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glimepiride (Rx)Brand and Other Names:Amaryl

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg
  • 4mg
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Type 2 Diabetes Mellitus

Initial: 1-2 mg PO qAM after breakfast or with first meal; may increase dose by 1-2 mg every 1-2 weeks; not to exceed 8 mg/day

Conversion from other oral hypoglycemic agents

  • Observe patients carefully for 1-2 weeks when being converted from long half-life sulfonylureas to glimepiride, because of potential for overlapping of hypoglycemic effects

Dosing considerations

  • Use in monotherapy or, if glycemic response to glimepiride is inadequate at maximum dose, with insulin or metformin

Dosing Modifications

Renal impairment: 1 mg PO qDay; titrate dose based on fasting blood glucose levels

Hepatic impairment: Not studied; not recommended in severe impairment; initiate therapy with 1 mg PO qDay and titrate carefully

Safety and efficacy not established

Prolonged hypoglycemia reported with use; titrate dose conservatively; monitor for hypoglycemic or hyperglycemic symptoms

Type 2 Diabetes Mellitus

1 mg PO qDay; titrate dose at weekly intervals to avoid hypoglycemia

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Interactions

Interaction Checker

glimepiride 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%

            Hypoglycemia (4-20%)

            1-10%

            Dizziness (1.7%)

            Asthenia (1.6%)

            Headache (1.5%)

            Nausea (1.1%)

            <1%

            Allergic skin reactions

            Erythema

            Morbilliform or maculopapular eruptions

            Pruritus

            Urticaria

            Diarrhea

            Gastrointestinal pain

            Vomiting

            Agranulocytosis

            Anemia

            Aplastic anemia

            Leukopenia

            Pancytopenia

            Thrombocytopenia, hemolytic

            Cholestasis

            Elevation of liver enzyme levels

            Hepatic porphyria reactions

            Jaundice (rare)

            Disulfiram-like reactions

            Hyponatremia

            Postmarketing Reports

            Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens- Johnson Syndrome

            Hemolytic anemia in patients with and without G6PD deficiency

            Hepatic impairment (eg, cholestasis, jaundice), as well as hepatitis, which may progress to liver failure

            Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis

            Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia

            Thrombocytopenia (including severe cases with platelet count <10,000/mcL) and thrombocytopenic purpura

            Hepatic porphyria reactions and disulfiram-like reactions

            Hyponatremia and SIADH, most often in patients on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone

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            Warnings

            Contraindications

            Hypersensitivity; sulfa allergy

            Type 1 diabetes

            Diabetic ketoacidosis (with or without coma)

            Complicated gestational diabetes mellitus

            Cautions

            Patients with risk of severe hypoglycemia: Elderly, debilitated, or malnourished; adrenal or pituitary insufficiency; patients with stress due to infection, fever, trauma, or surgery

            If patient is exposed to stress, it may be necessary to discontinue glimepiride and initiate insulin

            Use caution in hepatic/renal impairment

            Pregnancy, lactation

            Increased risk of cardiovascular mortality

            Persons allergic to other sulfonamide derivatives may develop allergic reaction to glimepiride

            Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy

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

            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

            Potential risk of ischemic cardiovascular (CV) events relative to placebo reported in meta-analysis studies, but not confirmed in long-term CV outcome trial versus metformin or sulfonylurea

            Dose-related edema, weight gain, and anemia may occur

            Macular edema reported

            Increased incidence of bone fracture reported

            Postmarketing reports for glimepiride include anaphylaxis, angioedema, and Stevens-Johnson syndrome; promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excretion in milk unknown; 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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            Pharmacology

            Mechanism of Action

            Initial effect to increase insulin secretion from beta cells; may also decrease rate of hepatic glucose production and increase insulin receptor sensitivity

            Absorption

            Bioavailability: 100%

            Initial effect: 1 hr

            Peak plasma time: 2-3 hr

            Max effect: 2-4 hr

            Duration: 24 hr

            Distribution

            Vd: 8.8 L

            Protein bound: 99.5%

            Metabolism

            Metabolized extensively by hepatic P450 enzyme CYP2C9 to less-active metabolites

            Metabolites: Cyclohexyl hydroxy methyl derivative (M1; mildly active) and the carboxyl derivative (M2; inactive)

            Elimination

            Half-life: 5-9 hr

            Total body clearance: 47.8 mL/min

            Excretion: Urine (60%); feces (40%)

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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.
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