Glyburide (Glyburide)

Trade Name : Glyburide

Hikma 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 Hikma 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

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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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  • Glyburide Tablets, USP (micronized) contain micronized (smaller particle size) glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as Glyburide Tablets, USP (micronized) tablets of 1.5 mg, 3 mg, and 6 mg strengths for oral administration. Inactive ingredients: colloidal silicon dioxide, pregelatinized maize starch, lactose monohydrate, magnesium stearate. In addition, the strength contains FD&C Blue No. 1 Aluminum Lake, and the tablet contains D&C Yellow No. 10 Aluminum Lake. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below:
  • Glyburide Tablets meet USP Dissolution Test 5.
  • No data
  • Glyburide Tablets, USP (micronized) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Glyburide tablets (micronized) are contraindicated in patients with:
  • 1. Known hypersensitivity or allergy to the drug.
  • 2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
  • 3. Type I diabetes mellitus.
  • 4. Concomitant administration of bosentan.
  • 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 tablets (micronized) 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.
  • Macrovascular Outcomes:
  • Bioavailability studies have demonstrated that glyburide tablets (micronized) 3 mg provide serum glyburide concentrations that are not bioequivalent to those from glyburide tablets (nonmicronized) 5 mg. Therefore, patients should be retitrated when transferred from glyburide tablets (nonmicronized) or other oral hypoglycemic agents.
  • Hypoglycemia: n- Arrayn- Array
  • Gastrointestinal Reactions:
  • Liver function abnormalities, including isolated transaminase elevations, have been reported.
  • Gastrointestinal disturbances, , nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced.
  • Dermatologic Reactions: n- eg
  • Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
  • Hematologic Reactions: n- Array
  • Metabolic Reactions:
  • Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.
  • Other Reactions:
  • In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001, or FDA at 1-800-FDA-1088 or u00a0
  • 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 glyburide tablets (nonmicronized) or other oral hypoglycemic agents.
  • There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets (micronized). 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, , inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, , 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 (micronized) may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
  • u00a0
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  • Glyburide Tablets, USP (micronized) 1.5 mg:
  • Bottles of 100 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9918-01
  • Bottles of 500 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9918-05
  • Glyburide Tablets, USP (micronized) 3 mg:
  • Bottles of 100 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9919-01
  • Bottles of 500 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9919-05
  • Bottles of 1000u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0143-9919-10
  • Glyburide Tablets, USP (micronized) 6 mg:
  • Bottles of 100 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9920-01
  • Bottles of 500 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-9920-05
  • Bottles of 1000u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0143-9920-10
  • Glyburide Tablets, USP (micronized) can be divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves.
  • Rx only
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.
  • Distributed by:
  • West-Ward Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • Manufactured by:
  • HIKMA Pharmaceuticals
  • P.O. Box 182400
  • Amman 11118 u2013 Jordan
  • Revised September 2017
  • NDC 0143-9918-01GlyBURIDE Tablets, USP(micronized)1.5 mg100 TabletsRx Only
  • NDC 0143-9919-01GlyBURIDE Tablets, USP(micronized)3 mg100u00a0TABLETSRx Only
  • NDC 0143-9920-01GlyBURIDE Tablets, USP(micronized)6 mg100 TabletsRx Only

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