DERMA-VET- 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:

Med-Pharmex, Inc.

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

DERMA-VET- NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE
ACETONIDE OINTMENT
MED-PHARMEX, INC.
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NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE
OINTMENT
FOR USE ONLY IN DOGS AND CATS
APPROVED BY FDA UNDER NADA # 140-810
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, as well as a dispensing
bottle 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; ne