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  • CLASSES

    Other Irrigating Solutions
    Otic Anti-infectives

    DEA CLASS

    Rx

    DESCRIPTION

    Provides antibacterial and antifungal action.
    Used in the external auditory canal and topically for wound care and for catheter instillation into the bladder.
    Glacial acetic acid is acetic acid of high purity (99.75%) and should always be diluted prior to human use to avoid serious caustic burns and other harms.

    COMMON BRAND NAMES

    Acetasol, Borofair, VoSoL

    HOW SUPPLIED

    Acetasol/Acetic Acid/Acetic Acid, Glacial/Borofair/VoSoL Auricular (Otic) Sol: 2%
    Acetic Acid, Glacial Intravesical Sol: 0.25%
    Acetic Acid, Glacial Irrigation Sol: 0.25%

    DOSAGE & INDICATIONS

    For the treatment of otitis externa.
    Otic dosage (acetic acid 2% solution)
    Adults, Adolescents, and Children >= 3 years

    Instill 4 to 6 drops into the external auditory canal. Maintain administration position for 5 minutes. Repeat the procedure every 2 to 3 hours.

    For urologic irrigation to prevent growth and proliferation of susceptible urinary pathogens (especially ammonia-forming bacteria) in patients with prolonged placement of an indwelling urethral catheter.
    Intravesical dosage (0.25% acetic acid bladder irrigant)
    Adults

    Administer by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. For continuous or intermittent irrigation, administer the 0.25% acetic acid bladder irrigation to correspond roughly to the rate of urine flow and adjust to maintain a urinary effluent pH of 4.5 to 5.0. Increasing flow rate reduces pH value, and vice-versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours.

    Adolescents

    The manufacturer does not supply specific information on dosing in adolescents. See adult dosage.

    For topical adjunctive wound management† of selected superficial wounds to reduce the growth of Pseudomonas aeruginosa.
    Topical irrigation soak dosage
    Adults

    Application of acetic acid irrigation soaks, in strengths up to 5%, may promote healing and removal of P. aeruginosa bacteria when used topically to selected wounds. Use dates back to 1916. One prospective study involved the use of 5% acetic acid soaks to 9 patients and compared them to alternately treated controls; two wounds were cleared of Pseudomonas species within 2 days and a further four within a week. Only one patient remained contaminated after 3 weeks. Following eradication of the organism, healing occurred rapidly in the responding patients. Solutions of acetic acid may cause discomfort, and their utility and efficacy in contemporary wound management is in question, given other therapeutic options. Frequent repeated application is needed to confer benefit, owing to the short duration of local action.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    No specific maximum dosage information is available.

    Geriatric

    No specific maximum dosage information is available.

    Adolescents

    No specific maximum dosage information is available.

    Children

    Children >= 3 years: No specific maximum dosage information is available for the otic solution; safety and efficacy of bladder irrigation have not been established.
    Children < 3 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration
    Other Topical Formulations

    NOTE: Acetic acid is not approved by the FDA for topical wound irrigation.
    Topical acetic acid irrigations, in various strengths from 1% up to 5%, are used as soaks for superficial wound care, with soaks applied frequently to maintain effectiveness.
    Wash hands before and application; use of gloves is recommended to avoid wound contamination.
    Do not store; prepared or opened acetic acid topical solutions should generally be used within 24 hours.
    This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    Extemporaneous Compounding-Topical

    NOTE: The extemporaneous preparation of topical acetic acid irrigations for wound care is not approved by the FDA.

    Otic Administration

    The patient should lie on the side with the affected ear uppermost.
    Instill 4 to 6 drops into the external auditory canal and maintain this position for 5 minutes.
    Repeat the procedure every 2 to 3 hours.

    Other Administration Route(s)

    Intravesical Administration:
    0.25% Acetic Acid Irrigation USP may be administered by gravity drip via an administration set connected to an indwelling urethral
    catheter designed for continuous or intermittent two-way flow.
    For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be continuous or intermittent two-way flow.
    Adjust to maintain a urinary effluent pH of 4.5 to 5.0. Nitrazine or other pH paper may be used to monitor pH; increasing flow rate reduces pH value and vice versa.
    With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours.
    Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly.
     
    Directions for use of PIC Containers:
    Not for injection.
    Aseptic technique is required.
    Caution – Before use, perform the following checks:
    (a) Read the label. Ensure solution is the one ordered and is within the expiration date.
    (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
    Use only if solution is clear and container and seal are intact.
    Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.
    Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.
    Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.
    Single dose container. Do not store once opened. Discard unused portion.

