Complete Up To Date Information about Neo-Predef with Tetracaine Ointment.
NADA Number: 015-433 | |
| Proprietary Name |
Neo-Predef® with Tetracaine Ointment |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Isoflupredone Acetate Myristyl-gamma-picolinium Chloride Tetracaine Hydrochloride Neomycin Sulfate |
| Species |
Cat, no use class stated or implied Horse, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Powder |
| Drug Form |
Powder |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1484b Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristyl-gammapicolinium chloride, topical powder. Specifications: The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 1 milligram of isoflupredone acetate, 5 milligrams of tetracaine hydrochloride and 0.2 milligram of myristyl-gamma-picolinium chloride in each gram of the product in a special adherent powder base. Conditions of use: Horses Amount: Apply as topical powder. Indications: It is used in horses in the treatment or adjunctive therapy of certain ear and skin conditions when such conditions are caused by or associated with neomycin-susceptible organisms and/or allergy. In addition the product is indicated as superficial dressing applied to minor cuts, wounds, lacerations, abrasions and for postsurgical application where reduction of pain and inflammatory response is deemed desirable. The product may be used as a dusting powder following amputation of tails, claws, and dew-claws and following ear trimming, castrating and such surgical procedures as ovariohysterectomies. Limitations No limitations are included in the CFR for this species when using this product in this amount. Dogs Amount: Apply as topical powder. Indications: It is used in dogs in the treatment or adjunctive therapy of certain ear and skin conditions when such conditions are caused by or associated with neomycin-susceptible organisms and/or allergy. In addition the product is indicated as superficial dressing applied to minor cuts, wounds, lacerations, abrasions and for postsurgical application where reduction of pain and inflammatory response is deemed desirable. The product may be used as a dusting powder following amputation of tails, claws, and dew-claws and following ear trimming, castrating and such surgical procedures as ovariohysterectomies. The product may also be used in the treatment of acute otitis externa in dogs, acute moist dermatitis and interdigital dermatitis in dogs. Limitations No limitations are included in the CFR for this species when using this product in this amount. Cats Amount: Apply as topical powder. Indications: It is used in cats in the treatment or adjunctive therapy of certain ear and skin conditions when such conditions are caused by or associated with neomycin-susceptible organisms and/or allergy. In addition the product is indicated as superficial dressing applied to minor cuts, wounds, lacerations, abrasions and for postsurgical application where reduction of pain and inflammatory response is deemed desirable. The product may be used as a dusting powder following amputation of tails, claws, and dew-claws and following ear trimming, castrating and such surgical procedures as ovariohysterectomies. Limitations No limitations are included in the CFR for this species when using this product in this amount. NAS/NRC status: These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by ?514.111 of this chapter, but may require bioequivalency and safety information. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
| Tolerances |
Tolerances are established for residues of parent neomycin in uncooked edible tissues as follows: a. In cattle, swine, sheep, and goats: 7.2 parts per million in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle. b. In turkeys: 7.2 ppm in skin with adhering fat, 3.6 parts per million in liver, and 1.2 ppm in muscle. c. In milk: 0.15 part per million. |