21 C.F.R. § 524.1484f Neomycin sulfate, prednisolone acetate, tetracaine hydrochloride eardrops.
Title 21 - Food and Drugs
(a) Specifications. The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension. (b) Sponsor. See No. 000009 in §510.600(c) of this chapter. (c) Conditions of use. (1) It is useful in treating such conditions as acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats. It is indicated as treatment or adjunctive therapy of certain ear conditions in dogs and cats caused by or associated with neomycin-susceptible organisms and/or allergy. In otitis externa, 2 to 6 drops may be placed in the external ear canal two or three times daily.1 (2) Incomplete response or exacerbation of corticosteroid responsive 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 2 or 3 days, or if redness, irritation, or swelling persists or increases, the diagnosis should be redetermined and appropriate therapeutic measures initiated. Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe animals being treated for evidence of hypersensitivity or allergy. If such signs are noted, therapy should be stopped.1 (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1 1 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.
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484f Neomycin sulfate, prednisolone acetate, tetracaine hydrochloride eardrops.
