Glyburide (Page 3 of 3)

OVERDOSAGE

Overdosage of sulfonylureas, including glyburide, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets or any other hypoglycemic agent. The patient’s fasting blood glucose must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Periodic glycosylated hemoglobin determinations should be performed.

Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

1. Usual Starting Dose
The usual starting dose of glyburide tablets as initial therapy is 2.5 mg to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS Section for patients at increased risk). Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Transfer of patients from other oral antidiabetic regimens to glyburide tablets should be done conservatively and the initial daily dose should be 2.5 mg to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide, to glyburide tablets, no transition period and no initial priming dose is necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.

Bioavailability studies have demonstrated that Glynase® 1 PresTab® 1 Tablets 3 mg are not bioequivalent to Glyburide Tablets USP, 5 mg. Therefore, these products are not substitutable and patients should be retitrated if transferred.

Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide tablets. If the insulin dose is less than 20 units daily, substitution of glyburide tablets 2.5 mg to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide tablets. In these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please refer to Usual Maintenance Dose for further explanation.

When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide tablets should be administered at least 4 hours prior to colesevelam.

2. Usual Maintenance Dose
The usual maintenance dose is in the range of 1.25 mg 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 tablets 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 tablets should be observed. A maintenance dose of 5 mg glyburide tablets provides approximately the same degree of blood glucose control as 250 mg to 375 mg chlorpropamide, 250 mg to 375 mg tolazamide, 500 mg to 750 mg acetohexamide, or 1000 mg 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 tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide tablets in increments of 1.25 mg to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide tablets 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 tablets. 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:

1.25 mg (peach colored, capsule-shaped, scored tablets, debossed with C on the left side of the score and P on the right side of the score on one side and 290 on the other side).
Bottles of 100 (NDC 0115-1742-01)
Bottles of 1000 (NDC 0115-1742-03)

2.5 mg (pink colored, capsule-shaped, scored tablets, debossed with C on the left side of the score and P on the right side of the score on one side and 291 on the other side).
Bottles of 100 (NDC 0115-1743-01)
Bottles of 1000 (NDC 0115-1743-03)

5 mg (light blue colored, capsule-shaped, scored tablets, debossed with C on the left side of the score and P on the right side of the score on one side and 292 on the other side).
Bottles of 100 (NDC 0115-1744-01)
Bottles of 1000 (NDC 0115-1744-03)

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

Dispense in well-closed containers with child-resistant closure.

2118-01

Rev. 07/2017

Manufactured by:
Halo Pharaceutical
Whippany, NJ 07981

Distributed by:
Impax Generics
Hayward, CA 94544

*Trademarks of their respective owners, not affiliated with Impax Laboratories, Inc.

PRINCIPAL DISPLAY PANEL

Glyburide Tablets, USP
1.25 mg, 100 TabletsNDC 0115-1742-01

NDC 0115-1742-01
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Glyburide Tablets, USP
2.5 mg, 100 TabletsNDC 0115-1743-01

NDC 0115-1743-01
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Glyburide Tablets, USP
5 mg, 100 TabletsNDC 0115-1744-01

NDC 0115-1744-01
(click image for full-size original)
GLYBURIDE glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1742
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM ALGINATE
TALC
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (peach colored) Score 2 pieces
Shape CAPSULE (capsule-shaped) Size 10mm
Flavor Imprint Code C;P;290
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1742-01 100 TABLET in 1 BOTTLE None
2 NDC:0115-1742-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206079 06/01/2016
GLYBURIDE glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1743
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM ALGINATE
TALC
D&C RED NO. 27
Product Characteristics
Color PINK Score 2 pieces
Shape CAPSULE (capsule-shaped) Size 10mm
Flavor Imprint Code C;P;291
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1743-01 100 TABLET in 1 BOTTLE None
2 NDC:0115-1743-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206079 06/01/2016
GLYBURIDE glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1744
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM ALGINATE
TALC
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (light blue) Score 2 pieces
Shape CAPSULE (capsule-shaped) Size 10mm
Flavor Imprint Code C;P;292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1744-01 100 TABLET in 1 BOTTLE None
2 NDC:0115-1744-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206079 06/01/2016
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 12/2019 Amneal Pharmaceuticals of New York LLC

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