§ 522.2640 Tylosin.

Specifications.(a) Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base).

Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows:

(1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section.

(2) No. 061133 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section.

Related tolerances.(c) See § 556.746 of this chapter.

Special considerations.(d) Labeling must bear the warning statements: “Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.”

Conditions of useBeef cattle and nonlactating dairy cattleAmount.(e) —(1) —(i) Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear.

Indications for use.Pasteurella multocidaArcanobacterium pyogenes;Fusobacterium necrophorumA. pyogenes.(ii) Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with and foot rot (necrotic pododermatitis) and calf diphtheria caused by and metritis caused by

Limitations.(iii) Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

SwineAmount.(2) —(i) Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.

Indications for use.Mycoplasma hyosynoviae;PasteurellaErysipelothrix rhusiopathiae;Treponema hyodysenteriae(ii) Treatment of swine arthritis caused by swine pneumonia caused by spp.; swine erysipelas caused by swine dysentery associated with when followed by appropriate medication in the drinking water and/or feed.

Limitations.(iii) Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs and catsAmount.(3) —(i) Administer 3 to 5 mg/lb of body weight by intramuscular injection at 12- to 24-hour intervals.

Indications for useDogs.StaphylococciStreptococciPasteurella multocida.(ii) —(A) Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by spp., hemolytic spp., and

Cats.StaphylococciStreptococci(B) Treatment of upper respiratory infections when caused by spp. and hemolytic spp. and for feline pneumonitis when caused by tylosin-susceptible organisms.

Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8974, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 88 FR 14900, Mar. 10, 2023; 88 FR 16549, Mar. 20, 2023; 88 FR 84701, Dec. 6, 2023]