500mg Film-Coated Tablet
BIGUANIDE

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FORMULATION:
Each film-coated tablet contains:
Metformin hydrochloride, USP ……......……..…………………………. 500 mg

PRODUCT DESCRIPTION:
Metformin hydrochloride (Sugadrop) 500 mg film coated tablet is an oral antihyperglycemic agent used in the management of Type 2 diabetes. Metformin hydrochloride (Sugadrop) 500 mg film coated tablet occurs as a white to off-white, round, biconvex and plain on both sides.

PHARMACODYNAMICS:
Metformin hydrochloride is a biguanide oral antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

PHARMACOKINETICS:
Metformin hydrochloride is slowly and incompletely absorbed from the gastrointestinal tract, the absolute bioavailability of a single 500 mg dose is reported to be about 50-60%, although this is reduced somewhat if taken with food. Following absorption, plasma protein binding is negligibly and it is excreted unchanged in the urine. The plasma elimination half-life is reported to range from about 2 to 6 hours after oral administration.

INDICATION:
For the treatment of Type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION:
Given by mouth in the treatment of non-insulin dependent diabetes mellitus in an initial dosage of 500 mg two or three times a day or 850 mg once or twice a day with or after meals, gradually increase if necessary to a maximum of 2 or 3 grams daily or as prescribed by the physician.