GLIPIZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northwind Pharmaceuticals, LLC

INN (International Name):

GLIPIZIDE

Composition:

GLIPIZIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glipizide tablets are 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.

Product summary:

Glipizide tablets USP, 10 mg are white, scored, round tablets debossed with Watson 461 and are available in bottles of 30 (NDC 51655-810-52), 60 (NDC 51655-810-25) and 90 (NDC 51655-810-26). Store below 30°C (86°F). Dispense in a tight container as defined in the USP. Keep this and all medication out of the reach of children. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. B 3/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE- GLIPIZIDE TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
GLIPIZIDETABLETS, USP
FOR ORAL USE
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, USP 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.
Each tablet, for oral administration, contains 5 mg or 10 mg
glipizide, USP. In addition,
each tablet contains the following inactive ingredients: colloidal
silicon dioxide;
croscarmellose sodium; lactose anhydrous; microcrystalline cellulose;
pregelatinized
starch 1500 (maize) 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.
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Extrapancreatic effects may play a part in