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GLYBURIDE AND METFORMIN HYDROCHLORIDE
Overview
What is GLYBURIDE AND METFORMIN HYDROCHLORIDE?
Glyburide and Metformin Hydrochloride Tablets contains two oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.
Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[-[2-(5-chloro--anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide is a white to off-white crystalline compound with a molecular formula of CHClNOS and a molecular weight of 494.01. Micronized Glyburide is used in Glyburide and Metformin Hydrochloride Tablets. The structural formula is represented below.
Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (,dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of CHClN (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown :
Glyburide and Metformin Hydrochloride Tablets is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin hydrochloride, and 5 mg glyburide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate. The 1.25 mg/250 mg tablet contains Opadry Yellow which containsHypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol and Iron Oxide Yellow.
The tablets are film coated, which provides color differentiation. Additionally 2.5 mg/500 mg tablet contains Opadry Pink which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and Iron Oxide Red. The 5 mg/500 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and D & C Yellow #10 Aluminium Lake.
What does GLYBURIDE AND METFORMIN HYDROCHLORIDE look like?
What are the available doses of GLYBURIDE AND METFORMIN HYDROCHLORIDE?
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What should I talk to my health care provider before I take GLYBURIDE AND METFORMIN HYDROCHLORIDE?
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How should I use GLYBURIDE AND METFORMIN HYDROCHLORIDE?
Glyburide and Metformin Hydrochloride Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
What interacts with GLYBURIDE AND METFORMIN HYDROCHLORIDE?
Glyburide and Metformin Hydrochloride Tablets is contraindicated in patients with :
1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see and ).
2. Known hypersensitivity to metformin hydrochloride or glyburide.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Glyburide and Metformin Hydrochloride Tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also .)
What are the warnings of GLYBURIDE AND METFORMIN HYDROCHLORIDE?
Metformin Hydrochloride
Lactic acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Glyburide and Metformin Hydrochloride Tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found.
The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Glyburide and Metformin Hydrochloride Tablets treatment should not be initiated in patients
80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, Glyburide and Metformin Hydrochloride Tablets should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, Glyburide and Metformin Hydrochloride Tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking Glyburide and Metformin Hydrochloride Tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, Glyburide and Metformin Hydrochloride Tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also
The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also ). Glyburide and Metformin Hydrochloride Tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of Glyburide and Metformin Hydrochloride Tablets, gastrointestinal symptoms, which are common during initiation of therapy with metformin, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking Glyburide and Metformin Hydrochloride Tablets do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling. (See also .)
Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).
Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking Glyburide and Metformin Hydrochloride Tablets, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery. (See also and .)
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 (Suppl. 2):747 to 830, 1970).
UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 g 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 benefits 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 hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
What are the precautions of GLYBURIDE AND METFORMIN HYDROCHLORIDE?
General
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glyburide and Metformin Hydrochloride Tablets or any other anti-diabetic drug.
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Patients receiving Glyburide and Metformin Hydrochloride Tablets in combination with a thiazolidinedione may be at risk for hypoglycemia.
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Weight gain was seen with the addition of rosiglitazone to Glyburide and Metformin Hydrochloride Tablets, similar to that reported for thiazolidinedione therapy alone.
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When a thiazolidinedione is used in combination with Glyburide and Metformin Hydrochloride Tablets, periodic monitoring of liver function tests should be performed in compliance with the labeled recommendations for the thiazolidinedione.
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Treatment of patients with glucose 6-phosphate dehydrogenase (G6DP) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Glyburide 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 benefits of Glyburide and Metformin Hydrochloride 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, glycosylated hemoglobin, renal function, and hematologic parameters.
The risks of lactic acidosis associated with metformin therapy, its symptoms, and conditions that predispose to its development, as noted in the and sections, should be explained to patients. Patients should be advised to discontinue Glyburide and Metformin Hydrochloride Tablets immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of Glyburide and Metformin Hydrochloride Tablets, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving Glyburide and Metformin Hydrochloride Tablets. (See printed below.)
Periodic fasting blood glucose and glycosylated hemoglobin (HbA) measurements should be performed to monitor therapeutic response.
Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. While megaloblastic anemia has rarely been seen with metformin therapy, if this is suspected, vitamin Bdeficiency should be excluded.
Glyburide and Metformin Hydrochloride Tablets
Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose 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 and Metformin Hydrochloride Tablets, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Glyburide and Metformin Hydrochloride Tablets, the patient should be observed closely for hypoglycemia. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid as compared to sulfonylureas, which are extensively bound to serum proteins.
Glyburide
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 and Metformin Hydrochloride Tablets, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Glyburide and Metformin Hydrochloride Tablets, the patient should be observed closely for loss of blood glucose control.
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 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 Hydrochloride
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A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration.