    STORAGE

    Generic:
    - Avoid excessive heat (above 104 degrees F)
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Acetasol:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Borofair:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    VoSoL:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Acetic acid use is contraindicated in any patient with a known hypersensitivity to acetic acid or any of the product components.
     
    Clinical studies of acetic acid irrigation have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Systemic absorption of the products is unlikely and thus clinical issues in geriatric patients versus younger subjects are not expected.

    Parenteral administration, transurethral resection of the prostate

    Acetic acid irrigation is not for injection or parenteral administration. It is for bladder or topical irrigation only. The bladder irrigation solution is also contraindicated during transurethral surgical procedures, such as transurethral resection of the prostate. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful. Absorption from open or irritated lesions of the bladder mucosa may result in systemic acidosis.

    Ophthalmic administration

    Acetic acid otic solution is for otic administration only; avoid ophthalmic administration.

    Tympanic membrane perforation

    Acetic acid otic use is contraindicated in patients with tympanic membrane perforation. Perforated tympanic membranes is considered a contraindication to the use of any external ear canal medication.

    Children, infants, neonates

    The safety and efficacy of acetic acid otic solution has not been established in children under three years of age. The safety and efficacy of acetic acid irrigation has not been established in neonates, infants and children.

    Pregnancy

    Acetic acid is classified in FDA pregnancy risk category C. No long term studies in animals have been performed. Minimal systemic absorption is expected from maternal use; however, safe use of acetic acid products during pregnancy has not been established. Therefore, before use of acetic acid in pregnant women or women of childbearing potential, the potential benefits should be weighed against possible risks to mother and fetus.

    Breast-feeding

    It is not know whether acetic acid is excreted in human milk; however, systemic absorption is expected to be low during maternal topical, bladder, or otic use. Clinically significant breast milk concentrations are not expected. Caution is warranted if the bladder irrigation is used in patients with mucosal damage as systemic acidosis may occur. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    superinfection / Delayed / 0-1.0
    hematuria / Delayed / 0-1.0
    metabolic acidosis / Delayed / 0-1.0
    urethral pain / Early / 0-1.0

    Mild

    skin irritation / Early / 10.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Acetic Acid, Glacial products.

    PREGNANCY AND LACTATION

    Pregnancy

    Acetic acid is classified in FDA pregnancy risk category C. No long term studies in animals have been performed. Minimal systemic absorption is expected from maternal use; however, safe use of acetic acid products during pregnancy has not been established. Therefore, before use of acetic acid in pregnant women or women of childbearing potential, the potential benefits should be weighed against possible risks to mother and fetus.

    It is not know whether acetic acid is excreted in human milk; however, systemic absorption is expected to be low during maternal topical, bladder, or otic use. Clinically significant breast milk concentrations are not expected. Caution is warranted if the bladder irrigation is used in patients with mucosal damage as systemic acidosis may occur. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    The exact mechanism by which acetic acid exerts its antibacterial and antifungal actions is unknown. Acetic acid is effective against microorganisms in patients with acute diffuse external otitis. In vitro tests, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% acetic acid.
     
    Irrigation of the urinary bladder with acetic acid solution in a concentration of 0.25% has 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 helps reduce formation of calcium encrustations in the indwelling catheter.
     
    Frequent application of acetic acid, in solutions of up to 5% strength, may promote healing and removal of bacteria when used topically to selected wounds. The use of acetic acid irrigations topically dates back to 1916 when it was reported that a 1% solution applied to superficial war wounds led to elimination of an organism called Bacillus pyocyaneas (e.g., Pseudomonas aeroginosa). Solutions of acetic acid may cause significant discomfort, may promote other organism overgrowth (e.g., S. auerus) , and their utility and efficacy in contemporary wound management is in question, given other therapeutic options. Frequent repeat application of soaks are needed to confer benefits due to a short duration of local action.

    PHARMACOKINETICS

    Acetic acid is administered topically as an otic solution and bladder irrigant. The metabolism and excretion of acetic acid is unknown.] Pharmacodynamically, repeat dosing is needed to confer effectiveness, due to short local duration of action of 1 hour or less.

    Topical Route

    Although specific information of the absorption and distribution is unknown, acetic acid acts locally and significant systemic absorption from topical wound application is unlikely.

    Other Route(s)

    Otic Route:
    Although specific information of the absorption and distribution is unknown, acetic acid acts locally and systemic absorption is unlikely. In otic administration, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% acetic acid. Quantitative absorption of acetic acid 2% from external auditory canal is not known.
     
    Intravesical Route:
    Although specific information of the absorption and distribution is unknown, acetic acid acts locally and systemic absorption from bladder instillation is unlikely.