Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1049
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METFORMIN HYDROCHLORIDE (Tablet)
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There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin hydrochloride is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age); the maximum recommended daily dose of metformin hydrochloride extended-release in adults is 2000 mg. Metformin hydrochloride should be given in divided doses with meals while metformin hydrochloride extended-release should generally be given once daily with the evening meal. Metformin should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Metformin hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended-release will be eliminated in the feces as a soft, hydrated mass. (See Patient Information printed below.)<br/>Recommended Dosing Schedule:<br/>Adults: In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals. The usual starting dose of metformin hydrochloride extended-release tablets is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin hydrochloride extended-release 2000 mg once daily, a trial of metformin hydrochloride extended-release 1000 mg twice daily should be considered. If higher doses of metformin are required, metformin hydrochloride should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. In a randomized trial, patients currently treated with metformin hydrochloride were switched to metformin hydrochloride extended-release. Results of this trial suggest that patients receiving metformin hydrochloride treatment may be safely switched to metformin hydrochloride extended-release once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from metformin hydrochloride to metformin hydrochloride extended-release, glycemic control should be closely monitored and dosage adjustments made accordingly .<br/>Pediatrics: The usual starting dose of metformin hydrochloride is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. Safety and effectiveness of metformin hydrochloride extended-release in pediatric patients have not been established.<br/>Transfer from Other Antidiabetic Therapy: When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.<br/>Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients: If patients have not responded to four weeks of the maximum dose of metformin monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin hydrochloride 500 mg and glyburide 20 mg were titrated to 1000/20 mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of metformin hydrochloride and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbAand plasma glucose response . However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea). If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin.<br/>Concomitant Metformin and Insulin Therapy in Adult Patients: The current insulin dose should be continued upon initiation of metformin therapy. Metformin therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for metformin hydrochloride and 2000 mg for metformin hydrochloride extended-release. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin. Further adjustment should be individualized based on glucose-lowering response.<br/>Specific Patient Populations: Metformin is not recommended for use in pregnancy. Metformin hydrochloride is not recommended in patients below the age of 10 years. Metformin hydrochloride extended-release is not recommended in pediatric patients (below the age of 17 years). The initial and maintenance dosing of metformin should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourishedpatients should not be titrated to the maximum dose of metformin. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly.
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Metformin is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of CHN���HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, and 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide and triacetin. Metformin hydrochloride extended-release tablets contain 500 mg of metformin hydrochloride as the active ingredient. Each tablet contains the inactive ingredients carnauba wax, microcrystalline cellulose, stearic acid, sodium stearyl fumerate, silicon dioxide, and magnesium stearate.
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Mechanism of Action: Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.<br/>Pharmacokinetics:<br/>Absorption and Bioavailability: The absolute bioavailability of a metformin hydrochloride 500 mg tablet given under fasting conditions is approximately 50 to 60%. Studies using single oral doses of metformin hydrochloride 500 mg to 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximatelya 40% lower mean peak plasma concentration (C), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (T) following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting. The clinical relevance of these decreases is unknown. Following a single oral dose of metformin hydrochloride extended-release, Cis achieved with a median value of 7 hours and a range of 4 hours to 8 hours. Peak plasma levels are approximately 20% lower compared to the same dose of metformin hydrochloride, however, the extent of absorption (as measured by AUC) is similar to metformin hydrochloride. At steady state, the AUC and Care less than dose proportional for metformin hydrochloride extended-release within the range of 500 mg to 2000 mg administered once daily. Peak plasma levels are approximately 0.6, 1.1, 1.4, and 1.8��g/mL for 500, 1000, 1500, and 2000 mg once-daily doses, respectively. The extent of metformin absorption (as measured by AUC) from metformin hydrochloride extended-release at a 2000 mg once-daily dose is similar to the same total daily dose administered as metformin hydrochloride tablets 1000 mg twice daily. After repeated administration of metformin hydrochloride extended-release, metformin did not accumulate in plasma. Within-subject variability in Cand AUC of metformin from metformin hydrochloride extended-release is comparable to that with metformin hydrochloride. Although the extent of metformin absorption (as measured by AUC) from the metformin hydrochloride extended-release tablet increased by approximately 50% when given with food, there was no effect of food on Cand Tof metformin. Both high and low fat meals had the same effect on the pharmacokinetics of metformin hydrochloride extended-release.