Glyburide (Glyburide)

Trade Name : Glyburide

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 1.5 mg/1

GLYBURIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glyburide (Glyburide) which is also known as Glyburide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1.5 mg/1 per ml. Read more

Glyburide (Glyburide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Glyburide Tablets USP contain micronized (smaller particle size) glyburide, USP which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound. Each tablet, for oral administration, contains 1.5 mg, 3 mg, or 6 mg of glyburide, USP. Inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. In addition, the 3 mg and 6 mg strengths contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The chemical name for glyburide, USP is 1-[[-[2-(5-Chloro--anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea. The structural formula is represented below:
  • CHClNOS M.W. 494.00
  • Glyburide Tablets USP meet USP n
  • No data
  • Glyburide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Glyburide tablets are contraindicated in patients with:
  • The 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. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (, 19 (Suppl. 2):747-830, 1970).
  • UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glyburide and of alternative modes of therapy.
  • Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
  • No data
  • No data
  • Overdosage of sulfonylureas, including glyburide, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological 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 which 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.
  • Patients should be retitrated when transferred from nonmicronized glyburide tablets or other oral hypoglycemic agents.
  • There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets. In addition to the usual monitoring of urinary glucose, the patientu2019s blood glucose must also be monitored 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. Glycosylated hemoglobin levels may also be of value in monitoring the patientu2019s response to therapy.
  • Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
  • Glyburide Tablets USP are supplied as follows:
  • Glyburide Tablets USP 1.5 mgn- 1.5 | 034n- N
  • NDC
  • Glyburide Tablets USP 3 mg n- 3 | 035n- N
  • NDC
  • NDC
  • Glyburide Tablets USP 6 mgn- 6 | 036n- N
  • NDC
  • Glyburide Tablets USP can be divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with safety closure. Keep container tightly closed.
  • Manufactured In Canada By:
  • Teva Canada Limited
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. M 10/2017
  • NDCu00a0n- 8034
  • GlyBURIDE
  • Tablets USPn- 1.5 mg
  • Rx only
  • 100 TABLETS
  • TEVA
  • Arrayn- Array
  • NDCu00a0n- 8035
  • GlyBURIDEn- Tablets USPn- 3 mg
  • Rx only
  • 100 TABLETS
  • TEVA
  • Arrayn- Array
  • NDCu00a0n- 8036
  • GlyBURIDEn- Tablets USPn- 6 mg
  • Rx only
  • 100 TABLETS
  • TEVA
  • Arrayn- Array

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