Glyburide by PD-Rx Pharmaceuticals, Inc. GLYBURIDE tablet

Glyburide by

Drug Labeling and Warnings

Glyburide by is a Prescription medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, 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

    Glyburide tablets USP are available in the following strengths and package sizes:

    5 mg (blue, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side).
    Bottles of 14, 15, 30, 60, 90, 100, 120, 180 and 360.

    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.

  • SPL UNCLASSIFIED SECTION

    Revised April 2018

    Manufactured for:
    Teva Pharmaceuticals USA, Inc.
    North Wales, PA 19454

    ©2018 sanofi-aventis U.S. LLC

  • PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

    Glyburide

    Tablets USP

    5 mg

    Rx only

    image

  • INGREDIENTS AND APPEARANCE
    GLYBURIDE 
    glyburide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43063-433(NDC:0093-9364)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC) GLYBURIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVAL (CAPSULE-SHAPED) Size13mm
    FlavorImprint Code GLYBUR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43063-433-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    2NDC: 43063-433-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    3NDC: 43063-433-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    4NDC: 43063-433-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    5NDC: 43063-433-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    6NDC: 43063-433-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    7NDC: 43063-433-98120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    8NDC: 43063-433-93180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    9NDC: 43063-433-86360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01753205/01/1984
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-433)

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