21 C.F.R. § 522.1044 Gentamicin sulfate injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to either 5, 50, or 100 milligrams of gentamicin. (b) Sponsors. (1) See No. 000061 in §510.600(c) of this chapter for use of: 5-milligrams-per-milliliter solution in swine as in paragraph (d)(4) of this section, 50-milligrams-per-milliliter solution in dogs and cats as in paragraph (d)(1) of this section, 50- and 100-milligrams-per-milliliter solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section. (2) [Reserved] (3) See No. 000010 for use of 50 milligrams-per-milliliter solution in dogs as in paragraph (d)(5) of this section. (4) See No. 059130 for use of 100 milligram-per-milliliter solution in turkeys as in paragraph (d)(2) of this section and in chickens as in paragraph (d)(3) of this section. (c) Related tolerances. See §556.300 of this chapter. (d) Conditions of use—(1) Dogs and cats—(i) Amount. Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution. (ii) Indications for use—(a) Dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis). (b) Cats. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis, pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia. (iii) Limitations. Administer intramuscularly or subcutaneously. If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Turkeys—(i) Amount. One milligram of gentamicin per 0.2 milliliter dose, using the 50- or 100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter. (ii) Indications for use. As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin. (iii) Limitations. For 1- to 3-day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment. (3) Chickens—(i) Amount. 0.2 milligram of gentamicin per 0.2 milliliter dose, using the 50- or 100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 1.0 milligram-per-milliliter. (ii) Indications for use. In day-old chickens, for prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin. (iii) Limitations. For use in day-old chickens only. Administer aseptically, injecting the diluted product subcutaneously in the neck. Do not slaughter treated animals for food for at least 5 weeks after treatment. (4) Swine—(i) Amount. 5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution. (ii) Indications for use. In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin. (iii) Limitations. For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment. (5) Dogs—(i) Amount. 2 milligrams of gentamicin per pound of body weight, twice daily on the first day, then once daily. (ii) Indications for use. For use in the treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and Staphylococcus aureus. (iii) Limitations. Administer intramuscularly or subcutaneously. If no improvement is seen after 3 days, treatment should be discontinued and the diagnosis reevaluated. Treatment not to exceed 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; 65 FR 45877, July 26, 2000]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1044 Gentamicin sulfate injection.
