Otagil 10/Otagil 20

Rosuvastatin Ca

Adjunct to diet for reduction of elevated total-C, LDL-C, Apo B, total-C: HDL-C & triglycerides & for increasing HDL-C in hyper- & dyslipidemic conditions. Reduce total mortality & risk of major CV events in adults w/ increased risk of atherosclerotic CV disease based on presence of CV disease risk markers. Adjunct to diet for dysbetalipoproteinemia (type III hyperlipoproteinemia). Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia & severe non-familial hypercholesterolemia); combined (mixed) dyslipidemia (type IIb); HoFH. Adjunctive therapy to diet to slow progression of atherosclerosis in adults as part of treatment strategy to lower total-C & LDL-C to target levels. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in adolescents at least 1 yr post-menarche, 10-17 yr w/ heterozygous familial hypercholesterolaemia (HeFH).

Initially 10 mg once daily. Patient requiring less aggressive LDL-C reductions, w/ predisposing factors to myopathy, Asian patient Initially 5 mg once daily. Severe hypercholesterolemia at high CV risk including w/ familial hypercholesterolemia Increased to 40 mg once daily. Severe renal impairment not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Ped patient 10-17 yr w/ HeFH 5-20 mg daily. Dose adjustments should be made at ≥4-wk interval. Max: 20 mg daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases >3 times ULN; myopathy. Concomitant use w/ cyclosporin. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Discontinue use if markedly elevated creatine kinase (>5 x ULN) occurs or if muscular symptoms are severe; ILD is suspected. Not to be used in patients 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. Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders or toxicity w/ another HMG-CoA reductase inhibitor or fibrate, situations where increased plasma levels occur. Risk factors for DM eg, fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN. Assess renal function during routine follow-up. Perform LFTs prior to & 3 mth following initiation. Patients w/ specific types of genetic polymorphisms increasing rosuvastatin exposure. Asian patients. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in combination w/ gemfibrozil. Concomitant use w/ fibrates, fibric acid derivatives eg, ciclosporin, nicotinic acid, azole antifungals, PIs, macrolides. Excessive alcohol consumption, history of hepatic disease. Severe renal impairment. Women of childbearing potential should use effective contraception. Childn <10 yr. Elderly >70 yr.

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

Increased plasma conc w/ OATP1B1 & BCRP inhibitors. Increased risk of myopathy w/ ciclosporin, gemfibrozil, fenofibrate, other fibrates, niacin ≥1 g daily. Increased exposure w/ PIs. Increased AUC w/ ezetimibe. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacid susp. Muscle-related events w/ fusidic acid. Decreased AUC & C_max w/ erythromycin. Severe myositis & myoglobinuria w/ fibrates. Increased INR w/ vit K antagonists. Increased AUC of ethinyl estradiol, norgestrel.

Dyslipidaemic Agents

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

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