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    Pharmacoepidemiolog Y & Public Health Pharmacy: Troglitazon E

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    Muhammad Fuad Aris
    Member of thiazolidinedione drug class Also known Rezulin(r) and Romazin(tm) introduced in late 6 / 5 / 12 1990 as antidiabetic agent that lower blood glucose by improving target cell response to insulin. United Kingdom withdrew troglitazone from its market in December 1997 after its adverse effects on the liver.

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    Pharmacoepidemiolog Y & Public Health Pharmacy: Troglitazon E

    Uploaded by

    Muhammad Fuad Aris
    27 views32 pages
    Member of thiazolidinedione drug class Also known Rezulin(r) and Romazin(tm) introduced in late 6 / 5 / 12 1990 as antidiabetic agent that lower blood glucose by improving target cell response to insulin. United Kingdom withdrew troglitazone from its market in December 1997 after its adverse effects on the liver.

    Original Title

    What is Troglitazone

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    Member of thiazolidinedione drug class Also known Rezulin(r) and Romazin(tm) introduced in late 6 / 5 / 12 1990 as antidiabetic agent that lower blood glucose by improving target cell response to insulin. United Kingdom withdrew troglitazone from its market in December 1997 after its adverse effects on the liver.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    27 views32 pages

    Pharmacoepidemiolog Y & Public Health Pharmacy: Troglitazon E

    Uploaded by

    Muhammad Fuad Aris
    Member of thiazolidinedione drug class Also known Rezulin(r) and Romazin(tm) introduced in late 6 / 5 / 12 1990 as antidiabetic agent that lower blood glucose by improving target cell response to insulin. United Kingdom withdrew troglitazone from its market in December 1997 after its adverse effects on the liver.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 32

    PHARMACOEPIDEMIOLOG Y & PUBLIC HEALTH PHARMACY

    TROGLITAZON E

    6/5/12

    INTRODUCTION

    ADVERSE DRUG REACTION REPORTS OF TROGLITAZON E

    MECHANISM OF ACTION

    CONTEN T
    PHARMACOVIGELENC E/POST MARKETING SURVEILLENCE

    6/5/12

    ADVERSE DRUG REACTION OF TROGLITAZON E

    What is Troglitazone ?

    6/5/12

    Member of thiazolidinedione drug class Also known Rezulin , Resulin and Romazin.

    Introduce in late 6/5/12 1990 as

    Who developed and manufactured ?

    6/5/12

    Developed by a Japanese company, Daiichi Sankyo Co., Ltd.

    Manufactured in the United States through ParkeDavis after being approved by the U.S. Food and Drug 6/5/12 Administration

    What Troglitazone do ?

    6/5/12

    In early manufactured as thiazolinedine antidiabetic agent that lower blood glucose by improving target cell response to insulin. Mechanism of action is dependent on presence of insulin for activity. Decrease hepatic glucose output and increase insulin dependent glucose disposal in skeletal muscle.

    6/5/12

    BUT!!!

    United Kingdom withdrewtroglitazonefrom its market in December 1997 after its adverse effects on the liver. U.S. purged the drug from its market in 2000.

    6/5/12

    Mechanism of Action

    6/5/12

    6/5/12

    Pharmacodynamic

    6/5/12

    6/5/12

    Pharmacokinetic

    6/5/12

    DISTRIBUTION
    v

    Troglitazone is extensively bound ( > 99%) toserum albumin. Mean apparent volume of distribution (V/F) of troglitazone following multiple-dose administration ranges from 10.5 to 26.5 Ukg of body weight.

    6/5/12

    ABSORPTION
    v

    Troglitazone is rapidly absorbed and given by oral administration. the time for maximum plasma concentration (tmax) occurs within 2 to 3 hours. of

    Food increases the extent absorption by 30% to 85%. 6/5/12

    METABOLISM
    v

    Sulfation and glucuronidation is the major routes of metabolism of troglitazone Thus, the major metabolites found in the plasma were the sulfate conjugate (Metabolite 1) followed by the quinone metabolite (Metabolite 3)

    6/5/12

    EXCRETION
    v

    Majority of the active drug and metabolites of pioglitazone are excreted in the bile and eliminated in the feces. Renal elimination is negligible. The metabolites of rosiglitazone are primarily excreted in the urine.

    6/5/12

    Pharmacovigilance/Post marketing surveillence

    6/5/12

    Troglitazone : Approval to Withdrawal

    Click to edit Master subtitle style

    6/5/12

    6/5/12

    6/5/12

    6/5/12

    Comparison of reported cases (n) of severe hepatitis, liver transplant and death related to troglitazone, rosiglitazone or pioglitazone therapy in type 2 diabetic patients

    6/5/12

    ADVERSE DRUG REACTION OF TROGLITAZONE

    6/5/12

    1.

    Hepatot oxicity
    Click to edit Master subtitle style

    q
    6/5/12

    Hepatic side

    4. Metabolic effects
    q

    Metabolic side effects including small changes in lipid levels

    5. Hematologic disorders
    q

    Small decreases in hemoglobin, hematocrit, and neutrophil counts Typically occur in the first four to eight weeks of therapy and may be related to an increase in plasma volume.

    6. Others
    6/5/12

    BENEFITS OF TROGLITAZONE
    v

    Type II diabetes mellitus drug

    v Anti-inflammatory drug

    v Promotes ovulation

    6/5/12

    RISK OF TROGLITAZONE
    1.

    Kidney disease Heart failure Thyroid disease Type 1 diabetes mellitus (insulin-dependent diabetes) have a serious infection, illness, or injury

    1.

    1.

    1.

    1.

    *may need to lower the dosage*


    . Troglitazone 6/5/12

    is in the FDA pregnancy category B.

    ADVERSE DRUG REACTION REPORTS OF TROGLITAZONE


    Click to edit Master subtitle style

    6/5/12

    Troglitazone (Rezulin)

    Indication:

    -Antidiabetic agent used for Type II diabetes ADR Problem: Hepatotoxicity

    Severe liver toxicity (since 1997) Liver injury and liver failure (90 cases of liver failure) Case of liver transplantation and deaths reported

    Drug interaction

    Warfarin : Few reports of this interaction exist

    6/5/12

    Warfarin has its effect increased by troglitazone

    THANK YOU

    6/5/12

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