Rozact

Rozact

rosuvastatin

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Patients w/ primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet & exercise is inadequate; homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatments eg, LDL aphaeresis. Reduction of elevated LDL-cholesterol, total cholesterol, triglycerides & apolipoprotein B & increase in HDL-cholesterol.
Dosage/Direction for Use
Individualized dosage. Initially 5 or 10 mg once daily in both statin naive patients or patients switched from another HMG-CoA reductase inhibitor, may be adjusted to the next dose level after 4 wk, if necessary. Patient w/ severe hypercholesterolaemia at high CV risk Max: 40 mg. Elderly >70 yr, patient w/ predisposing factors to myopathy & Asian patient Initially 5 mg. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Patient w/ hepatic impairment (Child-Pugh score 8 & 9) Max: 20 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patient w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 times the upper limit of normal; myopathy. Receiving concomitant cyclosporine. Pregnancy & lactation & women of childbearing potential not using appropriate contraceptive measures.
Special Precautions
Proteinuria in patients treated w/ higher doses. Consider renal function assessment during routine follow-up in patients treated w/ 40 mg dose. Effects on skeletal muscle eg, myalgia, myopathy & rarely rhabdomyolysis. Treatment should not be initiated if repeat test confirms baseline creatinine kinase >5 times the upper limit. Patients w/ predisposing factors for myopathy/rhabdomyolysis. 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. Patients should be advised to report promptly any inexplicable muscle pain, weakness or cramps, particularly if associated w/ malaise or fever. Discontinue therapy in markedly elevated creatinine kinase or if muscular symptoms are severe & cause daily discomfort. Additional neuromuscular & serologic testing may be necessary. Treatment w/ immunosuppressive agents may be required. Not to be use in patients w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolisis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures. 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. Increased HbA1c & serum glucose level. Increased exposure w/ Asian patients. May impair ability to drive or operate machinery due to dizziness. Renal impairment. Childn. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc & risk of myopathy w/ inhibitors of OATP1B1 & BCRP transporters. Increased exposure w/ PIs. Increased Cmax & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & niacin. Increased AUC w/ ezetimibe in hypercholesterolaemic patients. Decreased plasma conc of approximately 50% w/ antacid susp containing Al & Mg hydroxide. Decreased AUC by 20% & Cmax by 30% 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 or another coumarin anticoagulant). Increased plasma levels of ethinyl estradiol & norgestrel. Increased exposure in patients known to have the c.521CC or c.421AA genotype.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Rozact FC tab 10 mg
Packing/Price
3 × 10's
Form
Rozact FC tab 20 mg
Packing/Price
3 × 10's
Form
Rozact FC tab 40 mg
Packing/Price
3 × 10's
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