CFR

524.1883—Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

(a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains prednisolone sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate and 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of ointment.

(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of cats and dogs, such as those associated with allergic reactions or gross irritants. 1

Code of Federal Regulations

Footnote(s): 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.

(2) A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks. 1

(3) All topical ophthalmic preparations containing corticosteroids with or without an antimicrobial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until the infection is under control and corneal regeneration is well underway. 1

(4) For use only by or on the order of a licensed veterinarian. 1

Code of Federal Regulations

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]

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