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  • CLASSES

    Otic Corticosteroid/anti-infective Combinations

    DEA CLASS

    Rx

    DESCRIPTION

    Otic, combination antibacterial and antiinflammatory product
    Used for treatment of superficial bacterial infections of external auditory canal and infections of mastoidectomy and fenestration cavities caused by susceptible organisms
    Use limited to 10 consecutive days due to risk for permanent sensorineural hearing with prolonged neomycin use

    COMMON BRAND NAMES

    Coly-Mycin S, Cortisporin TC

    HOW SUPPLIED

    Coly-Mycin S/Neomycin, Colistin Sulfate, Hydrocortisone, Thonzonium Bromide Auricular (Otic) Susp

    DOSAGE & INDICATIONS

    For the treatment of superficial bacterial infections of the external auditory canal (i.e., otitis externa) caused by susceptible organisms, and for the treatment of infections of mastoidectomy and fenestration cavities caused by susceptible organisms.
    Otic dosage
    Adults

    5 drops in affected ear(s) 3 to 4 times daily. Alternatively, insert a cotton wick into the ear canal and saturate with the suspension. Keep the wick moist by adding additional suspension every 4 hours. Replace the wick at least once every 24 hours. Limit the treatment duration to 10 days. If the infection does not improve after 1 week of treatment, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed.

    Children and Adolescents

    4 drops in affected ear(s) 3 to 4 times daily. Alternatively, insert a cotton wick into the ear canal and saturate with the suspension. Keep the wick moist by adding additional suspension every 4 hours. Replace the wick at least once every 24 hours. Limit the treatment duration to 10 days. If the infection does not improve after 1 week of treatment, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed.

    MAXIMUM DOSAGE

    Adults

    Do not exceed 10 days of dosing per treatment course.

    Geriatric

    Do not exceed 10 days of dosing per treatment course.

    Adolescents

    Do not exceed 10 days of dosing per treatment course.

    Children

    Do not exceed 10 days of dosing per treatment course.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    STORAGE

    Coly-Mycin S:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Cortisporin TC:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of the colistin, hydrocortisone, neomycin, and thonzonium in combination for inflammatory and infectious conditions of the ear. Clinicians may wish to consult the individual monographs for more information about the specific contraindications and precautions of each agent.

    Aminoglycoside hypersensitivity, neomycin hypersensitivity

    Colistin; hydrocortisone; neomycin; thonzonium products are contraindicated in patients who are allergic to any of the components, including those patients with aminoglycoside hypersensitivity or neomycin hypersensitivity. During treatment, monitor patients for the development of neomycin hypersensitivity (i.e., low-grade erythema with swelling, dry scaling, and itching); consider discontinuing treatment if such symptoms are observed. The reaction generally resolves quickly upon stopping neomycin. Patients who develop this reaction should be instructed to avoid future use of neomycin-containing products.

    Herpes infection, varicella, viral infection

    Colistin; hydrocortisone; neomycin; thonzonium products are only approved to treat infections caused by susceptible bacteria. Use of the drug to treat an external auditory canal viral infection, such as varicella-zoster (e.g., chickenpox) or other herpes infection (e.g., herpes simplex or vaccinia), is contraindicated. Secondary infections from non-susceptible organisms, such as fungi, may occur with prolonged use of the drug; the recommended maximum duration is 10 days. The hydrocortisone component may mask infection or enhance existing infection. If the infection does not improve after one week, repeat cultures to identify the organism.

    Hearing impairment, renal disease, tympanic membrane perforation

    Treatment with neomycin-containing products may result in permanent sensorineural hearing impairment (i.e., hearing loss) if the drug is absorbed systemically. Neomycin induced ototoxicity results from cochlear damage, primarily destruction of hair cells in the organ of Corti. The risk increases in patients with renal disease and after prolonged use of the drug. Closely monitor all patients during treatment; extreme caution is advised if administering to patients with tympanic membrane perforation.

    Ocular exposure

    Colistin; hydrocortisone; neomycin; thonzonium products are for otic administration only. Take precautions to avoid ocular exposure.

