Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacologocal measures has been inadequate. Primary Hypercholesterolemia and Mixed Dyslipidemia: Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B,) triglycerides (TG) and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Limitations of Use: Doses of Pitavastatin greater than 6mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4mg once daily dosing of Pitavastatin. The effect of Pitavastatin on cardiovascular morbidity and mortality has not been determined. Pitavastatin has not been studied in Fredrickson Type I,III and V dyslipidemias.

This is not a substitute for consulting your doctor. Seek professional advice if you are experiencing any illness or symptoms.

General Dosing Information: The dose range for Pitavatatin is 1 to 4mg orally once daily at any time of the day with or without food. The recommended starting dose is 2mg and the maximum dose is 4mg. The starting dose and maintenance doses of Pitavastatin should be individualized according to patient characteristics, such as goal of therapy and response. After intiation or upon titration of Pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly. Dosage in Patients with Renal Impairment: Patient with moderate and severe renal impairment (glomerular filtration rate 30-59 mL/min/1.73 m2 and 15-29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving hemodialysis should receive a starting dose of Pitavatatin 1mg once daily and a maximum dose of Pitavastatin 2mg once daily. Use with Erythromycin: In patient taking erythromycin, a dose of Pitavastatin 1mg once daily should not be exceeded. Use with Rifampin: In patients taking rifampin, a dose of Pitavastatin 2mg once daily should not be exceeded. Or as prescribed by the physician.

May be taken with or without food.