CFR

524.960—Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

(a) Specifications. Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, with or without hydroxypropyl methylcellulose.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours.

(2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

(3) Limitations. (i) In treating ophthalmological conditions associated with bacterial infections, the drug is contraindicated in those cases in which microorganisms are not susceptible to the antibiotics incorporated in the drug.

(ii) The drug is contraindicated in infectious tuberculous lesions of the eye, early acute stages of viral diseases of the cornea and conjunctiva, herpes simplex lesions of the eye, and fungal infections of the conjunctiva and eyelids.

(iii) The usual precautions and contraindications for corticosteroids and adrenocorticoids are applicable with this drug. Corticosteroids may inhibit essential inflammatory responses intrinsic to the fundamental healing mechanism. Adrenocorticoid compounds have been reported to cause an increase in intraocular pressure. Intraocular pressure should be checked frequently. Ocular reexaminations should be made at frequent intervals during long-term therapy.

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996]

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