(a) Specifications. Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
(b) Sponsors. See Sec. 510.600(c) of this chapter:
(1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section:
(i) No. 054628 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;
(ii) No. 054771 for 100-, 250-, and 500-mg tablets;
(2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section:
(i) No. 061623 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
(ii) [Reserved]
(c) Conditions of use in dogs--(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours.
(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours.
(2) Indications for use--(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014] Sec. 520.390b Chloramphenicol capsules.
(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.
(b) Sponsors. See Nos. 050057 and 054771 in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals.
(d) Conditions of use in dogs--(1) Amount. 25 mg per pound of body weight every 6 hours.
(1) Amount. 25 mg per pound of body weight every 6 hours.
(2) Indications for use. For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014] Sec. 520.390c Chloramphenicol palmitate oral suspension.
(a) Specifications. Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs(1) Amount. 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.
(2) Indications for use. Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.
(3) Limitations. Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, 2014]