Animax
Dechra Veterinary Products
Fougera Pharmaceuticals Inc.
ANIMAX CREAM VETERINARY nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- CAUTION:
- ANIMAX DESCRIPTION:
- ACTIONS:
- INDICATIONS:
- ANIMAX CONTRAINDICATIONS:
- WARNINGS:
- PRECAUTIONS:
- SIDE EFFECTS:
- ANIMAX DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- STORAGE:
- TO OPEN:
- IMPORTANT:
- PRINCIPAL DISPLAY PANEL - 7.5 g Carton
- PRINCIPAL DISPLAY PANEL - 7.5 g Container
FULL PRESCRIBING INFORMATION
ANADA# 200-330. Approved by FDA.
For topical use on dogs and cats only.
Not for ophthalmic use.
CAUTION:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION:
Animax Cream combines nystatin, neomycin sulfate, thiostrepton and
triamcinolone acetonide.
Each gram contains:
nystatin................................................................................................................ 100,000 units
neomycin sulfate equivalent to neomycin base................................................................ 2.5 mg
thiostrepton ............................................................................................................. 2,500 units
triamcinolone acetonide ................................................................................................... 1 mg
in an aqueous non-irritating vanishing cream base of
polyoxyethylene fatty alcohol ether, sorbitol solution, propylene
glycol, white petrolatum, polyoxyl 40 stearate, glyceryl
monostearate, titanium dioxide, citric acid, ethylenediamine,
methylparaben, propylparaben.
ACTIONS:
By virtue of its four active ingredients, Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP) 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 antifungal 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 of gram-positive and gram-negative
bacteria. Together they provide comprehensive therapy against those organisms responsible for
most superficial bacterial infections.
INDICATIONS:
Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP) is indicated in the management of dermatologic disorders in dogs and cats, 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.
CONTRAINDICATIONS:
Animax Cream should not be used ophthalmically.
WARNINGS:
Animax Cream is indicated for use in
dogs and cats only. Not for use in animals which are raised for food.
Absorption of triamcinolone acetonide through topical application
and by licking may occur. Therefore animals should be observed
closely for signs of polydipsia, polyuria and increased weight gain
particularly when the preparation is used over large areas or for
extended periods of time.
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.
PRECAUTIONS:
Animax Cream (Nystatin-Neomycin Sulfate-
Thiostrepton-Triamcinolone Acetonide Cream USP) is not
intended for the treatment of deep abscesses or deep-seated
infections such as inflammation of the lymphatic vessels.
Parenteral antibiotic therapy is indicated in these infections.
Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone
Acetonide Cream USP has been extremely well tolerated. The
occurrence of systemic reactions is rarely a problem with topical
administration.
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.
Avoid ingestion. Oral or parental use of corticosteroids,
depending on dose, duration and specific steroid, may result in
inhibition of endogenous steroid production following drug
withdrawal.
SIDE EFFECTS:
SAP and SGPT (ALT) enzyme elevations, polydipsia and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.
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 Animax Cream may be applied as
often as 2 to 3 times daily, if necessary. Frequency of treatment
may be decreased as improvement occurs.
Clean affected areas, removing any encrusted discharge or
exudate. Apply Animax Cream (Nystatin-Neomycin Sulfate-
Thiostrepton-Triamcinolone Acetonide Cream USP) sparingly in a
thin film.
HOW SUPPLIED:
Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP) is supplied in tubes as follows:
7.5 gram tubes NDC 17033-123-75
15 gram tubes NDC 17033-123-15
STORAGE:
Store at room temperature; avoid excessive heat (104°F).
TO OPEN:
Use cap to puncture seal.
IMPORTANT:
Do not use if seal has been punctured or is not visible.
MANUFACTURED FOR:
Dechra Veterinary Products
Overland Park, KS 66211
I123 DECHRA R07/08 #288
PRINCIPAL DISPLAY PANEL - 7.5 g Carton
ANIMAX® OINTMENT
nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment
NET CONTENTS 7.5 g
NADA # 200-330. Approved by FDA
NDC 17033-123-75
PRINCIPAL DISPLAY PANEL - 7.5 g Container
NET CONTENTS 7.5 g
NDC 17033-123-75
ANIMAX® OINTMENT
nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment
NADA # 200-330. Approved by FDA.
Animaxnystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide CREAM
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