520.2345e—Tetracycline oral liquid.
(a) Specifications.
Each milliliter contains the equivalent of either 25 or 100 milligrams of tetracycline hydrochloride.
(b) Sponsor.
See No. 000069, in § 510.600(c) of this chapter for use of 25 or 100 milligrams per milliliter liquid in dogs as in paragraph (c)(1) of this section; see No. 000009 in § 510.600(c) of this chapter for use of 100 milligrams per milliliter liquid in dogs and cats as in paragraph (c)(2).
(c) Conditions of use—
(1) Dogs—
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.
(iv) National Academy of Sciences/National Research Council (NAS/NRC) status.
These conditions were NAS/NRC reviewed and found 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) Dogs and cats—
(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.