<br/>Distribution: The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride 850 mg averaged 654��358 L. Metformin is negligibly bound to plasma proteins, in contrast to sulfonylureas, which are more than 90% protein bound. Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin hydrochloride, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally<1��g/mL. During controlled clinical trials of metformin hydrochloride, maximum metformin plasma levels did not exceed 5��g/mL, even at maximum doses.<br/>Metabolism and Elimination: 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. Renal clearance (see Table 1) is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. 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 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution.<br/>Special Populations:<br/>CLINICAL STUDIES:<br/>METFORMIN HYDROCHLORIDE: In a double-blind, placebo-controlled, multicenter U.S. clinical trial involving obese patients with type 2 diabetes whose hyperglycemia was not adequately controlled with dietary management alone (baseline fasting plasma glucose [FPG] of approximately 240 mg/dL), treatment with metformin hydrochloride (up to 2550 mg/day) for 29 weeks resulted in significant mean net reductions in fasting and postprandial plasma glucose (PPG) and hemoglobin A(HbA) of 59 mg/dL, 83 mg/dL, and 1.8%, respectively, compared to the placebo group (see Table 2). A 29-week, double-blind, placebo-controlled study of metformin hydrochloride and glyburide, alone and in combination, was conducted in obese patients with type 2 diabetes who had failed to achieve adequate glycemic control while on maximum doses of glyburide (baseline FPG of approximately 250 mg/dL) (see Table 3). Patients randomized to the combination arm started therapy with metformin hydrochloride 500 mg and glyburide 20 mg. At the end of each week of the first four weeks of the trial, these patients had their dosages of metformin hydrochloride increased by 500 mg if they had failed to reach target fasting plasma glucose. After week four, such dosage adjustments were made monthly, although no patient was allowed to exceed metformin hydrochloride 2500 mg. Patients in the metformin hydrochloride only arm (metformin plus placebo) followed the same titration schedule. At the end of the trial, approximately 70% of the patients in the combination group were taking metformin hydrochloride 2000 mg/glyburide 20 mg or metformin hydrochloride 2500 mg/glyburide 20 mg. Patients randomized to continue on glyburide experienced worsening of glycemic control, with mean increases in FPG, PPG and HbAof 14 mg/dL, 3 mg/dL and 0.2%, respectively. In contrast, those randomized to metformin hydrochloride (up to 2500 mg/day) experienced a slight improvement, with mean reductions in FPG, PPG and HbAof 1 mg/dL, 6 mg/dL and 0.4%, respectively. The combination of metformin hydrochloride and glyburide was effective in reducing FPG, PPG and HbAlevels by 63 mg/dL, 65 mg/dL, and 1.7%, respectively. Compared to results of glyburide treatment alone, the net differences with combination treatment were -77 mg/dL, -68 mg/dL and -1.9%, respectively (see Table 3). The magnitude of the decline in fasting blood glucose concentration following the institution of metformin hydrochloride tablets therapy was proportional to the level of fasting hyperglycemia. Patients with type 2 diabetes with higher fasting glucose concentrations experienced greater declines in plasma glucose and glycosylated hemoglobin. In clinical studies, metformin hydrochloride, 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). In contrast to sulfonylureas, body weight of individuals on metformin hydrochloride tended to remain stable or even decrease somewhat (see Table 2 and 3). A 24-week, double-blind, placebo-controlled study of metformin hydrochloride 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). Patients randomized to receive metformin hydrochloride plus insulin achieved a reduction in HbAof 2.10%, compared to a 1.56% reduction in HbAachieved by insulin plus placebo. The improvement in glycemic control was achieved at the final study visit with 16% less insulin, 93.0 U/day vs 110.6 U/day, metformin hydrochloride plus insulin versus insulin plus placebo, respectively, p=0.04. A second double-blind, placebo-controlled study (n=51), with 16 weeks of randomized treatment, demonstrated that in patients with type 2 diabetes controlled on insulin for 8 weeks with an average HbAof 7.46��0.97%, the addition of metformin hydrochloride maintained similar glycemic control (HbA7.15��0.61 versus 6.97��0.62 for metformin hydrochloride plus insulin and placebo plus insulin, respectively) with 19% less insulin versus baseline (reduction of 23.68��30.22 versus an increase of 0.43��25.20 units for metformin hydrochloride plus insulin and placebo plus insulin, p<0.01). In addition, this study demonstrated that the combination of metformin hydrochloride plus insulin resulted in reduction in body weight of 3.11��4.30 lbs, compared to an increase of 1.30��6.08 lbs for placebo plus insulin, p=0.01.<br/>METFORMIN HYDROCHLORIDE EXTENDED-RELEASE: A 24-week, double-blind, placebo-controlled study of metformin hydrochloride extended-release, taken once daily with the evening meal, was conducted in patients with type 2 diabetes who had failed to achieve glycemic control with diet and exercise (HbA7.0-10.0%, FPG 126-270 mg/dL). Patients entering the study had a mean baseline HbAof 8.0% and a mean baseline FPG of 176 mg/dL. After 12 weeks treatment, mean HbAhad increased from baseline by 0.1% and mean FPG decreased from baseline by 2 mg/dL in the placebo group, compared with a decrease in mean HbAof 0.6% and a decrease in mean FPG of 23 mg/dL in patients treated with metformin hydrochloride extended-release 1000 mg once daily. Subsequently, the treatment dose was increased to 1500 mg once daily if HbAwas���7.0% but<8.0% (patients with HbA���8.0% were discontinued from the study). At the final visit (24-week), mean HbAhad increased 0.2% from baseline in placebo patients and decreased 0.6% with metformin hydrochloride extended-release. A 16-week, double-blind, placebo-controlled, dose-response study of metformin hydrochloride