Description:
NEO-PREDEF® WITH TETRACAINE POWDER
Rx
Pharmacia & Upjohn
NDC 0009-0584-01
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.
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
horses.
ADVANTAGES OF NEO-PREDEF WITH TETRACAINE
1.
Highly potent anti-inflammatory effect of isoflupredone acetate.
2.
Wide-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.
7.
Adherent to moist surfaces.
ISOFLUPREDONE ACETATE
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
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
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
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 mucous membranes.
INDICATIONS
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 ovariohysterectomies.
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.
CAUTION
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.
PRECAUTIONS
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.
APPLICATION
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.
HOW SUPPLIED
NEO-PREDEF with Tetracaine Powder is available
in 15 gram plastic insufflator bottles. Because of the hygroscopic properties of
neomycin sulfate, this bottle should be stored in a dry place. The cap
should be replaced when the bottle is not in use. The puffer bottle has been
designed to permit dusting when held in any position. Protecting the outlet from
moisture will aid in assuring proper function; therefore, the tip should not
be allowed to come in contact with moist membranes or weeping surfaces.
STORAGE
Store in a dry place at controlled room
temperature 20° to 25°C (68° to 77°F) [see USP].
Caution: Federal
(USA) law restricts this drug to use by or on the order of a licensed
veterinarian.
NADA #15-433
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