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GLUCOVANCE

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Overview

What is GLUCOVANCE?

GLUCOVANCE (Glyburide and Metformin HCl) Tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.



What does GLUCOVANCE look like?



What are the available doses of GLUCOVANCE?

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What should I talk to my health care provider before I take GLUCOVANCE?

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How should I use GLUCOVANCE?

GLUCOVANCE (Glyburide and Metformin HCl) Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage of GLUCOVANCE 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 GLUCOVANCE 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 HbA to 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 GLUCOVANCE 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.


What interacts with GLUCOVANCE?

GLUCOVANCE is contraindicated in patients with:


1.Severe renal impairment (eGFR below 30 mL/min/1.73m (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.


4.Concomitant administration of bosentan.



What are the warnings of GLUCOVANCE?

Metformin Hydrochloride

WARNING: LACTIC ACIDOSIS

Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL (see

).

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g.,carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see

If metformin-associated lactic acidosis is suspected, immediately discontinue GLUCOVANCE and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see

).

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY




What are the precautions of GLUCOVANCE?

General

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLUCOVANCE or any other antidiabetic drug.

GLUCOVANCE

Glyburide

Metformin Hydrochloride

Addition of Thiazolidinediones to GLUCOVANCE Therapy

Information for Patients

Patients should be informed of the potential risks and benefits of GLUCOVANCE 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 GLUCOVANCE 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 GLUCOVANCE, 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 GLUCOVANCE. (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 (eg, 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

GLUCOVANCE

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 GLUCOVANCE, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving GLUCOVANCE, 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



Metformin Hydrochloride

Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been conducted with the combined products in GLUCOVANCE. The following data are based on findings in studies performed with the individual products.

Glyburide

No animal studies have been conducted with the combined products in GLUCOVANCE. The following data are based on findings in studies performed with the individual products.

Metformin Hydrochloride

No animal studies have been conducted with the combined products in GLUCOVANCE. The following data are based on findings in studies performed with the individual products.

Pregnancy

Teratogenic Effects: Pregnancy Category B



Nonteratogenic Effects

Prolonged severe hypoglycemia (4-10 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 GLUCOVANCE be used during pregnancy. However, if it is used, GLUCOVANCE should be discontinued at least 2 weeks before the expected delivery date. (See .)

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. 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 GLUCOVANCE, taking into account the importance of the drug to the mother. If GLUCOVANCE is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

The safety and efficacy of GLUCOVANCE were evaluated in an active-controlled, double-blind, 26-week randomized trial involving a total of 167 pediatric patients (ranging from 9-16 years of age) with type 2 diabetes. GLUCOVANCE was not shown statistically to be superior to either metformin or glyburide with respect to reducing HbA from baseline (see ). No unexpected safety findings were associated with GLUCOVANCE in this trial.

Table 5: HbA (Percent) Change From Baseline at 26 Weeks: Pediatric Study
 Glyburide2.5 mgtabletsMetformin500 mgtabletsGLUCOVANCE1.25 mg/250 mgtablets
Mean Final Dose6.5 mg1500 mg3.1 mg/623 mg
Hemoglobin A N=49N=54N=57
  Baseline Mean (%)7.707.997.85
  Mean Change from Baseline−0.96−0.48−0.80
  Difference from Metformin  −0.32
  Difference from Glyburide  +0.16


Geriatric Use

Of the 642 patients who received GLUCOVANCE in double-blind clinical studies, 23.8% were 65 and older while 2.8% were 75 and older. Of the 1302 patients who received GLUCOVANCE in open-label clinical studies, 20.7% were 65 and older while 2.5% were 75 and older. No overall differences in effectiveness or safety were observed between these patients and younger patients, 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, GLUCOVANCE should only be used in patients with normal renal function (see , , and ). Because aging is associated with reduced renal function, GLUCOVANCE 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 GLUCOVANCE (see also and ).


What are the side effects of GLUCOVANCE?

GLUCOVANCE

In double-blind clinical trials involving GLUCOVANCE as initial therapy or as second-line therapy, a total of 642 patients received GLUCOVANCE, 312 received metformin therapy, 324 received glyburide therapy, and 161 received placebo. The percent of patients reporting events and types of adverse events reported in clinical trials of GLUCOVANCE (all strengths) as initial therapy and second-line therapy are listed in .

In a controlled clinical trial of rosiglitazone versus placebo in patients treated with GLUCOVANCE (n=365), 181 patients received GLUCOVANCE with rosiglitazone and 184 received GLUCOVANCE 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.

Disulfiram-like reactions have very rarely been reported in patients treated with glyburide tablets.

Table 6: Most Common Clinical Adverse Events (>5%) in Double-Blind Clinical Studies of GLUCOVANCE Used as Initial or Second-Line Therapy


Hypoglycemia

In controlled clinical trials of GLUCOVANCE 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 GLUCOVANCE are summarized in . The frequency of hypoglycemic symptoms in patients treated with GLUCOVANCE 1.25 mg/250 mg was highest in patients with a baseline HbA <7%, lower in those with a baseline HbA of between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA >8%. For patients with a baseline HbA between 8% and 11% treated with GLUCOVANCE 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 GLUCOVANCE experienced hypoglycemic symptoms. When rosiglitazone was added to GLUCOVANCE therapy, 22% of patients reported 1 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 1 patient discontinued for hypoglycemia. (See .)

Gastrointestinal Reactions

The incidence of gastrointestinal (GI) side effects (diarrhea, nausea/vomiting, and abdominal pain) in the initial therapy trial are summarized in . Across all GLUCOVANCE trials, GI symptoms were the most common adverse events with GLUCOVANCE and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued GLUCOVANCE therapy due to GI adverse events.

In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; GLUCOVANCE should be discontinued if this occurs.

Table 7: Treatment Emergent Symptoms of Hypoglycemia or Gastrointestinal Adverse Events in a Placebo- and Active-Controlled Trial of GLUCOVANCE as Initial Therapy



What should I look out for while using GLUCOVANCE?

GLUCOVANCE is contraindicated in patients with:

1.Severe renal impairment (eGFR below 30 mL/min/1.73m (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.

4.Concomitant administration of bosentan.


What might happen if I take too much GLUCOVANCE?


How should I store and handle GLUCOVANCE?

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].GLUCOVANCE (Glyburide and Metformin HCl) TabletsGLUCOVANCE tablet is a pale orange, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.GLUCOVANCE tablet is a yellow, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.GLUCOVANCE (Glyburide and Metformin HCl) TabletsGLUCOVANCE tablet is a pale orange, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.GLUCOVANCE tablet is a yellow, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.GLUCOVANCE (Glyburide and Metformin HCl) TabletsGLUCOVANCE tablet is a pale orange, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.GLUCOVANCE tablet is a yellow, capsule-shaped, bevel-edged, biconvex, film-coated tablet with "" debossed on one side and "" debossed on the opposite side.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

GLUCOVANCE combines glyburide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.

Non-Clinical Toxicology
GLUCOVANCE is contraindicated in patients with:

1.Severe renal impairment (eGFR below 30 mL/min/1.73m (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.

4.Concomitant administration of bosentan.

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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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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

Interactions

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