Neomycin, Polymyxin B, and Hydrocortisone (Otic)


VA CLASSIFICATION
Primary: OT250

Commonly used brand name(s): AK-Spore HC Otic; Antibiotic Ear; Cort-Biotic; Cortatrigen Ear; Cortatrigen Modified Ear Drops; Cortisporin; Cortomycin; Drotic; Ear-Eze; LazerSporin-C; Masporin Otic; Octicair; Octigen; Otic-Care; Otic-Care Ear; Otimar; Otisan; Otocidin; Otocort; Pediotic; UAD Otic.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial-corticosteroid (otic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Ear canal infections, external (treatment) or{05}{10}{11}{13}{17}{18}
Mastoidectomy cavity infections{11}{18} (treatment)—Otic neomycin, polymyxin B, and hydrocortisone combination is indicated in the treatment of external ear canal infections and mastoidectomy cavity infections caused by susceptible organisms. {06} {07} {08}

[Otitis media, chronic suppurative (treatment)]1—Otic neomycin, polymyxin B, and hydrocortisone combination is used in the treatment of chronic suppurative otitis media. {01} {04} {18}

—Not all species or strains of a particular organism may be susceptible to neomycin and polymyxin B.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Neomycin: Derived from Streptomyces fradiae . {02}
    Polymyxin B: Derived from polymyxin B 1 and polymyxin B 2, which are produced by the growth of Bacillus polymyxa . {03}

Chemical group—
    Neomycin: Aminoglycosides.
    Polymyxin B: Polypeptides.
    Hydrocortisone: Corticosteroids.
Molecular weight—
    Hydrocortisone: 362.47 {09}

Mechanism of action/Effect:

Neomycin—See Neomycin (Ophthalmic).

Polymyxin B—See Neomycin, Polymyxin B, and Bacitracin (Ophthalmic).

Hydrocortisone—See Corticosteroids (Otic).

Absorption:

Neomycin; polymyxin B; hydrocortisone—May be absorbed following topical application to the ear if the eardrum is perforated or tissue damage is present. {04}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to one aminoglycoside or polymyxin may be sensitive to other aminoglycosides or polymyxins also. {05} {06} {10}

Carcinogenicity

Long-term studies in animals (rats, rabbits, mice) given oral corticosteroids showed no carcinogenicity. {10} {13}

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies in humans have not been done for otic neomycin, polymyxin B, and hydrocortisone combination. {05} {10} {13}

Topical corticosteroids have been shown to be teratogenic in rabbits when applied at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied at a concentration of 15% on days 10 to 13 of gestation. {05} {10} {13}

FDA Pregnancy Category C. {05} {10} {13}

Breast-feeding

Oral hydrocortisone is distributed into breast milk. {05} {10} {13} It is not known if otic neomycin, polymyxin B, and hydrocortisone combination is distributed into breast milk. However, problems in humans have not been documented. {06}

Pediatrics

Appropriate studies on the relationship of age to the effects of otic neomycin, polymyxin B, and hydrocortisone combination have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of otic neomycin, polymyxin B, and hydrocortisone combination have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Sensitivity to aminoglycosides, polymyxins, or sulfites{10}
For hydrocortisone:
» Bullous myringitis
» Herpes simplex{06}{10}{11}
» Herpes zoster oticus
» Tubercular or fungal infections of the ear
» Vaccinia, varicella, or other viral disease of the ear{06}{10}{11}
For neomycin and/or polymyxin B {06}:
Otitis media, chronic or{11}
Perforated eardrum    (possibility of ototoxicity {05} {10} {11} {13})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent {06} {07}
    
Hypersensitivity{10}{11} (itching, skin rash, redness, swelling, or other sign of irritation in or around the ear not present before therapy)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Neomycin, Polymyxin B, and Hydrocortisone (Otic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to aminoglycosides, polymyxins, or sulfites

Pregnancy—Topical corticosteroids have been shown to be teratogenic in rabbits and mice

Proper use of this medication
Proper administration technique for otic solution and suspension {52} {53} {54}

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Not using longer than 10 days unless otherwise directed by physician

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within 1 week


Side/adverse effects
Signs of potential side effects, especially hypersensitivity


General Dosing Information
This medication may be warmed, but not above body temperature, prior to administration.

A cotton wick may be placed in the ear canal and then saturated with the suspension. The wick should be kept moist by adding suspension every 4 to 8 hours and it should be replaced at least once daily.

