Pitator

Pitator

pitavastatin

Manufacturer:

Orient Pharma

Distributor:

Zuellig

Marketer:

OEP Phils
Concise Prescribing Info
Contents
Pitavastatin Ca
Indications/Uses
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. Patient taking erythromycin Max: 1 mg once daily, rifampicin Max: 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
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 or 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. Increases in HbA1c & fasting serum glucose level have been reported w/ HMG-CoA reductase inhibitors including pitavastatin. 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.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Pitator FC tab 2 mg
Packing/Price
14's;28's
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