Vitor

Indonesia • Dexa Medica

Indication

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
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 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.

Composition

Pitavastatin 2 mg

Package

3 blisters of 10 tablets

Dosage Forms

Tablet

ATC Classification

C10A

Warning

Alcohol
Caution
This item may not be safe for use with alcohol. Use with caution and after consultation with your doctor.
Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.

Dosage

For All Ages

General dosing information:
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 Rifampin

In patients taking rifampin, a dose of pitavastatin 2 mg once daily should not be exceeded.

Use with Erythromycin

In patients taking erythromycin, a dose of pitavastatin 1 mg once daily should not be exceeded.

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