rosiglitazone (Rx)

Brand and Other Names:Avandia
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 2mg
  • 4mg
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Type 2 Diabetes Mellitus

Initial 4 mg PO qDay or divided q12hr

If inadequate response afer 8-12 weeks, may increase dose to 8 mg PO qDay or divided q12hr

Monitor: ALT at start of treatment, qMonth for 12 months then q3Months thereafter

Dosage Modifications

Active liver disease (ALT >2.5 x ULN): Do not inititate rosiglitazone

Renal impairment: No dosage adjustments required

Coadministration with sulfonylurea: Adjust sulfonylurea dose if hypoglycemia occurs

Safety and efficacy not established

See Adult dosing

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Interactions

Interaction Checker

and rosiglitazone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Increased LDL-cholesterol

            Increased HDL-cholesterol

            Increased total cholesterol

            1-10%

            Edema

            Hypertension

            Heart failure/congestive heart failure

            Myocardial ischemia

            Diarrhea

            Upper respiratory tract infection

            Frequency Not Defined

            Accidental injury

            Anemia

            Back pain

            Fatigue

            Headache

            Hypoglycemia

            Myalgia

            Sinusitis

            Weight gain

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            Warnings

            Black Box Warnings

            Congestive heart failure risk

            Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients

            After initiation, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema)

            If these signs and symptoms develop, the heart failure should be managed according to current standards of care

            Furthermore, discontinuation or dose reduction must be considered

            Not recommended in patients with symptomatic heart failure

            Initiation with established NYHA Class III or IV heart failure is contraindicated

            Contraindications

            Hypersensitivity to rosiglitazone

            Diabetic ketoacidosis

            Heart failure NYHA class III-IV

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

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unsafe

            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

            Lowers glucose by improving target cell response to insulin without increasing pancreatic cell secretion; activates nuclear peroxisome proliferator-activated receptor gamma, which influences the production of gene products involved in glucose and lipid metabolism

            Pharmacokinetics

            Bioavailability: 99%

            Onset of Action: Initial effect delayed; maximum effect may take up to 12 weeks

            Peak Plasma Time: 1 hr

            Protein Bound: >99%

            Half-Life: 3-4 hr

            Vd: 17.6 L

            Metabolism: by hepatic CYP2C8 & CYP2C9 (minor extent)

            Excretion: urine 64%; feces 22%

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.