glimepiride/rosiglitazone (Rx)

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Brand and Other Names:Avandaryl

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

rosiglitazone/glimepiride

tablet

  • 4mg/1mg
  • 4mg/2mg
  • 4mg/4mg
  • 8mg/2mg
  • 8mg/4mg
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Type 2 Diabetes

Starting Dose: 1 tab (4mg/1mg) qDay with first meal of day

Titrate: glimepiride component increased not to exceed 2 mg q1-2 week

Not to exceed 8 mg rosiglitazone/4 mg glimepiride

Dosage Modifications

Renal impairment, starting dose: 1 tab (4mg/1mg) qDay with first meal of day; titrate carefully

Hepatic impairment

  • Starting dose: 1 tab (4mg/1mg) qDay with first meal of day; titrate carefully
  • ALT <2.5 xULN: Use caution
  • ALT >2.5 xULN: Do not administer
  • ALT >3 xULN or jaundice after initiating therapy: Discontinue

Safety and efficacy not established

Starting Dose: 1 tab (4mg/1mg) qDay with first meal of day

Titrate dose carefully

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Interactions

Interaction Checker

and glimepiride/rosiglitazone

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%

            Edema (3%)

            Myocardial infarction (≤3%)

            Cerebrovascular accident (≤2%)

            Cardiac failure (≤3%)

            Headache (3-6%)

            Hypoglycemia (4-6%)

            Bone fracture (≤8%)

            Nasopharyngitis (4-5%)

            <1%

            Weight gain

            Cardiac failure

            Increased serum ALT

            Postmarketing Reports

            Thrombocytopenia and thrombocytopenic purpura

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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
            • There have been no clinical trials directly comparing cardiovascular risk of rosiglitazone and pioglitazone, another thiazolidinedione

            Contraindications

            History of a hypersensitivity reaction to rosiglitazone or glimepiride or any of the product’s ingredients

            History of allergic reaction to sulfonamide derivatives

            Diabetic ketoacidosis, with or without coma

            Heart failure NYHA Class III-IV

            Cautions

            Edema; thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin

            Hypersensitivity reactions reported in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome; if hypersensitivity reaction suspected, promptly discontinue therapy, assess for other potential causes for the reaction, and institute alternative treatment for diabetes

            Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents

            See also individual monographs

            • Rosiglitazone
            • Glimepiride
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if crosses into breast milk, avoid

            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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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            • 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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