GLIPIZIDE- glipizide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

GLIPIZIDE

Composition:

GLIPIZIDE 5 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: - Known hypersensitivity to the drug. - Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Product summary:

Glipizide tablets, USP for oral administration are available as: 5 mg: round, white, scored tablets, debossed GG 771 on one side and plain on the reverse side, and supplied as: NDC 49999-108-30 bottles of 30 NDC 49999-108-60 bottles of 60 NDC 49999-108-90 bottles of 90 10 mg: round, white, scored tablets, debossed GG 772 on one side and plain on the reverse side. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE- GLIPIZIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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. It has the following
structural formula:
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 of
glipizide. Inactive ingredients: colloidal
silicon dioxide, croscarmellose sodium, lactose (monohydrate),
magnesium stearate, microcrystalline
cellulose, and starch (corn).
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 control persists in some patients for up to 24 hours after