Orient Pharma




OEP Phils
Concise Prescribing Info
Pitavastatin Ca
Adjunct to diet for reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, triglyceride & to increase HDL cholesterol in adult patients w/ primary hyperlipidemia or mixed dyslipidemia when diet response & other nonpharmacological measures are inadequate.
Dosage/Direction for Use
Individualized dosage. 1-4 mg once daily. Recommended starting dose: 2 mg. Max: 4 mg. Moderate & severe renal impairment (GFR 30-59 mL/min/1.73 m2 & 15-29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving hemodialysis 1 mg once daily. Max: 2 mg once daily. Patients taking erythromycin Max: 1 mg once daily, rifampicin Max: 2 mg once daily.
May be taken with or without food.
Hypersensitivity. Active liver disease eg, unexplained persistent elevations of hepatic transaminase levels. Co-administration w/ cyclosporine. Pregnancy & lactation.
Special Precautions
Perform liver function test prior to initiation. Cases of myopathy & rhabdomyolysis; immune-mediated necrotizing myopathy. Predisposing factors for rhabdomyolysis (eg, hyperthyroidism). Alcohol consumption. Unexplained muscle pain, tenderness or weakness accompanied by malaise of fever. Concomitant use w/ fibrates or lipid-modifying doses of niacin; colchicine. Discontinue use if markedly elevated creatinine kinase levels, diagnosed or suspected myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis occurs. Endocrine function. Use effective contraception during treatment in females of reproductive potential. Renal impairment. Childn. Elderly.
Adverse Reactions
Rhabdomyolysis accompanied by myoglobinuria & acute renal failure & myopathy (including myositis); liver enzyme abnormalities. Arthralgia, headache, influenza & nasopharyngitis. Elevated creatine phosphokinase, hepatic transaminases, alkaline phosphatase, bilirubin & glucose. Rash, pruritus & urticaria.
Drug Interactions
Increased exposure w/ cyclosporine, erythromycin & rifampin. Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, colchicine & other fibrates. Enhanced risk of skeletal muscle effects w/ niacin.
ATC Classification
C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Pitator FC tab 2 mg
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