21 C.F.R. § 522.56 Amikacin sulfate injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains 50 milligrams of amikacin (as the sulfate). (b) Sponsor. See Nos. 000856 and 059130 in §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]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.56 Amikacin sulfate injection.
