21 C.F.R. § 520.2123a Spectinomycin dihydrochloride pentahydrate tablets.
Title 21 - Food and Drugs
(a) Specifications. The spectinomycin dihydrochloride pentahydrate used in manufacturing the drug is the antibiotic substance produced by growth of Streptomyces flavopersicus (var. Abbott) or the same antibiotic substance produced by any other means. (b) Sponsor. See No. 061623 in §510.600(c) of this chapter. (c) Special considerations. The quantities of spectinomycin cited in this section refer to the equivalent weight of base activity for the drug. (d) Conditions of use. (1) The tablets are administered orally to dogs in the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin. (2) The drug is administered orally to provide 10 milligrams per pound of body weight twice daily. The tablets may be placed in the animal's mouth or crushed and administered in milk or in the feed. Dosage may be continued for 4 consecutive days. Should no improvement be observed, discontinue drug and redetermine diagnosis. (3) 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 47 FR 14149, Apr. 2, 1982; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2123a Spectinomycin dihydrochloride pentahydrate tablets.
