DiaBeta (Glyburide Tablets)
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DiaBeta (Glyburide Tablets)

Diaβeta®
(glyburide) Tablets USP 1.25, 2.5 and 5 mg

DRUG DESCRIPTION

Diaβeta® (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. Diaβeta 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. Diaβeta (glyburide tablets) 1.25 mg tablets USP also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 5 mg tablets USP also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1. Chemically, Diaβeta (glyburide tablets) 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:

Diaβeta (glyburide) Structural Formula Illustration

The molecular weight is 493.99. The aqueous solubility of Diaβeta (glyburide tablets) increases with pH as a result of salt formation.

What are the possible side effects of glyburide (DiaBeta, Glynase PresTab, Micronase)?

Stop using glyburide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, confusion or weakness;
  • easy bruising or bleeding, purple or red pinpoint spots under your skin;...

Read All Potential Side Effects and See Pictures of DiaBeta »

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Diaβeta (glyburide tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with Diaβeta (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 Diaβeta (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 Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) 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 Diaβeta (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®* PresTab®* Tablets 3 mg are not bioequivalent to Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) . If the insulin dose is less than 20 units daily, substitution of Diaβeta (glyburide tablets) 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 Diaβeta (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 Diaβeta (glyburide tablets) . In these patients, insulin dosage is decreased by 50% and Diaβeta (glyburide tablets) 5 mg daily is started. Please refer to Usual Maintenance Dose for further explanation.
  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 Diaβeta (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 Diaβeta (glyburide tablets) should be observed. A maintenance dose of 5 mg Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) 5 mg concomitantly with a 50% reduction in insulin
    dose. Progressive withdrawal of insulin and increase of Diaβeta (glyburide tablets) in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and Diaβeta (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 Diaβeta (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

Diaβeta (glyburide) tablets USP are available in the following strengths and package sizes:

1.25 mg (peach, capsule-shaped, flat faced, beveled edge tablet debossed “Dia β” with a score line between the “Dia” and the “?” on one side and plain on the other side).

Bottles of 50 (NDC 0039-0053-05)

2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed “Dia β” with a score line between the “Dia” and “?” on one side and plain on the other side).

Bottles of 100 (NDC 0039-0051-10)
Bottles of 500 (NDC 0039-0051-50)

5 mg (green, capsule-shaped, flat faced, beveled edge tablet debossed “Dia β” with a score line between the “Dia” and “β” on one side and plain on the other side).

Bottles of 100 (NDC 0039-0052-10)
Bottles of 500 (NDC 0039-0052-50)
Bottles of 1000 (NDC 0039-0052-70)

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.

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE Sections.

Gastrointestinal Reactions

Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) ; 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 Diaβeta (glyburide tablets) . Disulfiram-like reactions have been reported very rarely with Diaβeta. 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

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.

Read the DiaBeta (glyburide tablets) Side Effects Center for a complete guide to possible side effects »

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 Diaβeta (glyburide tablets) , the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Diaβeta (glyburide tablets) , the patient should be observed closely for loss of control.

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 Diaβeta (glyburide tablets) , the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving Diaβeta (glyburide tablets) , the patient should be observed closely for hypoglycemia.

An increased incidence of elevated liver enzymes was observed in patients receiving glyburide concomitantly with bosentan. Therefore this combination should not be used. (See CONTRAINDICATIONS.)

Diaβeta (glyburide tablets) 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.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

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 2½ 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 Diaβeta (glyburide tablets) 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.

PRECAUTIONS

General

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Diaβeta (glyburide tablets) or any other anti-diabetic drug.

Hypoglycemia

All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Severe renal or hepatic insufficiency may cause elevated blood levels of Diaβeta (glyburide tablets) and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious, prolonged hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy, the elderly, and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents.

Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue Diaβeta (glyburide tablets) and administer insulin.

The effectiveness of any oral hypoglycemic drug, including Diaβeta (glyburide tablets) , in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given.

Hemolytic Anemia

Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Diaβeta (glyburide tablets) belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.

Laboratory Tests

Periodic fasting blood glucose measurements should be performed to monitor therapeutic response. A glycosylated hemoglobin determination should also be performed periodically.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Diaβeta (glyburide tablets) is non-mutagenic when studied in the Salmonella microsome test (Ames test) and in the DNA damage/alkaline elution assay. Studies in rats at doses up to 300 mg/kg/day for 18 months showed no carcinogenic effects.

