Ezuvas

Adjunct to diet for primary hypercholesterolaemia as substitution therapy in adults adequately controlled w/ individual substances given concurrently at same dose level as in fixed dose combination, but as separate products; in patients w/ HoFH. Reduces risk of CV events as substitution therapy in patients w/ CHD & history of acute coronary syndrome (ACS), who are adequately controlled w/ individual substances given concurrently at same dose level as in fixed dose combination, but as separate products.

1 tab once daily. Take either ≥2 hr before or ≥4 hr after bile acid sequestrant.

May be taken with or without food.

Hypersensitivity. Patients w/ myopathy. Concomitant ciclosporin use. Active liver disease including unexplained, persistent elevation of serum transaminases & any serum transaminase elevation >3x ULN. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Severe cutaneous adverse reactions including SJS & DRESS. Discontinue treatment immediately if signs & symptoms suggestive of severe skin reactions appear; myopathy is suspected or confirmed; in case of aggravated symptoms of myasthenia gravis or ocular myasthenia; if creatine kinase (CK) levels are markedly elevated (>5x ULN) or muscular symptoms are severe & cause daily discomfort (even if CK levels are >5x ULN); cholelithiasis is suspected. Discontinue treatment or reduce dose if serum transaminase level is >3x ULN. Not suitable for initial therapy. Not to initiate treatment if CK levels are elevated at baseline (>5x ULN). Not to restart treatment if patient develops SJS & DRESS while on therapy. Not to be used in patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Myalgia, myopathy & rhabdomyolysis. Consecutive transaminase elevations (≥3x ULN). Patients w/ pre-disposing factors for myopathy/rhabdomyolysis eg, renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, age >70 yr, increased plasma levels, concomitant use of fibrates. Alcoholic patients or those w/ history of liver disease. Report immediately any unexplained muscle pain, tenderness or weakness before starting treatment. Perform confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline (>5x ULN) at the start of treatment; LFTs 3 mth following treatment initiation. Closely monitor signs & symptoms of severe skin reactions. Monitor INR. Treat secondary hypocholesterolemia caused by hypothyroidism or nephrotic syndrome prior to initiating therapy. Not recommended in concomitant use w/ gemfibrozil; PIs. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Concomitant use w/ ciclosporin, nicotinic acid, azole antifungals & macrolides. May affect ability to drive or operate machines. Not recommended in moderate (Child Pugh score 7-9) or severe (Child Pugh score >9) liver dysfunction. Women of childbearing potential should use appropriate contraceptives. Discontinue treatment if patient becomes pregnant during therapy. Lactation. Not recommended in childn <18 yr. Rosuvastatin: Discontinue treatment in patients where use of systemic fusidic acid treatment is essential throughout fusidic acid treatment duration; if patient develops ILD. Immune-mediated necrotising myopathy during or after treatment characterised by proximal muscle weakness & elevated serum CK. Proteinuria w/ higher doses. ILD w/ long-term therapy. Asian. Monitor patients at risk for DM.

DM; headache, dizziness; constipation, nausea, abdominal pain, diarrhoea, flatulence; myalgia; asthenia, fatigue; increased ALT &/or AST. SJS, erythema multiforme, DRESS.

Increased AUC w/ ciclosporin. Increased risk of myopathy including rhabdomyolysis w/ fusidic acid. Increased INR w/ vit K antagonists (eg, warfarin, fluindione or another coumarin anticoagulant). Rosuvastatin: Increased AUC w/ ezetimibe; regorafenib; atazanavir/ritonavir; velpatasvir; ombitasvir/paritaprevir/ritonavir/dasabuvir; grazoprevir/elbasvir; glecaprevir/pibrentasvir; lopinavir/ritonavir; clopidogrel; eltrombopag; darunavir/ritonavir; tipranavir/ritonavir; dronedarone; itraconazole; simperevir. Decreased AUC w/ baicalin. Increased exposure w/ PIs. Increased plasma conc & risk of myopathy w/ transporter protein inhibitors. Increased C_max & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin. Decreased plasma conc w/ Al- & Mg-containing antacid. Decreased AUC_0-t & C_max w/ erythromycin. Increased ethinyl estradiol & norgestrel AUC. Decreased renal function, increased CPK level & rhabdomyolysis w/ ticagrelor. Ezetimibe: Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Increased total conc w/ fenofibrate or gemfibrozil. Decreased mean AUC w/ colestyramine.

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.

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