METFORMIN HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Institutional Inc.

INN (Algemene Internationale Benaming):

METFORMIN HYDROCHLORIDE

Samenstelling:

METFORMIN HYDROCHLORIDE 500 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS). - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such

Product samenvatting:

Metformin Hydrochloride Tablets, USP are available containing 500 mg or 1000 mg of metformin hydrochloride, USP. The 500 mg tablets are white to off-white, film-coated, round, unscored tablets with blackberry scent debossed with MF over 1 on one side of the tablet and G on the other side. They are available as follows: NDC 51079-172-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1000 mg tablets are white to off-white, film-coated, oblong, scored tablets with blackberry scent debossed with MF to the left side of the score and 3 to the right side of the score on one side of the tablet and G to the left side of the score and G to the right side of the score on the other side. They are available as follows: NDC 51079-174-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Metformin hydrochloride is 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 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, USP contain 500 mg, 850 mg or 1000 mg
of metformin
hydrochloride, USP. In addition, each tablet contains the following
inactive ingredients: artificial
blackberry flavor, macrogol, magnesium stearate, 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 fasting