520.1660b—Oxytetracycline hydrochloride capsules.
(a) Specifications.
The drug is in capsule form with each capsule containing 125 or 250 milligrams of oxytetracycline hydrochloride. Oxytetracycline is the antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means.
(c) Conditions of use.
(1)
It is used in dogs and cats for the treatment of bacterial pneumonia caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis caused by Escherichia coli, urinary tract infections caused by Escherichia coli, and wound infections caused by Staphylococcus aureus. 1
Code of Federal Regulations
Footnote(s): 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(2)
The drug is administered orally to dogs and cats at a dosage level of 25-50 milligrams per pound of body weight per day in divided doses at 12-hour intervals. The drug can be used for continuation of compatible antibiotic therapy following parenteral oxytetracycline administration where rapidly attained, sustained antibiotic blood levels are required. The duration of treatment required to obtain favorable response will depend to some extent on the severity and degree of involvement and the susceptibility of the infectious agent. Clinical response to antibiotic therapy usually occurs within 48 to 72 hours. If improvement is not observed within that period, the diagnosis and course of treatment should be reconsidered. To assure adequate treatment, administration of the drug should continue for at least 48 hours following favorable clinical response. 1