[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1044b]

[Page 303-304]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524_OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 524.1044b  Gentamicin sulfate, betamethasone valerate otic solution.

    (a) Specifications. Each cubic centimeter of solution contains 
gentamicin sulfate equivalent to 3 milligrams of gentamicin base and 
betamethasone valerate equivalent to 1 milligram of betamethasone 
alcohol.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used or indicated for use in 
dogs in the treatment of acute and chronic otitis externa caused by 
bacteria sensitive to gentamicin; the drug is also used or indicated for 
use in dogs and cats in the treatment of superficial infected lesions 
caused by bacteria sensitive to gentamicin.
    (2)(i) For the treatment of acute and chronic canine otitis externa 
caused by bacteria sensitive to gentamicin, the drug is administered by 
instillation of 3 to 8 drops of solution into the ear canal twice daily 
for 7 to 14 days. Duration of treatment will depend upon the severity of 
the condition and the response obtained. The duration of treatment and/
or frequency of the dosage may be reduced but care should be taken not 
to discontinue therapy prematurely. The external ear and ear canal 
should be properly cleaned and dried before treatment. Remove foreign 
material, debris, crusted exudates, etc., with suitable nonirritating 
solutions. Excessive hair should be clipped from the treatment area of 
the external ear.
    (ii) For the treatment of canine and feline superficial infected 
lesions caused by bacteria sensitive to gentamicin, the lesion and 
adjacent area should be properly cleaned before

[[Page 304]]

treatment. Excessive hair should be removed. A sufficient amount of the 
drug should be applied to cover the treatment area. The drug should be 
administered twice daily for 7 to 14 days.
    (3) If hypersensitivity to any of the components occurs treatment 
with this product should be discontinued and appropriate therapy 
instituted. Concomitant use with other drugs known to induce ototoxicity 
is not recommended. This preparation should not be used in conditions 
where corticosteroids are contraindicated. Do not administer parenteral 
corticosteroids during treatment with this drug. The antibiotic 
sensitivity of the pathogenic organism should be determined prior to use 
of this preparation.
    (4) For use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975. Redesignated at 41 FR 14189, Apr. 2, 1976, 
and amended at 52 FR 7832, Mar. 13, 1987; 61 FR 48624, Sept. 16, 1996]