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
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 upper limit of normal under previous statin treatment. Concomitant use of fibrates, statins, danazol, ciclosporin or potent CYP450 inhibitors. Hepatic impairment. Moderate to severe renal insufficiency (GFR <60 mL/min/1.73 m2). Pregnancy & lactation. Paed <18 yr.
Special Precautions
Discontinue use if myopathy or interstitial lung disease is suspected. Immune-mediated necrotizing myopathy; skeletal muscle toxicity. Predisposing factors for rhabdomyolysis. History of pulmonary embolism; DM, pancreatitis. Monitor transaminase levels prior to, every 3 mth after 1st 12-mth treatment & periodically thereafter. Temporarily w/draw therapy few days prior to elective major surgery. Concomitant use w/ CYP3A4 inhibitors, niacin ≥1 g daily. Not to be used w/ fusidic acid. Avoid use w/ grapefruit juice. 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. Mild renal insufficiency (GFR 60-80 mL/min/1.73 m2). Elderly ≥65 yr.
Adverse Reactions
Increased blood creatinine. Upper resp tract infection, gastroenteritis; increased platelet count; increased ALT.
Drug Interactions
Increased risk of myopathy & rhabdomyolysis w/ CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, nefazodone, danazol, ciclosporin, amiodarone, amlodipine, diltiazem, verapamil, gemfibrozil, other fibrates or statins, niacin (≥1 g daily), fusidic acid, colchicine. Increased plasma exposure w/ grapefruit juice. Enhanced effects of vit K antagonists. Reversible paradoxical HDL-C reduction w/ glitazones. Decreased plasma exposure w/ rifampicin. Monitor w/ CYP2C19-, CYP2A6-, CYP2C9-metabolised drugs.
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 FC tab
Packing/Price
30's (RM150/pack)
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