[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.56]

[Page 216]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.56  Amikacin sulfate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of amikacin (as the sulfate).
    (b) Sponsor. See Nos. 000856 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight twice daily.
    (2) Indications for use. The drug is used in dogs for treatment of 
genitourinary tract infections (cystitis) caused by susceptible strains 
of Escherichia coli and Proteus spp. and skin and soft tissue infections 
caused by susceptible strains of Pseudomonas spp. and E. coli.
    (3) Limitations. The drug is administered intramuscularly or 
subcutaneously. Treat dogs with skin and soft tissue infections for a 
minimum of 7 days and those with genitourinary infections for 7 to 21 
days or until culture is negative and asymptomatic. If no response is 
observed after 3 days of treatment, therapy should be discontinued and 
the case reevaluated. Maximum duration of therapy should not exceed 30 
days. Systemic aminoglycoside therapy is contraindicated in dogs with 
seriously impaired renal function. Not for use in breeding dogs as 
reproductive studies have not been conducted. Use with extreme caution 
in dogs in which hearing acuity is required for functioning. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[52 FR 11816, Apr. 13, 1987; 52 FR 15412, Apr. 28, 1987, as amended at 
53 FR 27851, July 25, 1988; 62 FR 23357, Apr. 30, 1997]