No drug related effects were noted in any of the criteria evaluated in the two year oncogenicity study of glyburide in mice.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Diaβeta (glyburide tablets) 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, Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) is used during pregnancy, it should be discontinued at least two weeks before the expected delivery date.

Nursing Mothers

Although it is not known whether Diaβeta (glyburide tablets) is excreted in human milk, some sulfonylureas are known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue administering the drug, taking into account the importance of the drug to the mother. If Diaβeta (glyburide tablets) is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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.)

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage of sulfonylureas, including Diaβeta (glyburide tablets) , 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.

CONTRAINDICATIONS

Diaβeta (glyburide tablets) is contraindicated in patients:

  1. With known hypersensitivity to the drug or any of its excipients.
  2. With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin.
  3. Treated with bosentan.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) 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, Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) .

Pharmacokinetics

Single-dose studies with Diaβeta (glyburide tablets) in 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 with Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) showed no reliable correlation between administered dose and serum drug level.

The major metabolite of Diaβeta (glyburide tablets) is the 4-trans-hydroxy derivative. A second metabolite, the 3cis-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.

Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) 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 Diaβeta (glyburide tablets) . It has not been shown that this difference in protein binding will result in fewer drug-drug interactions with Diaβeta in clinical use.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be informed of the potential risks and advantages of Diaβeta (glyburide tablets) 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.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be informed of the potential risks and advantages of Diaβeta (glyburide tablets) 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.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Diaβeta®
(glyburide) Tablets USP 1.25, 2.5 and 5 mg

DRUG DESCRIPTION

Diaβeta® (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. Diaβeta 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. Diaβeta (glyburide tablets) 1.25 mg tablets USP also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 5 mg tablets USP also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1. Chemically, Diaβeta (glyburide tablets) 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:

Diaβeta (glyburide) Structural Formula Illustration

The molecular weight is 493.99. The aqueous solubility of Diaβeta (glyburide tablets) increases with pH as a result of salt formation.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Diaβeta®
(glyburide) Tablets USP 1.25, 2.5 and 5 mg

DRUG DESCRIPTION

Diaβeta® (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. Diaβeta 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. Diaβeta (glyburide tablets) 1.25 mg tablets USP also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 5 mg tablets USP also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1. Chemically, Diaβeta (glyburide tablets) 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:

Diaβeta (glyburide) Structural Formula Illustration

The molecular weight is 493.99. The aqueous solubility of Diaβeta (glyburide tablets) increases with pH as a result of salt formation.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Diaβeta®
(glyburide) Tablets USP 1.25, 2.5 and 5 mg

DRUG DESCRIPTION

Diaβeta® (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. Diaβeta 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. Diaβeta (glyburide tablets) 1.25 mg tablets USP also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Diaβeta (glyburide tablets) 5 mg tablets USP also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1. Chemically, Diaβeta (glyburide tablets) 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:

Diaβeta (glyburide) Structural Formula Illustration

The molecular weight is 493.99. The aqueous solubility of Diaβeta (glyburide tablets) increases with pH as a result of salt formation.

Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.

DiaBeta Patient Information Including Side Effects

Brand Names: DiaBeta, Glynase PresTab, Micronase

Generic Name: glyburide (Pronunciation: GLYE bue ride)

What is glyburide (DiaBeta)?

Glyburide is an oral diabetes medicine that helps control blood sugar levels.

Glyburide is used to treat type 2 diabetes (non-insulin dependent).

This medication is not for treating type 1 diabetes.

Glyburide may also be used for other purposes not listed in this medication guide.

