Cholib

Cholib

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fenofibrate 145 mg, simvastatin 20 mg
Indications/Uses
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.
Dosage/Direction for Use
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 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.
Special Precautions
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. 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).
Adverse Reactions
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.
Drug Interactions
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. 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.
MIMS Class
Dyslipidaemic Agents
ATC Classification
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.
Presentation/Packing
Form
Cholib 145/20 mg FC tab
Packing/Price
30's
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