Cholestor

Cholestor

rosuvastatin

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Adjunct to dietary therapy in the management of primary hypercholesterolemia & mixed dyslipidemia; management of hypertriglyceridemia. Management of homozygous familial hypercholesterolemia. Prevention of CV events.
Dosage/Direction for Use
Primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia Initially 10 mg once daily. Patients requiring less aggressive LDL-cholesterol reductions or have predisposing factors for myopathy Initially 5 mg once daily. Max: 40 mg/day. Homozygous familial hypercholesterolaemia Initially 20 mg once daily. Max: 40 mg/day. Hypertriglyceridemia Initially 10 mg once daily. Usual dose range: 5-40 mg/day. Max: 40 mg once daily. Prevention of CV events Initially 5 or 10 mg once daily in both statin-naive patients or patients switched from another HMG-CoA reductase inhibitor. If necessary, dose adjustment to 20 mg can be made after 2-4 wk. Patients w/ severe renal impairment (CrCl <30 mL/min/1.73 m2) who are not undergoing hemodialysis 5 mg once daily. Max: 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained, persistent increase in serum aminotransferase conc. Pregnancy & lactation.
Special Precautions
Women of childbearing age. Discontinue use if muscle pain of calf, back or entire body; serum CK conc become markedly elevated or if myopathy occurs; if increases in AST or ALT conc of ≥3x ULN persist. Perform LFTs before &, at 6- & 12-wk after initiation of therapy & periodically thereafter. Increased risk of rhabdomyolysis in patients w/ renal or hepatic impairment, chronic alcoholism, hypothyroidism, using high doses of rosuvastatin, geriatric patients. Temporarily withhold in patients experiencing an acute, serious condition suggestive of myopathy or predisposing to the development of acute renal failure secondary to rhabdomyolysis (eg, hypotension, sepsis, dehydration, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, uncontrolled seizures). Asian patients. Consider dose reduction in patients who have unexplained persistent proteinuria during routine urinalysis testing. Concomitant use w/ any statins or agents used to lower cholesterol levels or drugs that may decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine); digoxin, warfarin; certain azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine & amiodarone; colchicine (especially in elderly or renal impairment patients).
Adverse Reactions
Myalgia, constipation, asthenia, abdominal pain, & nausea.
Drug Interactions
Decreased plasma conc w/ Al & Mg hydroxide antacids. Potential pharmacodynamic interaction w/ bile acid sequestrant. Increased peak plasma conc & AUC w/ cyclosporine. Increased risk of adverse musculoskeletal effects w/ gemfibrozil. Increased plasma conc of ethinyl estradiol & norgestrel. Increased INR w/ warfarin.
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
Cholestor tab 10 mg
Packing/Price
3 × 10's
Form
Cholestor tab 20 mg
Packing/Price
3 × 10's
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