kinase following strenuous exercise or in presence of any plausible alternative cause of increased creatine kinase; re-measure w/in 5-7 days if significantly elevated at baseline (>5 x ULN). Patients w/ pre-disposing factors for rhabdomyolyis (eg, elderly ≥65 yr; female; renal impairment; uncontrolled hypothyroidism; hypoalbuminaemia; personal or familial history of hereditary muscular disorders; previous history of muscular toxicity w/ a statin or a fibrate; alcohol abuse) should measure creatine kinase levels prior to treatment. Discontinue treatment if myopathy is suspected. Temporarily discontinue therapy for few days prior to elective major surgery & when any major medical or surgical condition supervenes. Possible myopathy &/or rhabdomyolysis when co-administered w/ daptomycin; temporarily suspend daptomycin in patients w/ pre-disposing factors for myopathy or rhabdomyolysis. Monitor transaminase levels prior to treatment, every 3 mth during the 1st 12 mth of treatment, & thereafter periodically. Discontinue if AST & ALT levels increase to >3 x ULN; symptoms indicative & confirmed diagnosis of hepatitis (eg, jaundice, pruritus); interstitial lung disease develops. Patients who consume substantial alcohol quantities. Pancreatitis. Cognitive impairment. Monitor patients at risk of DM (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN). History of pulmonary embolism. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption; fructose intolerance, sucrase-isomaltase insufficiency. May cause allergic reactions due to sunset yellow FCF (E110). Dizziness may affect ability to drive & use machines. Mild renal insufficiency (estimated GFR 60-89 mL/min/1.73 m²).

Increased blood creatinine. Upper resp tract infection, gastroenteritis; increased platelet count; increased ALT. Fenofibrate: Increased blood homocysteine level. GI signs & symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence); increased transaminases.

Increased risk of myopathy & rhabdomyolysis w/ potent CYP450 3A4 inhibitors [eg, itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV PIs (eg, nelfinavir), cobicistat & nefazodone]; danazol; ciclosporin; amiodarone, amlodipine, diltiazem & verapamil. May increase simvastatin plasma conc by BCRP inhibitors including products containing elbasvir or grazoprevir. Increased simvastatin AUC by gemfibrozil. Increased risk of myopathy or rhabdomyolysis by concomitant administration of daptomycin. Concomitant administration w/ niacin; fusidic acid; colchicine (in patients w/ renal insufficiency). Increased plasma exposure to simvastatin acid w/ grapefruit juice. Enhanced effects of vit K antagonists. Reversible paradoxical HDL-C reduction w/ glitazones. Decreased simvastatin plasma exposure by rifampicin. Co-administration w/ drugs metabolised by CYP2C19, CYP2A6, or especially CYP2C9 w/ narrow therapeutic index.

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.

POM