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:

B. Braun Medical Inc.

INN (International Name):

ACETIC ACID

Composition:

ACETIC ACID 0.25 g 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. 0.25% Acetic Acid Irrigation USP is not for injection. This solution is contraindicated for irrigation during transurethral surgical procedures.

Product summary:

0.25% Acetic Acid Irrigation USP is supplied sterile and nonpyrogenic in 1000 mL and 500 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C). 

Authorization status:

New Drug Application

Summary of Product characteristics

ACETIC ACID- ACETIC ACID IRRIGANT
B. BRAUN MEDICAL INC.
----------
0.25% ACETIC ACID
IRRIGATION USP
PACKAGE INSERT
PIC™ (PLASTIC IRRIGATION CONTAINERS)
UROLOGIC IRRIGATING FLUID FOR PATIENTS REQUIRING PROLONGED
INDWELLING URETHRAL CATHETERIZATION.
NOT FOR TRANSURETHRAL SURGICAL PROCEDURES.
NOT FOR INJECTION.
RX ONLY
DESCRIPTION
Each 100 mL contains:
Glacial Acetic Acid USP 0.25 g
Water for Injection USP qs
pH: 3.1 (2.8-3.4)
Calculated Osmolarity: 42 mOsmol/liter
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULAMOLECULAR WEIGHT
Glacial Acetic Acid USP
CH COOH
60.05
0.25% Acetic Acid Irrigation USP is a prediluted, sterile,
nonpyrogenic aqueous solution
suitable for urologic irrigation. It contains no preservatives or
added buffers. The
solution is hypotonic.
The plastic container is a copolymer of ethylene and propylene
formulated and
developed for parenteral drugs. The copolymer contains no plasticizers
and exhibits
virtually no leachability. The plastic container is also virtually
impermeable to vapor
transmission and therefore, requires no overwrap to maintain the
proper drug
concentration. The safety of the plastic container has been confirmed
by biological
evaluation procedures. The material passes Class Vl testing as
specified in the U.S.
Pharmacopeia for Biological Tests — Plastic Containers. These tests
have shown that the
container is nontoxic and biologically inert.
Not made with natural rubber latex, PVC or DEHP.
CLINICAL PHARMACOLOGY
Irrigation of the urinary bladder with acetic acid solution in a
concentration of 0.25% has
3
been shown to exert an antimicrobial action against a variety of
microorganisms
(especially ammonia-forming bacteria) that frequently gain access to
the urinary bladder
in patients who require prolonged indwelling urethral catheterization.
Its antimicrobial
action is dependent on administration via the indwelling catheter at a
sufficient rate
(continuous or intermittent) to maintain an effluent pH of 5.0 or
lower. Maintenance of
low pH of bladder urine also