522.2640—Tylosin.
(a) Specifications.
Each milliliter of sterile solution of 50 percent propylene glycol with 4 percent benzyl alcohol contains 50 to 200 milligrams of tylosin activity (as tylosin base). Tylosin conforms to the appropriate antibiotic standard. Tylosin contains at least 95 percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and tylosin D of which at least 80 percent is tylosin A as determined by a method entitled “Determination of Factor Content in Tylosin by High Performance Liquid Chromatography,” which is incorporated by reference. Copies are available from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) Sponsors.
(1)
See No. 000986 in § 510.600(c) of this chapter for use in paragraphs (e)(1), (2), and (3) of this section.
(2)
See No. 000010 in § 510.600(c) of this chapter for use as in paragraphs (e)(1) and (2) of this section.
(e) Conditions of use—
(1) Beef cattle and nonlactating dairy cattle—
Amount. 8 milligrams per pound of body weight once daily.
(ii) Indications for use.
Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes.
(iii) Limitations.
Administer intramuscularly for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. Do not inject more than 10 milliliters per site. Do not use in lactating dairy cattle. Use a 50-milligram-per-milliliter solution for calves weighing less than 200 pounds. Do not administer within 21 days of slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(ii) Indications for use.
Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
(iii) Limitations.
Administer intramuscularly for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. Do not inject more than 5 milliliters per site. Do not administer within 14 days of slaughter. If tylosin medicated drinking water is used as 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.
(3) Dogs and cats—
(i) Amount.
3 to 5 milligrams per pound of body weight at 12- to 24-hour intervals.
(ii) Indications for use—
(a) Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida.
(b) Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosin susceptible organisms.
(iii) Limitations.
For intramuscular use only. If there is no response to therapy in 5 days, diagnosis and treatment should be reassessed. Use a 50-milligram-per-milliliter solution only. Dogs and cats receiving a dose of less than 50 milligrams (1 milliliter) should be dosed with a tuberculin syringe. Federal law restricts this drug to use by or on the order of a licensed veterinarian.