GLIPIZIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

ANI Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide is 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.

Descriptif du produit:

Glipizide Tablets USP, 5 mg are available as white to off-white, round, flat-faced, beveled edge tablets, bisected and debossed on one side with “315” above bisect and debossed with “ANI” on the other side, containing 5 mg of glipizide. They are available in: Bottles of 100 tablets                 NDC 62559-315-01 Bottles of 1000 tablets               NDC 62559-315-10 Glipizide Tablets USP, 10 mg are available as white to off-white, round, flat-faced, beveled edge tablets, bisected and debossed on one side with “316” above bisect and debossed with “ANI” on the other side, containing 10 mg of glipizide. They are available in: Bottles of 100 tablets                 NDC 62559-316-01 Bottles of 1000 tablets               NDC 62559-316-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 08/2022 LB4530-00

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

GLIPIZIDE- GLIPIZIDE TABLET
ANI PHARMACEUTICALS, INC.
----------
GLIPIZIDE TABLETS USP
_FOR ORAL USE_
RX ONLY
DESCRIPTION
Glipizide Tablets USP are 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 USP for oral use are available in 5 and 10 mg strengths.
Each tablet contains the following inactive ingredients: lactose
monohydrate;
microcrystalline cellulose; pregelatinized corn starch; silicon
dioxide; 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
21
27
5
4
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
hypogl