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pitavastatin (Rx)Brand and Other Names:Livalo

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg
  • 4mg

Hypercholesterolemia

2 mg PO qDay

May increase to 4 mg PO qDay if necessary

Renal Impairment

Moderate-to-severe (CrCl 15-60 mL/min/1.73 m²): 1 mg PO qDay initially; not to exceed 2 mg PO qDay

End stage renal disease: 1 mg PO qDay initially; not to exceed 2 mg PO qDay

Hepatic Impairment

Contraindicated in active liver disease or unexplained  transaminase elevations

Safety and efficacy not established

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Interactions

Interaction Checker

pitavastatin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Constipation

            Diarrhea

            Back pain

            Joint pain

            Myalgias

            Myopathy

            Rhabdomyolysis

            Increased alkaline phosphatase

            Increased bilirubin

            Increased CPK

            Increased blood glucose

            Reversible amnesia

            Memory impairment

            Hyperglycemia

            Confusion

            Pruritus

            Urticaria

            Rash

            Nasopharyngitis

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            Warnings

            Contraindications

            Hypersensitivity

            Active liver disease or persistent unexplained elevations of hepatic transaminases

            Pregnancy

            Breastfeeding

            Concurrent use wit cyclosporine

            Cautions

            Non-serious and reversible cognitive side effects may occur

            Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake

            Caution in history of liver or renal impairment

            If symptoms of hepatotoxicity (hyperbilirubinemia or jaundice) occurs, discontinue therapy; if no alternate etiology explains the symptoms do not restart therapy

            Heavy alcohol use

            Risk of rhabdomyolysis

            Myopathy, risk of myopathy increases when coadministered with fibrates, niacin, cyclosporine, colchicine, and CYP2C9 inhibitors (eg, fluconazole, gemfibrozil, nevirapine, sulfisoxazole)

            Withhold or discontinue if myopathy develops, renal failure, or transaminase levels >3x ULN

            Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persist despite discontinuing statin

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            HMG-CoA reductase inhibitor, inhibits rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase

            Absorption

            Bioavailability: 51%

            Peak Plasma Time: 1 hr

            Onset: 2-4wks

            Distribution

            Protein Binding: >99%

            Metabolism

            Metabolism: Hepatic via UGT1A3 and UGT2B7; minimally through CYP2C9 and OATP1B1

            Elimination

            Half-Life: 12 hr

            Excretion: Feces (79%); urine (15%)

            Pharmacogenomics

            SLCO1B1 (OATP1B1) CC genotype significantly increases AUCs of parent drug and metabolites compared with the CT or TT genotypes

            This polymorphism is proposed to reduced transport into the liver, the main site of statin metabolism and elimination, resulting in elevated plasma concentrations

            SLCO1B1 polymorphism is thought to have a lesser effect on the more hydrophilic statins (eg, rosuvastatin, fluvastatin) compared with more those that are more lipophilic (eg, atorvastatin, pravastatin, simvastatin)

            Other genetic polymorphisms of elimination (eg, CYP450, P-glycoprotein) for each individual drug must also be considered to explain variability for statin clearance among patients that exhibit SCLO1B1 polymorphism

            SLCO1B1 CC genotype is most common in Caucasians and Asians (15%)

            Risk of myopathy is 2.6- to 4.3-fold higher if the C allele is present and 16.9-fold higher in CC homozygotes compared with TT homozygotes

            Genetic testing laboratories

            • Optivia Biotechnology, Inc (http://optiviabio.com/index.html)
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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