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Generic Name: Metformin hydrochloride, dosage Form: tablet, film coated, medically reviewed on January 1, 2018, show On This Page. View All, metformin Description, metformin hydrochloride tablets, USP are oral antihyperglycemic drugs used in the management of metformin images type 2 diabetes. Metformin hydrochloride diamide hydrochloride) is not chemically or pharmacologically related to metformin images any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 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 pKa of Metformin.4. The pH of a 1 aqueous solution of Metformin hydrochloride.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1,000 mg of Metformin hydrochloride USP. Each tablet contains the inactive ingredients povidone, microcrystalline cellulose, sodium starch glycolate and magnesium stearate. In addition, the coating for the tablets metformin images contains hypromellose and polyethylene glycol. Metformin - Clinical Pharmacology, 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 (except in special circumstances, see. Precautions ) 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. Pharmacokinetics, absorption and Bioavailability, the absolute bioavailability of a Metformin hydrochloride 500 mg tablet given under fasting conditions is approximately 50. Studies using single oral doses of Metformin hydrochloride tablets 500 mg to 1,500 mg, and 850 mg to 2,550 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 approximately a 40 lower mean peak plasma concentration (Cmax metformin images a 25 lower area under the plasma concentration versus time curve (AUC and a 35-minute prolongation of time to peak plasma. The clinical relevance of these decreases is unknown. Distribution, the apparent volume of distribution (V/F) of Metformin following single oral doses of Metformin hydrochloride tablets 850 mg averaged. 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 tablets, 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 tablets, maximum Metformin plasma levels did not exceed 5 g/mL, even at maximum doses. Metabolism and Elimination, metformin images 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.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 metformin images route within the first 24 hours, with a plasma elimination half-life of approximately.2 hours. In blood, the elimination half-life is approximately.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Patients with Type 2 Diabetes, 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. Renal Impairment, in patients with decreased renal function, the plasma and blood half-life of Metformin is prolonged and the renal clearance is decreased (see Table 1; also see. Contradictions, warnings, precautions, and, dosage AND administration ). Hepatic Impairment, no pharmacokinetic studies of Metformin have been conducted in patients with hepatic insufficiency (see. Geriatrics, limited data from controlled pharmacokinetic studies of Metformin hydrochloride tablets in healthy metformin images elderly metformin images subjects suggest that total plasma clearance of Metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects. 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; also see. Warnings, precautions, and, dosage AND administration table 1: Select Mean (S.D.) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of Metformin Hydrochloride. Subject Groups: Metformin Hydrochloride dosea (number of subjects) Cmaxb (g/mL) Tmaxc (hrs) Renal Clearance (mL/min) Healthy, nondiabetic adults: 500 mg single dose (24) 850 mg single dose (74)d 850 mg three times daily for 19 dosese (9).03 (0.33).60 (0.38).01 (0.42).75 (0.81). Gender Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender (males 19, females 16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of Metformin hydrochloride tablets was comparable in males and females.