METFORMIN HYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Direct Rx

DCI (Denominação Comum Internacional):

METFORMIN HYDROCHLORIDE

Composição:

METFORMIN HYDROCHLORIDE 1000 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Metformin Hydrochloride Tablets USP, 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 USP is contraindicated in patients with: 0.1 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). 0.2 Known hypersensitivity to metformin hydrochloride. 0.3 Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin Hydrochloride Tablets USP 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.

Resumo do produto:

Metformin Hydrochloride Tablets, USP 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossing “H/104” on one side and plain on the other side. Bottles of 60 NDC 61919-397-60 Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Packaged and Distributed by: DirectRX

Status de autorização:

Abbreviated New Drug Application

Características técnicas

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
DIRECT RX
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METFORMIN HYDROCHLORIDE
DESCRIPTION SECTION
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:
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 USP contain 500 mg, 850 mg, or 1000 mg
of
metformin hydrochloride. Each tablet contains the inactive ingredients
povidone (K-30),
povidone (K-90), pregelatinized starch, and magnesium stearate. In
addition, the coating
for the tablets contains artificial blackberry flavor, hypromellose
and polyethylene glycol.
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 Bioavailabil