21 C.F.R. § 520.2330   Sulfisoxazole tablets.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.2330   Sulfisoxazole tablets.

(a) Specifications. Each tablet contains 260 milligrams (4 grains) of sulfisoxazole.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer one tablet orally per 4 pounds of body weight.1

1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Indications for use. Use in dogs and cats as an aid in treatment of bacterial pneumonia and bacterial enteritis when caused by organisms sensitive to sulfisoxazole.1

(3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 days after disappearance of clinical symptoms. (Administration of one-half daily dosage at 12-hour intervals or one-third daily dosage at 8-hour intervals will provide a more constant blood level.) Provide adequate supply of drinking water. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian.1

[43 FR 60895, Dec. 29, 1978]

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