CLINICAL PHARMACOLOGY Mechanism of Action:
Pitavastatin competitively inhibits HMG-CoA reductase, which is a
rate-determining enzyme involved with biosynthesis of cholesterol, in a manner
of competition with the substrate so that it inhibits cholesterol synthesis in
the liver. As a result, the expression of LDL-receptors followed by the uptake
of LDL from blood to liver is accelerated and then the plasma TC decreases.
Further, the sustained inhibition of cholesterol synthesis in the liver
decreases levels of very low density lipoproteins.
INDICATIONS AND USAGE
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.
Primary Hyperlipidemia and Mixed Dyslipidemia:
LIVALO® 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 LIVALO 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 LIVALO.
The effect of LIVALO on cardiovascular morbidity and mortality has not been
LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.
DOSAGE AND ADMINISTRATION General Dosing Information:
The dose range for LIVALO 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 LIVALO should be
individualized according to patient characteristics, such as goal of therapy and
After initiation or upon titration of LIVALO, lipid levels should be analyzed
after 4 weeks and the dosage adjusted accordingly.
Dosage in Patients with Renal Impairment:
Patients 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 LIVALO
1 mg once daily and a maximum dose of LIVALO 2 mg once daily.
Use with Erythromycin:
In patients taking erythromycin, a dose of LIVALO 1 mg once daily should
not be exceeded.
Use with Rifampin:
In patients taking rifampin, a dose of LIVALO 2 mg once daily should not
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The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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