Rovastar

Rovastar

rosuvastatin

Manufacturer:

Interbat

Marketer:

Interbat
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet & exercise. Reduction of elevated LDL-cholesterol, total cholesterol, triglycerides & apolipoprotein B & increase in HDL-cholesterol. Homozygous familial hypercholesterolaemia as an adjunct to diet & other lipid-lowering treatment (eg, LDL apheresis).
Dosage/Direction for Use
10-mg tab Statin naïve patients or patients switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily, may be increased to the next dose level after 4 wk. Severe hypercholesterolaemia at high CV risk Max dose: 40 mg. Severe renal impairment (CrCl < 30 mL/min/1.73 m2) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Elderly >70 yr & patient w/ predisposing factors to myopathy Initially 5 mg. 20-mg tab 20 mg once daily. If needed, max: 40 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 x ULN; myopathy; concomitant cyclosporin therapy. Women of childbearing potential, pregnancy & lactation. 20 mg: Concomitant use of fibrates w/ the 40-mg dose.
Special Precautions
Consider renal function assessment during routine follow-up in patients treated w/ 40-mg dose. Patients who consume excessive quantities of alcohol &/or have a history of liver disease; w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. Perform liver function tests prior to initiation of therapy & 3 mth later. Report promptly any inexplicable muscle pain, weakness or cramps, particularly if associated w/ malaise or fever. Patients w/ predisposing factors for myopathy/rhabdomyolysis. 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, situations where an increase in plasma levels may occur, concomitant use of fibrates. Additional neuromuscular & serologic testing may be necessary. Increased HbA1c & serum glucose level. Concomitant administration w/ products that interact w/ protein transporter (eg, OATP1B1 & BCRP). Patients known to have the c.521CC or c.421AA genotype. May impair ability to drive or operate machinery. Childn. Elderly >70 yr. 10 mg: Monitor marked creatinine kinase elevation. 20 mg: Discontinue therapy in markedly elevated creatinine kinase or if muscular symptoms are severe & cause daily discomfort. Patients at high risk for developing diabetes; Asian patients.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Increased rosuvastatin exposure w/ SLCO1B1 (OATP1B1) c.521CC & ABCG2 (BCRP) c.421AA. 10 mg: Vit K antagonists, gemfibrozil (need dose adjustment) & other lipid-lowering agents, cyclosporine, erythromycin, OC/hormone replacement therapy. Increased rosuvastatin exposure w/ protease inhibitors. Increased risk of myopathy w/ transporter protein inhibitors eg, ritonavir, atazanavir, lopinavir, darunavir, tipranavir, fosamprenavir. Ezetimibe. Eltrombopag. Dronedarone. Itraconazole. Aleglitazar. Silyramin. Fenofibrate. Rifampin. Ketoconazole. Fluconazole. 20 mg: Increased plasma conc & increased risk of myopathy w/ inhibitors of OATP1B1 & BCRP transporters. Increased AUC w/ PIs (eg, atazanavir, ritonavir). Increased Cmax & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & niacin. Increased AUC w/ ezetimibe in hypercholesterolaemic subjects. Decreased Cmax & AUC w/ erythromycin. Increased AUC w/ simeprevir, clopidogrel, lopinavir, eltrombopag, darunavir, tipranavir, dronedarone, itraconazole. Decreased AUC w/ baicalin. May either increase or decrease INR in patients taking vit K antagonists (eg, warfarin). Increased AUC of 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
Rovastar FC tab 10 mg
Packing/Price
3 × 10's (Rp300,000/boks)
Form
Rovastar FC tab 20 mg
Packing/Price
30's
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