ACETIC ACID irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)

Available from:

Hospira, Inc.

INN (International Name):

ACETIC ACID

Composition:

ACETIC ACID 250 mg in 100 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

0.25% Acetic Acid Irrigation, USP is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia-forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. This solution is contraindicated for irrigation during transurethral surgical procedures.

Product summary:

0.25% Acetic Acid Irrigation, USP is supplied in single-dose irrigation containers as follows: List Container Size (mL) 6143 Semi-rigid 250 & 1000 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October, 2004  ©Hospira 2004                                                       EN-0098                                                           Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Authorization status:

New Drug Application

Summary of Product characteristics

ACETIC ACID- ACETIC ACID IRRIGANT
HOSPIRA, INC.
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0.25% ACETIC ACID IRRIGATION, USP
_UROLOGIC IRRIGATING FLUID FOR PATIENTS REQUIRING PROLONGED
INDWELLING_
_URETHRAL CATHETERIZATION...NOT FOR TRANSURETHRAL SURGICAL
PROCEDURES._
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
SEMI-RIGID IRRIGATION CONTAINER
R only
DESCRIPTION
0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic aqueous
solution of Glacial Acetic Acid,
USP for irrigation of the urinary bladder by the transurethral route
(NOT FOR TUR). Each 100 mL
contains 250 mg of Glacial Acetic Acid, in water for injection.
The solution is hypotonic, 42 mOsmol/liter (calc.), in relation to the
extracellular fluid compartment of
the body (280 mOsmol/liter) and has a pH of 3.1 (2.8 to 3.4).
Other than the active ingredient, acetic acid, the solution contains
no bacteriostat, antimicrobial agent or
added buffer and is intended only for use as a single-dose irrigation.
When smaller volumes are
required the unused portion should be discarded.
The solution is a urinary bladder antimicrobial, acidifying irrigant.
Glacial Acetic Acid, USP is chemically designated acetic acid (C H O )
a liquid miscible with water.
It has the following structural formula:
CH COOH
Water for Injection is chemically designated H O.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The container requires no vapor barrier to
maintain the proper drug
concentration.
Solutions in contact with the plastic container may leach out certain
chemical components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of the plastic
container materials.
Exposure to temperatures above 25°C/77°F during transport and
storage will lead to minor losses in
moisture content. Higher temperatures lead to greater losses. It is
unlikely that these minor losses will
lead to clinically significant changes within the expiration period.
CLINICAL PHARMACOLOGY
Irrigation of the urinary bladde