METFORMIN HYDROCHLORIDE tablet film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

REMEDYREPACK INC.

INN (Kansainvälinen yleisnimi):

METFORMIN HYDROCHLORIDE

Koostumus:

METFORMIN HYDROCHLORIDE 500 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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DESCRIPTION
Metformin hydrochloride tablets, USP are an oral antihyperglycemic
drug used in the management of
type 2 diabetes. Metformin hydrochloride (1,1-Dimethylbiguanide
monohydrochloride) 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 to off-white crystalline
powder with a molecular formula of
C
H
N
•HCl and a molecular weight of 165.62. 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 contain 500 mg, 850 mg or 1000 mg of
metformin hydrochloride.
Each tablet contains the following inactive ingredients: artificial
blackberry flavor, magnesium stearate,
polyethylene glycol, polyvinyl alcohol, povidone, talc 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 hydrochloride 500 mg
tablet given under