21 C.F.R. § 520.447

Current through October 31, 2024
Section 520.447 - Clindamycin solution
(a)Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
(b)Sponsors. See Nos. 051311, 054771, 058829, 061133, and 069043 in § 510.600(c) of this chapter.
(c)Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)Conditions of use -
(1)Dogs -
(i)Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
(ii)Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens; dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens; and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
(2) Cats-
(i)Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a maximum of 14 days.
(ii)Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus, S. intermedius, Streptococcus spp.; deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis; and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.

21 C.F.R. §520.447

67 FR 54954 , Aug. 27, 2002, as amended at 67 FR 78684 , Dec. 26, 2002; 68 FR 55824 , Sept. 29, 2003; 69 FR 31734 , June 7, 2004; 71 FR 39543 , July 13, 2006; 72 FR 19796 , Apr. 20, 2007; 78 FR 17596 , Mar. 22, 2013; 78 FR 30197 , May 22, 2013; 79 FR 28819 , May 20, 2014; 81 FR 17607 , Mar. 30, 2016; 84 FR 8972 , Mar. 13, 2019
81 FR 17607, 3/30/2016; 84 FR 8972, 3/13/2019