21 C.F.R. § 520.2610 Trimethoprim and sulfadiazine tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains 30 milligrams (5 milligrams of trimethoprim and 25 milligrams of sulfadiazine), 120 milligrams (20 milligrams of trimethoprim and 100 milligrams of sulfadiazine), 480 milligrams (80 milligrams of trimethoprim and 400 milligrams of sulfadiazine) or 960 milligrams (160 milligrams of trimethoprim and 800 milligrams of sulfadiazine). (b) Sponsor. See Nos. 000061 and 000856 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses. (2) The drug is given orally at 30 milligrams per kilogram of body weight per day (14 milligrams per pound per day), or as follows: (3) The drug is given once daily. Alternatively, especially in severe infections, the initial dose may be followed by one-half the recommended daily dose every 12 hours. If no improvement is seen in 3 days, discontinue therapy and reevaluate diagnosis. (4) Administer for 2 to 3 days after symptoms have subsided. Do not treat for more than 14 consecutive days. (5) During long term treatment, periodic platelet counts and white and red blood cell counts are recommended. (6) The drug should not be used in patients showing marked liver parenchymal damage or blood dyscrasia, nor in those with a history of sulfonamide sensitivity. (7) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [41 FR 3853, Jan. 27, 1976, as amended at 44 FR 32214, June 5, 1979; 46 FR 23231, Apr. 24, 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, Mar. 12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2610 Trimethoprim and sulfadiazine tablets.
------------------------------------------------------------------------ Number of Animal body weight (pounds) tablets------------------------------------------------------------------------ 30 mg tablets------------------------------------------------------------------------2.2......................................................... 14.4......................................................... 26.6......................................................... 38.8......................................................... 4------------------------------------------------------------------------ 120 mg tablets------------------------------------------------------------------------Up to 9..................................................... 110 to 19.................................................... 220 to 29.................................................... 330 to 40.................................................... 4------------------------------------------------------------------------ 480 mg tablets------------------------------------------------------------------------30 to 40.................................................... 140 to 60.................................................... 1\1/2\60 to 80.................................................... 280 to 110................................................... 3Over 110.................................................... 4------------------------------------------------------------------------
