Rosuva

Rosuvastatin

Adult, adolescent & childn ≥6 yr w/ primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidaemia (type IIb) as adjunct to diet when response to diet or non-pharmacological treatments (eg, exercise, wt reduction) are inadequate; HoFH as adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Prevention of major CV events in patients estimated to have high risk for 1st CV event, as adjunct to correction of other risk factors.

Hypercholesterolemia Statin naïve or patients switched from another HMG CoA reductase inhibitor Initially 5-10 mg once daily. Adjust next dose after 4 wk if necessary. 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. Prevention of CV events 20 mg daily. Heterozygous familial hypercholesterolemia Childn & adolescents 6-17 yr (Tanner Stage <II-V) Initially 5 mg once daily, 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. HoFH Initially 5-10 mg once daily. Childn 6-17 yr Max dose: 20 mg once daily. Patient w/ mild to moderate renal impairment (CrCl <60 mL/min); pre-disposing factors to myopathy, age >70 yr & Asian patient Recommended start dose: 5 mg.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease including unexplained, persistent serum transaminase elevations & any elevation >3x ULN; myopathy. Concomitant use w/ ciclosporin; combination of sofosbuvir/velpatasvir/voxilaprevir. 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); signs & symptoms suggestive of severe cutaneous adverse reactions including SJS & DRESS appear; suspected patient has developed ILD; throughout duration of fusidic acid treatment in patients where use of systemic fusidic acid is essential. Discontinue or reduce dose if serum transaminase level is >3x ULN. Not to start treatment if CK levels are significantly elevated at baseline (>5x ULN). Not to be restarted if patient develops SJS or DRESS during treatment. Not to be used in patients 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). Proteinuria in patients treated w/ higher doses (40 mg); skeletal muscle effects eg, myalgia, myopathy & rhabdomyolysis; immune-mediated necrotising myopathy; ILD w/ long-term therapy; risk of hyperglycaemia. Patients w/ predisposing factors for myopathy/rhabdomyolysis; excessive alcohol intake; history of liver disease. Asian patients. Treat underlying disease prior to initiating therapy in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Consider renal function assessment during routine follow-up of patients treated w/ 40 mg dose. Measure CK levels in patients w/ inexplicable muscle pain, weakness or cramps, particularly if associated w/ malaise or fever. Perform confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline; LFTs prior to, & 3 mth following initiation of treatment. Closely monitor for signs & symptoms of severe skin reactions. Monitor patients at risk (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN) clinically & biochemically. Not recommended in combination w/ gemfibrozil. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Concomitant use w/ ezetimibe; gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolide antibiotics; various PIs in combination w/ ritonavir. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Increased systemic exposure in patients w/ Child-Pugh scores 8-9. Women of childbearing potential should use appropriate contraceptive measures. Discontinue treatment if patient becomes pregnant. Not recommended in childn <6 yr.

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

Increased plasma conc & risk of myopathy w/ transporter protein inhibitors including hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased exposure w/ PIs. Increased AUC w/ ciclosporin & ezetimibe. Increased C_max & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses of niacin. Decreased plasma conc w/ Al & Mg hydroxide containing antacid. Decreased AUC & C_max w/ erythromycin. Increased INR of vit K antagonists eg, warfarin. Increased AUC of ethinyl estradiol & norgestrel. Increased risk of myopathy including rhabdomyolysis w/ fusidic acid.

Dyslipidaemic Agents

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

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