TRITOP- neomycin sulfate, isoflupredone acetate, and tetracaine hydrochloride ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Available from:

Zoetis Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

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).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TRITOP- NEOMYCIN SULFATE, ISOFLUPREDONE ACETATE, AND TETRACAINE
HYDROCHLORIDE OINTMENT
ZOETIS INC.
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TRITOP
BRAND OF NEOMYCIN SULFATE, ISOFLUPREDONE ACETATE, TETRACAINE
HYDROCHLORIDE TOPICAL OINTMENT
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.
DESCRIPTION
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.
ISOFLUPREDONE ACETATE
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
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 o