RiteMed Rosuvastatin

RiteMed Rosuvastatin

rosuvastatin

Manufacturer:

Lek Pharma

Distributor:

RiteMED
Concise Prescribing Info
Contents
Rosuvastatin
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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.
Presentation/Packing
Form
RiteMed Rosuvastatin FC tab 20 mg
Packing/Price
30's (P964.29/box, P32.14/film-coated tab)
Form
RiteMed Rosuvastatin FC tab 10 mg
Packing/Price
30's (P26.79/film-coated tab, P803.57/box)
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