盐酸二甲双胍口服液说明书（英文）.pdf

RIOMET®

(metformin hydrochloride oral solution)

Rx only

DESCRIPTION
RIOMET (metformin hydrochloride oral solution) is an oral antihyperglycemic drug used in the
management of type 2 diabetes. Metformin hydrochloride, USP (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, USP is a white crystalline powder with a molecular formula of
C4H11N5•HCl and a molecular weight of . Metformin hydrochloride, USP g is soluble
in 20 mL of water. The pKa of metformin is . The pH of a 1% aqueous solution of metformin
hydrochloride is .
RIOMET contains 500 mg of metformin hydrochloride per 5 mL and the following inactive
ingredients: Cherry flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin
calcium, and xylitol.
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