Ruchol

Rosuvastatin Ca

To reduce LDL-C, Apo B, triglycerides & to increase HDL-C in management of hyperlipidaemias including primary hypercholesterolemia (type IIa), mixed dyslipidaemia (type IIb) & hypertriglyceridaemia (type IV). May also be used in patients w/ HoFH. To reduce progression of atherosclerosis.

Initially 5-10 mg once daily. Maintenance: 5-40 mg once daily. Patient w/ high CV risk factor who do not achieve target cholesterol conc at lower class & do not have risk factor for adverse effect Maintenance: 40 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ myopathy. Concomitant use w/ sofosbuvir/velpatasvir/voxilaprevir; ciclosporin. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Discontinue if creatine kinase (CK) levels are markedly elevated (>5 x ULN) or if muscular symptoms are severe & cause daily discomfort; interstitial lung disease is suspected. 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. Proteinuria. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis. Do not measure CK following strenuous exercise or in presence of plausible alternative cause of CK increase. Clinical monitoring is recommended in patients w/ predisposing factors for myopathy/rhabdomyolysis. Immune-mediated necrotising myopathy. Patients consuming excessive quantities of alcohol &/or have history of liver disease. Carry out LFTs prior to & 3 mth following initiation of treatment. Patients w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. DM. Not recommended in combination w/ gemfibrozil; PIs. Contains azo colouring agents [eg, allura red AC (E129) & sunset yellow FCF (E110)] which may cause allergic reactions. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Women of childbearing potential should use appropriate contraception. Paed population. Elderly >70 yr.

GI disturbances.

Plasma conc may be increased & increased risk of myopathy w/ OATP1B1 & BCRP inhibitors. Increased AUC w/ ciclosporin; ezetimibe. Exposure may be strongly increased w/ PIs eg, atazanavir/ritonavir. Increased C_max & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & niacin (≥1 g/day). Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC & C_max w/ erythromycin. May increase INR w/ vit K antagonists eg, warfarin or another coumarin anticoagulant. Increased AUC of ethinylestradiol & norgestrel. May increase risk of myopathy w/ fusidic acid.

Dyslipidaemic Agents

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

Rx