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Glynase
Overview
What is Glynase?
GLYNASE PresTab Tablets contain micronized (smaller particle size) glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as GLYNASE PresTab Tablets of 1.5 mg, 3 mg, and 6 mg strengths for oral administration. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose, magnesium stearate. In addition, the strength contains FD&C Blue No. 1 Aluminum Lake, and the tablet contains D&C Yellow No. 10 Aluminum Lake. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below:
What does Glynase look like?
What are the available doses of Glynase?
Sorry No records found.
What should I talk to my health care provider before I take Glynase?
Sorry No records found
How should I use Glynase?
GLYNASE PresTab Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Patients should be retitrated when transferred from MICRONASE or Diabeta or other oral hypoglycemic agents.
There is no fixed dosage regimen for the management of diabetes mellitus with GLYNASE PresTab Tablets. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, , inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, , loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy.
Short-term administration of GLYNASE PresTab may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
What interacts with Glynase?
- GLYNASE PresTab Tablets are contraindicated in patients with:
- Known hypersensitivity or allergy to the drug.
- Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
- Type I diabetes mellitus.
- Concomitant administration of bosentan.
What are the warnings of Glynase?
Sorry No Records found
What are the precautions of Glynase?
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLYNASE PresTab or any other anti-diabetic drug.
Bioavailability studies have demonstrated that GLYNASE PresTab Tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from MICRONASE Tablets 5 mg. Therefore, patients should be retitrated when transferred from MICRONASE or Diabeta or other oral hypoglycemic agents.
General
Hypoglycemia
All sulfonylureas including GLYNASE PresTab are capable of producing severe hypoglycemia. Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may cause elevated drug levels of glyburide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious 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 the elderly and in people who are taking beta-adrenergic blocking drugs. 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. The risk of hypoglycemia may be increased with combination therapy.
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 GLYNASE PresTab and administer insulin.
The effectiveness of any hypoglycemic drug, including GLYNASE PresTab, 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 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 GLYNASE PresTab is first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.
Hemolytic Anemia
Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because GLYNASE PresTab 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 post marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.
Information for Patients
Patients should be informed of the potential risks and advantages of GLYNASE PresTab and of alternative modes of therapy. They also should be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or 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 also should be explained.
Physician Counseling Information for Patients
In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. Use of GLYNASE PresTab or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of GLYNASE PresTab or other antidiabetic medications. Maintenance or discontinuation of GLYNASE PresTabs or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.
Laboratory Tests
Therapeutic response to GLYNASE PresTab Tablets should be monitored by frequent urine glucose tests and periodic blood glucose tests. Measurement of glycosylated hemoglobin levels may be helpful in some patients.
Drug Interactions
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, 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 risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of GLYNASE PresTab and bosentan is contraindicated.
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.
A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism of action for this interaction is not known.
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.
Metformin
In a single-dose interaction study in NIDDM subjects, decreases in glyburide AUC and C were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain. Coadministration of glyburide and metformin did not result in any changes in either metformin pharmacokinetics or pharmacodynamics.
Colesevelam
Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and C of 32% and 47%, respectively. The reductions in glyburide AUC and C were 20% and 15%, respectively when administered 1 hour before, and not significantly changed (-7% and 4%, respectively) when administered 4 hours before colesevelam.
Topiramate
A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). There was a 22% decrease in C and a 25% reduction in AUC for glyburide during topiramate administration. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, and C was reduced by 18% and 25%, respectively. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Studies in rats at doses up to 300 mg/kg/day for 18 months showed no carcinogenic effects. Glyburide is nonmutagenic when studied in the Salmonella microsome test (Ames test) and in the DNA damage/alkaline elution assay.
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
Reproduction studies have been performed in rats and rabbits at doses up to 500 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to glyburide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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 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 GLYNASE PresTab 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 glyburide is excreted in human milk, some sulfonylurea drugs 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 the drug, taking into account the importance of the drug to the mother. If the drug 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
Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs. Hypoglycemia may be difficult to recognize in the elderly (see ). The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see ).
Elderly patients are prone to develop renal insufficiency, which may put them at risk of hypoglycemia. Dose selection should include assessment of renal function.
What are the side effects of Glynase?
Hypoglycemia:
Gastrointestinal Reactions:
Liver function abnormalities, including isolated transaminase elevations, have been reported.
Gastrointestinal disturbances, , nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced.
Dermatologic Reactions:
eg
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Hematologic Reactions:
Metabolic Reactions:
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:
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 Glynase?
GLYNASE PresTab Tablets are contraindicated in patients with:
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 (Suppl. 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 GLYNASE PresTab 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.
What might happen if I take too much Glynase?
Overdosage of sulfonylureas, including glyburide, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological 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 which 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 Glynase?
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx onlyGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx onlyGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx onlyGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx onlyGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx onlyGLYNASE PresTab Tablets are supplied as follows:GLYNASE PresTab Tablets 1.5 mgGLYNASE PresTab Tablets 3 mgGLYNASE PresTab Tablets 6 mgThe PresTab Tablet can be divided in half for a more flexible dosing regimen. Press gently on the score and the PresTab Tablet will split in even halves.Rx only
Clinical Information
Chemical Structure
No Image foundClinical 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 be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs. The combination of glyburide and metformin may have a synergistic effect, since both agents act to improve glucose tolerance by different but complementary mechanisms.
Some patients who are initially responsive to oral hypoglycemic drugs, including glyburide, may become unresponsive or poorly responsive over time. Alternatively, glyburide may be effective in some patients who have become unresponsive to one or more other sulfonylurea drugs.
In addition to its blood glucose lowering actions, glyburide produces a mild diuresis by enhancement of renal free water clearance. Disulfiram-like reactions have very rarely been reported in patients treated with glyburide.
Non-Clinical Toxicology
GLYNASE PresTab Tablets are contraindicated in patients with: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 (Suppl. 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 GLYNASE PresTab 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.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, 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 risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of GLYNASE PresTab and bosentan is contraindicated.
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.
A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism of action for this interaction is not known.
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.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLYNASE PresTab or any other anti-diabetic drug.
Bioavailability studies have demonstrated that GLYNASE PresTab Tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from MICRONASE Tablets 5 mg. Therefore, patients should be retitrated when transferred from MICRONASE or Diabeta or other oral hypoglycemic agents.
Hypoglycemia:
Gastrointestinal Reactions:
Liver function abnormalities, including isolated transaminase elevations, have been reported.
Gastrointestinal disturbances, , nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced.
Dermatologic Reactions:
eg
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Hematologic Reactions:
Metabolic Reactions:
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:
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/"
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