GLIPIZIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
11-07-2023

Aktivni sastojci:

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

Dostupno od:

Preferred Pharmaceuticals, Inc.

INN (International ime):

GLIPIZIDE

Sastav:

GLIPIZIDE 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Glipizide tablets 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.

Proizvod sažetak:

Glipizide Tablets, USP are supplied as white to off-white, round, scored tablets, imprinted as follows: 5 mg- “APO” on the side and “GLP” over bisect “5” on the other side; 10 mg- “APO” on one side and “GLP” over bisect “10” on the other side.  5mg bottles Bottle of 30 - 68788-0141-3 Bottle of 60 - 68788-0141-6 Bottle of 90 - 68788-0141-9 Bottle of 100 - 68788-0141-1 10 mg Bottles: Bottle of 30 - 68788-0142-3 Bottle of 60 - 68788-0142-6 Bottle of 90 - 68788-0142-9 Bottle of 100 - 68788-0142

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

                                GLIPIZIDE- GLIPIZIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
GLIPIZIDE TABLETS, USP 5 MG AND 10 MG
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, USP for oral use are available in 5 and 10 mg strengths.
Inert ingredients are: anhydrous lactose; colloidal silicon dioxide;
magnesium stearate;
sodium starch glycolate.
Meets 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 of
oral sulfonylurea
hypoglycemic drugs.
Blood sugar co
                                
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