Zenon

Adjunct to diet for primary hypercholesterolaemia (heterozygous familial) or HoFH as substitution therapy in adults adequately controlled w/ the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.

1 FC tab daily. Co-administration w/ bile acid sequestrants Dosing should occur either ≥2 hr before or ≥4 hr after administration of bile acid sequestrant. Elderly >70 yr, moderate renal impairment (CrCl <60 mL/min), Asian, patient w/ predisposing factor to myopathy Initially rosuvastatin 5 mg.

May be taken with or without food: Swallow whole tab & take it w/ water.

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

Not suitable for initial therapy. Discontinue immediately if myopathy, ILD, cholelithiasis is suspected. Treatment should not be started if repeat test confirms baseline creatine kinase >5 x ULN. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis including renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous 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. Discontinue therapy if CK levels are markedly elevated (>5 x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are </=5x ULN). Immune-mediated necrotizing myopathy (rarely). Not recommended in combination w/ gemfibrozil; certain PIs. Not to be used in any 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). Carry out LFTs 3 mth following initiation of treatment. Treat underlying disease in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome prior to initiating therapy. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Proteinuria. DM. ILD (long-term therapy). Concomitant use w/ fibrates or niacin; Monitor INR if co-administered w/ anticoagulants (eg, warfarin, another coumarin anticoagulant, or fluindione. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Dizziness may occur which may affect ability to drive & use machines. Not recommended in moderate (Child Pugh score 7-9) or severe (Child Pugh score >9) hepatic impairment. Women of childbearing potential should use appropriate contraceptive measures. Discontinue use if patient becomes pregnant. Asians. Not recommended for use in childn & adolescents <18 yr. Elderly >70 yr.

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

Increased AUC w/ ciclosporin. May increase INR w/ vit K antagonists eg, warfarin, another coumarin anticoagulant or fluindione. Ezetimibe: Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Modest increase in total conc w/ fenofibrate or gemfibrozil. Decreased mean AUC w/ colestyramine. Rosuvastatin: Increased C_max & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin; fusidic acid. Increased exposure w/ PIs eg, atazanavir/ritonavir. Increased plasma conc & risk of myopathy w/ OATP1B1 & BRCP inhibitors. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC_(0-t) & C_max w/ erythromycin. Increased AUC of ethinyl estradiol & norgestrel. Renal insufficiency & potential effect in renal excretion w/ ticagrelor. Increased AUC w/ atazanavir/ritonavir, regorafenib, lopinavir/ritonavir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, grazoprevir/elbasvir, glecaprevir/pibrentasvir, clopidogrel, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole. Decreased AUC w/ baicalin.

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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