Patients with a known hypersensitivity to any component of this products. Pitavastatin is contraindicated in patients with active liver disease , which may include unexplained persistent elevations of hepatic transaminase levels.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
HMG-CoA reductase inhibitor, inhibits rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase
Interaction
Increased bioavailability w/ erythromycin and rifampicin. Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, colchicine, niacin and other fibrates.
Potentially Fatal: Ciclosporin significantly increases pitavastatin exposure.
Pregnancy Category Note
Pregnancy
Contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy during pregnancy; therapy should be discontinued as soon as pregnancy is recognized
May cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during therapy
Lactation
Contraindicated during breastfeeding; there is no available information on effects of drug on breastfed infant or effects of drug on milk production; however, another drug in this class passes into human milk; because of potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment
Adult Dose
Oral
Hypercholesterolemia
Adult: 2 mg once daily.
May increase to 4 mg qDay if necessary.
Hepatic Impairment
Contraindicated in active liver disease or unexplained transaminase elevations
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment: Moderate to severe (CrCl 15-60 mL/min, not on haemodialysis) and ESRD (on haemodialysis): Initial: 1 mg once daily. Max: 2 mg once daily.
Administration
May be taken with or without food.
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