Roswin

Rosuvastatin

Patients w/ primary hypercholesterolemia type IIa including heterozygous familial hypercholesterolemia or mixed dyslipidemia type IIIb as an adjunct to diet when response to diet & exercise is inadequate. Reduces elevated LDL-cholesterol, total cholesterol, triglycerides & Apo B & increases HDL-C. Patients w/ homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatment eg, LDL aphaeresis.

Individualized dosage. Statin naive or patient switching from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily. Dose adjustment can be made after 4 wk. Patient w/ severe hypercholesterolemia at high CV risk or w/ familial hypercholesterolemia Max: 40 mg. Elderly >70 yr Initially 5 mg once daily. Severe renal impairment CrCl <30 mL/min/1.73 m² not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Hepatic impairment Child-Pugh 8-9 Max: 20 mg daily. Asian Initially 5 mg daily. Max: 20 mg once daily. Patient w/ predisposing factors to myopathy Initially 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease eg, unexplained, persistent elevations & any serum tranaminase elevation exceeding 3 times the upper limit of normal; myopathy; receiving concomitant cyclosporine. During pregnancy & lactation & in women of childbearing potential not using appropriate contraceptive measures.

Patients who consume excessive quantities of alcohol &/or have history of liver disease. Carry out liver function tests prior to & 3 mth following the initiation of treatment. Discontinue treatment or reduce the dose if the level of serum transaminases is >3 times the upper limit of normal. Patients w/ secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Skeletal muscle effects eg, uncomplicated myalgia, myopathy & rarely rhabdomyolysis in patients treated w/ >20 mg dose. Patients should report inexplicable muscle pain or weakness immediately particularly if associated w/ malaise or fever. Measure creatinine kinase levels. Discontinue treatment if creatinine kinase levels >5 times the upper limit of normal or if muscular symptomes are severe & caused daily discomfort even if creatinine kinase levels ≤5 times the upper limit of normal. Treatment should not be initiated if repeat test confirms baseline creatinine kinase levels >5 times the upper limit of normal. Concomitant use w/ fibrate in 40 mg dose treatment is contraindicated. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, elderly >70 yr, cases that may increase plasma levels & concomitant use w/ fibrate. Not to be used in patients w/ acute serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures. Increased HbA1c & serum glucose levels. Patients at high risk for developing for diabetes. Dizziness may occur that may impair ability to drive & operate machinery. Discontinue treatment during pregnancy.

Headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

Increased INR in patients treated concomitantly w/ vit K antagonists eg, warfarin. Concomitant use w/ gemfibrozil may result to 2-fold increase in C_max & AUC. Increased risk of myopathy w/ concomitant use w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses ≥1 g/day of niacin. Increased plasma conc in patients treated w/ protease inhibitors. Concomitant treatment w/ cyclosporin. Decreased plasma conc of approximately 50% w/ concomitant use of antacid susp containing Al & Mg hydroxide. Co-administration w/ itraconazole may increase AUC by 28%. Concomitant use w/ erythromycin may decrease AUC_(0-t) by 20% & C_max by 30% due to increased gut motility by erythromycin. Concomitant use w/ OCs may increase ethinyl estradiol & norgestrel AUC by 26-34% respectively.

Dyslipidaemic Agents

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

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