21 C.F.R. § 520.2612 Trimethoprim and sulfadiazine oral suspension.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of oral suspension contains 60 milligrams of drug (10 milligrams of trimethoprim and 50 milligrams of sulfadiazine). (b) Sponsor. See No. 000061 in §510.600 of this chapter. (c) Conditions of use. Dogs—(1) Dosage. 1 milliliter (10 milligrams of trimethoprim and 50 milligrams of sulfadiazine) per 5 pounds of body weight. (2) Indications for use. 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. (3) Limitations. For oral use only. Administer the recommended dose once daily or one-half the recommended daily dose every 12 hours. Administer for 2 to 3 days after symptoms have subsided. If no improvement is seen in 3 days, discontinue therapy and reevaluate diagnosis. Do not treat for more than 14 consecutive days. During long-term treatment, a complete blood count is recommended. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 19168, May 7, 1985, as amended at 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
§ 520.2612 Trimethoprim and sulfadiazine oral suspension.
