RiteMed Rosuvastatin

RiteMed Rosuvastatin



Lek Pharma


Concise Prescribing Info
Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet & other treatment is inadequate. Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate.
Dosage/Direction for Use
Individualized dosage. May be given at any time of the day. Adult Hypercholesterolemia Statin naive or patients switched from another HMG CoA reductase inhibitor Initially 5 or 10 mg once daily, may be adjusted dose after 4 wk. Severe hypercholesterolemia high risk CV risk Max: 40 mg. Childn & adolescent 10-17 yr (boys Tanner Stage ≥II & girls at least 1 yr post-menarche) Initially 5 mg daily. Usual dose: 5-20 mg once daily. Max: 20 mg. Elderly >70 yr Initially 5 mg. Asian & patient w/ predisposing factors to myopathy Initially 5 mg. Moderate renal impairment (CrCl <60 mL/min) Initially 5 mg.
May be taken with or without food.
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 times the upper limit of normal. Severe renal impairment; myopathy. Ciclosporin. Doses >40 mg in patients w/ predisposing factors for myopathy/rhabdomyolysis [moderate renal impairment (CrCl <60 mL/min), hypothyroidism, family history of muscular disorder & muscular toxicity w/ another HMG CoA reductase inhibitor or fibrate, alcohol abuse, Asian patients, fibrates]. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Proteinuria; myalgia, myopathy, rhabdomyolysis (rarely); interstitial lung disease (long-term therapy); risk of DM. Patients w/ predisposing factors for myopathy/rhabdomyolysis; history of liver disease; secondary hypercholesterolemia. Report immediately if inexplicable muscle pain, weakness or cramps occur, particularly if associated w/ malaise or fever. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Perform confirmatory test w/in 5-7 days if creatinine kinase (CK) levels is elevated; discontinue CK levels if markedly elevated (>5x ULN). Require liver function test prior to & 3 mth following treatment. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ gemfibrozil, ciclosporin, nicotinic acid, azoles, PIs & macrolides. Excessive alcohol consumption. Dizziness may occur when driving or operating machines. Asian patients. Pregnancy & lactation. Not recommended for childn <10 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia; proteinuria; myalgia, myopathy (including myositis), increased creatine kinase & transaminases.
Drug Interactions
Increased AUC w/ ciclosporin. May increase INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increased Cmax & AUC w/ gemfibrozil & other lipid-lowering products. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin. 40-mg dose is contraindicated w/ fibrate. Increase exposure w/ PIs. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC(0-t) & Cmax w/ erythromycin. My increase AUC of OCs/hormone replacement therapy eg, ethinyl estradiol & norgestrel.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
RiteMed Rosuvastatin FC tab 20 mg
30's (P964.29/box, P32.14/film-coated tab)
RiteMed Rosuvastatin FC tab 10 mg
30's (P26.79/film-coated tab, P803.57/box)
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