ENTEDERM- nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E), Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297), Thiostrepton (UNII: HR4S203Y18) (Thiostrepton - UNII:HR4S203Y18), Triamcinolone acetonide (UNII: F446C597KA) (Triamcinolone acetonide - UNII:F446C597KA)

Available from:

MWI

INN (International Name):

Nystatin

Composition:

Nystatin 100000 [iU] in 1 mL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment is particularly useful in the treatment of acute and chronic otitis of varied 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.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ENTEDERM - NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE
ACETONIDE OINTMENT
MWI
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NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE
OINTMENT
FOR USE ONLY IN DOGS AND CATS NADA 140-810, APPROVED BY
FDA.
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
antimi