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pravastatin (Rx)Brand and Other Names:Pravachol

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 10mg (generic only)
  • 20mg
  • 40mg
  • 80mg
more...

Hyperlipidemia, Primary Prevention of Coronary Events, Secondary Prevention of Cardiovascular Events

May be beneficial for prophylaxis of cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol.

10-40 mg PO qDay; not to exceed 80 mg/day

Initiate with 10 mg qHS if taking immunosuppressants like cyclosporine concurrently; not to exceed 20 mg/day

Limit maximum to 40 mg/day if taking concurrently with clarithromycin

Dose adjustments should be made at intervals of 4 weeks or more; individualize dosing according to baseline LDL cholesterol levels

Dosing Considerations

Overdose management

  • Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFTs, eye lens opacities
  • Treatment is supportive

Dosing Modifications

Renal impairment

  • 10 mg PO qDay initially

Hepatic impairment

  • Contraindicated if active liver disease or unexplained persistent elevations of serum transaminases

Dosage Forms & Strengths

tablets

  • 10mg (generic only)
  • 20mg
  • 40mg
  • 80mg
more...

Heterozygous Familial Hypercholesterolemia

8-13 years: 20 mg PO qDay

14-18 years: 40 mg PO qDay

Coadministration with cyclosporine: Initiate with 10 mg qHS; not to exceed 20 mg/day

Limit maximum to 40 mg/day if taking concurrently with clarithromycin

Dose adjustments should be made at intervals of 4 weeks or more; individualize dosing according to baseline LDL cholesterol levels

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Interactions

Interaction Checker

pravastatin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea/vomiting (7%)

            Diarrhea (6%)

            Headache (2-6%)

            Chest pain (4%)

            Fatigue (4%)

            Rash (4%)

            Cough (3%)

            Heartburn (3%)

            Flulike symptoms (2%)

            Myalgia (2%)

            Frequency Not Defined

            Myopathy

            Rhabdomyolysis

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            Warnings

            Contraindications

            Hypersensitivity

            Active liver disease, elevated LFTs

            Pregnancy, lactation

            Cautions

            Nonserious and reversible cognitive side effects may occur

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

            Risk of rhabdomyolysis; predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment; discontinue if myopathy develops

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

            Max response 4-6 weeks

            Recent liver disease, symptoms of liver disease

            Heavy alcohol use

            Use caution with other drugs that increase risk of myopathy (eg, fibrates)

            Rule out secondary causes of hyperlipedemia before initiating therapy

            Monitor liver function periodically

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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Enters breast milk; 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.

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            Pharmacology

            Mechanism of Action

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

            Absorption

            Bioavailability: 17%

            Onset: 2 weeks

            Peak effect: 4 weeks

            Peak serum time: 1-1.5 hr

            Distribution

            Protein bound: 43-55%

            Vd: 0.46 L/kg

            Metabolism

            Undergoes extensive first-pass extraction by liver

            Metabolites: 3-alpha-hydroxy isomer and 3-alpha, 5-beta, 6-beta trihydroxy metabolite (inactive)

            Elimination

            Half-life: 2.6-3.2 hr

            Excretion: Feces (71%); urine (<20%)

            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 reduce 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)
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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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