Ear & Skin Medication
TRITOP Topical Ointment is
indicated as treatment or adjunctive therapy of certain ear and skin
conditions in dogs, cats and horses caused by or associated with neomycin
susceptible organisms and/or allergy. In addition, it is indicated as
superficial dressing applied to minor cuts, wounds, lacerations, abrasions,
and for post surgical application where reduction of pain and inflammatory
response is deemed desirable.
Isoflupredone acetate is 14 times as potent as
hydrocortisone as an anti-inflammatory steroid as measured by the cotton
pellet implantation assay.
Isoflupredone acetate markedly
inhibits inflammatory reaction through its controlling influence on
connective tissue and vascular components. Topically applied isoflupredone
acetate is rapidly effective. In otitis externa, wounds of the concha,
ulcerations of the ear flaps, and irritated lesions of the skin, the
inflammatory response may also be effectively inhibited by isoflupredone
acetate. Chronic conditions respond more slowly and relapses are more
Neomycin is an antibiotic
substance derived from cultures of the soil organism
Streptomyces fradiae. Its antimicrobial range includes both
gram-positive and gram-negative organisms commonly responsible for or
associated with otic infections, such as staphylococci, streptococci,
Escherichia coli, Aerobacter aerogenes, and many
strains of Proteus and Pseudomonas organisms. It is not active against
fungi. Neomycin is unusually nontoxic for epithelial cells in tissue culture
and is nonirritating in therapeutic concentrations. The presence of neomycin
in TRITOP Topical Ointment affords control
of infections caused by neomycin susceptible organisms.
Tetracaine hydrochloride is a
topical anesthetic agent that is more potent than either procaine or cocaine
in comparable concentrations and has greater ability than procaine to
penetrate mucous membranes. The duration of anesthetic action of tetracaine
exceeds that produced by either butacaine or phenacaine.
OF TRITOP OINTMENT
1. Potent anti-inflammatory
effect of isoflupredone acetate.
2. Broad-spectrum bactericidal
effect of neomycin.
3. Rapid anesthetic effect of
4. Prompt relief of symptoms.
5. Reduces further
6. Ease of application.
TRITOP Topical Ointment is
useful in treating such conditions as acute otitis externa in dogs and to a
lesser degree, chronic otitis externa in dogs. It also is effective in
treating anal gland infections and moist dermatitis in the dog and is a
useful dressing for minor cuts, lacerations, abrasions, and post surgical
therapy in the horse, cat, and dog.
TRITOP Topical Ointment may
also be used following amputation of dewclaws, tails and claws, following
ear trimming and castrating operations.
In treatment of otitis
externa and other inflammatory conditions of the external ear canal, a
quantity of ointment sufficient to fill the external ear canal may be
applied one to three times daily. When used on the skin or mucous membranes,
cleanse the affected area, apply a small amount of the ointment and spread
or rub in gently. The involved area may be treated one to three times a day
and these daily applications continued in accordance with the clinical
response. Limit treatment to the period when local anesthesia is essential
to control self-inflicted trauma.
Federal (USA) law restricts this drug to use by or on the order of a
Not for human use.
Clinical and experimental data
have demonstrated that corticosteroids administered orally or by injection
to animals may induce the first stage of parturition if used during the last
trimester of pregnancy and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta and metritis.
administered to dogs, rabbits, and rodents during pregnancy have resulted in
cleft palate in offspring. Corticosteroids administered to dogs during
pregnancy have also resulted in other congenital anomalies, including
deformed forelegs, phocomelia, and anasarca.
For Use in
Before instilling any
medication into the ear, examine the external ear canal thoroughly to be
certain the tympanic membrane is not ruptured in order to avoid the
possibility of transmitting infection to the middle ear as well as damaging
the cochlea or vestibular apparatus from prolonged contact. If hearing or
vestibular dysfunction is noted during the course of treatment discontinue
use of TRITOP Topical Ointment.
Incomplete response or
exacerbation of corticosteroid responsive lesions may be due to the presence
of non-susceptible organisms or to prolonged use of antibiotic-containing
preparations resulting in over-growth of non-susceptible organisms,
particularly Monilia. Thus, if improvement is not noted within two or three
days, or if redness, irritation, or swelling persists or increases, the
diagnosis should be redetermined and appropriate therapeutic measures
Tetracaine and neomycin have
the potential to sensitize. Care should be taken to observe animals being
treated for evidence of hypersensitivity or allergy to TRITOP Topical
Ointment (neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride
ointment). If such signs are noted, therapy with TRITOP Topical Ointment
should be stopped.
TRITOP Topical Ointment is
available in 10 gram tubes with a special applicator tip.
Store at controlled room
temperature 20° to 25°C (68° to 77°F)