Rosuvastatin Stella

Rosuvastatin Stella

rosuvastatin

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Concise Prescribing Info
Contents
Rosuvastatin
Indications/Uses
Adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, & triglycerides & increase HDL-C in adults w/ primary hyperlipidemia or mixed dyslipidemia when response to diet & nonpharmacological interventions alone has been inadequate; reduce total-C, LDL-C, & ApoB levels in adolescents 10-17 yr (boys & 1-yr post-menarchal girls) w/ heterozygous familial hypercholesterolemia if LDL-C >190 or >160 mg/dL after an adequate trial of diet therapy & there is +ve family history of premature CV disease (CVD) or ≥2 other CVD risk factors. Adjunct to diet for adults w/ hypertriglyceridemia; primary dysbetalipoproteinemia (type III hyperlipoproteinemia). Adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, total-C, & ApoB in adults w/ HoFH. Adjunct to diet to lower total-C & LDL-C to target levels & slow the progression of atherosclerosis in adults. Reduce risk of stroke, MI & arterial revascularization procedures in individuals w/o clinically evident CHD but w/ increased risk of CVD based on age (men ≥50 yr & women ≥60 yr), hsCRP ≥2 mg/L, & presence of at least 1 additional CVD risk factor eg, HTN, low HDL-C, smoking, or family history of premature CHD.
Dosage/Direction for Use
5-40 mg once daily. Usual starting dose: 10-20 mg. Only use the 40-mg dose for patients who have not achieved their LDL-C goal utilizing the 20-mg dose. Heterozygous familial hypercholesterolemia in adolescent 10-17 yr Individualize dose & adjust at ≥4-wk intervals. Usual dose range: 5-20 mg daily. Max: 20 mg daily. HoFH Initiate w/ 20 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant ciclosporin. Patients w/ myopathy; active liver disease including unexplained, persistent serum transaminase elevations & any elevation >3x ULN; severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation. 40 mg: Patients w/ pre-disposing factors for myopathy/rhabdomyolysis eg, moderate renal impairment (CrCl <60 mL/min), 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 increase in plasma levels may occur, Asian patients, concomitant use of fibrates.
Special Precautions
Proteinuria w/ higher doses. Assessment of renal function should be considered during routine follow-up of patients treated w/ 40-mg dose. Skeletal muscle effects (eg, myalgia, myopathy & rhabdomyolysis) w/ all doses, particularly doses >20 mg. Do not start treatment if creatine kinase levels are significantly elevated at baseline (>5x ULN). Caution in 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, age >70 yr, situations where increase in plasma levels may occur, concomitant use of fibrates). Do not use in any patient w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Perform liver function tests prior to treatment initiation & thereafter when clinically indicated. Increased exposure in Asians. Discontinue therapy in case of interstitial lung disease. Risk of DM. Reports of increased HbA1c & fasting serum glucose levels. Not recommended w/ PIs unless rosuvastatin dose is adjusted. Do not co-administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Women of childbearing potential should use appropriate contraception.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc w/ transporter proteins eg, hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased exposure w/ ciclosporin, PIs, gemfibrozil, ezetimibe. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid-lowering doses (≥1 g/day) of niacin; systemic fusidic acid. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacid. Decreased Cmax & AUC w/ erythromycin. Increased INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increased AUC of ethinyl estradiol & norgestrel.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Rosuvastatin Stella FC tab 10 mg
Packing/Price
3 × 10's
Form
Rosuvastatin Stella FC tab 20 mg
Packing/Price
3 × 10's
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