Rosuvastatin Sandoz

Rosuvastatin Ca

Adjunct to diet in primary hypercholesterolaemia or mixed dyslipidaemia (type IIb) when response to diet or non-pharmacological treatments (eg, exercise, wt reduction) are inadequate. Adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate in homozygous familial hypercholesterolaemia. Prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event as adjunct to correction of other risk factors. Slow or delay the progression of atherosclerosis. Reduces total cholesterol, LDL-C & Apo B in childn & adolescents 6-17 yr w/ heterozygous familial hypercholesterolemia (HeFH).

Hypercholesterolaemia Statin naïve or patients switched from another HMG-CoA reductase inhibitor 5 or 10 mg once daily. Patients w/ severe hypercholesterolaemia at high CV risk (in particular those w/ familial hypercholesterolaemia), who do not achieve treatment goal on 20 mg, & in whom routine follow-up will be performed Final titration to max dose: 40 mg. Childn & adolescents 10-17 yr (boys Tanner Stage II & above, & girls who are at least 1 yr post-menarche) Initially 5 mg daily. Usual dosage range: 5-20 mg once daily. Prevention of CV events 20 mg daily. HeFH Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Elderly >70 yr; Asian patients, patients w/ predisposing factors to myopathy; moderate renal impairment (CrCl <60 mL/min) 5 mg.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease including unexplained persistent serum transaminases elevations exceeding 3x ULN; myopathy. Combination of sofosbuvir/velpatasvir/voxilaprevir & ciclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation. 40 mg dose: Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, 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, Asian patients, concomitant use of fibrates, moderate renal impairment (CrCl <60 mL/min).

Discontinue therapy 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); throughout duration of fusidic acid treatment in patients where use of systemic fusidic acid is essential; signs & symptoms suggestive of severe cutaneous adverse reactions including SJS & DRESS appear; suspected patient has developed ILD. Discontinue or reduce dose if level of serum transaminases >3x ULN. Patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome should be treated prior to initiating therapy. Not recommended in asymptomatic patients the routine monitoring of CK levels. Not to be used in any patient w/ acute, serious condition suggestive of myopathy or predisposing to renal failure development secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, 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, age >70 yr. Patients who consume excessive quantities of alcohol &/or w/ history of liver disease. Increased incidence of myositis & myopathy in patients receiving other HMG-CoA reductase inhibitors w/ fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolide antibiotics. Proteinuria. Skeletal muscle effects eg, myalgia, myopathy & rhabdomyolysis. Immune-mediated necrotising myopathy during or after treatment. Serious hepatic events. Increased exposure in Asian subjects. Consider renal function assessment during routine follow-up of patients treated w/ 40 mg dose. Perform confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline (>5x ULN). Not to be started treatment if repeat test confirms a baseline CK >5x ULN. Carry out LFTs prior to & 3 mth following treatment initiation. Monitor both clinically & biochemically those patients at risk of raise blood glucose & high risk of future diabetes (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN). Not recommended in combination w/ gemfibrozil. Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Concomitant use w/ various PIs in combination w/ ritonavir. May affect ability to drive or operate machinery. Severe renal impairment. Increased systemic exposure in patients w/ Child-Pugh scores 8-9. Women of childbearing potential should use appropriate contraceptive measures. Discontinue use if patient becomes pregnant. Not suitable for paed patients (40 mg dose). Not recommended for use in childn <10 yr.

DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

Increased plasma conc & risk of myopathy w/ medicinal products inhibitors transporter proteins including hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased exposure w/ PIs. Increased AUC & C_max in combination of 2 PIs (300 mg atazanavir/100 mg ritonavir), respectively. Increased C_max & AUC w/ gemfibrozil. Concomitant use w/ fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin & fusidic acid. Decreased plasma conc w/ antacid susp containing Al- & Mg- hydroxide. Decreased AUC & C_max w/ erythromycin. Increased risk for accumulation w/ ticagrelor. Increased AUC w/ sofosbuvir/velpatasvir/voxilaprevir, ciclosporin, darolutamide, regorafenib, atazanavir/ritonavir, simeprevir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, grazoprevir/elbasvir, glecaprevir/pibrentasvir, lopinavir/ritonavir, clopidogrel, eltrombopag, darunavir, tipranavir, dronedarone, itraconazole & ezetimibe. Decreased AUC w/ baicalin. Increased INR w/ vit K antagonists eg, warfarin or another coumarin anticoagulant. Increased ethinyl estradiol & norgestrel AUC w/ OCs.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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