21 CFR Ch. I (4–1–12 Edition) § 524.1484C

§ 524.1484c 21 CFR Ch. I (4–1–12 Edition)

§ 524.1484c Neomycin sulfate, equivalent to 3.5 milligrams of neomy- isoflupredone acetate, tetracaine cin base, 5 milligrams of hydro- hydrochloride ointment. cortisone acetate, and 5 milligrams of (a) Specifications. The drug contains 5 tetracaine hydrochloride in each gram milligrams of neomycin sulfate (equiv- of ointment. alent to 3.5 milligrams of neomycin (b) Sponsor. See No. 000009 in base), 1 milligram of isoflupredone ace- § 510.600(c) of this chapter. tate, and 5 milligrams of tetracaine hy- (c) Conditions of use. (1) It is indicated drochloride in each gram of ointment. for treating acute otitis externa and, (b) Sponsor. See No. 000009 in to a lesser degree, chronic otitis § 510.600(c) of this chapter. externa in dogs and cats. In treatment (c) Conditions of use. (1) It is used in of ear canker and other inflammatory treating such conditions as acute otitis conditions of the external ear canal, a externa in dogs and to a lesser degree, quantity of ointment sufficient to fill chronic otitis externa in dogs. It also is the external ear canal may be applied effective in treating anal gland infec- one to three times daily.1 tions and moist dermatitis in the dog (2) Tetracaine and neomycin have the and is a useful dressing for minor cuts, potential to sensitize. Care should be lacerations, abrasions, and post-sur- taken to observe animals being treated gical therapy in the horse, cat, and for evidence of hypersensitivity or al- dog. It may also be used following am- lergy to the product. If such signs are putation of dewclaws, tails and claws, noted, therapy with the product should following ear trimming and castrating be stopped. Incomplete response or ex- operations. acerbation of corticosteroid responsive (2) In treatment of otitis externa and lesions may be due to the presence of other inflammatory conditions of the nonsusceptible organisms or to pro- external ear canal, a quantity of oint- longed use of antibiotic-containing ment sufficient to fill the external ear preparations resulting in overgrowth of canal may be applied one to three nonsusceptible organisms, particularly times daily. When used on the skin or Monilia.1 mucous membranes, the affected area (3) Federal law restricts this drug to should be cleansed, and a small amount use by or on the order of a licensed vet- of the ointment applied and spread or erinarian.1 rubbed in gently. The involved area [40 FR 13873, Mar. 27, 1975, as amended at 49 may be treated one to three times a FR 21922, May 24, 1984] day and these daily applications con- tinued in accordance with the clinical § 524.1484e Neomycin sulfate and poly- response. myxin B sulfate ophthalmic solu- (3) Tetracaine and neomycin have the tion. potential to sensitize. Care should be (a) Specifications. Each milliliter of taken to observe animals being treated the ophthalmic preparation contains for evidence of hypersensitivity or al- 5.0 milligrams neomycin sulfate (3.5 lergy to the drug. If such signs are milligrams neomycin base), and 10,000 noted, therapy with the drug should be Units of polymyxin B sulfate. stopped. Treatment should be limited (b) Sponsor. See No. 000856 in to the period when local anesthesia is § 510.600(c) of this chapter. essential to control self-inflicted trau- (c) Conditions of use. (1) The drug is ma. recommended for the treatment of bac- (4) Federal law restricts this drug to terial infections associated with top- use by or on the order of a licensed vet- ical ophthalmological conditions such erinarian. as corneal injuries, superficial kera- titis, conjunctivitis, keratocon- [40 FR 13873, Mar. 27, 1975, as amended at 43 junctivities, and blepharitis in the dog. FR 18172, Apr. 28, 1978]

§ 524.1484d Neomycin sulfate, hydro- 1 These conditions are NAS/NRC reviewed cortisone acetate, tetracaine hydro- and deemed effective. Applications for these chloride ear ointment. uses need not include effectiveness data as specified by § 514.111 of this chapter, but may (a) Specifications. The product con- require bioequivalency and safety informa- tains 5 milligrams of neomycin sulfate, tion.

