(a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 milligrams (mg) tetracycline hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours.
(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours.
(2) Indications for use. For treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 50182, Aug. 26, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, 2014] Sec. 520.2345b Tetracycline tablets.
(a) Specifications. Each tablet contains 100, 250, or 500 milligrams of tetracycline (as the hydrochloride).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(1) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(2) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(3) Limitations. Administer orally; continue treatment until symptoms of the disease have subsided and temperature is normal for 48 hours; not for use in animals raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37327, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] Sec. 520.2345c Tetracycline boluses.
(a) Specifications. Each bolus contains 500 milligrams of tetracycline (as the hydrochloride).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.720 of this chapter.
(d) Conditions of use. Calves--(1) Amount. 10 milligrams per pound of body weight per day in divided doses.
(1) Amount. 10 milligrams per pound of body weight per day in divided doses.
(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia caused by Pasteurella spp., Hemophilus spp., and Klebsiella spp.
(ii) Limitations. Administer orally for 3 to 5 days; do not slaughter animals for food within 14 days of treatment; use as sole source of tetracycline.
(iii) National Academy of Sciences/National Research Council (NAS/NRC) status. The conditions of use specified in paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in Sec. 514.111 of this chapter, but may require bioequivalency and safety information.
(2) Amount. 10 milligrams per pound of body weight per day in two divided doses.
(i) Indications for use. Treatment of bacterial pneumonia caused by organisms susceptible to tetracycline, bacterial enteritis caused by E. coli, and salmonella organisms susceptible to tetracycline.
(ii) Limitations. Administer orally for not more than 5 days; do not slaughter animals for food within 12 days of treatment; use as sole source of tetracycline. [57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, 2014] Sec. 520.2345d Tetracycline powder.
(a) Specifications. Each pound of powder contains 25, 102.4, or 324 grams tetracycline hydrochloride.
(b) Sponsors. See sponsors listed in Sec. 510.600(c) of this chapter for conditions of use as in paragraph (d) of this section:
(1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section.
(2) No. 054628: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.
(3) No. 054771: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.
(4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as in paragraph (d) of this section.
(5) No. 000010: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this section.
(c) Related tolerances. See Sec. 556.720 of this chapter.
(d) Conditions of use. It is administered in drinking water as follows:
(1) Calves--(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline.
(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 000010 and within 5 days of treatment for Nos. 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Swine--(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline.
(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 000010 and within 4 days of treatment for Nos. 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.
(3) Chickens--(i) Amount. Chronic respiratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon.
(i) Amount. Chronic respiratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon.
(ii) Indications for use. Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.
(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in chickens producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline.
(4) Turkeys--(i) Amount. For infectious synovitis: 400 milligrams per gallon. For complicating bacterial organisms associated with bluecomb (transmissible enteritis or coronaviral enteritis): 25 milligrams per pound of body weight per day.
(i) Amount. For infectious synovitis: 400 milligrams per gallon. For complicating bacterial organisms associated with bluecomb (transmissible enteritis or coronaviral enteritis): 25 milligrams per pound of body weight per day.
(ii) Indications for use. Control of infectious synovitis caused by M. synoviae; control of bluecomb complicated by organisms sensitive to tetracycline.
(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in turkeys producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline. [59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, 2014] Sec. 520.2345e Tetracycline solution.
(a) Specifications. Each milliliter contains the equivalent of either 25 or 100 milligrams of tetracycline hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(1) Dogs--(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(ii) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to Escherichia coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(iii) Limitations. Administer orally; continue treatment until symptoms have subsided and the temperature is normal for 48 hours; not for use in animals which are raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats--(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(ii) Indications for use. Treatment of infections caused by organisms susceptible to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(iii) Limitations. Administer orally; continue treatment until the temperature has been normal for 48 hours; not for use in food-producing animals; Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] Sec. 520.2345f Tetracycline phosphate complex and sodium novobiocin capsules.
(a) Specifications. Each capsule contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin.
(b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 10 milligrams of each antibiotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours.
(1) Amount. 10 milligrams of each antibiotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours.
(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] Sec. 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets.
(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin, or 180 milligrams of tetracycline hydrochloride and 180 milligrams of novobiocin.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 10 milligrams of each antibiotic per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds).
(1) Amount. 10 milligrams of each antibiotic per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds).
(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] Sec. 520.2345h Tetracycline hydrochloride, sodium novobiocin, andprednisolone tablets.
(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride, 60 milligrams of novobiocin, and 1.5 milligrams of prednisolone or 180 milligrams of tetracycline hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of prednisolone.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 10 milligrams of each antibiotic and 0.25 milligram of prednisolone per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to be continued with novobiocin and tetracycline alone at the same dose schedule for an additional 3 days or longer as needed.
(1) Amount. 10 milligrams of each antibiotic and 0.25 milligram of prednisolone per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to be continued with novobiocin and tetracycline alone at the same dose schedule for an additional 3 days or longer as needed.
(2) Indications for use. Treatment of acute and chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, when it is necessary to initially reduce the severity of associated clinical signs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28832, May 20, 2014]