Animal NDC 54771-1584-1 Neo-predef With Tetracaine
Neomycin Sulfate, Isoflupredone Acetate, And Tetracaine Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 54771-1584-1 |
| Proprietary Name | Neo-predef With Tetracaine 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 | Neomycin Sulfate, Isoflupredone Acetate, And Tetracaine Hydrochloride 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 | Zoetis Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| 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 | NADA015433 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. |
Neo-predef With Tetracaine Images
Neo-predef With Tetracaine 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.
Table of Contents
Caution
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Description
NEO-PREDEF with Tetracaine Powder contains in each gram neomycin sulfate, 5 mg (equivalent to 3.5 mg neomycin); isoflupredone acetate, 1 mg; tetracaine hydrochloride, 5 mg; myristyl-gamma-picolinium chloride (as a preservative); and lactose hydrous. Because of the prompt, potent, and specific actions of the individual components, this combination is well suited for the treatment of certain ear and skin conditions occurring in dogs, cats and horses.
Advantages Of Neo-Predef With Tetracaine
| 1. Highly potent anti-inflammatory effect of isoflupredone acetate. 2. Wide-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. 7. Adherent to moist surfaces. |
Isoflupredone Acetate
Isoflupredone acetate markedly inhibits inflammatory reaction through its controlling influence on connective tissue and vascular components. Topically applied isoflupredone acetate is usually 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 NEO-PREDEF with Tetracaine Powder affords control of neomycin-sensitive organisms.
Tetracaine
Tetracaine hydrochloride is a topical anesthetic agent that is more potent than either procaine or cocaine in comparable concentration. 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.
Indications
NEO-PREDEF with Tetracaine Powder is indicated in the 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. NEO-PREDEF with Tetracaine Powder may be used as a dusting powder following amputation of tails, claws, and dew-claws; following ear trimming and castrating; and following such surgical procedure as ovariohysterectomies.
Applied superficially, it has been used successfully in the treatment of acute otitis externa in dogs, acute moist dermatitis and interdigital dermatitis in the dog, and as a dusting powder to various minor cuts, lacerations, and abrasions in the horse, cat and dog.
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 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 use of NEO-PREDEF with Tetracaine Powder.
Incomplete response or exacerbation of corticosteroid-response lesions may be due to the presence of nonsusceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia. Thus, if improvement is not noted within two or three days, or if redness, irritation, or swelling persists or increases, the diagnosis should be redetermined and appropriate therapeutic measures initiated.
Application
After cleansing the affected area, NEO-PREDEF with Tetracaine Powder is applied by compressing the sides of the container with short, sharp squeezes. In most instances a single daily application will be sufficient; however, it may be applied one to three times daily, as required.
How Supplied
NEO-PREDEF with Tetracaine Powder is available in 15 gram plastic insufflator bottles. Because of the hygroscopic properties of neomycin sulfate, this bottle should be stored in a dry place. The cap should be replaced when the bottle is not in use. This puffer bottle has been designed to permit dusting when held in any position. Protecting the outlet from moisture will aid in assuring proper function; therefore, the tip should not be allowed to come in contact with moist membranes or weeping surfaces.
Storage
Store in a dry place at controlled room temperature 20° to 25°C (68° to 77°F).
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