NEO-PREDEF® WITH TETRACAINE POWDER
brand of neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride topical powder
For Use in Animals Only
For topical ear and skin use in dogs, cats and horses.
Ear mites are tiny parasites that live on the skin in the ear canal and feed on tissue debris and tissue fluids. They spend their entire lives on the host, laying eggs in the ear canal and on the surrounding fur. A fast, safe, clean way to treat ear mites, MILBEMITE® (0.1% milbemycin oxime) OTIC Solution kills 99 to 100% of the infestation in 7 to 30 days.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
NEO-PREDEF with Tetracaine Powder contains in each gram neomycin sulfate, 5 mg (equivalent to 3.5 mg
neomycin); isoflupredone acetate, 1 mg; tetracaine hydrochloride, 5 mg; myristyl-gamma-picolinium chloride,
0.2 mg; also lactose hydrous. Because of the prompt, potent, and specific actions of the individual components,
this combination is well suited for the treatment of certain ear and skin conditions occurring in dogs, cats and
ADVANTAGES OF NEO-PREDEF WITH TETRACAINE
Highly potent anti-inflammatory effect of isoflupredone acetate.
Wide-spectrum bactericidal effect of neomycin .
Rapid anesthetic effect of tetracaine.
Prompt relief of symptoms.
Reduces further self-inflicted trauma.
Ease of application.
Adherent to moist surfaces.
Isoflupredone acetate markedly inhibits inflammatory reaction through its controlling influence on connective
tissue and vascular components. Topically applied isoflupredone acetate is usually 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 NEO-PREDEF with Tetracaine Powder affords control of neomycin-sensitive organisms.
Tetracaine hydrochloride is a topical anesthetic agent that is more potent than either procaine or cocaine in
comparable concentration. 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.
Myristyl-gamma-picolinium Chloride is highly germicidal, nonirritating and relatively nontoxic. In solution it
reduces surface tension (a surfactant), possesses detergent and emulsifying actions, and exhibits properties
which favor the penetration and wetting of tissue surfaces. The drug is effective against a wide range of
organisms, its active ingredient killing in ten minutes Staphylococcus aureus in dilutions up to 1:85,000 at 37
degrees Centigrade; E. typhosa in dilutions up to 1:140,000; Esch. coli in dilutions up to 1:40,000, and S.
dysenteriae in dilutions up to 1:80,000.
Myristyl-gamma-picolinium Chloride has been used, per se, for preoperative disinfection of the skin, for
application to superficial injuries, for irrigating deep wounds, and for application to infections and wounds of
NEO-PREDEF with Tetracaine Powder is indicated in the 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. NEO-PREDEF with Tetracaine Powder may be used as a dusting powder following amputation of tails, claws, and
dew-claws; following ear trimming and castrating; and following such surgical procedure as
Applied superficially, it has been used successfully in the treatment of acute otitis externa in dogs, acute moist
dermatitis and interdigital dermatitis in the dog, and as a dusting powder to various minor cuts, lacerations, and
abrasions in the horse, cat and dog.
After cleansing the affected area, NEO-PREDEF with Tetracaine Powder is applied by compressing the sides of
the container with short, sharp squeezes. In most instances a single daily application will be sufficient; however,
it may be applied one to three times daily, as required.
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 NEO-PREDEF with Tetracaine Powder.
Incomplete response or exacerbation of corticosteroid-response lesions may be due to the presence of
nonsusceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of
nonsusceptible 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 initiated.
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.
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.
Store in a dry place at controlled room temperature 20° to 25°C (68° to 77°F)