Animal NDC 54925-003-15 Derma-vet

Nystatin, Neomycin Sulfate, Thiostrepton And Triamcinolone Acetonide

Animal NDC Product Code 54925-003-15

Field Name Field Value
Animal NDC Code 54925-003-15
Proprietary Name Derma-vet What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Nystatin, Neomycin Sulfate, Thiostrepton And Triamcinolone Acetonide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Med-pharmex, Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Triamcinolone Acetonide
  • Neomycin Sulfate
  • Thiostrepton
  • Nystatin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA140810 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Derma-vet Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

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 unitsneomycin sulfate (equivalent to neomycin base) 2.5 mgthiostrepton 2,500 unitstriamcinolone acetonide 1.0 mgNystatin, 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 of gram-positive and gram-negative bacteria. Together they provide comprehensive therapy against those organisms responsible for most superficial bacterial infections.

Indications & Usage

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.

Warnings And Precautions

WARNINGS: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 the offspring. In dogs, other congenital anomalies have resulted; deformed forelegs, phocomelia, and anasarca. PRECAUTIONS:Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment 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 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 the 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.Cushing's
syndrome has been reported in association with prolonged or repeated
steriod 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 & Administration

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: Clean 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 a 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 DISORDERS: Clean affected areas, removing any encrusted discharge or exudate. Apply nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment sparingly in a thin film.

Storage And Handling

STORAGE:240 mL bottle: Do not store above 86°F.  7.5 mL, 15 mL, 30 mL tubers: Store at room temperature; avoid excessive heat (104°F).Manufactured by Med-Pharmex, Inc. Pomona, CA 91767Revised 10/98

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.