
diabeta
Pharmaranks rates Diabeta 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Diabeta (Glyburide) is a sulfonylurea used to treat Type 2 Diabetes Mellitus.
Glyburide · by Sanofi Aventis US
Available as a generic: Glyburide
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Glyburide
- Drug class
- Sulfonylurea
- Form
- Tablet
- Strength
- Glyburide 1.25MG · Glyburide 2.5MG · Glyburide 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- type 2 diabetes mellitus
- Manufacturer
- Sanofi Aventis US
- Half-life
- about 10 hours (terminal/elimination half-life) (how long it stays in your system)
- What the pharmacy pays
- ~$1.97 for 30 — not your price
- FDA application
- NDA017532
What is Diabeta?
From the FDA label: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
How to use
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…
Side effects
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…
Warnings
Important safety information
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.
Who should not take Diabeta
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.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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.
How long does Glyburide stay in your body?
The elimination half-life of glyburide is about 10 hours (terminal/elimination half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label says the fall in glyburide serum levels in healthy people is biphasic — this 10 hours is the terminal (elimination) phase, not the earlier distribution phase. Glyburide is not a prodrug. It has two metabolites (the 4-trans-hydroxy and 3-cis-hydroxy derivatives), but the label states they are only weakly active (about 1/400th and 1/40th as active as glyburide in rabbits) and "probably contribute no significant hypoglycemic action in humans," so there is no active metabolite that outlasts the parent in a clinically meaningful way. The label gives no separate half-life numbers for older adults, kidney impairment, or liver impairment — it does warn that impaired kidney or liver function can raise glyburide levels and that liver impairment reduces gluconeogenesis, both raising hypoglycemia risk, and that older adults are prone to kidney insufficiency and are particularly susceptible to hypoglycemia. Glyburide is unusual among sulfonylureas in being cleared by two routes, roughly 50% in bile and 50% in urine, as metabolites. This is a pharmacokinetic figure, not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Glyburide tablets, USP — FDA label (DailyMed), CLINICAL PHARMACOLOGY / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Diabeta ranks — best-rated sulfonylurea for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Diabeta treat?
- Diabeta (Glyburide) may be used to treat type 2 diabetes mellitus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Diabeta rated?
- pharmaranks gives Diabeta a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Diabeta cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.97 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Glimepiride — about $1.00 on the same basis.
- Is there a coupon or discount for Diabeta?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Diabeta. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Diabeta?
- Diabeta is marketed by Sanofi Aventis US. You can see Sanofi Aventis US's full profile, rating, and other products on pharmaranks.
- Is Diabeta a brand-name or generic drug?
- Diabeta is a brand-name product with the active ingredient Glyburide. Lower-cost generic equivalents containing Glyburide are available — ask your pharmacist.
- Is Diabeta available over the counter?
- No. Diabeta is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Diabeta come in?
- Diabeta is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Diabeta?
- Diabeta is classified as sulfonylurea, per the FDA's Established Pharmacologic Class.
- Is Diabeta FDA-registered?
- Diabeta is on record with the U.S. FDA under application number NDA017532. You can verify this on its official FDA label.
- Has Diabeta been recalled by the FDA?
- Diabeta has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Diabeta safe?
- There's no single safe-or-not verdict. pharmaranks gives Diabeta a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Diabeta?
- Diabeta's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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diabeta
70/100