Lypstaplus

Adjunct to diet for primary hypercholesterolemia 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 tab daily. 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.

Hypersensitivity. Patients w/ myopathy. Concomitant use w/ ciclosporin. Active liver disease including 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 contraception. Pregnancy & lactation.

Discontinue use if signs & symptoms suggestive of severe cutaneous adverse reactions including SJS & DRESS appear; creatine kinase (CK) levels are markedly elevated (>5 x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤5 x ULN; ILD is suspected to have developed. Not suitable for initial therapy. Not to be used in any patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis. 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. Proteinuria. Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, 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, age >70 yr, situations where increased plasma levels may occur. DM. Not recommended in combination w/ gemfibrozil; certain PIs. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Concomitant use w/ ciclosporin, azole antifungals, PIs & macrolides; niacin; fibrates; ciclosporin. Monitor INR in concomitant use w/ warfarin, another coumarin anticoagulant or fluindione. Asians. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Dizziness may occur which may affect ability to drive vehicles or operate 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 contraception. Childn <18 yr.

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

May increase INR w/ vit K antagonists eg, warfarin, another coumarin anticoagulant or fluindione. Rosuvastatin: Increased AUC w/ ciclosporin, regorafenib, atazanavir/ritonavir, simeprevir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, grazoprevir/elbasvir, glecaprevir/pibrentasvir, lopinavir/ritonavir, clopidogrel, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole. Decreased AUC w/ erythromycin, baicalin. Plasma conc may be increased & may increase risk of myopathy w/ OATP1B1 & BCRP inhibitors. Increased risk of myopathy w/ fenofibrate & other fibrates; fusidic acid. May increase risk of myopathy w/ systemic fusidic acid. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC_0-t & C_max w/ erythromycin. Increased AUC of ethinyl estradiol & norgestrel AUC. Renal insufficiency & potential effect in renal excretion w/ ticagrelor. Ezetimibe: Modest increase in total conc w/ gemfibrozil; fenofibrate. Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Decreased mean 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