Rosufen

Per 160 mg/10 mg FC tab Fenofibrate 160 mg, rosuvastatin Ca 10 mg. Per 160 mg/20 mg FC tab Fenofibrate 160 mg, rosuvastatin Ca 20 mg

Adjunct to diet to reduce elevated total-C, LDL-C, apo B & TG levels & to increase HDL-C.

1 tab once daily after dinner.

Should be taken with food.

Hypersensitivity. Pre-existing gall bladder disease. Hepatic or severe renal dysfunction including primary biliary cirrhosis & patients w/ unexplained persistent liver function abnormality & elevations of serum transaminases exceeding 3 x ULN. Pregnancy & lactation.

Discontinue therapy if AST & ALT levels increase to >3 x ULN or 100 IU; muscle toxicity or ILD is suspected. Pancreatitis. Increased risk of rhabdomyolysis in patients w/ predisposing factors for myopathy &/or rhabdomyolysis including personal or familial history of hereditary muscular disorders, hypothyroidism & high alcohol intake. Not recommended in concomitant use w/ certain PIs. Concomitant use w/ another fibrate or HMG-CoA reductase inhibitor; oestrogens or contraceptives containing oestrogens. Monitor transaminase levels every 3 mth during the 1st 12 mth of treatment. Interrupt treatment when creatinine level is >50% ULN. Measure creatinine during the 1st 3 mth after initiation of treatment & periodically thereafter. Creatinine kinase measurement. Clinically & biochemically monitor patients at risk of future diabetes (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN). Dizziness may occur which may affect ability to drive & use machine. Mild to moderate renal insufficiency. Women of childbearing potential should use appropriate contraceptive measures. Elderly >70 yr.

Rosuvastatin: DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia. Fenofibrate: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea & flatulence); moderately elevated levels of serum transaminases.

Reduce dose of concomitant coumarin oral anticoagulants. Fenofibrate: Risk of renal deterioration w/ cyclosporine. Carefully monitor patients in co-administration w/ CYP2C19, CYP2A6 & especially CYP2C9 metabolised drugs w/ narrow therapeutic index. Rosuvastatin: Increased risk of myopathy w/ cyclosporine. Plasma conc & risk of myopathy may be increased w/ OATP1B1 & BCRP inhibitors. Concomitant use w/ PIs. May increase INR w/ vit K antagonists eg, warfarin or another coumarin anticoagulant. Increased AUC of ethinyl estradiol & norgestrel. May increase risk of myopathy including rhabdomyolysis w/ systemic fusidic acid.

Dyslipidaemic Agents

C10BA09 - rosuvastatin 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