Glyburide (Glyburide)

Trade Name : Glyburide

Impax Generics

TABLET

Strength 1.25 mg/1

GLYBURIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

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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 Impax Generics. It is available in strength of 1.25 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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Glyburideu00a0Tablets, USPu00a0are an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide Tablets, USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate anhydrous USP, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide Tablets USP, 1.25 mg also contain FD&C Yellow #6 Aluminum Lake. Glyburide Tablets USP, 2.5 mg also contain D&C Red #27 Aluminum Lake. Glyburide Tablets USP, 5 mg also contain FD&C Blue #1 Aluminum Lake. Chemically, glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea.
The CAS Registry Number is 10238-21-8.
The structural formula is:
The molecular weight is 493.99. The aqueous solubility of glyburide increases with pH as a result of salt formation.

Glyburideu00a0appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by whichu00a0glyburide lowers blood glucose during long-term administration has not been clearly established.
With chronic administration in Type II diabetic patients, the blood glucose lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
In addition to its blood glucose lowering actions,u00a0glyburide produces a mild diuresis by enhancement of renal free water clearance. Clinical experience to date indicates an extremely low incidence of disulfiram-like reactions in patients while taking glyburide tablets.
Single-dose studies withu00a0glyburide tabletsu00a0in normal subjects demonstrate significant absorption within one hour, peak drug levels at about four hours, and low but detectable levels at twenty-four hours. Mean serum levels of glyburide, as reflected by areas under the serum concentration-time curve, increase in proportion to corresponding increases in dose. Multiple-dose studies withu00a0glyburide tabletsu00a0in diabetic patients demonstrate drug level concentration-time curves similar to single-dose studies, indicating no build-up of drug in tissue depots. The decrease of glyburide in the serum of normal healthy individuals is biphasic, the terminal half-life being about 10 hours. In single-dose studies in fasting normal subjects, the degree and duration of blood glucose lowering is proportional to the dose administered and to the area under the drug level concentration-time curve. The blood glucose lowering effect persists for 24 hours following single morning doses in non-fasting diabetic patients. Under conditions of repeated administration in diabetic patients, however, there is no reliable correlation between blood drug levels and fasting blood glucose levels. A one-year study of diabetic patients treated withu00a0glyburide showed no reliable correlation between administered dose and serum drug level.
The major metabolite ofu00a0glyburide is the 4-trans-hydroxy derivative. A second metabolite, the 3-cis-hydroxy derivative, also occurs. These metabolites contribute no significant hypoglycemic action since they are only weakly active (1/400th and 1/40th, respectively, as glyburide) in rabbits.
Glyburideu00a0is excreted as metabolites in the bile and urine, approximately 50% by each route. This dual excretory pathway is qualitatively different from that of other sulfonylureas, which are excreted primarily in the urine.
Sulfonylurea drugs are extensively bound to serum proteins. Displacement from protein binding sites by other drugs may lead to enhanced hypoglycemic action. , the protein binding exhibited byu00a0glyburide is predominantly non-ionic, whereas that of other sulfonylureas (chlorpropamide, tolbutamide, tolazamide) is predominantly ionic. Acidic drugs such as phenylbutazone, warfarin, and salicylates displace the ionic-binding sulfonylureas from serum proteins to a far greater extent than the non-ionic binding glyburide. It has not been shown that this difference in protein binding will result in fewer drug-drug interactions withu00a0glyburide in clinical use.

Glyburide Tablets, USPu00a0are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Glyburide tablets areu00a0contraindicated in patients:
1.u00a0u00a0With known hypersensitivity to the drug or any of its excipients.2.u00a0u00a0With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma.u00a0u00a0u00a0u00a0 These conditions should be treated with insulin.3.u00a0u00a0Treated with 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 (supp. 2): 747u2013830, 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 approximatelyu00a02u00bd 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 ofu00a0glyburide 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.
Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glyburide as well.

No data

Hypoglycemia:
Gastrointestinal Reactions:
Dermatologic Reactions:
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Hematologic Reactions:
Metabolic Reactions:
Other Reactions:
In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.

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.

There is no fixed dosage regimen for the management of diabetes mellitus withu00a0glyburide tabletsu00a0or 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 ofu00a0glyburide tabletsu00a0may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
1.u00a0 n The usual starting dose ofu00a0glyburide tabletsu00a0as 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 tou00a0glyburide tabletsu00a0should be done conservatively and the initial daily dose should be 2.5 mgu00a0to 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 Glynasen PresTabn 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 ofu00a0glyburide tabletsu00a02.5 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 onu00a0glyburide tabletsu00a05 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% andu00a0glyburide tabletsu00a05 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
No exact dosage relationship exists betweenu00a0glyburide tabletsu00a0and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg ofu00a0glyburide tabletsu00a0should be observed. A maintenance dose of 5 mgu00a0glyburide tabletsu00a0provides approximately the same degree of blood glucose control as 250 mgu00a0to 375 mg chlorpropamide, 250 mg to 375 mg tolazamide, 500 mgu00a0to 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.u00a0Maximum Dose
4. Dosage Interval
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.)

Glyburide Tablets,u00a0USP are available in the following strengths and package sizes:
1.25 mg (peach colored, capsule-shaped, scored tablets, debossed with on the left side of the score and on the right side of the score on one side and on the other side).Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 (NDC 0115-1742-01)Bottles of 1000u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 (NDC 0115-1742-03)
2.5 mg (pink colored, capsule-shaped, scored tablets, debossed with on the left side of the score and on the right side of the score on one side and on the other side).Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0(NDC 0115-1743-01)Bottles of 1000u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0(NDC 0115-1743-03)
5 mg (light blue colored, capsule-shaped, scored tablets, debossed with on the left side of the score and on the right side of the score on one side and on the other side).Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0(NDC 0115-1744-01)Bottles of 1000u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0(NDC 0115-1744-03)
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with child-resistant closure.
2118-01
Rev. 07/2017
Manufactured by:Halo PharaceuticalWhippany, NJ 07981
Distributed by:Impax GenericsHayward, CA 94544
*Trademarks of their respective owners, not affiliated with Impax Laboratories, Inc.

Glyburide Tablets, USP1.25 mg, 100 TabletsNDC 0115-1742-01

Glyburide Tablets, USP2.5 mg, 100 TabletsNDC 0115-1743-01

Glyburide Tablets, USP5 mg, 100 TabletsNDC 0115-1744-01

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Glyburide (Glyburide)

Trade Name : Glyburide

TABLET

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Glyburide (Glyburide)

Trade Name : Glyburide

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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