GLIPIZIDE - glipizide tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Disponível em:

Sun Pharmaceutical Industries, Inc.

DCI (Denominação Comum Internacional):

GLIPIZIDE

Composição:

GLIPIZIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Glipizide tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide tablets are contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Resumo do produto:

Glipizide Tablets, USP, 5 mg are white to off-white colored, round, biconvex tablets with '398' debossed on one side and scoreline on the other side are available as follows: Bottles of 100 NDC 57664-398-88 Bottles of 500 NDC 57664-398-13 Bottles of 1000 NDC 57664-398-18 Glipizide Tablets, USP, 10 mg are white to off-white colored, round, biconvex tablets with '399' debossed on one side and scoreline on the other side are available as follows: Bottles of 100 NDC 57664-399-88 Bottles of 500 NDC 57664-399-13 Bottles of 1000 NDC 57664-399-18 RECOMMENDED STORAGE: Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted 15˚ to 30˚C (59˚ to 86˚F) [See USP Controlled Room Temperature]. Manufactured by: Sun Pharmaceutical Industries Limited. Survey No. 259/15, Dadra 396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 5495T06 Iss: 11/2014

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GLIPIZIDE - GLIPIZIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
GLIPIZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea
class.
The Chemical Abstracts name of glipizide is
1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)
ethyl]phenyl]sulfonyl]urea.
The molecular formula is C H N O S;the molecular weight is 445.55; the
structural formula is shown
below:
Glipizide is a whitish, odorless powder with a pKa of 5.9. It is
insoluble in water and alcohols, but
soluble in 0.1 _N _NaOH; it is freely soluble in dimethylformamide.
Glipizide tablets for oral use are
available in 5 and 10 mg strengths.
Each tablet contains the following inactive ingredients: lactose
monohydrate, corn starch, pregelatinized
starch, microcrystalline cellulose, colloidal silicon dioxide and
stearic acid.
CLINICAL PHARMACOLOGY
Mechanism of Action: The primary mode of action of glipizide in
experimental animals appears to be
the stimulation of insulin secretion from the beta cells of pancreatic
islet tissue and is thus dependent on
functioning beta cells in the pancreatic islets. In humans, glipizide
appears to lower the blood glucose
acutely by stimulating the release of insulin from the pancreas, an
effect dependent upon functioning
beta cells in the pancreatic islets. The mechanism by which Glipizide
lowers blood glucose during
long-term administration has not been clearly established. In man,
stimulation of insulin secretion by
glipizide in response to a meal is undoubtedly of major importance.
Fasting insulin levels are not
elevated even on long-term glipizide administration, but the
postprandial insulin response continues to
be enhanced after at least 6 months of treatment. The insulinotropic
response to a meal occurs within 30
minutes after an oral dose of glipizide in diabetic patients, but
elevated insulin levels do not persist
beyond the time of the meal challenge. Extrapancreatic effects may
play a part in the mechanism of
action of oral sulfonylurea hypoglycemic drug