Glyburide by REMEDYREPACK INC. GLYBURIDE tablet

Glyburide by

Drug Labeling and Warnings

Glyburide by is a Prescription medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

2. Usual Maintenance Dose

The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (See Dosage Interval Section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response.

No exact dosage relationship exists between Glyburide and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg of Glyburide should be observed. A maintenance dose of 5 mg Glyburide provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.

When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of Glyburide 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of Glyburide in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and Glyburide are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should self-test their blood for glucose and their urine for acetone at least 3 times daily and report results to their physician. Self-testing of urinary glucose is a less desirable alternative. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

3. Maximum Dose

Daily doses of more than 20 mg are not recommended.

4. Dosage Interval

Once-a-day therapy is usually satisfactory, based upon usual meal patterns and a 10 hour half-life of Glyburide. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.

In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. (See PRECAUTIONS Section.)

  • HOW SUPPLIED

    2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side).

    NDC: 70518-2695-0 100 in 1 BOX

    NDC: 70518-2695-1 1 in 1 POUCH

    Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].

    Dispense in well-closed containers with safety closures.

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • SPL UNCLASSIFIED SECTION

    Revised April 2018

    Manufactured for:

    Teva Pharmaceuticals USA, Inc.

    North Wales, PA 19454

    ©2018 sanofi-aventis U.S. LLC

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Glyburide

    GENERIC: glyburide

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-2695-0

    NDC: 70518-2695-1

    COLOR: pink

    SHAPE: OVAL

    SCORE: Two even pieces

    SIZE: 13 mm

    IMPRINT: GLYBUR

    PACKAGING: 1 in 1 POUCH

    OUTER PACKAGING: 100 in 1 BOX

    ACTIVE INGREDIENT(S):

    INACTIVE INGREDIENT(S):

    Remedy_Label

    MM2

  • INGREDIENTS AND APPEARANCE
    GLYBURIDE 
    glyburide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70518-2695(NDC:0093-9433)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC) GLYBURIDE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeOVAL (CAPSULE-SHAPED) Size13mm
    FlavorImprint Code GLYBUR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70518-2695-0100 in 1 BOX04/16/2020
    1NDC: 70518-2695-11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01753204/16/2020
    Labeler - REMEDYREPACK INC. (829572556)

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