NIKP-Pitavastatin

Hypercholesterolemia & familial hypercholesterolemia. Primary hyperlipidemia & mixed dyslipidemia. Reduction of elevated total cholesterol, LDL-C, Apo B, triglycerides & increase HDL-C & Apo A1 when diet response & other measures are inadequate.

Initially 2 mg once daily. Maintenance dose: 1-4 mg once daily. Max: 4 mg once daily. Concomitant use w/ erythromycin Max: 1 mg daily. Concomitant use w/ rifampicin Max: 2 mg daily. Moderate (GFR 30-59 mL/min/1.73 m²) & severe (GFR 15-29 mL/min/1.73 m²; w/o dialysis) renal impairment & ESRD w/ hemodialysis Initially 1 mg daily. Max: 2 mg daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent evaluations in serum aminotransferase (transaminase) conc. Concomitant use w/ cyclosporine. Women who are or may become pregnant. Nursing women.

Stop medicine & immediately consult a physician when there is muscle pain at the area of gastrocnemius, back or body; serum transaminases level >3x ULN. Not to be used in patients w/ liver disease. Chronic alcoholic or hypothyroidism. May increase risk of blood sugar elevation. Analyze lipid levels after 4 wk after initiation or upon dose titration & adjust dose accordingly. Perform hepatic function test pre/post-dose 6 & 12 mth respectively; monitor every 6 mth. Increased risk of myopathy or rhabdomyolysis w/ concomitant use w/ azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone. Concomitant use w/ digoxin & warfarin; colchicine. Hepatic or renal impairment. Use effective contraception during treatment in women of childbearing potential; discontinue use if patient becomes pregnant while taking the drug. Do not use during pregnancy & lactation. Paed <18 yr. Elderly >75 yr; increased risk of rhabdomyolysis w/ high dose.

Myalgia, back pain, diarrhea, constipation & pain in extremity. Arthralgia, headache, flu & nasopharyngitis; lab abnormalities including increased conc of creatinine kinase, aminotransferases, alkaline phosphatase, bilirubin & glucose.

Increased risk of myopathy/rhabdomyolysis w/ colchicine; fibric acid derivatives (eg, gemfibrozil, fenofibrate); niacin. Decreased peak plasma conc & increased AUC w/ digoxin; enalapril. Increased peak plasma conc & AUC w/ erythromycin; gemfibrozil; fenofibrate; cyclosporine. Decreased peak plasma conc & AUC w/ ezetimibe. Closely monitor prothrombin time & INR w/ warfarin.

Dyslipidaemic Agents

C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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