21 CFR 520.1263a - Lincomycin hydrochloride monohydrate tablets and sirup.

Code of Federal Regulations - Title 21: Food and Drugs (December 2005)


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TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS

520.1263a - Lincomycin hydrochloride monohydrate tablets and sirup.

  (a) Specifications. The sirup contains lincomycin hydrochloride equivalent to either 25 milligrams or 50 milligrams of lincomycin.

  (b) Sponsor. See No. 000009 in 510.600(c) of this chapter.

  (c) Conditions of use. (1) The drug is indicated in infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci.

  (2) It is administered orally to dogs and cats at a dosage level of 10 mgs per pound of body weight every 12 hours, or 7 mgs per pound of body weight every 8 hours. Treatment may be continued for periods as long as 12 days if clinical judgment indicates.

  (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 44 FR 7130, Feb. 6, 1979; 64 FR 403, Jan. 5, 1999]

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