METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 850 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Metformin hydrochloride tablets is 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 hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PREC

Produkt oppsummering:

Product: 63629-1396 NDC: 63629-1396-1 60 TABLET, FILM COATED in a BOTTLE NDC: 63629-1396-2 30 TABLET, FILM COATED in a BOTTLE NDC: 63629-1396-3 120 TABLET, FILM COATED in a BOTTLE NDC: 63629-1396-4 90 TABLET, FILM COATED in a BOTTLE NDC: 63629-1396-5 100 TABLET, FILM COATED in a BOTTLE NDC: 63629-1396-6 180 TABLET, FILM COATED in a BOTTLE

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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RX ONLY
METFORMIN HYDROCHLORIDE TABLETS
(METFORMIN HYDROCHLORIDE TABLETS, USP)
DESCRIPTION
Metformin hydrochloride tablets 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 :Metformin hydrochloride is a white to
off-white crystalline compound
with a molecular formula of C4H11N5 • HCl and a molecular weight of
165.63. Metformin
hydrochloride is freely soluble in water and is practically insoluble
in acetone, ether, and chloroform.
The pKa 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 inactive ingredients Sodium
Starch Glycolate, Povidone, Corn
Starch, Colloidal Silicon Dioxide and Magnesium Stearate. In addition,
the coating for the 500 mg, 850
mg and 1000 mg tablets contains Opadry White which contains :
Hypromellose, Talc, Polyethylene
glycol 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 whi