Glyburide 5 mg Tablet, 1,000-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sulfonylurea class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Glyburide is used along with diet and exercise, and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Glyburide is in a class of medications called sulfonylureas. Glyburide lowers blood sugar by causing the pancreas to produce insulin (a natural substance that is needed to break down sugar in the body) and helping the body use insulin efficiently. This medication will only help lower blood sugar in people whose bodies produce insulin naturally. Glyburide is not...
Read the full MedlinePlus article ↗- Great question. Diet and exercise are the foundation of managing type 2 diabetes, but sometimes they aren't enough on their own. Glyburide gives your pancreas a nudge to release mo...
- What exactly does glyburide do — and why do I need it if I'm already watching my diet?
- Low blood sugar — called hypoglycemia — is the main risk with glyburide. Watch for shakiness, sweating, sudden hunger, dizziness, confusion, or a fast heartbeat. If you catch it ea...
- How do I know if my blood sugar is going too low, and what should I do?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Glyburide — tap one for details:
Glyburide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII R4OXA9G5BV
A fatty acid salt derived from palm and stearic oils. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking together.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII C269C4G2ZQ
Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.064 | $63.90 / 1000 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1297 | $129.70 / 1000 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1224 | $122.40 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glyburide 5 mg 00093-8344-01 | Teva | 100 tablets | $0.064 | AB1 | Availability likely | — |
| Glyburide 5 mgthis 00093-9364-10 | TEVA | 1000 tablets | $0.064 | AB2 | Availability likely | — |
| Glyburide 5 mg 23155-0058-01 | Heritage | 100 tablets | $0.064 | AB1 | Availability likely | — |
| Glyburide 5 mg 62135-0585-90 | Chartwell | 90 tablets | $0.064 | AB1 | Availability likely | — |
| Glyburide 5 mg 72241-0040-05 | Modavar | 100 tablets | $0.064 | AB1 | Availability likely | — |
| Glyburide 5 mg 75834-0204-00 | Nivagen | 1000 tablets | $0.070 | AB1 | Discontinued | +9% |
| Glyburide 5 mg 50090-0495-00 | A-S | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 50090-6196-00 | A-S | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 50090-6607-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 50090-7859-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 51655-0492-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 63187-0667-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| glyburide 5 mg 65841-0834-01 | Zydus | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 66267-0103-30 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-3452-03 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-3677-00 | NuCare | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-3702-06 | NuCare | 60 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-4695-03 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-5030-00 | NuCare | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68071-5215-00 | NuCare | 100 tablets | — | AB1 | FDA listed | — |
| glyburide 5 mg 68382-0658-01 | Zydus | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68788-4073-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 68788-8508-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 70518-4035-00 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 71209-0011-05 | Cadila | 100 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 71335-0150-01 | Bryant | 30 tablets | — | AB1 | Discontinued | — |
| Glyburide 5 mg 71335-2771-01 | Bryant | 30 tablets | — | AB1 | FDA listed | — |
| Glyburide 5 mg 82804-0150-00 | Proficient | 100 tablets | — | AB1 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00093-9364-01 | 100 TABLET in 1 BOTTLE (0093-9364-01) | $0.0639 / ea | $6.39 | 1984-05-01 | Active |
| 00093-9364-05 | 500 TABLET in 1 BOTTLE (0093-9364-05) | $0.0697 / ea | $34.85 | 1984-05-01 | Active |
| 00093-9364-10 You're viewing this | 1000 TABLET in 1 BOTTLE (0093-9364-10) | $0.0639 / ea | $63.85 | 1984-05-01 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0639 NADAC).
This pack accounts for about 7.2% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00093-9364-10?
What is the difference between NDC 00093-9364-10 and NDC 00093-9364-01?
What NDC number is used to bill for this package of Glyburide 5 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of diabetes mellitus with Glyburide 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 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 as initial therapy is 2.5 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 should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide, to Glyburide, 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 ® Trademarks of their respective owners, not affiliated with sanofi-aventis. PresTab ® 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. If the insulin dose is less than 20 units daily, substitution of Glyburide 2.5 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 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. In these patients, insulin dosage is decreased by 50% and Glyburide 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 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 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…
⛔ Contraindications ▾
CONTRAINDICATIONS Glyburide is contraindicated in patients: With known hypersensitivity to the drug or any of its excipients. With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin. Treated with bosentan.
⚠️ Warnings ▾
WARNINGS SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY 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 ( Diabetes 19 (supp. 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. Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glyburide as well.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Hypoglycemia See PRECAUTIONS and OVERDOSAGE Sections. Gastrointestinal Reactions Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glyburide should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported.
Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.8% of treated patients. They tend to be dose-related and may disappear when dosage is reduced. Dermatologic Reactions Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in 1.5% of treated patients.
