METFORMIN HYDROCHLORIDE tablet film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

MAH:

McKesson Contract Packaging

INN:

METFORMIN HYDROCHLORIDE

composition:

METFORMIN HYDROCHLORIDE 500 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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METFORMIN HYDROCHLORIDE TABLETS USP
500 MG AND 1000 MG
RX ONLY
DESCRIPTION
Metformin hydrochloride tablets USP are oral antihyperglycemic drugs
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:
C H N •HCl M.W. 165.63
Metformin hydrochloride is a white to off-white crystalline compound.
Metformin hydrochloride is
freely soluble in water and is practically insoluble in acetone,
ether, and chloroform. The pK of
metformin is 12.4. The pH of a 1% aqueous solution of metformin
hydrochloride is 6.68.
Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, hypromellose, magnesium stearate, polyethylene glycol,
povidone and titanium dioxide.
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 hydr