Rozuor

Adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adults adequately controlled w/ individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. Substitution treatment in adults w/ CHD & history of acute coronary syndrome, who are adequately controlled w/ individual substances administered simultaneously at the same dose level as in the fixed combination medicinal product, but as separate products.

Adult 1 cap of the given strength daily, taken at the same time each day. Patient w/ genetic polymorphism Lower daily dose is recommended.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN; myopathy. Concomitant use w/ sofosbuvir/velpatasvir/voxilaprevir; cyclosporine. Severe renal impairment (CrCl <30 mL/min). During pregnancy & breast-feeding & in women of childbearing potential not using appropriate contraception.

Not suitable for initial therapy in patients w/ pre-disposing factors to myopathy, Asian ancestry, moderate renal impairment (CrCl <60 mL/min), elderly >70 yr. Immediately discontinue in case of signs & symptoms of severe cutaneous adverse reactions including SJS & DRESS; suspected myopathy. Do not restart at any time in patient who has developed a serious reaction eg, SJS or DRESS. Discontinue therapy in case of aggravation of symptoms of myasthenia gravis or ocular myasthenia; markedly elevated creatine kinase (CK) levels (>5 x ULN) or muscular symptoms that are severe & cause daily discomfort (even if CK levels are ≤5 x ULN); suspected ILD. Treatment should not be started if repeat test confirms baseline CK >5 x ULN. Caution in patients w/ pre-disposing factors for myopathy/rhabdomyolysis including renal impairment, hypothyroidism, personal/family history of hereditary muscular disorders, history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates, age >70 yr; who consume excessive quantities of alcohol &/or have a history of liver disease. Concomitant use w/ gemfibrozil or PIs is not recommended. Do not use in any patient w/ an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. LFTs should be carried out prior to, & 3 mth following the initiation of rosuvastatin treatment. Treat underlying disease prior to initiating therapy in patients w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. Reports of proteinuria w/ high doses of rosuvastatin (particularly 40 mg). Clinically & biochemically monitor patients at risk of hyperglycemia (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN). Discontinue therapy & perform gallbladder investigations if cholelithiasis is suspected in patients receiving Rozuor & fibrates. Monitor INR in concomitant use w/ warfarin, another coumarin anticoagulant, or fluindione. Dizziness may occur which may affect ability to drive & use machines. Not recommended in patients w/ moderate (Child Pugh score 7-9) or severe (Child Pugh score >9) liver dysfunction. Immediately discontinue treatment if patient becomes pregnant. Women of childbearing potential should use appropriate contraception. Increased exposure in Asian subjects. Not recommended in childn <18 yr.

DM; headache, dizziness; constipation, nausea, abdominal pain, diarrhea, flatulence; myalgia; asthenia, fatigue; increased ALT &/or AST.

Rosuvastatin: Increased plasma conc & risk of myopathy w/ inhibitors of hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin; fusidic acid. Increased AUC values w/ cyclosporine. Increased exposure w/ PIs. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC_0-τ & C_max w/ erythromycin. Increased INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increased AUC of ethinyl estradiol & norgestrel w/ OCs. Decreased renal function, increased CPK level & rhabdomyolysis w/ ticagrelor. Ezetimibe: Possible risk of cholelithiasis & gallbladder disease w/ fenofibrates. Modest increases in conc w/ fenofibrate or gemfibrozil. Decreased AUC w/ cholestyramine.

Dyslipidaemic Agents

C10BA06 - rosuvastatin and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.

Rx