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(2) The recommended dosage is 1 to 2 (3) Federal law restricts this drug to drops per eye every 6 hours. use by or on the order of a licensed vet- (3) In treating ophthalmological con- erinarian.1 ditions associated with bacterial infec- § 524.1484g Neomycin sulfate- tions the drug is contraindicated in thiabendazole-dexamethasone solu- those cases in which microorganisms tion. are nonsusceptible to the antibiotics (a) Specifications. Each cubic centi- incorporated in the drug. meter of neomycin sulfate- (4) Federal law restricts this drug to thiabendazole-dexamethasone solution use by or on the order of a licensed vet- contains: 40 milligrams of erinarian. thiabendazole, 3.2 milligrams of neo- [40 FR 13873, Mar. 27, 1975, as amended at 61 mycin (from neomycin sulfate), and 1 FR 5507, Feb. 13, 1996] milligram of dexamethasone. (b) Sponsor. See No. 050604 in § 524.1484f Neomycin sulfate, prednis- § 510.600(c) of this chapter. olone acetate, tetracaine hydro- (c) Conditions of use. (1) The drug is chloride eardrops. recommended for use as an aid in the treatment of bacterial, mycotic, and (a) Specifications. The product con- inflammatory dermatoses and otitis tains 5 milligrams of neomycin sulfate externa in dogs and cats. equivalent to 3.5 milligrams of neomy- (2) In treating dermatoses affecting cin base, 2.5 milligrams of prednisolone areas other than the ear, the surface of acetate, and 5 milligrams of tetracaine the lesions should be well moistened hydrochloride in each milliliter of ster- (two to four drops per square inch) ile suspension. twice daily. In treating otitis externa, (b) Sponsor. See No. 000009 in five to 15 drops of the drug should be § 510.600(c) of this chapter. instilled in the ear twice daily. The (c) Conditions of use. (1) It is useful in drug is limited to 7 days maximum du- treating such conditions as acute otitis ration of administration. externa and, to a lesser degree, chronic (3) For use only by or on order of a li- otitis externa in dogs and cats. It is in- censed veterinarian. dicated as treatment or adjunctive [40 FR 13873, Mar. 27, 1975, as amended at 62 therapy of certain ear conditions in FR 63271, Nov. 28, 1997] dogs and cats caused by or associated with neomycin-susceptible organisms § 524.1484h Neomycin, penicillin, poly- myxin, hydrocortisone suspension. and/or allergy. In otitis externa, 2 to 6 drops may be placed in the external ear (a) Specifications. Each milliliter of canal two or three times daily.1 suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 (2) Incomplete response or exacer- milligrams of neomycin, 10,000 inter- bation of corticosteroid responsive le- national units of penicillin G procaine, sions may be due to the presence of 5,000 international units of polymyxin nonsusceptible organisms or to pro- B sulfate, 2 milligrams of hydro- longed use of antibiotic-containing cortisone acetate, and 1.25 milligrams preparations resulting in overgrowth of of hydrocortisone sodium succinate. nonsusceptible organisms, particularly (b) Sponsor. See 000009 in § 510.600(c) of Monilia. Thus, if improvement is not this chapter. noted within 2 or 3 days, or if redness, (c) Special considerations. The labeling irritation, or swelling persists or in- shall state: This medication contains creases, the diagnosis should be rede- penicillin. Allergic reactions in hu- termined and appropriate therapeutic mans are known to occur from topical measures initiated. Tetracaine and ne- exposure to penicillin. omycin have the potential to sensitize. Care should be taken to observe ani- 1 These conditions are NAS/NRC reviewed mals being treated for evidence of and deemed effective. Applications for these hypersensitivity or allergy. If such uses need not include effectiveness data as specified by § 514.111 of this chapter, but may signs are noted, therapy should be require bioequivalency and safety informa- stopped.1 tion.

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