21 C.F.R. § 520.2220b Sulfadimethoxine tablets and boluses.
Title 21 - Food and Drugs
(a) Sponsors. Approval to firms identified in §510.600(c) of this chapter as follows: (1) To 000069, approval for use as in paragraphs (d)(1), (d)(2), and (d)(3) of this section. (2) To 000061, approval for use as in paragraph (d)(2). (b) Related tolerances. See §556.640 of this chapter. (c) [Reserved] (d) It is used as follows: (1) Cattle—(i) Amount. 1.25 to 2.5 grams per 100 pounds body weight. (ii) Indications for use. Treatment of foot rot, bacterial pneumonia, shipping fever, and calf diphtheria. (iii) Limitations. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat from 4 to 5 days; do not administer within 7 days of slaughter; milk that has been taken from animals during treatment and 60 hours (5 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (2) Dogs and cats. (i) Amount. 12.5 to 25 milligrams per pound of body weight. (ii) Indications for use. Treatment of sulfadimethoxine-susceptible bacterial infections. (iii) Limitations. Administer 25 milligrams per pound of body weight on the first day followed by 12.5 milligrams per pound of body weight per day until the animal is free of symptoms for 48 hours. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Beef cattle and nonlactating dairy cattle—(i) Amount. 12.5-gram-sustained-release bolus. (ii) Indications for use. Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella spp. sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine. (iii) Limitations. Administer one bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 43488, Sept. 22, 1975; 49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR 15684, Apr. 1, 1999; 70 FR 16934, Apr. 4, 2005]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2220b Sulfadimethoxine tablets and boluses.
