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DiaBeta
Overview
What is DiaBeta?
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 1.25 mg tablets USP also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. Diaβeta 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Diaβeta 5 mg tablets USP also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1. Chemically, Diaβeta 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 Diaβeta increases with pH as a result of salt formation.
What does DiaBeta look like?
What are the available doses of DiaBeta?
Sorry No records found.
What should I talk to my health care provider before I take DiaBeta?
Sorry No records found
How should I use DiaBeta?
Diaβeta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
There is no fixed dosage regimen for the management of diabetes mellitus with Diaβeta 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 may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
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 Section.)
What interacts with DiaBeta?
- Diaβeta 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.
What are the warnings of DiaBeta?
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 ( 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 Diaβeta 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.
What are the precautions of DiaBeta?
General
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Diaßeta or any other anti-diabetic drug.
Hypoglycemia
Hemolytic Anemia
Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Diaβeta 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.
Information for Patients
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Laboratory Tests
Periodic fasting blood glucose measurements should be performed to monitor therapeutic response. A glycosylated hemoglobin determination should also be performed periodically.
Drug Interactions
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Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and Cof 32% and 47%, respectively. When glyburide was administered 1 hour before colesevelam, the reductions in glyburide AUC and Cwere 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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
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Pregnancy
Teratogenic Effects
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 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 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 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
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What are the side effects of DiaBeta?
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.
What should I look out for while using DiaBeta?
Diaβeta is contraindicated in patients:
What might happen if I take too much DiaBeta?
Overdosage of sulfonylureas, including Diaβeta, 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.
How should I store and handle DiaBeta?
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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)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 "β" 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 "β" on one side and plain on the other side).Bottles of 100 (NDC 0039-0051-10)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 1000 (NDC 0039-0052-70)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Diaβeta 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 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 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.
Non-Clinical Toxicology
Diaβeta is contraindicated in patients: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, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Diaβeta, 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 Diaβeta and bosentan is contraindicated (see ).
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, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving Diaβeta, the patient should be observed closely for hypoglycemia.
Diaβeta 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.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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