§522.1044. Gentamicin.
21 C.F.R. § 522.1044
Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin.
No. 000061 for use of 5 mg per milliliter (/mL) solution in swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section.
No. 058005 for use of 5 mg/mL solution in swine as in paragraph (d)(4) of this section.
No. 069043 for use of 50 mg/mL solution in dogs as in paragraph (d)(5) of this section.
Nos. 016592 and 061133 for use of 100 mg/mL solution in turkeys as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section.
Related tolerances. See § 556.300 of this chapter.
Conditions of use—
Dogs and cats—
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.
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.
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.
Turkeys—
Amount. Administer subcutaneously in the neck 1 mg of gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted with sterile saline to a concentration of 5 mg/mL.
Indications for use. As an aid in the prevention of early mortality in 1- to 3-day old turkey poults due to Arizona paracolon infections susceptible to gentamicin.
Limitations. Injected poults must not be slaughtered for food for at least 9 weeks after treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Chickens—
Amount. Administer subcutaneously in the neck 0.2 mg of gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted with sterile saline to a concentration of 1.0 mg/mL.
Indications for use. For prevention of early mortality in day-old chickens caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin.
Limitations. Injected chicks must not be slaughtered for food for at least 5 weeks after treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Swine—
Amount. Administer 5 mg of gentamicin as a single intramuscular dose using the 5 mg/mL solution.
Indications for use. For treatment of porcine colibacillosis in piglets up to 3 days old caused by strains of Escherichia coli sensitive to gentamicin.
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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs—
Amount. 2 milligrams of gentamicin per pound of body weight, twice daily on the first day, then once daily.
Indications for use. For use in the treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and Staphylococcus aureus.
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.
Notes, amendments, and revision history
Amendments
[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; 71 FR 76901, Dec. 22, 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 88 FR 16547, Mar. 20, 2023]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 71 FR 76901, Dec. 22, 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 88 FR 16547, Mar. 20, 2023]