GLIPIZIDE AND METFORMIN HYDROCHLORIDE- glipizide and metformin hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

GLIPIZIDE

Composition:

GLIPIZIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glipizide and metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide and metformin hydrochloride tablets are contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to glipizide or metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Glipizide and metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in a

Product summary:

Glipizide and metformin hydrochloride tablets USP are available as follows: 5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in bottles of 900 (NDC 0179-0205-88). STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. I 12/2015 Repackaged By: KAISER FOUNDATION HOSPITALS Livermore, CA 94551

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE AND METFORMIN HYDROCHLORIDE- GLIPIZIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Glipizide and metformin hydrochloride tablets USP contain 2 oral
antihyperglycemic drugs used in the
management of type 2 diabetes, glipizide, USP and metformin
hydrochloride, USP.
Glipizide, USP is an oral antihyperglycemic drug of the sulfonylurea
class. The chemical name for
glipizide, USP is 1-cyclohexyl-3-[[
_p_-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea.
Glipizide, USP is a whitish, odorless powder with a pK
of 5.9. It is insoluble in water and alcohols,
but soluble in 0.1 _N _NaOH; it is freely soluble in
dimethylformamide. The structural formula is
represented below.
C
H
N
O
S M.W. 445.55
Metformin hydrochloride, USP is an oral antihyperglycemic drug used in
the management of type 2
diabetes. Metformin hydrochloride, USP ( _N_,
_N-_dimethylimidodicarbonimidic diamide
monohydrochloride) is not chemically or pharmacologically related to
sulfonylureas,
thiazolidinediones, or α-glucosidase inhibitors. It is a white to
off-white crystalline compound.
Metformin hydrochloride, USP is freely soluble in water and is
practically insoluble in acetone, ether,
and chloroform. The pK
of metformin is 12.4. The pH of a 1% aqueous solution of metformin
hydrochloride, USP is 6.68. The structural formula is as shown:
C
H
ClN
M.W. 165.63
Glipizide and metformin hydrochloride tablets USP for oral
administration contain 2.5 mg glipizide,
USP with 250 mg metformin hydrochloride, USP, 2.5 mg glipizide, USP
with 500 mg metformin
hydrochloride, USP, and 5 mg glipizide, USP with 500 mg metformin
hydrochloride, USP. In addition,
a
21
27
5
4
a
4
12
5
each tablet contains the following inactive ingredients: corn starch,
croscarmellose sodium, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol-part. hydrolyzed, povidone,
talc, and titanium dioxide. Additionally, 2.5 mg/250 mg and 5