CORTISPORIN Otic Solution Sterile(neomycin and polymyxin B sulfates
and hydrocortisone otic solution, USP)
polymyxin b sulfate and
hydrocortisone suspension Monarch Pharmaceuticals, Inc.
CORTISPORIN Otic Solution Sterile (neomycin and polymyxin B sulfates
and hydrocortisone otic solution, USP)
CORTISPORIN Otic Solution (neomycin and polymyxin B sulfates
and hydrocortisone otic solution, USP) is a sterile antibacterial and anti-inflammatory
solution for otic use. Each mL contains: neomycin sulfate equivalent to 3.5
mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units,
and hydrocortisone 10 mg (1%). The vehicle contains potassium metabisulfite
0.1% (added as a preservative) and the inactive ingredients cupric sulfate,
glycerin, hydrochloric acid, propylene glycol, and Water for Injection.
sulfate is the sulfate salt of neomycin B and C, which are produced by the
growth of Streptomyces fradiae Waksman (Fam.
Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of
neomycin standard per mg, calculated on an anhydrous basis. The structural
Polymyxin B sulfate is the sulfate
salt of polymyxin B1 and B2, which are produced by the
growth of Bacillus polymyxa (Prazmowski)
Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin
B units per mg, calculated on an anhydrous basis. The structural formulae
20-dione, is an anti-inflammatory hormone. Its structural formula is:
Corticoids suppress the inflammatory response to a variety
of agents and they may delay healing. Since corticoids may inhibit the body’s
defense mechanism against infection, a concomitant antimicrobial drug may
be used when this inhibition is considered to be clinically significant in
a particular case.
The anti-infective components in
the combination are included to provide action against specific organisms
susceptible to them. Neomycin sulfate and polymyxin B sulfate together are
considered active against the following microorganisms: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter
species, Neisseria species,
and Pseudomonas aeruginosa. This product
does not provide adequate coverage against Serratia
marcescens and streptococci, including Streptococcus
The relative potency of corticosteroids
depends on the molecular structure, concentration, and release from the vehicle.
Indications and Usage
For the treatment of superficial bacterial infections of
the external auditory canal caused by organisms susceptible to the action
of the antibiotics.
This product is contraindicated in those individuals who
have shown hypersensitivity to any of its components.
product should not be used if the external auditory canal disorder is suspected
or known to be due to cutaneous viral infection (for example, herpes simplex
virus or varicella zoster virus).
Neomycin can induce permanent sensorineural hearing loss
due to cochlear damage, mainly destruction of hair cells in the organ of Corti.
The risk of ototoxicity is greater with prolonged use; therefore, duration
of therapy should be limited to 10 consecutive days (see PRECAUTIONS:
Patients being treated with eardrops
containing neomycin should be under close clinical observation. Due to its
acidity which may cause burning and stinging, CORTISPORIN Otic Solution should
not be used in any patients with a perforated tympanic membrane.
sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity
reactions (primarily skin rash) due to topical neomycin is not known. Discontinue
this product promptly if sensitization or irritation occurs.
using neomycin-containing products to control secondary infection in the chronic
dermatoses, such as chronic otitis externa or stasis dermatitis, it should
be borne in mind that the skin in these conditions is more liable than is
normal skin to become sensitized to many substances, including neomycin. The
manifestation of sensitization to neomycin is usually a low-grade reddening
with swelling, dry scaling, and itching; it may be manifest simply as a failure
to heal. Periodic examination for such signs is advisable, and the patient
should be told to discontinue the product if they are observed. These symptoms
regress quickly on withdrawing the medication. Neomycin-containing applications
should be avoided for the patient thereafter.
potassium metabisulfite, a sulfite that may cause allergic-type reactions
including anaphylactic symptoms and life-threatening or less severe asthmatic
episodes in certain susceptible people. The overall prevalence of sulfite
sensitivity in the general population is unknown and probably low. Sulfite
sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
As with other antibiotic preparations, prolonged use may
result in overgrowth of nonsusceptible organisms, including fungi.
the infection is not improved after 1 week, cultures and susceptibility tests
should be repeated to verify the identity of the organism and to determine
whether therapy should be changed.
not be continued for longer than 10 days.
cross-reactions may occur which could prevent the use of any or all of the
following antibiotics for the treatment of future infections: kanamycin; paromomycin;
streptomycin; and possibly, gentamicin.
Information for Patients
Avoid contaminating the dropper with material from the ear,
fingers, or other source. This caution is necessary if the sterility of the
drops is to be preserved.
If sensitization or irritation
occurs, discontinue use immediately and contact your physician.
not use in the eyes.
Systemic effects of excessive levels of hydrocortisone may
include a reduction in the number of circulating eosinophils and a decrease
in urinary excretion of 17-hydroxycorticosteroids.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals (rats, rabbits, mice) showed
no evidence of carcinogenicity attributable to oral administration of corticosteroids.
Pregnancy Category C. Corticosteroids have been shown to
be teratogenic in rabbits when applied topically at concentrations of 0.5%
on days 6 to 18 of gestation and in mice when applied topically at a concentration
of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled
studies in pregnant women. Corticosteroids should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Hydrocortisone appears in human milk following oral administration
of the drug. Since systemic absorption of hydrocortisone may occur when applied
topically, caution should be exercised when CORTISPORIN Otic Solution is used
by a nursing woman.
The safety and effectiveness of CORTISPORIN Otic Solution
in otitis externa have been established in the pediatric age group 2 years
to 16 years of age. There is inadequate data to establish safety and effectiveness
in otitis externa for pediatric patients under 2 years of age.1
Clinical studies of CORTISPORIN Otic Solution did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
Neomycin occasionally causes skin sensitization. Ototoxicity
and nephrotoxicity have also been reported (see WARNINGS).
Adverse reactions have occurred with topical use of antibiotic combinations
including neomycin and polymyxin B. Exact incidence figures are not available
since no denominator of treated patients is available. The reaction occurring
most often is allergic sensitization. In one clinical study, using a 20% neomycin
patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%)
individuals in the general population.2 In another study, the incidence
was found to be approximately 1%.3
local adverse reactions have been reported with topical corticosteroids, especially
under occlusive dressings: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, secondary infection,
skin atrophy, striae, and miliaria. Stinging and burning have been reported
when this product has gained access to the middle ear.
Dosage and Administration
Therapy with this product should be limited to 10 consecutive
The external auditory canal should be thoroughly
cleansed and dried with a sterile cotton applicator.
adults, four drops of the solution should be instilled into the affected ear
3 or 4 times daily. For infants and children, three drops are suggested because
of the smaller capacity of the ear canal.
should lie with the affected ear upward and then the drops should be instilled.
This position should be maintained for 5 minutes to facilitate penetration
of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
preferred, a cotton wick may be inserted into the canal and then the cotton
may be saturated with the solution. This wick should be kept moist by adding
further solution every 4 hours. The wick should be replaced at least once
every 24 hours.
Bottle of 10 mL with sterilized dropper (NDC 61570-034-10).
Store at 15° to 25°C (59° to 77°F).
CORTISPORIN Otic Suspension bottle of 10 mL with sterilized dropper.
PEDIOTIC® Suspension bottle of 7.5 mL with sterilized dropper.
Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution
for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head
Neck Surg. 1997; 123: 1193–1200.
Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odom RB,
Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine,
and benzocaine: relationships between age, sex, history of exposure, and reactivity
to standard patch tests and use tests in a general population. Arch