Label: TRITOP- neomycin sulfate, isoflupredone acetate, and tetracaine hydrochloride ointment

  • NDC Code(s): 54771-1583-1, 54771-1583-2
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 28, 2017

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  • SPL UNCLASSIFIED SECTION

    For Use in Animals Only

    For topical ear and skin use in dogs, cats and horses

    Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    TRITOP Topical Ointment (neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride ointment) contains in each gram the potent anti-inflammatory agent isoflupredone acetate 1 mg (0.1%); the antibiotic neomycin sulfate, 5 mg (0.5%) (equivalent to 3.5 mg neomycin); and the topical anesthetic tetracaine hydrochloride, 5 mg (0.5%). This combination is well suited for the treatment or adjunctive therapy of many ear and skin conditions, as well as a dressing for superficial wounds occurring in dogs, cats and horses.

    Its action is specific as to anti-inflammatory, bactericidal, and anesthetic properties.

  • ISOFLUPREDONE ACETATE

    It has been reported by research workers that isoflupredone acetate is 14 times as potent as hydrocortisone as an anti-inflammatory steroid as measured by the cotton pellet implantation assay.

    Isoflupredone acetate markedly inhibits inflammatory reaction through its controlling influence on connective tissue and vascular components. Topically applied isoflupredone acetate is rapidly effective. In otitis externa, wounds of the concha, ulcerations of the ear flaps, and irritated lesions of the skin, the inflammatory response may also be effectively inhibited by isoflupredone acetate. Chronic conditions respond more slowly and relapses are more frequent.

  • NEOMYCIN

    Neomycin is an antibiotic substance derived from cultures of the soil organism Streptomyces fradiae. Its antimicrobial range includes both gram-positive and gram-negative organisms commonly responsible for or associated with otic infections, such as staphylococci, streptococci, Escherichia coli, Aerobacter aerogenes, and many strains of Proteus and Pseudomonas organisms. It is not active against fungi. Neomycin is unusually nontoxic for epithelial cells in tissue culture and is nonirritating in therapeutic concentrations. The presence of neomycin in TRITOP Topical Ointment affords control of infections caused by neomycin susceptible organisms.

  • TETRACAINE

    Tetracaine hydrochloride is a topical anesthetic agent that is more potent than either procaine or cocaine in comparable concentrations and has greater ability than procaine to penetrate mucous membranes. The duration of anesthetic action of tetracaine exceeds that produced by either butacaine or phenacaine.

    Many investigators have demonstrated that local anesthesia plays a significant part in the promotion of healing, especially where pain is a prominent factor. It is believed that trauma stimulates local pain receptors, which results in reflex vasodilation, edema, tenderness, and muscular spasm.

    If the reflex is abolished through use of a local anesthetic such as tetracaine, amelioration of these tissue changes that interfere with healing is favored. The local anesthetic action of tetracaine has proved to be of great value in alleviating the pain reflex in painful skin and ear conditions.

  • ADVANTAGES OF TRITOP TOPICAL OINTMENT

    1. Potent anti-inflammatory effect of isoflupredone

        acetate.

    2. Broad-spectrum bactericidal effect of neomycin.

    3. Rapid anesthetic effect of tetracaine.

    4. Prompt relief of symptoms.

    5. Reduces further self-inflicted trauma.

    6. Ease of application.



  • INDICATIONS

    TRITOP Topical Ointment is indicated as treatment or adjunctive therapy of certain ear and skin conditions in dogs, cats and horses caused by or associated with neomycin susceptible organisms and/or allergy. In addition, it is indicated as superficial dressing applied to minor cuts, wounds, lacerations, abrasions, and for post surgical application where reduction of pain and inflammatory response is deemed desirable.

    TRITOP Topical Ointment is useful in treating such conditions as acute otitis externa in dogs and to a lesser degree, chronic otitis externa in dogs. It also is effective in treating anal gland infections and moist dermatitis in the dog and is a useful dressing for minor cuts, lacerations, abrasions, and post surgical therapy in the horse, cat, and dog.

    TRITOP Topical Ointment may also be used following amputation of dewclaws, tails and claws, following ear trimming and castrating operations.

  • WARNINGS

    Not for human use. Do not use in horses intended
    for human consumption.

    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

    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 infec­ tion 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 use of TRITOP Topical Ointment.

    Incomplete response or exacerbation of corti­ costeroid responsive lesions may be due to the
    presence of non­susceptible organisms or to prolonged use of antibiotic­containing prepara­ tions
    resulting in over­growth of non­susceptible organisms, particularly Monilia. Thus, if improve­ ment
    is not noted within two or three days, or if redness, irritation, or swelling persists or
    increases, the diagnosis should be redetermined and appro­ priate therapeutic measures initiated.

    Tetracaine and neomycin have the potential to sensitize.  Care  should  be  taken  to  observe
    animals  being  treated  for  evidence  of  hyper­ sensitivity or allergy to TRITOP Topical
    Ointment (neomycin sulfate, isoflupredone acetate, tetra­ caine hydrochloride ointment). If such
    signs are py with TRITOP Topical Ointment should be stopped.

  • ADMINISTRATION

    In treatment of otitis externa and other inflammatory
    conditions of the external ear canal, a quantity
    of ointment sufficient to fill the external ear canal
    may be applied one to three times daily. When
    used on the skin or mucous membranes, cleanse
    the affected area, apply a small amount of the ointment
    and spread or rub in gently. The involved
    area may be treated one to three times a day and
    these daily applications continued in accordance
    with the clinical response. Limit treatment to the
    period when local anesthesia is essential to control
    self-inflicted trauma.
    In treatment of otitis externa and other inflammatory
    conditions of the external ear canal, a quantity
    of ointment sufficient to fill the external ear canal
    may be applied one to three times daily. When
    used on the skin or mucous membranes, cleanse
    the affected area, apply a small amount of the ointment
    and spread or rub in gently. The involved
    area may be treated one to three times a day and
    these daily applications continued in accordance
    with the clinical response. Limit treatment to the
    period when local anesthesia is essential to control
    self-inflicted trauma.

  • HOW SUPPLIED

    TRITOP Topical Ointment is available in 10 gram tubes with a special applicator tip.

    STORAGE

    Store at controlled room temperature 20° to 25° C (68° to 77° F).

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Revised: March 2013 PAA036267

  • PRINCIPAL DISPLAY PANEL - 10 g Tube Label

    Tritop®
    Topical Ointment
    neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride ointment
    Ear — Topical Ointment For Use in Animals Only

    Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed
    veterinarian.

    Tritop carton label

  • INGREDIENTS AND APPEARANCE
    TRITOP 
    neomycin sulfate, isoflupredone acetate, and tetracaine hydrochloride ointment
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-1583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    ISOFLUPREDONE ACETATE (UNII: 55P9TUL75S) (ISOFLUPREDONE - UNII:HYS0B45Z2S) ISOFLUPREDONE ACETATE1 mg  in 1 g
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE5 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1583-21 in 1 CARTON
    1NDC:54771-1583-110 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03002501/13/1965
    Labeler - Zoetis Inc. (828851555)