TRITOP- neomycin sulfate, isoflupredone acetate, and tetracaine hydrochloride ointment
Zoetis Inc.
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For Use in Animals Only
For topical ear and skin use in dogs, cats and horses
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
TRITOP Topical Ointment (neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride ointment) contains in each gram the potent anti-inflammatory agent isoflupredone acetate 1 mg (0.1%); the antibiotic neomycin sulfate, 5 mg (0.5%) (equivalent to 3.5 mg neomycin); and the topical anesthetic tetracaine hydrochloride, 5 mg (0.5%). This combination is well suited for the treatment or adjunctive therapy of many ear and skin conditions, as well as a dressing for superficial wounds occurring in dogs, cats and horses.
Its action is specific as to anti-inflammatory, bactericidal, and anesthetic properties.
It has been reported by research workers that 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 frequent.
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.
Many investigators have demonstrated that local anesthesia plays a significant part in the promotion of healing, especially where pain is a prominent factor. It is believed that trauma stimulates local pain receptors, which results in reflex vasodilation, edema, tenderness, and muscular spasm.
If the reflex is abolished through use of a local anesthetic such as tetracaine, amelioration of these tissue changes that interfere with healing is favored. The local anesthetic action of tetracaine has proved to be of great value in alleviating the pain reflex in painful skin and ear conditions.
1. Potent anti-inflammatory effect of isoflupredone
acetate.
2. Broad-spectrum bactericidal effect of neomycin.
3. Rapid anesthetic effect of tetracaine.
4. Prompt relief of symptoms.
5. Reduces further self-inflicted trauma.
6. Ease of application.
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.
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.
Not for human use. Do not use in horses intended
for human consumption.
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.
Additionally, corticosteroids 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.
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 infec tion 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 corti costeroid responsive lesions may be due to the
presence of nonsusceptible organisms or to prolonged use of antibioticcontaining prepara tions
resulting in overgrowth of nonsusceptible organisms, particularly Monilia. Thus, if improve ment
is not noted within two or three days, or if redness, irritation, or swelling persists or
increases, the diagnosis should be redetermined and appro priate therapeutic measures initiated.
Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe
animals being treated for evidence of hyper sensitivity or allergy to TRITOP Topical
Ointment (neomycin sulfate, isoflupredone acetate, tetra caine hydrochloride ointment). If such
signs are py with TRITOP Topical Ointment should be stopped.
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.
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.
TRITOP
neomycin sulfate, isoflupredone acetate, and tetracaine hydrochloride ointment |
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Labeler - Zoetis Inc. (828851555) |