GLIPIZIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Aphena Pharma Solutions - Tennessee, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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.  5 mg Bottles:   100’s (NDC 60505-0141-0) 500’s (NDC 60505-0141-2) 1,000’s (NDC 60505-0141-1) 18,000’s (NDC 60505-0141-8) 10 mg Bottles: 100’s (NDC 60505-0142-0) 500’s (NDC 60505-0142-2) 1,000’s (NDC 60505-0142-1) 10,000’s (NDC 60505-0142-4)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GLIPIZIDE- GLIPIZIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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.
Extrapancreatic effects may play a part in the mechanism of action of
oral sulfonylurea hypoglycemic
drugs.
Blood sugar con