21 C.F.R. § 524.1881b Prednisolone acetate-neomycin sulfate sterile suspension.
Title 21 - Food and Drugs
(a) Specifications. Prednisolone acetate-neomycin sulfate sterile suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base) in each milliliter of sterile suspension. (b) Sponsor. See No. 000009 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is indicated for treating infectious, allergic and traumatic keratitis and conjunctivitis, acute otitis externa, and chronic otitis externa in dogs and cats. (2) For beginning treatment of acute ocular inflammations 1 or 2 drops may be placed in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, the dosage may be reduced to 1 drop 2 to 4 times daily. In otitis externa, 2 to 6 drops may be placed in the external ear canal 2 or 3 times daily. (3) All topical ophthalmic preparations containing corticosteroids with or without an anti-microbial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway. (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1881b Prednisolone acetate-neomycin sulfate sterile suspension.
