Resortin
Nystatin, Neomycin Sulfate, Thiostrepton and Triamcinolone Acetonide Ointment
For Use Only in Dogs and Cats
CAUTION: Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Description:
Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment
is an ointment in a non-irritating vehicle, a polyethylene and mineral oil gel
base.
Each mL contains:
nystatin
100,000
Units neomycin sulfate (equivalent to neomycin base)
.2.5 mg.
thiostrepton
..........................................................................................2,500
Units triamcinolone acetonide
.1.0 mg.
Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment
is supplied in tubes of 1/4 fl. oz. (7.5 mL), 1/2 fl. oz. (15 mL) and 1 fl. oz.
(30 mL), each with an elongated tip for easy application and in dispensing
bottles of 8 fl. oz. (240 mL). The preparation is intended for local therapy in
a variety of cutaneous disorders of cats and dogs; it is especially useful in
disorders caused, complicated or threatened by bacterial and/or candidal
(monilial) infections.
Actions:
By virtue of its four active ingredients, the ointment provides four basic
therapeutic effects: anti-inflammatory, antipruritic, antifungal and
antibacterial. Triamcinolone acetonide is a potent synthetic corticosteroid
providing rapid and prolonged symptomatic relief on topical administration.
Inflammation, edema and pruritis promptly subside and lesions are permitted to
heal. Nystatin is the first well-tolerated anti-fungal antibiotic of dependable
efficacy for the treatment of cutaneous infections caused by Candida albicans
(monilia). Nystatin is fungistatic in vitro against a variety of yeast and
yeast-like fungi including many fungi pathogenic to animals. No appreciable
activity is exhibited against bacteria. Thiostrepton has a high order of
activity against gram-positive organisms, including many which are resistant to
other antibiotics; neomycin exerts antimicrobial action against a wide range or
gram-positive and gram-negative bacteria. Together they provide comprehensive
therapy against those organisms responsible for most superficial bacterial
infections.
Indications:
Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment
is particularly useful in the treatment of acute and chronic otitis of various
etiologies, in interdigital cysts in cats and dogs, and in anal gland
infections in dogs. The preparation is also indicated in the management of
dermatologic disorders characterized by inflammation and dry or exudative
dermatitis, particularly those caused, complicated or threatened by bacterial
or candidal (Candida albicans) infections. It is also of value in eczematous
dermatitis; contact dermatitis and seborrheic dermatitis and as an adjunct in
the treatment of dermatitis due to parasitic infestation.
Warning:
Clinical and experimental data have demonstrated that corticosteroids
administered orally or by injection to animals may induce the first stage or
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 the offspring. In dogs, other
congenital anomalies have resulted; deformed forelegs, phocorneliia and
anasarca.
Precautions:
Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment
is not intended for the treatment of deep abscesses of deep-seated infections
such as inflammation of the lymphatic vessels. Parenteral antibiotic therapy is
indicated by these infections. Nystatin, neomycin sulfate, thiostrepton and
triamcinolone acetonide ointment has been extremely well tolerated. Cutaneous
reactions attributable to its use have been extremely rare. The occurrence of
systemic reactions is rarely a problem with topical administration.
There is some evidence that corticosteroids can be absorbed after topical
application and cause systemic effects. Therefore, an animal receiving
nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment
therapy should be observed closely for signs such as polydipsia, polyuria and
increased weight gain. Nystatin, neomycin sulfate, thiostrepton and
triamcinolone acetonide ointment is not generally recommended for the treatment
of deep or puncture wounds or serious burns.
Sensitivity to neomycin may occur. If redness, irritation or swelling persists
or increases, discontinue use. Do not use if pus is present since the drug may
allow the infection to spread. Keep this and all medications out of reach of
children.
Avoid ingestion. Oral or parenteral use of corticosteroids (depending on dose,
duration of use and specific steroid) may result in inhibition of endogenous
steroid production following drug withdrawal.
Side Effects:
SAP and SGPT (ALT) enzyme elevations, polydipsia/polyuria, vomiting and
diarrhea (occasionally bloody) have been observed following parenteral or
systemic use of synthetic corticosteroids in dogs.
Cushings syndrome has been reported in association with prolonged or repeated
steroid therapy in dogs.
Temporary hearing loss has been reported in conjunction with treatment of
otitis with products containing corticosteroids. However, regression usually
occurred following withdrawal of the drug. If hearing dysfunction is noted
during the course of treatment with nystatin, neomycin sulfate, thiostrepton
and triamcinolone acetonide ointment, discontinue its use.
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
the use of nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide
ointment.
Dosage and Administration:
Frequency of administration is dependent on the severity of the condition. For
mild inflammations, application may range from once daily to once a week; for
severe conditions nystatin, neomycin sulfate, thiostrepton and triamcinolone
acetonide ointment may be applied as often as two to three times daily, if
necessary. Frequency of treatment may be decreased as improvement occurs.
Wear gloves during the administration of the ointment or wash hands immediately
after application.
OTITIS: Clear ear canal of impacted cerumen. Inspect canal and
remove any foreign bodies such as grass awns, ticks, etc. Instill three to five
drops of nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide
ointment.
Preliminary use of local anesthetic such as Proparacaine Hydrochloride
Ophthalmic Solution may be advisable.
INFECTED ANAL GLANDS, CYSTIC AREAS, ETC.: Drain gland or cyst and then fill
with nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide
ointment.
OTHER DERMATOLOGIC ORDERS: Clean affected areas, removing any
encrusted discharge or exudates. Apply nystatin, neomycin sulfate, thiostrepton
and triamcinolone acetonide ointment sparingly in a thin film.
Storage:
240 mL bottle. Do not store above 86°F, 7.5 mL, 15mL, 30mL tubes: Store at room
temperature; avoid excessive heat (104°F).
Manufactured by Med-Pharmex, Inc.
Pomona, CA 91767
Revised 10/9