Glipizide and Metformin Hydrochloride

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Overview

What is Glipizide and Metformin Hydrochloride?

Glipizide and metformin hydrochloride tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride.

Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. Glipizide is a whitish, odorless powder with a pK of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below.

CHNOS M.W. 445.55

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. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

CHClN M.W. 165.63

Glipizide and metformin hydrochloride is available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, starch, talc, and titanium dioxide. Additionally, 2.5 mg/250 mg and 5 mg/500 mg tablets contain iron oxide black, iron oxide red, and iron oxide yellow. The tablets are film-coated, which provides color differentiation.

What does Glipizide and Metformin Hydrochloride look like?

What are the available doses of Glipizide and Metformin Hydrochloride?

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What should I talk to my health care provider before I take Glipizide and Metformin Hydrochloride?

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How should I use Glipizide and Metformin Hydrochloride?

Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage of

glipizide 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 glipizide/2000 mg metformin.

With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glipizide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbA should 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, 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 glipizide and metformin hydrochloride tablet therapy in patients taking concomitant glipizide (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.

What interacts with Glipizide and Metformin Hydrochloride?

Glipizide and metformin hydrochloride tablets are contraindicated in patients with:

- 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 ).
- Known hypersensitivity to glipizide or metformin hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Glipizide 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 Glipizide and Metformin Hydrochloride?

Metformin Hydrochloride

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with

glipizide 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.

Glipizide and metformin hydrochloride tablet 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,

glipizide 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, glipizide 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 glipizide and metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, glipizide and metformin hydrochloride tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).

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 PRECAUTIONS).

Glipizide 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 glipizide 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

glipizide 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 PRECAUTIONS).

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 glipizide 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 CONTRAINDICATIONS and PRECAUTIONS).

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 1 of 4 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 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and benefits of glipizide and of alternative modes of therapy.

Although only 1 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 Glipizide and Metformin Hydrochloride?

General

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glipizide and metformin hydrochloride tablets or any other antidiabetic drug.

Information for Patients

Patients should be informed of the potential risks and benefits of glipizide and metformin hydrochloride tablets and alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions; a regular exercise program; and 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 glipizide and metformin hydrochloride tablets immediately and 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 glipizide 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 glipizide and metformin hydrochloride tablets (see printed below).

Laboratory Tests

Periodic fasting blood glucose (FBG) and 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 B deficiency should be excluded.

Drug Interactions

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include 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 glipizide 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 glipizide 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.

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including non-steroidal anti-inflammatory agents, some azoles, 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 glipizide and metformin hydrochloride tablets, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide and metformin hydrochloride tablets, the patient should be observed closely for loss of blood glucose control. binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide and metformin hydrochloride tablets with these drugs.

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. The effect of concomitant administration of fluconazole and glipizide has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single oral daily dose for 7 days, the mean percent increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35% to 81%).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been conducted with the combined products in glipizide and metformin hydrochloride tablets. The following data are based on findings in studies performed with the individual products.

A 20 month study in rats and an 18 month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 75 times the human dose showed no effects on fertility.

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 4 times the maximum recommended human daily (MRHD) dose of 2000 mg of the metformin component of glipizide 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 3 times the MRHD dose of the metformin component of glipizide and metformin hydrochloride tablets based on body surface area comparisons.

Pregnancy

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. It is not recommended that glipizide and metformin hydrochloride tablets be used during pregnancy. However, if they are used, glipizide and metformin hydrochloride tablets should be discontinued at least 1 month before the expected delivery date (see , , ).

Nursing Mothers

Although it is not known whether glipizide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue glipizide and metformin hydrochloride tablets, taking into account the importance of the drug to the mother. If glipizide and metformin hydrochloride tablets are discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

Safety and effectiveness of glipizide and metformin hydrochloride tablets in pediatric patients have not been established.

Geriatric Use

Of the 345 patients who received glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg and 2.5 mg/500 mg in the initial therapy trial, 67 (19.4%) were aged 65 and older while 5 (1.4%) were aged 75 and older. Of the 87 patients who received glipizide and metformin hydrochloride tablets in the second-line therapy trial, 17 (19.5%) were aged 65 and older while 1 (1.1%) was at least aged 75. No overall differences in effectiveness or safety were observed between these patients and younger patients in either the initial therapy trial or the second-line therapy trial, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Metformin hydrochloride is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, glipizide and metformin hydrochloride tablets should only be used in patients with normal renal function (see ; ; and , ). Because aging is associated with reduced renal function, glipizide and metformin hydrochloride tablets should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of glipizide and metformin hydrochloride tablets (see also and ).

What are the side effects of Glipizide and Metformin Hydrochloride?

Glipizide and Metformin Hydrochloride Tablets

In a double-blind 24 week clinical trial involving glipizide and metformin hydrochloride tablets as initial therapy, a total of 172 patients received glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, 173 received glipizide and metformin hydrochloride tablets, 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in .

In a double-blind 18 week clinical trial involving glipizide and metformin hydrochloride tablets as second-line therapy, a total of 87 patients received glipizide and metformin hydrochloride tablets, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in .

**Table 4: Clinical Adverse Events > 5% in any Treatment Group, by Primary Term, in Initial Therapy Study**
	Number (%) of Patients

Upper respiratory infection	12 (7.1)	15 (8.5)	17 (9.9)	14 (8.1)
Diarrhea	8 (4.7)	15 (8.5)	4 (2.3)	9 (5.2)
Dizziness	9 (5.3)	2 (1.1)	3 (1.7)	9 (5.2)
Hypertension	17 (10.0)	10 (5.6)	5 (2.9)	6 (3.5)
Nausea/vomiting	6 (3.5)	9 (5.1)	1 (0.6)	3 (1.7)
	Number (%) of Patients
Adverse Event	The dose of glipizide was fixed at 30 mg daily; doses of metformin and glipizide and metformin hydrochloride tablets were titrated.
Diarrhea	11 (13.1)	13 (17.3)	16 (18.4)
Headache	5 (6.0)	4 (5.3)	11 (12.6)
Upper respiratory infection	11 (13.1)	8 (10.7)	9 (10.3)
Musculoskeletal pain	6 (7.1)	5 (6.7)	7 (8.0)
Nausea/vomiting	5 (6.0)	6 (8.0)	7 (8.0)
Abdominal pain	7 (8.3)	5 (6.7)	5 (5.7)
UTI	4 (4.8)	6 (8.0)	1 (1.1)

What should I look out for while using Glipizide and Metformin Hydrochloride?

Glipizide and metformin hydrochloride tablets are contraindicated in patients with:

Glipizide 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 Glipizide and Metformin Hydrochloride?

How should I store and handle Glipizide and Metformin Hydrochloride?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146 Glipizide and metformin hydrochloride tablets are available as follows:2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:bottles of 100 ().2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:bottles of 10 ()bottles of 30 ()bottles of 60 ().5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:bottles of 10 () bottles of 30 () bottles of 60 ().STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Israel By:TEVA PHARMACEUTICAL IND. LTD.Jerusalem, 91010, IsraelManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 10/2009Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Glipizide and metformin hydrochloride tablets combine glipizide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.

Glipizide 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. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. The mechanism by which glipizide lowers blood glucose during long-term administration has not been clearly established. In man, stimulation of insulin secretion by glipizide in response to a meal is undoubtedly of major importance. Fasting insulin levels are not elevated even on long-term glipizide administration, but the postprandial insulin response continues to be enhanced after at least 6 months of treatment.

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

Glipizide and metformin hydrochloride tablets are contraindicated in patients with:

Glipizide 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 ).

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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