[Title 21 CFR 520.222]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 520.222 - Bunamidine hydrochloride.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  520.222
  Sec. 520.222
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    ORAL DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 520.222   Bunamidine hydrochloride.

    (a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine 
hydrochloride.

[[Page 138]]

    (b) Specifications. The drug is an oral tablet containing 100, 200, 
or 400 milligrams of bunamidine hydrochloride.
    (c) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs for the treatment of the tapeworms Dipylidium 
caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for 
the treatment of the tapeworms Dipylidium caninum and Taenia 
taeniaeformis.
    (2) It is administered to cats and dogs at the rate of 25 to 50 
milligrams per kilogram of body weight. The drug should be given on an 
empty stomach and food should not be given for 3 hours following 
treatment.
    (3) Tablets should not be crushed, mixed with food, or dissolved in 
liquid. Repeat treatments should not be given within 14 days. The drug 
should not be given to male dogs within 28 days prior to their use for 
breeding. Do not administer to dogs or cats having known heart 
conditions.
    (4) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996]