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Rosiglitazone

    Brands

    DEA Class; Rx

    Common Brand Names; Avandia

    •  Antidiabetics, Thiazolidinediones

    Thiazolidinedione (TZD) oral antidiabetic; targets insulin resistance
    Used in adults with type 2 diabetes mellitus; not used with insulin due to increased risks for heart failure
    Monitor closely; TZDs can cause or exacerbate heart failure (boxed warning)

    Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin, or who have inadequate glycemic control on a meglitinide alone or metformin alone

    Hypersensitivity to rosiglitazone

    Diabetic ketoacidosis

    Heart failure NYHA class III-IV

    Active liver disease: do not start rosiglitazone if ALT >2.5 x ULN

    • Increased LDL-cholesterol
    • Increased HDL-cholesterol
    • Increased total cholesterol
    • Edema
    • Hypertension
    • Heart failure/congestive heart failure
    • Myocardial ischemia
    • Diarrhea
    • Upper respiratory tract infection
    • Accidental injury
    • Anemia
    • Back pain
    • Fatigue
    • Headache
    • Hypoglycemia
    • Myalgia
    • Sinusitis
    • Weight gain

    Fluid retention, which may exacerbate or lead to heart failure, may occur; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk of other cardiovascular effects

    If ALT >3 x ULN stop treatment; if 1.5-3 x normal, retest qWeek until normal or 3 x normal and need to discontinue

    Not for use in diabetes mellitus type 1; mechanism requires presence of endogenous insulin; use with insulin may increase risk of heart failure; not recommended

    Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin; dose-related edema and weight gain may occur

    When used in combination with other hypoglycemic agents, a dose reduction of concomitant agent may be necessary to reduce risk of hypoglycemia

    Associated with rare cases of new onset or worsening of macular edema

    May result in ovulation in some premenopausal anovulatory women; ensure adequate contraception

    Increased risk of fractures of upper arm, hand, or foot in female patients

    Dose-related decreases in hemoglobin and hemocrit reported

    Limited data in pregnant women are not sufficient to determine drug- associated risk for major birth defects or miscarriage

    There are no data on presence of rosiglitazone in human milk, effects on breastfed infant, or on milk production

    Adults

    8 mg/day PO.

    Geriatric

    8 mg/day PO.

    Adolescents

    Safety and efficacy have not been established; off-label data suggest 8 mg/day PO.

    Children

    10 years and older: Safety and efficacy have not been established; off-label data suggest 8 mg/day PO.
    Less than 10 years: Safety and efficacy have not been established.

    Infants

    Not indicated.

    Rosiglitazone

    tablet

    • 2mg
    • 4mg