Glyburide 1.25 mg-D-TEV

oblong, white, imprinted with GLYBUR

GlyBURIDE 1.25 mg-GG

round, white, imprinted with cor 123

Glyburide 1.25 mg-GRE

round, white, imprinted with G 3725

Glyburide 1.25 mg-M-TEV

round, white, imprinted with N 342, 1.25

Glyburide 1.5 mg-MYL

oblong, white, imprinted with M 113

Glyburide 2.5 mg-COP

oblong, pink, imprinted with GLYBUR, 433 433

Glyburide 2.5 mg-D-TEV

oblong, pink, imprinted with GLYBUR, 433 433

Glyburide 2.5 mg-GRE

round, pink, imprinted with G 3726

Glyburide 2.5 mg-M-TEV

round, white, imprinted with N 343, 2.5

Glyburide 2.5 mg-NVP

round, peach, imprinted with N 343, 2.5

Glyburide 3 mg-MYL

oblong, yellow, imprinted with M 125

Glyburide 5 mg -COP

oblong, blue, imprinted with GLYBUR, 364 364

Glyburide 5 mg-D-TEV

oblong, blue, imprinted with GLYBUR

GlyBURIDE 5 mg-GG

round, green, imprinted with cor 125

Glyburide 5 mg-GRE

round, blue, imprinted with G 3727

Glyburide 5 mg-M-TEV

round, green, imprinted with N 344, 5

Glyburide 5 mg-NVP

round, green, imprinted with N 344, 5

Glyburide 6 mg-MYL

oblong, blue, imprinted with M 142

Glyburide Micronized 1.5 mg-STA

oval, white, imprinted with MOVA, MO3 1.5

Glyburide Micronized 1.5 mg-TEV

oval, white, imprinted with 1.5 034, N

Glyburide Micronized 3 mg-COP

hexagonal, green, imprinted with COPLEY, 381 381

Glyburide Micronized 3 mg-STA

oval, blue, imprinted with MOVA, MO4 3.0

Glyburide Micronized 3 mg-TEV

oval, blue, imprinted with 3 035, N

Glyburide Micronized 6 mg-TEV

oval, blue, imprinted with 6 036, N

Glynase 3 mg

oblong, blue, imprinted with PT PT, GLYNASE 3

Glynase 6 mg

oblong, yellow, imprinted with PT PT, GLYNASE 6

What are the possible side effects of glyburide (DiaBeta)?

Stop using glyburide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, confusion or weakness;
  • easy bruising or bleeding, purple or red pinpoint spots under your skin; or
  • headache, trouble concentrating, memory problems, feeling unsteady, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • mild nausea, heartburn, feeling full;
  • joint or muscle pain;
  • blurred vision; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the DiaBeta (glyburide tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about glyburide (DiaBeta)?

You should not use this medication if you are allergic to glyburide, if you are being treated with bosentan (Tracleer), if you have type 1 (insulin-dependent) diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking glyburide, tell your doctor if you are allergic to sulfa drugs, if you have been using insulin or chlorpropamide (Diabinese), or if you have hemolytic anemia (a lack of red blood cells), an enzyme deficiency (G6PD), a nerve disorder, liver disease, or kidney disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Side Effects Centers

DiaBeta Patient Information including How Should I Take

What should I discuss with my health care provider before taking glyburide (DiaBeta)?

You should not use this medication if you are allergic to glyburide, or:

  • if you are being treated with bosentan (Tracleer);
  • if you have type 1 (insulin-dependent) diabetes; or
  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure you can safely take glyburide, tell your doctor if you have any of these other conditions:

  • hemolytic anemia (a lack of red blood cells);
  • an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
  • a nerve disorder affecting bodily functions;
  • liver or kidney disease;
  • if you are allergic to sulfa drugs; or
  • if you have been using insulin or taking chlorpropamide (Diabinese).

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with glyburide.

FDA pregnancy category C. It is not known whether glyburide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether glyburide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have low blood sugar while taking glyburide.

How should I take glyburide (DiaBeta)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take glyburide with your first meal of the day, unless your doctor tells you otherwise.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking glyburide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your glyburide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

If there are any changes in the brand, strength, or type of glyburide you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

Store at room temperature, protected from moisture, heat, and light.

Side Effects Centers

DiaBeta Patient Information including If I Miss a Dose

What happens if I miss a dose (DiaBeta)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (DiaBeta)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.A glyburide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking glyburide (DiaBeta)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Avoid exposure to sunlight or tanning beds. Glyburide can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect glyburide (DiaBeta)?

Tell your doctor about all other medications you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • disopyramide (Norpace);
  • fluconazole (Diflucan), ketoconazole (Nizoral);
  • fluoxetine (Prozac);
  • rifampin (Rifadin, Rimactane, Rifater);
  • an ACE inhibitor such as enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others; or
  • an antibiotic such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and others.

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol (Proventil, Ventolin);
  • clonidine (Catapres);
  • reserpine; or
  • beta-blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others.

You may be more likely to have hyperglycemia (high blood sugar) if you take glyburide with:

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • heart or blood pressure medications (Cartia, Cardizem, Nifedical, Covera, Verelan, and others);
  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
  • seizure medicines (Dilantin and others); and
  • diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you take glyburide with:

  • clarithromycin (Biaxin);
  • exenatide (Byetta);
  • probenecid (Benemid);
  • heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • sulfa drugs (Bactrim, Gantanol, Septra, and others);
  • a monoamine oxidase inhibitor (MAOI); and
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of glyburide on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about glyburide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision date: 10/14/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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