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  • CLASSES

    Otic Corticosteroid/anti-infective Combinations

    DEA CLASS

    Rx

    DESCRIPTION

    Otic solution for otitis externa; acetic acid has antifungal and antibacterial action; hydrocortisone has anti-inflammatory and antipruritic properties; acetic acid is considered active against the following microorganisms: Aspergillus sp., Pseudomonas sp., and Candida sp.

    COMMON BRAND NAMES

    Acetasol HC, Otomycet-HC, VoSoL HC

    HOW SUPPLIED

    Acetasol HC/Hydrocortisone, Acetic Acid/Hydrocortisone, Acetic Acid, Glacial/Otomycet-HC/VoSoL HC Auricular (Otic) Sol: 1-2%

    DOSAGE & INDICATIONS

    For the treatment of superficial bacterial infections of the external auditory canal (i.e., otitis externa) caused by susceptible organisms.
    NOTE: If the infection does not improve after 1 week of treatment, cultures and susceptibility tests should be performed to determine whether therapy should be changed.
    Otic dosage
    Adults, Geriatric, Adolescents, and Children >= 3 years

    Insert a cotton wick into the external ear canal and saturate with the solution. Keep wick moist by adding 3 to 5 drops of solution every 4 to 6 hours. Replace wick at least once every 24 hours. If preferred, the wick may be removed after 24 hours; however, continue to instill 3 to 5 drops into the ear(s) 3 to 4 times daily for as long as indicated. The lower end of the dosage range is usually recommended in children.

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information is not available.

    Elderly

    Maximum dosage information is not available.

    Adolescents

    Maximum dosage information is not available.

    Children

    >= 3 years: Maximum dosage information is not available.
    < 3 years: Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    ADMINISTRATION

    Otic Administration

    For application to the external ear canal only. Do not use in the eyes.
    Carefully remove all cerumen and external debris to allow acetic acid; hydrocortisone to contact infected surfaces directly.
    Prior to administration, the solution may be warmed by holding the bottle in the hand for 1—2 minutes.
    Patients should lie with the affected ear upward. This position should be maintained for a few minutes to facilitate penetration of the drops into the external ear canal.
    To promote continuous contact, a cotton wick should be inserted into the external ear canal and saturated with the solution. The wick should be kept moist (see Dosage). Repeat, if necessary, for the opposite ear. The wick should be replaced at least once every 24 hours. If preferred, the wick may be removed after 24 hours; however, the patient should continue to instill the drops as directed for as long as indicated.
    Care should be taken to avoid contamination. Each dropper is for use by a single patient only. Do not touch the tip of the dropper to the ear, fingertips, or other surface.
    Do not rinse the dropper after use; keep container tightly closed.

    STORAGE

    Generic:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Acetasol HC:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Otomycet-HC:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    VoSoL HC:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of acetic acid; hydrocortisone combination product for treatment of selected otic infections. Clinicians may wish to consult the individual drug monographs for more information about each specific agent.

    Corticosteroid hypersensitivity

    Acetic acid; hydrocortisone is contraindicated in patients with a known or suspected hypersensitivity to any of the product ingredients, such as hydrocortisone sensitivity (corticosteroid hypersensitivity). VoSoL HC also contains propylene glycol and benzethonium chloride. Discontinue use immediately if irritation or a rash develops.

    Herpes infection, varicella

    Acetic acid; hydrocortisone otic is listed by the manufacturer as being contraindicated in patients with herpes infection (e.g., herpes simplex or vaccinia) and varicella. It is recommended that acetic acid; hydrocortisone should not be used for longer than 10 days to avoid development of secondary infections. If the initial infection is not improved after 7—10 days of therapy, cultures are recommended to guide further treatment.

    Tympanic membrane perforation

    All otic medications are generally contraindicated in patients with tympanic membrane perforation (e.g., ruptured eardrum). Otic preparations, such as acetic acid; hydrocortisone, should be used sparingly to prevent accumulation of excess debris (i.e., cerumen) in the ear.

    Ocular exposure, ophthalmic administration, parenteral administration

    Avoid ocular exposure of acetic acid; hydrocortisone otic preparations. Acetic acid; hydrocortisone is not for ophthalmic administration or parenteral administration.

    Children, infants, neonates

    The safety and effectiveness of acetic acid; hydrocortisone in children below the age of 3, including infants and neonates, have not been established.

    Pregnancy

    Acetic acid; hydrocortisone otic solution is classified in FDA pregnancy risk category C and should be used with caution during pregnancy. Significant systemic absorption of the otic product components is not expected in normal prescription use of limited duration (i.e., 7—10 days). However, no adequate and well controlled studies have been conducted in pregnant women.

    Breast-feeding

    The manufacturer does not make any recommendations for the use of acetic acid; hydrocortisone otic solution during breast-feeding. Drugs, such as acetic acid, administered via the otic route generally exert a local effect and may result in minimal systemic absorption; clinically significant breast milk concentrations are not expected. Hydrocortisone is excreted into breast milk after systemic administration. Trace amounts of endogenous hydrocortisone (cortisol) are excreted in breast milk; however, no reports of exogenous hydrocortisone excretion into breast milk exist. The American Academy of Pediatrics (AAP) states that another steroid, prednisone, is usually compatible with breast-feeding. Another report states that systemic steroids used in asthma patients are compatible with breast-feeding. 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 drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    superinfection / Delayed / Incidence not known

    Mild

    skin irritation / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Acetic Acid; Hydrocortisone products.

    PREGNANCY AND LACTATION

    Pregnancy

    Acetic acid; hydrocortisone otic solution is classified in FDA pregnancy risk category C and should be used with caution during pregnancy. Significant systemic absorption of the otic product components is not expected in normal prescription use of limited duration (i.e., 7—10 days). However, no adequate and well controlled studies have been conducted in pregnant women.

    The manufacturer does not make any recommendations for the use of acetic acid; hydrocortisone otic solution during breast-feeding. Drugs, such as acetic acid, administered via the otic route generally exert a local effect and may result in minimal systemic absorption; clinically significant breast milk concentrations are not expected. Hydrocortisone is excreted into breast milk after systemic administration. Trace amounts of endogenous hydrocortisone (cortisol) are excreted in breast milk; however, no reports of exogenous hydrocortisone excretion into breast milk exist. The American Academy of Pediatrics (AAP) states that another steroid, prednisone, is usually compatible with breast-feeding. Another report states that systemic steroids used in asthma patients are compatible with breast-feeding. 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 drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action:•Acetic acid: Acetic acid is an organic acid with bacteriostatic and fungistatic properties. Acetic acid penetrates the bacterial cell wall and disrupts the cell membrane. Acetic acid is considered active against the following microorganisms: Aspergillus sp., Pseudomonas sp., and Candida sp.•Hydrocortisone: Hydrocortisone is indicated when otitis externa is complicated by inflammation or itching. Topical application of hydrocortisone produces anti-inflammatory, antipruritic, and vasoconstrictor actions. The activity is thought to result at least in part from binding with a steroid receptor. The anti-inflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Tachyphylaxis to the anti-inflammatory effects of corticosteroids may occur with repeated application; withdrawal of the drug restores response.

    PHARMACOKINETICS

    Acetic acid; hydrocortisone is administered as an otic solution. There are no specific pharmacokinetic data describing acetic acid; hydrocortisone.

    Other Route(s)

    Otic Route
    Acetic acid is completely oxidized by the body and does not affect systemic pH. Hydrocortisone is metabolized in the skin. Except when applied to large areas or for an extended period of time, systemic absorption of these agents is negligible.