Furosemide increased the metformin plasma and blood Cby 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with metformin, the Cand AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance. No information is available about the interaction of metformin and furosemide when coadministered chronically.
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A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin Cand AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. Tand half-life were unaffected. Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine.
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Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of Glyburide and Metformin Hydrochloride Tablets and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.
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No animal studies have been conducted with the combined products in Glyburide and Metformin Hydrochloride Tablets. The following data are based on findings in studies performed with the individual products.
Glyburide
Studies in rats with glyburide alone at doses up to 300 mg/kg/day (approximately 145 times the maximum recommended human daily dose of 20 mg for the glyburide component of Glyburide and Metformin Hydrochloride Tablets based on body surface area comparisons) for 18 months revealed no carcinogenic effects. In a two-year oncogenicity study of glyburide in mice, there was no evidence of treatment-related tumors.
There was no evidence of mutagenic potential of glyburide alone in the following tests: microsome test (Ames test) and in the DNA damage/alkaline elution assay.
Metformin Hydrochloride
Long-term carcinogenicity studies were performed with metformin alone in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively. These doses are both approximately four times the maximum recommended human daily dose of 2000 mg of the metformin component of Glyburide and Metformin Hydrochloride Tablets based on body surface area comparisons. No evidence of carcinogenicity with metformin alone was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin alone in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day of metformin alone.
There was no evidence of a mutagenic potential of metformin alone in the following tests: Ames test (), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the mouse micronucleus test were also negative.
Fertility of male or female rats was unaffected by metformin alone when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose of the metformin component of Glyburide and Metformin Hydrochloride Tablets based on body surface area comparisons.
Glyburide and Metformin Hydrochloride Tablets
In a controlled clinical trial of rosiglitazone versus placebo in patients treated with Glyburide and Metformin Hydrochloride Tablets (n=365), 181 patients received Glyburide and Metformin Hydrochloride Tablets with rosiglitazone and 184 received Glyburide and Metformin Hydrochloride Tablets with placebo.
Edema was reported in 7.7% (14/181) of patients treated with rosiglitazone compared to 2.2% (4/184) of patients treated with placebo. A mean weight gain of 3 kg was observed in rosiglitazone-treated patients.
Hypoglycemia
In controlled clinical trials of Glyburide and Metformin Hydrochloride Tablets there were no hypoglycemic episodes requiring medical intervention and/or pharmacologic therapy; all events were managed by the patients. The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy trial of Glyburide and Metformin Hydrochloride Tablets are summarized in . The frequency of hypoglycemic symptoms in patients treated with Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250 mg was highest in patients with a baseline HbA<7%, lower in those with a baseline HbAof between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA>8%. For patients with a baseline HbAbetween 8% and 11% treated with Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30 to 35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with Glyburide and Metformin Hydrochloride Tablets experienced hypoglycemic symptoms. When rosiglitazone was added to Glyburide and Metformin Hydrochloride Tablets therapy, 22% of patients reported one or more fingerstick glucose measurements ≤50 mg/dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only one patient discontinued for hypoglycemia. (See : : .)
Gastrointestinal Reactions
| Adverse Event | Number (%) of Patients | ||||
|---|---|---|---|---|---|
| Placebo N=161 | Glyburide N=324 | Metformin N=312 | Glyburide and Metformin Hydrochloride TabletsN=642 | ||
| Upper respiratory infection | 22 (13.7) | 57 (17.6) | 51 (16.3) | 111 (17.3) | |
| Diarrhea | 9 (5.6) | 20 (6.2) | 64 (20.5) | 109 (17.0) | |
| Headache | 17 (10.6) | 37 (11.4) | 29 (9.3) | 57 (8.9) | |
| Nausea/vomiting | 10 (6.2) | 17 (5.2) | 38 (12.2) | 49 (7.6) | |
| Abdominal pain | 6 (3.7) | 10 (3.1) | 25 (8.0) | 44 (6.9) | |
| Dizziness | 7 (4.3) | 18 (5.6) | 12 (3.8) | 35 (5.5) | Variable | Placebo N=161 | Glyburide Tablets N=160 | Metformin Tablets N=159 | Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250 mg Tablets N=158 | Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg Tablets N=162 |
| Mean Final Dose | 0 mg | 5.3 mg | 1317 mg | 2.78 mg/557 mg | 4.1 mg/824 mg |
| Number (%) of patients with symptoms of hypoglycemia | 5 (3.1) | 34 (21.3) | 5 (3.1) | 18 (11.4) | 61 (37.7) |
| Number (%) of patients with gastrointestinal adverse events | 39 (24.2) | 38 (23.8) | 69 (43.3) | 50 (31.6) | 62 (38.3) |
OVERDOSAGE
Glyburide
Overdosage of sulfonylureas, including glyburide tablets, 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 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.