    Pregnancy

    Colistin; hydrocortisone; neomycin; thonzonium products are classified as FDA pregnancy risk category C. No adequate and well controlled studies have been conducted in pregnant women, and it is unknown if the drug can cause fetal harm. Aminoglycosides, like neomycin, can cause congenital deafness in humans if administered during pregnancy; however, topically administered neomycin is not expected to produce significant systemic concentrations. In animal studies, corticosteroids, such as hydrocortisone, have been shown to be teratogenic in animals when administered systemically at relatively low doses and after dermal application. For colistin, no embryo/fetal effects were observed when administering doses equivalent to those delivered with otic application. Administer the drug during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Breast-feeding

    The manufacturer recommends that colistin; hydrocortisone; neomycin; thonzonium products be used with caution in women who are breast-feeding. Hydrocortisone and colistin appear in breast milk following oral administration, although it should be noted that there is a minimal possibility of systemic absorption following topical 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. Otic use of neomycin results in minimal systemic absorption. 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.

    Infants, neonates

    Safety and efficacy of colistin; hydrocortisone; neomycin; thonzonium products have not been established in infants or neonates.

    ADVERSE REACTIONS

    Severe

    hearing loss / Delayed / Incidence not known
    renal failure (unspecified) / Delayed / Incidence not known
    skin atrophy / Delayed / Incidence not known

    Moderate

    superinfection / Delayed / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    Mild

    pruritus / Rapid / 0-1.0
    rash / Early / 0-1.0
    skin irritation / Early / Incidence not known
    striae / Delayed / Incidence not known
    hypertrichosis / Delayed / Incidence not known
    miliaria / Delayed / Incidence not known
    xerosis / Delayed / Incidence not known
    folliculitis / Delayed / Incidence not known
    skin hypopigmentation / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Colistin; Hydrocortisone; Neomycin; Thonzonium products.

    PREGNANCY AND LACTATION

    Pregnancy

    Colistin; hydrocortisone; neomycin; thonzonium products are classified as FDA pregnancy risk category C. No adequate and well controlled studies have been conducted in pregnant women, and it is unknown if the drug can cause fetal harm. Aminoglycosides, like neomycin, can cause congenital deafness in humans if administered during pregnancy; however, topically administered neomycin is not expected to produce significant systemic concentrations. In animal studies, corticosteroids, such as hydrocortisone, have been shown to be teratogenic in animals when administered systemically at relatively low doses and after dermal application. For colistin, no embryo/fetal effects were observed when administering doses equivalent to those delivered with otic application. Administer the drug during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    The manufacturer recommends that colistin; hydrocortisone; neomycin; thonzonium products be used with caution in women who are breast-feeding. Hydrocortisone and colistin appear in breast milk following oral administration, although it should be noted that there is a minimal possibility of systemic absorption following topical 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. Otic use of neomycin results in minimal systemic absorption. 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

    •Colistin: Surface active agent that disrupts the structure of the bacterial cell membrane. Colistin binds in a detergent-like fashion to gram-negative bacterial cell membrane phospholipids by displacing calcium and magnesium. The loss of integrity of the membrane and increased permeability of the cell envelope results in leaking of cell contents and, subsequently, cell death. Colistin also actively binds to the lipid A portion of endotoxin in the outer membrane of gram-negative bacteria, which inactives the endotoxin. The clinical significance of potentially preventing or reducing endotoxin-induced shock is unclear. Colistin has been shown to have bactericidal activity against many aerobic gram-negative organisms by exhibiting 'concentration-dependent killing', which is described as the principle that bactericidal effects increase as the concentration increases.
    •Hydrocortisone: Antiinflammatory activity is thought to result from induction of phospholipase A2 inhibitory proteins (lipocortins). These proteins may control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid, which is released from membrane phospholipids by phospholipase A2.
    •Neomycin: Neomycin is bacteriocidal. It inhibits bacterial protein synthesis through irreversible binding to the 30S ribosomal subunit of susceptible bacteria. Neomycin is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. Neomycin may also inhibit DNA polymerase.
    •Thonzonium: Surface active agent that aids in the dispersion and penetration of cellular debris and exudate.

    PHARMACOKINETICS

    Colistin, hydrocortisone, neomycin, and thonzonium combination products are applied topically to the ear. Pharmacokinetic data are limited for these combination products.

    Other Route(s)

    Otic Route
    When used as directed, significant systemic concentration of colistin and neomycin are not anticipated; however, increased absorption of neomycin may occur if applied to denuded or damaged epithelium. Topical hydrocortisone is metabolized in the skin. Although, like neomycin, systemic absorption of hydrocortisone may increase if applied to skin that is damage or inflamed.