extended-release, taken once daily with the evening meal or twice daily with meals, was conducted in patients with type 2 diabetes who had failed to achieve glycemic control with diet and exercise (HbA7.0-11.0%, FPG 126-280 mg/dL). Changes in glycemic control and body weight are shown in Table 6. Compared with placebo, improvement in glycemic control was seen at all dose levels of metformin hydrochloride extended-release tablets and treatment was not associated with any significant change in weight . A 24-week, double-blind, randomized study of metformin hydrochloride extended-release, taken once daily with the evening meal, and metformin hydrochloride tablets, taken twice daily (with breakfast and evening meal), was conducted in patients with type 2 diabetes who had been treated with metformin hydrochloride 500 mg twice daily for at least 8 weeks prior to study entry. The metformin hydrochloride dose had not necessarily been titrated to achieve a specific level of glycemic control prior to study entry. Patients qualified for the study if HbAwas���8.5% and FPG was���200 mg/dL. Changes in glycemic control and body weight are shown in Table 7. After 12 weeks of treatment, there was an increase in mean HbAin all groups; in the metformin hydrochloride extended-release 1000 mg group, the increase from baseline of 0.23% was statistically significant . Changes in lipid parameters in the previously described placebo-controlled dose-response study of metformin hydrochloride extended-release are shown in Table 8. Changes in lipid parameters in the previously described study of metformin are shown in Table 9.<br/>Pediatric Clinical Studies: In a double-blind, placebo-controlled study in pediatric patients aged 10 to 16 years with type 2 diabetes (mean FPG 182.2 mg/dL), treatment with metformin hydrochloride (up to 2000 mg/day) for up to 16 weeks (mean duration of treatment 11 weeks) resulted in a significant mean net reduction in FPG of 64.3 mg/dL, compared with placebo (see Table 10).
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Metformin hydrochloride tablets, 500 mg, round, white, film coated, unscored, debossed MP 751 Bottles of 100 NDC 53489-467-01Bottles of 250 NDC 53489-467-03Bottles of 500 NDC 53489-467-05Bottles of 1000 NDC 53489-467-10Bulk Container NDC 53489-467-88 Metformin hydrochloride tablets, 850 mg, round, white, film coated, unscored, debossed MP 752 Bottles of 100 NDC 53489-468-01Bottles of 250 NDC 53489-468-03Bottles of 500 NDC 53489-468-05Bottles of 1000 NDC 53489-468-10Bulk Container NDC 53489-468-88 Metformin hydrochloride tablets, 1000 mg, oval, white, film coated, scored, debossed MP 753 Bottles of 100 NDC 53489-469-01Bottles of 250 NDC 53489-469-03Bottles of 500 NDC 53489-469-05Bottles of 1000 NDC 53489-469-10Bulk Container NDC 53489-469-88 Metformin hydrochloride extended-release tablets, 500 mg, capsule shaped, light yellow tablet, debossed MP 755 on one side and blank on the other side. Bottles of 30 NDC 53489-585-07Bottles of 60 NDC 53489-585-06Bottles of 100 NDC 53489-585-01Bottles of 250 NDC 53489-585-03Bottles of 500 NDC 53489-585-05Bottles of 1000 NDC 53489-585-10 Store at 20��to 25��C (68��to 77��F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
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Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; 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��g/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. Metformin 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, metformin 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, metformin 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 metformin, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure . 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 thepossible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur . Metformin 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 metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence ofgastrointestinal 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 metformin 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. 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 metformin, 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. .
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Metformin Hydrochloride
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METFORMIN HYDROCHLORIDE (Tablet)
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In a U.S. double-blind clinical study of metformin hydrochloride in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride patients, and that were more common in metformin hydrochloride- than placebo-treated patients, are listed in Table 11. Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin hydrochloride. Additionally, the following adverse reactions were reported in���1.0 -���5.0% of metformin hydrochloride patients and were more commonly reported with metformin hydrochloride than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation. In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with metformin hydrochloride extended-release in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release and 195 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release patients, and that were more common in metformin hydrochloride extended-release- than placebo-treated patients, are listed in Table 12. Diarrhea led to discontinuation of study medication in 0.6% of patients treated with metformin hydrochloride extended-release. Additionally, the following adverse reactions were reported in���1.0% -���5.0% of metformin hydrochloride extended-release patients and were more commonly reported with metformin hydrochloride extended-release than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.<br/>Pediatric Patients: In clinical trials with metformin hydrochloride in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
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Metformin, as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is indicated in patients 10 years of age and older, and metformin hydrochloride extended-release is indicated in patients 17 years of age and older. Metformin may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).
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METFORMIN HYDROCHLORIDE
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