---
kind: "section"
citation: "21 C.F.R. § 522.2610"
title: "21"
number: "522.2610"
heading: "Trimethoprim and sulfadiazine."
url: "https://uscodex.org/cfr/21/522.2610"
---

# §522.2610. Trimethoprim and sulfadiazine.

- (a) **Specifications.** Each milliliter (mL) contains:
  - (1) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or
  - (2) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).
- (b) **Sponsors.** See Nos. 000061 and 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Dogs—**
    - (i) **Amount.** 1 mL of the product described in [paragraph (a)(1)](#a-1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.
    - (ii) **Indications for use.** For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.
    - (iii) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.
  - (2) **Horses—**
    - (i) **Amount.** 2 mL of the product described in [paragraph (a)(2)](#a-2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.
    - (ii) **Indications for use.** For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.
    - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014]