Ingredients in every tablet
Each package contains
|ATC Level 1||C - Cardiovascular system|
|ATC Level 2||C10 - Lipid Modifying Agents|
|ATC Level 3||C10A - Lipid Modifying Agents; Plain|
FOR ALL AGES
The dose range for pitavastatin is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. The starting dose and maintenance doses of pitavastatin should be individualized according to patient characteristics, such as goal of therapy and response. After initiation or upon titration of pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.
PATIENTS WITH RENAL IMPAIRMENT
Patients with moderate and severe renal impairment (glomerular filtration rate 30 – 59 ml/minute/1.73 m2 and 15 – 29 ml/minute/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving hemodialysis should receive a starting dose of pitavastatin 1 mg once daily and a maximum dose of pitavastatin 2 mg once daily.
USE WITH ERYTHROMYCIN
In patients taking erythromycin, a dose of pitavastatin 1 mg once daily should not be exceeded.
USE WITH RIFAMPIN
In patients taking rifampin, a dose of pitavastatin 2 mg once daily should not be exceeded.
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 nonpharmacological measures has been inadequate.
1. Primary hyperlipidemia 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 Adults patients with primary hyperlipidemia or mixed dyslipidemia.
2. Limitations of use
Doses of pitavastatin greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg 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.