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6% with Glucophage XR. Response to all diabetic therapies should be monitored by periodic measurements of fasting blood glucose and glycosylated hemoglobin levels, with a goal of decreasing these levels toward the normal range. 4. In patients with advanced age, GLUCOPHAGE and Glucophage XR should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging is associated with reduced renal function. In the presence of normal renal function, there are no differences between single- or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects (see Table 1 ), nor is there any accumulation of metformin in either group at usual clinical doses. ). Alcohol intake —Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients in the GLUCOPHAGE only arm (metformin plus placebo) followed the same titration schedule. Not significant using analysis of variance (values shown in table). Patients randomized to the combination arm started therapy with GLUCOPHAGE 500 mg and glyburide 20 mg. Glucophage XR 500 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, and magnesium stearate. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Although the extent of metformin absorption (as measured by AUC) from the Glucophage XR tablet increased by approximately 50% when given with food, there was no effect of food on C max and T max of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Peak plasma levels are approximately 20% lower compared to the same dose of GLUCOPHAGE, however, the extent of absorption (as measured by AUC) is similar to GLUCOPHAGE. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Once a patient is stabilized on any dose level of GLUCOPHAGE or Glucophage XR, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters. GLUCOPHAGE and Glucophage XR should be withdrawn until the situation is clarified. Both high and low fat meals had the same effect on the pharmacokinetics of Glucophage XR. Metformin is negligibly bound to plasma proteins, in contrast to sulfonylureas, which are more than 90% protein bound. Monitoring of renal function —Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. At steady state, the AUC and C max are less than dose proportional for Glucophage XR within the range of 500 to 2000 mg administered once daily. After week 4, such dosage adjustments were made monthly, although no patient was allowed to exceed GLUCOPHAGE 2500 mg. Compared with placebo, improvement in glycemic control was seen at all dose levels of Glucophage XR (metformin hydrochloride) Extended-Release Tablets and treatment was not associated with any significant change in weight (see DOSAGE AND ADMINISTRATION for dosing recommendations for GLUCOPHAGE and Glucophage XR). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of GLUCOPHAGE was comparable in males and females. Change in clinical status of patients with previously controlled type 2 diabetes —A patient with type 2 diabetes previously well controlled on GLUCOPHAGE or Glucophage XR who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Glucophage XR contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Patients should be counselled against excessive alcohol intake, either acute or chronic, while receiving GLUCOPHAGE or Glucophage XR. Impaired hepatic function —Since impaired hepatic function has been associated with some cases of lactic acidosis, GLUCOPHAGE and Glucophage XR should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. The absolute bioavailability of a GLUCOPHAGE 500 mg tablet given under fasting conditions is approximately 50% to 60%. GLUCOPHAGE or Glucophage XR alone does not usually cause hypoglycemia, although it may occur when GLUCOPHAGE or Glucophage XR is used in conjunction with oral sulfonylureas and insulin. ). The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking GLUCOPHAGE or Glucophage XR and by use of the minimum effective dose of GLUCOPHAGE or Glucophage XR. Thereafter, both glucose and glycosylated hemoglobin should be monitored. While megaloblasticanemia has rarely been seen with GLUCOPHAGE therapy, if this is suspected, vitamin B 12. 5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. Changes in lipid parameters in the previously described placebo-controlled dose-response study of Glucophage XR are shown in Table 8. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving GLUCOPHAGE or Glucophage XR. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Use of concomitant medications that may affect renal function or metformin disposition —Concomitant medication(s) that may affect renal function or result in significant hemodynamic change or may interfere with the disposition of metformin, such as cationic drugs that are eliminated by renal tubular secretion (see PRECAUTIONS: Drug Interactions ), should be used with caution. Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with GLUCOPHAGE). Patients should be informed of the potential risks and benefits of GLUCOPHAGE or Glucophage XR and of alternative modes of therapy. Glucophage XR (metformin hydrochloride) Extended-Release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because impaired hepatic function may significantly limit the ability to clear lactate, GLUCOPHAGE and Glucophage XR should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Kinetic study done following dose 19, given fasting. Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia). ). Renal clearance (see Table 1 ) is approximately 3. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. Furosemide increased the metformin plasma and blood C max by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. GLUCOPHAGE and Glucophage XR are contraindicated in patients with. At usual clinical doses and dosing schedules of GLUCOPHAGE, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. (See Patient Information printed below. The effectiveness of oral antidiabetic drugs in lowering blood glucose to a targeted level decreases in many patients over a period of time. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. A 24-week, double-blind, placebo-controlled study of GLUCOPHAGE plus insulin versus insulin plus placebo was conducted in patients with type 2 diabetes who failed to achieve adequate glycemic control on insulin alone (see Table 5 ). Lactic acidosis is a medical emergency that must be treated in a hospital setting. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. In patients in whom development of renal dysfunction is anticipated, renal function should be assessed more frequently and GLUCOPHAGE or Glucophage XR discontinued if evidence of renal impairment is present. If acidosis of either form occurs, GLUCOPHAGE or Glucophage XR must be stopped immediately and other appropriate corrective measures initiated (see also WARNINGS ). Patients randomized to receive GLUCOPHAGE plus insulin achieved a reduction in HbA 1c of 2. No pharmacokinetic studies of metformin have been conducted in patients with hepatic insufficiency. 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. After repeated administration of Glucophage XR, metformin did not accumulate in plasma. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function (see Table 1 ). Hypoxic states —Cardiovascular collapse (shock) from whatever cause, acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. In addition, GLUCOPHAGE and Glucophage XR should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).
The extent of metformin absorption (as measured by AUC) from Glucophage XR at a 2000 mg once-daily dose is similar to the same total daily dose administered as GLUCOPHAGE tablets 1000 mg twice daily. Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of GLUCOPHAGE or vitamin B 12 supplementation. The GLUCOPHAGE dose had not necessarily been titrated to achieve a specific level of glycemic control prior to study entry. Such management often results in prompt reversal of symptoms and recovery. 6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Decreases in glyburide AUC and C max were observed, but were highly variable. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking GLUCOPHAGE or Glucophage XR, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see DOSAGE AND ADMINISTRATION: Concomitant GLUCOPHAGE or Glucophage XR and Oral Sulfonylurea Therapy in Adult Patients ). (See also PRECAUTIONS. (See also CONTRAINDICATIONS and PRECAUTIONS. Therefore, in patients in whom any such study is planned, GLUCOPHAGE or Glucophage XR should be temporarily discontinued at the time of or prior to the procedure, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal. Combined results (average means) of five studies: mean age 32 years (range 23-59 years). Metformin hydrochloride ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. All Consumer Professional Pill ID Interactions News FDA Alerts Approvals Pipeline Clinical Trials Care Notes Encyclopedia Dictionary Natural Products. 10%, compared to a 1. GLUCOPHAGE and Glucophage XR 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. 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. 56% reduction in HbA 1c achieved by insulin plus placebo. Table 4: Summary of Mean Percent Change From Baseline of Major Serum Lipid Variables at Final Visit (29-week studies). GLUCOPHAGE or Glucophage XR may be reinstituted after the acute episode is resolved. When such events occur in patients on GLUCOPHAGE or Glucophage XR therapy, the drug should be promptly discontinued. Macrovascular Outcomes —There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLUCOPHAGE or Glucophage XR or any other antidiabetic drug. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive GLUCOPHAGE or Glucophage XR. Hypoglycemia —Hypoglycemia does not occur in patients receiving GLUCOPHAGE or Glucophage XR alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol. Each tablet contains the inactive ingredients povidone and magnesium stearate. A 24-week, double-blind, randomized study of Glucophage XR, taken once daily with the evening meal, and GLUCOPHAGE (metformin hydrochloride) Tablets, taken twice daily (with breakfast and evening meal), was conducted in patients with type 2 diabetes who had been treated with GLUCOPHAGE 500 mg twice daily for at least 8 weeks prior to study entry. Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. The pK a of metformin is 12. Limited data from controlled pharmacokinetic studies of GLUCOPHAGE in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and C max is increased, compared to healthy young subjects. Measurement of hematologic parameters on an annual basis is advised in patients on GLUCOPHAGE or Glucophage XR and any apparent abnormalities should be appropriately investigated and managed (see PRECAUTIONS: Laboratory Tests ). Changes in lipid parameters in the previously described study of GLUCOPHAGE and Glucophage XR are shown in Table 9. In clinical studies, GLUCOPHAGE, alone or in combination with a sulfonylurea, lowered mean fasting serum triglycerides, total cholesterol, and LDL cholesterol levels, and had no adverse effects on other lipid levels (see Table 4 ). Loss of control of blood glucose —When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur. In addition, GLUCOPHAGE and Glucophage XR should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. The clinical relevance of these decreases is unknown. GLUCOPHAGE (metformin hydrochloride) Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. During initial dose titration, fasting glucose can be used to determine the therapeutic response. Patients with type 2 diabetes with higher fasting glucose concentrations experienced greater declines in plasma glucose and glycosylated hemoglobin. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. At such times, it may be necessary to withhold GLUCOPHAGE or Glucophage XR and temporarily administer insulin. In a patient with lactic acidosis who is taking GLUCOPHAGE or Glucophage XR, the drug should be discontinued immediately and general supportive measures promptly instituted. Before initiation of GLUCOPHAGE or Glucophage XR therapy and at least annually thereafter, renal function should be assessed and verified as normal. In these patients, routine serum vitamin B 12 measurements at 2- to 3-year intervals may be useful. In blood, the elimination half-life is approximately 17. Vitamin B 12 levels —In controlled clinical trials of GLUCOPHAGE of 29 weeks duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels, without clinical manifestations, was observed in approximately 7% of patients. In contrast to sulfonylureas, body weight of individuals on GLUCOPHAGE tended to remain stable or even decrease somewhat (see Tables 2 and 3 ). Following a single oral dose of Glucophage XR, C max is achieved with a median value of 7 hours and a range of 4 to 8 hours. Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels. Elderly subjects, mean age 71 years (range 65-81 years). After administration of a single oral GLUCOPHAGE 500 mg tablet with food, geometric mean metformin C max and AUC differed less than 5% between pediatric type 2 diabetic patients (12-16 years of age) and gender- and weight-matched healthy adults (20-45 years of age), all with normal renal function. The magnitude of the decline in fasting blood glucose concentration following the institution of GLUCOPHAGE (metformin hydrochloride) Tablets therapy was proportional to the level of fasting hyperglycemia. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Measurements of glycosylated hemoglobin may be especially useful for evaluating long-term control (see also DOSAGE AND ADMINISTRATION ). 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. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6. The pH of a 1% aqueous solution of metformin hydrochloride is 6. Changes in glycemic control and body weight are shown in Table 7. Patients should be advised to discontinue GLUCOPHAGE or Glucophage XR immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Glyburide —In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. At the final visit (24-week), mean HbA 1c had increased 0. No studies of metformin pharmacokinetic parameters according to race have been performed. Should secondary failure occur with either GLUCOPHAGE or Glucophage XR or sulfonylurea monotherapy, combined therapy with GLUCOPHAGE or Glucophage XR and sulfonylurea may result in a response. The pharmacokinetics of Glucophage XR in patients with type 2 diabetes are comparable to those in healthy normal adults. 68. Glucophage XR 750 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, and magnesium stearate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Once a patient is stabilized on any dose level of GLUCOPHAGE or Glucophage XR, 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. Metformin partitions into erythrocytes, most likely as a function of time. 2 hours. Within-subject variability in C max and AUC of metformin from Glucophage XR is comparable to that with GLUCOPHAGE. Patients should be informed that Glucophage XR must be swallowed whole and not crushed or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet. 2% from baseline in placebo patients and decreased 0. This phenomenon, which may be due to progression of the underlying disease or to diminished responsiveness to the drug, is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective during initial therapy. Changes in glycemic control and body weight are shown in Table 6. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients. Furosemide —A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration.
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