Rosustyn

Rosuvastatin

Adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate for the treatment of primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) in adults, adolescents & childn ≥10 yr. Adjunct to correction of other risk factors for the prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event.

Treatment of hypercholesterolaemia Initially 5 mg or 10 mg once daily. Adjust to next dose level after 4 wk, if necessary. Consider final titration to max dose of 40 mg only in patients w/ severe hypercholesterolaemia at high CV risk (particularly those w/ familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, & in whom routine follow-up will be performed. Prevention of CV events 20 mg daily. Childn & adolescent 10-17 yr (Tanner stage <II-V) w/ heterozygous familial hypercholesterolaemia Initially 5 mg daily. Dose range: 5-20 mg once daily. Elderly >70 yr; patient w/ moderate renal impairment (CrCl <60 mL/min); patient of Asian ancestry; patient w/ predisposing factor to myopathy Initially 5 mg.

May be taken with or without food.

Hypersensitivity. Concomitant use of ciclosporin. Patients w/ myopathy; active liver disease (including unexplained, persistent serum transaminase elevations & any serum transaminase elevation >3x ULN); severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation. 40-mg dose: Concomitant use of fibrates. Alcohol abuse. Situations where an increase in plasma levels may occur. Patients w/ hypothyroidism; personal or family history of hereditary muscular disorders; previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate; moderate renal impairment (CrCl <60 mL/min). Asian patients.

Risk of proteinuria in patients treated w/ higher doses (particularly 40 mg). Assess renal function during routine follow-up of patients treated w/ 40-mg dose. Risk of skeletal muscle effects (eg, myalgia, myopathy, & rarely rhabdomyolysis). Do not start treatment if creatine kinase (CK) levels are significantly elevated at baseline (>5x ULN). Discontinue therapy if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels ≤5x ULN). Do not use in patients w/ acute, serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, uncontrolled seizures, or severe metabolic, endocrine & electrolyte disorders). Caution in patients who consume excessive quantities of alcohol &/or have history of liver disease. Perform LFTs prior to & 3 mth following treatment initiation. Discontinue treatment or reduce dose in case of serum transaminase levels >3x ULN. Treat underlying disease prior to initiating rosuvastatin therapy in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Risk of ILD, especially w/ long-term therapy. Discontinue therapy in case of suspected ILD. Risk of increases in HbA1c & fasting serum glucose levels. Very rare reports of immune-mediated necrotising myopathy during or after treatment. Rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion). Caution when combined w/ ezetimibe. Combination w/ gemfibrozil is not recommended. Do not co-administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Concomitant use w/ certain PIs is not recommended. Consider when driving vehicles or operating machines that dizziness may occur during treatment. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Assess renal function in patients w/ Child-Pugh scores 8-9. No experience in patients w/ Child-Pugh scores >9. Women of childbearing potential should use appropriate contraception. Safety & efficacy of doses >20 mg have not been studied in childn & adolescents 10-17 yr (Tanner stage <II-V) w/ heterozygous familial hypercholesterolaemia. Not recommended for use in childn <10 yr.

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

Increased plasma conc w/ OATP1B1 & BCRP inhibitors. Increased exposure w/ ciclosporin; regorafenib; PIs (eg, atazanavir/ritonavir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, grazoprevir/elbasvir, glecaprevir/pibrentasvir, lopinavir/ritonavir, darunavir/ritonavir, tipranavir/ritonavir); clopidogrel; gemfibrozil; eltrombopag; dronedarone; itraconazole; ezetimibe. Increased risk of myopathy when given concomitantly w/ gemfibrozil, fenofibrate, other fibrates, & lipid-lowering doses of niacin (≥1 g/day). Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased exposure w/ erythromycin; baicalin. Treatment initiation or dose up-titration of rosuvastatin in patients treated concomitantly w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant) may result in increased INR, while discontinuation or down-titration may result in decreased INR. Increased plasma levels of ethinyl estradiol & norgestrel. Co-administration w/ systemic fusidic acid may increase risk of myopathy, including rhabdomyolysis.

Dyslipidaemic Agents

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

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