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Glipizide and Metformin HCl
Overview
What is Glipizide and Metformin HCl?
Glipizide and Metformin HCl 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 molecular formula of C H N O S, a molecular weight of 445.55 and a pK of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. 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 C H ClN (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:
Glipizide and Metformin HCl Tablets are 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: Sodium Starch Glycolate, Corn Starch, Povidone, Magnesium Stearate, Colloidal Silicon Dioxide, Hypromellose, Talc, Titanium Dioxide, Polyethylene Glycol 6000, Propylene Glycol and Iron Oxide Red. The tablets are film coated, which provides color differentiation.
What does Glipizide and Metformin HCl look like?
What are the available doses of Glipizide and Metformin HCl?
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What should I talk to my health care provider before I take Glipizide and Metformin HCl?
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How should I use Glipizide and Metformin HCl?
Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
General Considerations
Dosage of Glipizide and Metformin HCl 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 HCl Tablets and to identify the minimum effective dose for the patient. Thereafter, HbA1c 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 HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c, 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 HCl Tablets 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.
When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, Glipizide and Metformin HCl Tablets should be administered at least 4 hours prior to colesevelam.
Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise Alone
For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 mg/dL to 320 mg/dL a starting dose of Glipizide and Metformin HCl Tablets 2.5 mg/500 mg twice daily should be considered. The efficacy of Glipizide and Metformin HCl Tablets in patients whose FPG exceeds 320 mg/dL has not been established. Dosage increases to achieve adequate glycemic control should be made in increments of 1 tablet per day every 2 weeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg Glipizide and Metformin HCl Tablets per day given in divided doses. In clinical trials of Glipizide and Metformin HCl Tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day.
Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin
For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 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 Glipizide and Metformin HCl Tablets should not exceed the daily doses of glipizide 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.
Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to Glipizide and Metformin HCl Tablets 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glipizide and Metformin HCl Tablets should be titrated as described above to achieve adequate control of blood glucose.
Recommendations for Use in Renal Impairment
Assess renal function prior to initiation of Glipizide and Metformin HCl Tablets and periodically thereafter.
Glipizide and Metformin HCl Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m .
Initiation of Glipizide and Metformin HCl Tablets in patients with an eGFR between 30 - 45 mL/minute/1.73 m is not recommended.
In patients taking Glipizide and Metformin HCl Tablets whose eGFR later falls below 45 mL/min/1.73 m , assess the benefit risk of continuing therapy.
Discontinue Glipizide and Metformin HCl Tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m . (See
.)
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue Glipizide and Metformin HCl Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Glipizide and Metformin HCl Tablets if renal function is stable.
Specific Patient Populations
Glipizide and Metformin HCl Tablets are not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of Glipizide and Metformin HCl Tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Glipizide and Metformin HCl Tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See
and
.)
What interacts with Glipizide and Metformin HCl?
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What are the warnings of Glipizide and Metformin HCl?
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
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 HCl?
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What are the side effects of Glipizide and Metformin HCl?
Glipizide and Metformin HCl Tablets
In a double-blind 24-week clinical trial involving Glipizide and Metformin HCl Tablets as initial therapy, a total of 172 patients received Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, 173 received Glipizide and Metformin HCl 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 HCl Tablets as second-line therapy, a total of 87 patients received Glipizide and Metformin HCl Tablets, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in
.
Hypoglycemia
In a controlled initial therapy trial of Glipizide and Metformin HCl Tablets 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, and 16 (9.3%) for Glipizide and Metformin HCl Tablets 2.5 mg/500 mg. Among patients taking either Glipizide and Metformin HCl Tablets 2.5 mg/250 mg or Glipizide and Metformin HCl Tablets 2.5 mg/500 mg, 9 (2.6%) patients discontinued Glipizide and Metformin HCl Tablets due to hypoglycemic symptoms and 1 required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of Glipizide and Metformin HCl Tablets 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for Glipizide and Metformin HCl Tablets. One (1.1%) patient discontinued Glipizide and Metformin HCl Tablets therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See
)
Gastrointestinal Reactions
Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both Glipizide and Metformin HCl Tablets dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued Glipizide and Metformin HCl Tablets therapy due to gastrointestinal (GI) adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among Glipizide and Metformin HCl Tablets, glipizide and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued Glipizide and Metformin HCl Tablets therapy due to GI adverse events.
Glipizide
Gastrointestinal Reactions
Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; Glipizide and Metformin HCl Tablets should be discontinued if this occurs.
| Adverse Event | 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 | ||||
| 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 HCl?
Glipizide and Metformin HCl Tablets are contraindicated in patients with:
1. Severe renal impairment (eGFR below 30 mL/min/1.73 m )(see
and
).
2. Known hypersensitivity to glipizide or metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
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 (
Diabetes 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 might happen if I take too much Glipizide and Metformin HCl?
Glipizide
Overdosage of sulfonylureas, including glipizide, 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. Clearance of glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
Metformin Hydrochloride
Overdose of metformin hydrochloride has occurred, including ingestion of amounts >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.
How should I store and handle Glipizide and Metformin HCl?
Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a white to off white, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a white to off white, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a white to off white, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a white to off white, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a white to off white, capsule shape, film-coated tablet with debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet is a pink coloured, capsule shape, film-coated tablet with debossed on one side and plain on the other side.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Glipizide and Metformin HCl Tablets combines 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 HCl Tablets are contraindicated in patients with:1. Severe renal impairment (eGFR below 30 mL/min/1.73 m )(see and ).
2. Known hypersensitivity to glipizide or metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
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 (
Diabetes 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.
Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of furosemide concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of furosemide.
Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of Furosemide. Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide.
Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to Furosemide-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
Glipizide and Metformin HCl Tablets
In a double-blind 24-week clinical trial involving Glipizide and Metformin HCl Tablets as initial therapy, a total of 172 patients received Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, 173 received Glipizide and Metformin HCl 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 HCl Tablets as second-line therapy, a total of 87 patients received Glipizide and Metformin HCl Tablets, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in .
Hypoglycemia
In a controlled initial therapy trial of Glipizide and Metformin HCl Tablets 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, and 16 (9.3%) for Glipizide and Metformin HCl Tablets 2.5 mg/500 mg. Among patients taking either Glipizide and Metformin HCl Tablets 2.5 mg/250 mg or Glipizide and Metformin HCl Tablets 2.5 mg/500 mg, 9 (2.6%) patients discontinued Glipizide and Metformin HCl Tablets due to hypoglycemic symptoms and 1 required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of Glipizide and Metformin HCl Tablets 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for Glipizide and Metformin HCl Tablets. One (1.1%) patient discontinued Glipizide and Metformin HCl Tablets therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See )
Gastrointestinal Reactions
Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both Glipizide and Metformin HCl Tablets dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued Glipizide and Metformin HCl Tablets therapy due to gastrointestinal (GI) adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among Glipizide and Metformin HCl Tablets, glipizide and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued Glipizide and Metformin HCl Tablets therapy due to GI adverse events.
Glipizide
Gastrointestinal Reactions
Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; Glipizide and Metformin HCl Tablets should be discontinued if this occurs.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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