Therapy should not be continued for more than 10 days. {10} {11} {13}

If infection has not improved within 1 week, condition should be re-evaluated. {10} {11} {13}


Otic Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION USP

Usual adult and adolescent dose
Ear canal infections, external
Topical, to the ear canal, 4 drops three or four times a day. {05} {07} {10} {17}

Mastoidectomy cavity infections or
[Otitis media, chronic suppurative]1
Topical, to the mastoidectomy cavity or ear canal, 4 to 10 drops every six to eight hours. {04}

Note: In the treatment of mastoidectomy cavity infections, the dose depends on the size of the mastoidectomy cavity. Some cavities may require up to 1 or 2 dropperfuls of otic solution or suspension in adults. {04}



Usual pediatric dose
Ear canal infections, external
Topical, to the ear canal, 3 drops three or four times a day. {05} {07} {10} {17}

Mastoidectomy cavity infections
Topical, to the mastoidectomy cavity, 4 or 5 drops every six to eight hours. {04}

Note: In the treatment of mastoidectomy cavity infections, the dose depends on the size of the mastoidectomy cavity. {04}


[Otitis media, chronic suppurative]1
Topical, to the ear canal, 2 to 5 drops every six to eight hours. {04}


Strength(s) usually available
U.S.—


3.5 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 10 mg of hydrocortisone per mL (Rx) [AK-Spore HC Otic{14} (potassium metabisulfite) (propylene glycol) (glycerin)] [Antibiotic Ear{21}{25}] [Cortatrigen Modified Ear Drops{21}{26}{30} (potassium metabisulfite) (propylene glycol) (glycerin)] [Cort-Biotic{38}] [Cortisporin{10}{32} (potassium metabisulfite 0.1%) (cupric sulfate) (glycerin) (hydrochloric acid) (propylene glycol)] [Drotic{21}{27}{45} (potassium metabisulfite) (propylene glycol) (glycerin)] [Ear-Eze{21}{29} (potassium metabisulfite) (propylene glycol) (glycerin)] [LazerSporin-C{39}] [Masporin Otic{33}] [Octicair{05}{21}{40} (potassium metabisulfite) (propylene glycol) (glycerin)] [Octigen{34}] [Otic-Care{21}{28}{50} (glycerin) (hydrochloric acid) (propylene glycol) (potassium metabisulfite)] [Otic-Care Ear{51} (glycerin) (hydrochloric acid) (propylene glycol) (potassium metabisulfite)] [Otimar{36}] [Otocidin{35}] [Otocort{21}][Generic]{12}{23}{42}

Canada—


3.5 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 10 mg of hydrocortisone per mL (Rx) [Cortisporin{19} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • For the ear.
   • Continue medicine for full time of treatment.


NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION USP

Usual adult and adolescent dose
Ear canal infections, external
Topical, to the ear canal, 4 drops three or four times a day. {07} {11} {13} {18}

Mastoidectomy cavity infections; or
[Otitis media, chronic suppurative]1
Topical, to the mastoidectomy cavity or ear canal, 4 to 10 drops every six to eight hours. {04}

Note: In the treatment of mastoidectomy cavity infections, the dose depends on the size of the mastoidectomy cavity. Some cavities may require up to 1 or 2 dropperfuls of otic solution or suspension in adults. {04}



Usual pediatric dose
Ear canal infections, external
Topical, to the ear canal, 3 drops three or four times a day. {07} {11} {13}

Mastoidectomy cavity infections
Topical, to the mastoidectomy cavity, 4 or 5 drops every six to eight hours. {04}

Note: In the treatment of mastoidectomy cavity infections, the dose depends on the size of the mastoidectomy cavity. {04}


[Otitis media, chronic suppurative]1
Topical, to the ear canal, 2 to 5 drops every six to eight hours. {04}


Strength(s) usually available
U.S.—


3.5 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 10 mg of hydrocortisone per mL (Rx) [AK-Spore HC Otic{15} (cetyl alcohol) (propylene glycol) (polysorbate 80) (thimerosal)] [Antibiotic Ear{22}{25}] [Cortatrigen Ear{22}{30} (cetyl alcohol) (propylene glycol) (polysorbate 80) (thimerosal)] [Cort-Biotic{38}] [Cortisporin{13}{46} (thimerosal 0.01% ) (cetyl alcohol) (propylene glycol) (polysorbate 80)] [Cortomycin{37}] [Masporin Otic{33}] [Octigen{34}] [Otic-Care{22}{28}{48} (cetyl alcohol) (polyoxyl 40 stearate) (polysorbate 80) (propylene glycol) (sulfuric acid) (benzalkonium chloride)] [Otic-Care Ear{49} (cetyl alcohol) (propylene glycol) (polysorbate 80) (thimerosal)] [Otimar{36}] [Otisan{24}{41}] [Otocort{22}] [Pediotic{11}{20}{47} (thimerosal 0.001% ) (cetyl alcohol) (glyceryl monostearate) (mineral oil) (polyoxyl 40 stearate) (propylene glycol)] [UAD Otic{22}{31}{44}][Generic]{12}{23}{43}

Canada—


3.5 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 10 mg of hydrocortisone per mL (Rx) [Cortisporin{08}{19} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. {05}

Auxiliary labeling:
   • Shake well. {13}
   • For the ear.
   • Continue medicine for full time of treatment.



Revised: 06/02/1995



References
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  1. Neosporin ophthalmic ointment package insert (BW—US), Rev 11/83, Rec 3/22/85.
  1. Panel comments, 12/22/86.
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  1. Pediotic suspension package insert (BW—US), Rev 4/88, Rec 6/89.
  1. Cortisporin otic solution package insert (BW—US), Rev 7/88, Rec 6/89.
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  1. Reviewers' responses to Pediatrics Advisory Panel Memos #34, 39, and 42 of 11/16/94, 1/11/95, and 2/21/95, respectively.
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