GLIPIZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotheca Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

The 10 mg tablet is white, round biconvex tablets with bisect, debossed '10' on one side. NDC 12634-790-00 Bottles of 10 NDC 12634-790-01 Bottles of 100 NDC 12634-790-09 Bottles of 35 NDC 12634-790-12 Bottles of 120 NDC 12634-790-18 Bottles of 180 NDC 12634-790-40 Bottles of 40 NDC 12634-790-42 Bottles of 42 NDC 12634-790-45 Bottles of 45 NDC 12634-790-50 Bottles of 50 NDC 12634-790-52 Blister Pack of 12 NDC 12634-790-54 Blister Pack of 14 NDC 12634-790-57 Blister Pack of 20 NDC 12634-790-59 Blister Pack of 30 NDC 12634-790-60 Bottles of 60 NDC 12634-790-61 Blister Pack of 10 NDC 12634-790-63 Blister Pack of 3 NDC 12634-790-66 Blister Pack of 6 NDC 12634-790-67 Blister Pack of 7 NDC 12634-790-69 Blister Pack of 9 NDC 12634-790-71 Bottles of 30 NDC 12634-790-74 Bottles of 24 NDC 12634-790-78 Bottles of 28 NDC 12634-790-79 Bottles of 25 NDC 12634-790-80 Bottles of 20 NDC 12634-790-81 Bottles of 21 NDC 12634-790-82 Bottles of 12 NDC 12634-790-84 Bottles of 14 NDC 12634-790-85 Bottles of 15 NDC 12634-790-90 Bottles of 90 NDC 12634-790-91 Blister Pack of 1 NDC 12634-790-92 Bottles of 2 NDC 12634-790-93 Bottles of 3 NDC 12634-790-94 Bottles of 4 NDC 12634-790-95 Bottles of 5 NDC 12634-790-96 Bottles of 6 NDC 12634-790-97 Bottles of 7 NDC 12634-790-98 Bottles of 8 NDC 12634-790-99 Bottles of 9 Store at 20º to 25 ºC (68º to 77º F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE- GLIPIZIDE TABLET
APOTHECA INC.
----------
GLIPIZIDE TABLETS, USP
_FOR ORAL USE_
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.
Each tablet, for oral administration, contains 5 mg or 10 mg
glipizide. In addition, each tablet contains
the following inactive ingredients: anhydrous lactose,
microcrystalline cellulose, corn starch, silicon
dioxide, stearic acid.
Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.
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.
21
27
5
4
Extrapancreatic effects may play a part in the mechanism of action o