Metformin Hydrochloride
Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see ). Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
DOSAGE AND ADMINISTRATION
General Considerations
Dosage of Glyburide and Metformin Hydrochloride Tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin.
With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Glyburide and Metformin Hydrochloride Tablets and to identify the minimum effective dose for the patient. Thereafter, HbAshould be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbAto normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA(glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone.
No studies have been performed specifically examining the safety and efficacy of switching to Glyburide and Metformin Hydrochloride Tablets therapy in patients taking concomitant glyburide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.
Glyburide and Metformin Hydrochloride Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise
Recommended starting dose: 1.25 mg/250 mg once or twice daily with meals.
For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Glyburide and Metformin Hydrochloride Tablets is 1.25 mg/250 mg once a day with a meal. As initial therapy in patients with baseline HbA>9% or an FPG >200 mg/dL, a starting dose of Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 1.25 mg/250 mg per day every two weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose. In clinical trials of Glyburide and Metformin Hydrochloride Tablets as initial therapy, there was no experience with total daily doses greater than 10 mg/2000 mg per day.
Glyburide and Metformin Hydrochloride Tablets Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin
Recommended starting dose: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals.
For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of Glyburide and Metformin Hydrochloride Tablets is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Glyburide and Metformin Hydrochloride Tablets should not exceed the daily doses of glyburide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day.
For patients previously treated with combination therapy of glyburide (or another sulfonylurea) plus metformin, if switched to Glyburide and Metformin Hydrochloride Tablets, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glyburide and Metformin Hydrochloride Tablets should be titrated as described above to achieve adequate control of blood glucose.
Addition of Thiazolidinediones to Glyburide and Metformin Hydrochloride Tablets Therapy
For patients not adequately controlled on Glyburide and Metformin Hydrochloride Tablets, a thiazolidinedione can be added to Glyburide and Metformin Hydrochloride Tablets therapy. When a thiazolidinedione is added to Glyburide and Metformin Hydrochloride Tablets therapy, the current dose of Glyburide and Metformin Hydrochloride Tablets can be continued and the thiazolidinedione initiated at its recommended starting dose. For patients needing additional glycemic control, the dose of the thiazolidinedione can be increased based on its recommended titration schedule. The increased glycemic control attainable with Glyburide and Metformin Hydrochloride Tablets plus a thiazolidinedione may increase the potential for hypoglycemia at any time of day. In patients who develop hypoglycemia when receiving Glyburide and Metformin Hydrochloride Tablets and a thiazolidinedione, consideration should be given to reducing the dose of the glyburide component of Glyburide and Metformin Hydrochloride Tablets. As clinically warranted, adjustment of the dosages of the other components of the antidiabetic regimen should also be considered.
Specific Patient Populations
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WARNINGS
HOW SUPPLIED
Glyburide and Metformin Hydrochloride Tablets USP
Glyburide and Metformin Hydrochloride Tablets is a pale yellow, oval shaped, biconvex, film coated tablets with “I 25” debossed on one side and plain on the other side.
Glyburide and Metformin Hydrochloride Tablets is a pale orange, oval shaped, biconvex, film coated tablets with “I 23” debossed on one side and plain on the other side.
Glyburide and Metformin Hydrochloride Tablets is a yellow, oval shaped, biconvex, film coated tablets with “I 24” debossed on one side and plain on the other side.
STORAGE
Store at 25° C (77° F). [See USP Controlled Room Temperature.]
Dispense in light-resistant containers.
GLUCOPHAGE is a registered trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.
Micronase is a registered trademark of Pharmacia & Upjohn Company.
Rx Only
Manufactured for
Dr. Reddy’s Laboratories Inc.,
Bridgewater, NJ 08807 USA
Manufactured by
USV LIMITED
H-17/H-18, OIDC, Mahatma Gandhi
Udyog Nagar, Dabhel, Daman 396210, India
Issued 06/09
| Glyburide and Metformin Hydrochloride Tablets USP | NDC 55111-XXX-XX for unit of use | |||
| Glyburide (mg) | Metformin hydrochloride (mg) | Bottle of | ||
| 100 | 500 | 1000 | ||
| 1.25 | 250 | 695-01 | 695-05 | 695-10 |
| 2.5 | 500 | 696-01 | 696-05 | 696-10 |
| 5 | 500 | 697-01 | 697-05 | 697-10 |
PATIENT INFORMATION ABOUT
Glyburide and Metformin Hydrochloride Tablets
Your doctor has prescribed Glyburide and Metformin Hydrochloride Tablets to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.
People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.
The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness.