These may be transient and may disappear despite continued use of Glyburide. Bullous reactions, erythema multiforme, and exfoliative dermatitis, have been reported. If skin reactions persist, the drug should be discontinued.
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. Hematologic Reactions Leukopenia, agranulocytosis, thrombocytopenia, which occasionally may present as purpura, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas. Metabolic Reactions Hepatic porphyria reactions have been reported with sulfonylureas; however, these have not been reported with Glyburide.
Disulfiram-like reactions have been reported very rarely with Glyburide. 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.
Glyburide can cause weight gain. Other Reactions Changes in accommodation and/or blurred vision have been reported with glyburide and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.
In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.
🔄 Drug Interactions ▾
Drug Interactions The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, ACE inhibitors, disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Glyburide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Glyburide, the patient should be observed closely for loss of control.
An increased incidence of elevated liver enzymes was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of glyburide and bosentan is contraindicated (see CONTRAINDICATIONS ). A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported.
Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known. A possible interaction between glyburide and fluoroquinolone antibiotics has been reported resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism for this interaction is not known.
Possible interactions between glyburide and coumarin derivatives have been reported that may either potentiate or weaken the effects of coumarin derivatives. The mechanism of these interactions is not known. Rifampin may worsen glucose control of glyburide because rifampin can significantly induce metabolic isozymes of glyburide such as CYP2C9 and 3A4.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Glyburide, the patient should be closely observed for loss of control.
When such drugs are withdrawn from a patient receiving Glyburide, the patient should be observed closely for hypoglycemia. Glyburide may increase cyclosporine plasma concentration and potentially lead to its increased toxicity. Monitoring and dosage adjustment of cyclosporine are therefore recommended when both drugs are coadministered.
Colesevelam Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and C max of 32% and 47%, respectively. When glyburide was administered 1 hour before colesevelam, the reductions in glyburide AUC and C max were 20% and 15%, respectively, and not significantly changed (-7% and 4%, respectively) when administered 4 hours before colesevelam. Therefore, glyburide should be administered at least 4 hours prior to colesevelam.
Glyburide is mainly metabolized by CYP 2C9 and to a lesser extent by CYP 3A4. There is a potential for drug-drug interaction when glyburide is coadministered with inducers or inhibitors of CYP 2C9, which should be taken into account when considering concomitant therapy.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Glyburide has been shown to affect the maturation of the long bones (humerus and femur) in rat pups when given in doses 6250 times the maximum recommended human dose. These effects, which were seen during the period of lactation and not during organogenesis, are a shortening of the bones with effects to various structures of the long bones, especially in humerus and femur. There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, Glyburide should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Nonteratogenic Effects Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery.
This has been reported more frequently with the use of agents with prolonged half-lives. If Glyburide is used during pregnancy, it should be discontinued at least two weeks before the expected delivery date.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use In US clinical studies of glyburide, 1406 of 2897 patients were ≥60 years and 515 patients were ≥70 years. Differences in safety and efficacy were not determined between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are particularly susceptible to hypoglycemic action of glucose-lowering drugs.
Hypoglycemia may be difficult to recognize in the elderly (see PRECAUTIONS ). The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. In three published studies of 20 to 51 subjects each, mixed results were seen in comparing the pharmacokinetics of glyburide in elderly versus younger subjects.
However, observed pharmacodynamic differences indicate the necessity for dosage titration to a specified therapeutic response. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents. (See PRECAUTIONS, General ; and DOSAGE AND ADMINISTRATION .)
🆘 Overdosage ▾
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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Glyburide appears 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 which Glyburide 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, Glyburide 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.
Pharmacokinetics Single-dose studies with Glyburide in normal subjects demonstrate significant absorption within 1 hour, peak drug levels at about 4 hours, and low but detectable levels at 24 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 with Glyburide in 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 with Glyburide showed no reliable correlation between administered dose and serum drug level. The major metabolite of Glyburide 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. Glyburide is 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.
In vitro , the protein binding exhibited by Glyburide 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 with Glyburide in clinical use.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Glyburide tablets USP are available in the following strengths and package sizes: 1.25 mg (white to off-white, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 50 (NDC 0093-9477-53) 2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 100 (NDC 0093-9433-01) Bottles of 500 (NDC 0093-9433-05) 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 100 (NDC 0093-9364-01) Bottles of 500 (NDC 0093-9364-05) Bottles of 1000 (NDC 0093-9364-10) 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.
📦 Storage and Handling ▾
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.
📋 Description ▾
DESCRIPTION Glyburide is 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 USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP.
Glyburide 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Glyburide 5 mg tablets USP 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.
Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be informed of the potential risks and advantages of Glyburide and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose. The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
Primary and secondary failure should also be explained.