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gemfibrozil (Rx)Brand and Other Names:Lopid

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 600mg
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Hypertriglyceridemia, Hypercholesterolemia

600 mg PO q12hr

Administration: 30 min before morning & evening meals

Dosing Considerations

Monitor: Serum lipoproteins

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

Overdose management

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

Dosing Modifications

Renal impairment

  • Mild to moderate: Use caution, if baseline serum creatine in patient is >2mg/dL; deterioration of renal function reported in such patients
  • Severe: Contraindicated

Hepatic impairment

  • Contraindicated

Safety and efficacy not established

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Interactions

Interaction Checker

gemfibrozil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dyspepsia (20%)

            1-10%

            Abdominal pain (10%)

            Atrial fibrillation (1%)

            Diarrhea (7%)

            Fatigue (4%)

            N/V (3%)

            Eczema (2%)

            Rash (2%)

            Vertigo (2%)

            Constipation (1%)

            Headache (1%)

            <1%

            Myalgia

            Rhabdomyolysis (especially with admin with statin)

            Acute appendicitis

            Cholelithiasis

            Angioedema

            Hypokalemia

            Eosinophilia

            Myopathy

            Synovitis

            Taste disturbance

            Xerostomia

            Flatulence

            Rash

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            Warnings

            Contraindications

            Hypersensitivity

            Severe liver/renal disease

            Primary biliary cirrhosis

            Preexisting gallbladder disease

            Coadministration with repaglinide, simvastatin, or dasabuvir

            Cautions

            If response inadequate after 3 months, discontinue gemfibrozil

            Risk for myopathy/rhabdomyolysis increases with renal impairment

            Risk for myopathy/rhabdomyolysis increases with concurrent HMG-CoA reductase inhibitors use (eg, atorvastatin, pravastatin)

            If coadministered with anticoagulants, reduce anticoagulant dose and monitor prothrombin time until stabilized

            Coadministration with bile acid resin binding agents decreases gemfibrozil AUC by 30%

            May increase risk of malignancy

            Rule out secondary causes of hyperlipidemia prior to initiating therapy; discontinue if lipid response not seen

            Use with caution in patients taking warfarin; adjustments in warfarin may be required

            Cases of cholelithiasis reported with gemfibrozil therapy; gemfibrozil may increase cholesterol excretion into bile; if cholelithiasis suspected, perform gallbladder studies; discontinue therapy if gallstones found

            Coadministration with repaglinide shown to increase repaglinide plasma concentrations (8-fold increase); prolongs hypoglycemic effect; may result in severe hypoglycemia

            Gemfibrozil inhibits CYP2C8 enzyme activity; may increase exposure of CYP2C8 substrates; consider dose reduction of CYP2C8 substrates when administered concomitantly

            Gemfibrozil may increase exposure of OATP1B1 drug substrates when administered concomitantly; consider dose reduction of OATP1B1 substrates when administered concomitantly

            Myopathy, including rhabdomyolysis, reported with chronic administration of colchicine at therapeutic doses; use caution, especially in the elderly and patients with renal dysfunction

            Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia reported; periodic blood counts are recommended during first 12 months of therapy

            Elevations in serum transaminases seen with use; periodic liver function studies recommended; therapy should be terminated if abnormalities persist

            Worsening renal insufficiency upon addition of therapy in individuals with baseline plasma creatinine >2.0 mg/dL reported; in such patients, consider the use of alternative therapy against risks and benefits of a lower dose of metformin

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Not recommended

            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

            Inhibits peripheral lipolysis; decreases hepatic uptake of free fatty acids, which may in turn inhibit secretion of VLDL; may increase HDL-cholesterol (mechanism unknown)

            Absorption

            Peak serum time: 1-2 hr

            Distribution

            Protein bound: 99%

            Metabolism

            Enterohepatic circulation

            Elimination

            Half-life: 1.5 hr

            Excretion: Urine (70%); feces (6%)

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            Formulary

            FormularyPatient Discounts

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            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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