High blood sugar can be lowered by diet and exercise, by a number of oral medications, and by insulin injections. Before taking Glyburide and Metformin Hydrochloride Tablets you should first try to control your diabetes by exercise and weight loss. Even if you are taking Glyburide and Metformin Hydrochloride Tablets, you should still exercise and follow the diet recommended for your diabetes.
Yes it does. Glyburide and Metformin Hydrochloride Tablets combines two glucose-lowering drugs, glyburide and metformin. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glyburide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control.
When blood sugar cannot be lowered enough by Glyburide and Metformin Hydrochloride Tablets your doctor may prescribe injectable insulin or take other measures to control your diabetes.
Glyburide and Metformin Hydrochloride Tablets, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to Glyburide and Metformin Hydrochloride Tablets (see ).
The most common side effects of Glyburide and Metformin Hydrochloride Tablets are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your Glyburide and Metformin Hydrochloride Tablets with meals can help reduce these side effects.
Less frequently, symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.
Glyburide and Metformin Hydrochloride Tablets rarely causes serious side effects. The most serious side effect that Glyburide and Metformin Hydrochloride Tablets can cause is called lactic acidosis.
Lactic acidosis is caused by a buildup of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.
It’s also important for your liver to be working normally when you take Glyburide and Metformin Hydrochloride Tablets. Your liver helps remove lactic acid from your bloodstream.
Q11. Are there other risk factors for lactic acidosis?
Your risk of developing lactic acidosis from taking Glyburide and Metformin Hydrochloride Tablets is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your physician.
Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat.
If you notice these symptoms, or if your medical condition has suddenly changed, stop taking Glyburide and Metformin Hydrochloride Tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.
Q13. What does my doctor need to know to decrease my risk of lactic acidosis?
Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking Glyburide and Metformin Hydrochloride Tablets temporarily.
You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Glyburide and Metformin Hydrochloride Tablets therapy will need to be stopped temporarily in such instances.
Q14. Can I take Glyburide and Metformin Hydrochloride Tablets with other medications?
Remind your doctor that you are taking Glyburide and Metformin Hydrochloride Tablets when any new drug is prescribed or a change is made in how you take a drug already prescribed. Glyburide and Metformin Hydrochloride Tablets may interfere with the way some drugs work and some drugs may interfere with the action of Glyburide and Metformin Hydrochloride Tablets.
Q15. What if I become pregnant while taking Glyburide and Metformin Hydrochloride Tablets?
Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take Glyburide and Metformin Hydrochloride Tablets during pregnancy.
Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of Glyburide and Metformin Hydrochloride Tablets if you are nursing a child.
Q16. How do I take Glyburide and Metformin Hydrochloride Tablets?
Your doctor will tell you how many Glyburide and Metformin Hydrochloride Tablets to take and how often. This should also be printed on the label of your prescription. You will probably be started on a low dose of Glyburide and Metformin Hydrochloride Tablets and your dosage will be increased gradually until your blood sugar is controlled.
Q17. Where can I get more information about Glyburide and Metformin Hydrochloride Tablets?
This leaflet is a summary of the most important information about Glyburide and Metformin Hydrochloride Tablets. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as Glyburide and Metformin Hydrochloride Tablets and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.
GLUCOPHAGE is a registered trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.
Micronase is a registered trademark of Pharmacia & Upjohn Company.
*Lanoxin is a registered trademark of GlaxoSmithKline.
**Lasix is a registered trademark of Aventis Pharma, Inc.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.
Rx Only
Manufactured for
Dr. Reddy’s Laboratories Inc.,
Bridgewater, NJ 08807 USA
Manufactured by
USV LIMITED
H-17/H-18, OIDC, Mahatma Gandhi
Udyog Nagar, Dabhel, Daman 396210, India
Issued 06/09
What are the side effects of GLYBURIDE AND METFORMIN HYDROCHLORIDE?
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What should I look out for while using GLYBURIDE AND METFORMIN HYDROCHLORIDE?
Glyburide and Metformin Hydrochloride Tablets is contraindicated in patients with :
1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see and ).
2. Known hypersensitivity to metformin hydrochloride or glyburide.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Glyburide and Metformin Hydrochloride Tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also .)
What might happen if I take too much GLYBURIDE AND METFORMIN HYDROCHLORIDE?
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How should I store and handle GLYBURIDE AND METFORMIN HYDROCHLORIDE?
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Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Glyburide and Metformin Hydrochloride Tablets combines glyburide and metformin hydrochloride, two antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.
Glyburide appears to lower 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 patients with type 2 diabetes, 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.
Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Non-Clinical Toxicology
Glyburide and Metformin Hydrochloride Tablets is contraindicated in patients with :1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see and ).
2. Known hypersensitivity to metformin hydrochloride or glyburide.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Glyburide and Metformin Hydrochloride Tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also .)
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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