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glyburide (Rx)Brand and Other Names:Diabeta, Glynase, more...Glynase PresTab

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 1.25mg
  • 2.5mg
  • 5mg

tablet, micronized

  • 1.5mg
  • 3mg
  • 5mg
  • 6mg
more...

Type 2 Diabetes Mellitus

Regular tablets

  • Initial: 2.5-5 mg PO qDay
  • Maintenance: 1.25-20 mg PO qDay or q12hr
  • Not to exceed 20 mg/day
  • Consider administering q12hr for doses >10 mg/day

Micronized tablets

  • Initial: 1.5-3 mg PO qDay
  • Maintenance: 0.75-12 mg PO qDay
  • Not to exceed 12 mg/day
  • Patients at risk for hypoglycemia: 0.75 mg PO qDay initially

Transferring from insulin therapy to glyburide

  • Current insulin dose <20 units: Discontinue insulin and initiate glyburide dose at 2.5-5 mg/day (regular) or 1.5-3 mg/day (micronized)
  • Current insulin dose 20-40 units: Discontinue insulin and initiate glyburide dose at 5 mg/day (regular) or 3 mg/day (micronized)
  • Current insulin dose >40 units: Decrease insulin dose by 50% and initiate glyburide dose at 5 mg/day (regular) or 3 mg/day (micronized); increase glyburide dose by 1.25-2.5 mg (regular) or 0.75-1.5 mg/day (micronized); decrease insulin dose gradually, based on patient’s response as glyburide dose increased

Dosage Modifications

Renal impairment: If CrCl <50 mL/min; caution advised

Hepatic impairment: Use conservative initial and maintenance doses; avoid use in severe liver disease

Spinal Cord Injury (Orphan)

Orphan designation for treatment of acute spinal cord injury

Sponsor

  • Remedy Pharmaceuticals, Inc; 122 W. 27th Street 10th Floor; New York, NY 10001

Subarachnoid Hemorrhage (Orphan)

Orphan designation for treatment of acute subarachnoid hemorrhage

Sponsor

  • Remedy Pharmaceuticals, Inc; 122 W. 27th Street 10th Floor; New York, NY 10001

Safety and efficacy not established

Type 2 Diabetes

Initial: 1.25 mg/day if nonmicronized tablets or 0.75 mg/day of micronized tablets

Depending on glucose response, may increase dose by no more than 1.25-2.5 mg (regular) or 0.75-1.5 mg (micronized) every week

May administer maintenance dose of 1.25-20 mg/day (regular) or 0.75-12 mg/day (micronized); for better satisfactory response may divide dose q12hr for patients taking >10 mg/day (regular) or >6 mg/day (micronized)

Dosing considerations

Because the elderly are susceptible to the hypoglycemic effects of glucose-lowering drugs, the question of how tightly glucose levels should be controlled is controversial

Recognizing hypoglycemia in the elderly may be challenging

Monitoring other parameters associated with cardiovascular disease, such as blood pressure and cholesterol, may be more important than normalized glycemic control

Initial and maintenance dosing should be conservative

Use caution in patients with renal insufficiency

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Interactions

Interaction Checker

glyburide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Angioedema

            Urticaria

            Rash

            Morbilliform eruptions

            Pruritus

            Photosensitivity reaction

            Heartburn

            Vasculitis

            Disulfiram-like reaction

            Hyponatremia

            Nocturia

            Agranulocytosis

            Hemolytic anemia

            Pancytopenia

            Thrombocytopenia

            Porphyria cutanea tarda

            Arthralgia

            Paresthesia

            Myalgia

            Blurred vision

            Diuretic effect (minor)

            Hypoglycemia

            Nausea/vomiting

            Cholestatic jaundice and hepatitis, which occur only rarely, may progress to liver failure

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            Warnings

            Contraindications

            Hypersensitivity; sulfa allergy

            Type 1 diabetes

            Diabetic ketoacidosis

            Coadministration with bosentan; increased risk of hepatotoxicity

            Cautions

            Patients with risk of severe hypoglycemia: Elderly, debilitated, or malnourished or with adrenal or pituitary insufficiency

            Patients with stress due to infection, fever, trauma, or surgery

            Caution in hepatic or renal insufficiency

            Caution in pregnancy/lactation

            Administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin

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

            There are no clinical studies establishing conclusive evidence of macrovascular risk reduction with anti-diabetic drugs

            All sulfonylureas are capable of producing severe hypoglycemia

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Not known if crosses into breast milk; avoid use in nursing women

            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 is to increase beta-cell insulin secretion

            May also decrease rate of hepatic glucose production and increase insulin receptor sensitivity

            Absorption

            Bioavailability: Variable, depending on oral dosage form

            Onset: 15-60 min after a single dose (increase in serum insulin levels)

            Duration: <24 hr

            Vd: 9-10 L

            Peak serum time: 2-4 hr (adults)

            Distribution

            Protein bound: 99%

            Metabolism

            Metabolized extensively in the liver to less-active metabolites

            Metabolites: 4-trans-hydroxyglyburide, 3-cis-hydroxyglyburide (active)

            Elimination

            Half-life: 10 hr (DiaBeta); 4 hr (Glynase, PresTab)

            Excretion: Urine (50%), feces (50%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            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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