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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
[CITE: 21CFR520.1805]



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
Sec. 520.1805 Piperazine phosphate with thenium closylate tablets.

(a)Specifications. Each scored tablet contains the equivalent of 250 milligrams piperazine hexahydrate (as piperazine phosphate) and 125 milligrams thenium (as thenium closylate) or 500 milligrams piperazine hexahydrate (as piperazine phosphate) and 250 milligrams thenium (as thenium closylate).

(b)Sponsor. See No. 000061 in 510.600(c) of this chapter.

(c)Conditions of use --(1)Amount. Administer orally to dogs as follows:

Number of Tablets at Each of the Two Doses

Animal weight (lb)375 mg750 mg
2 but less than 51/2
5 but less than 1011/2
10 or heavier21

(2)Indications for use. For removal of immature (fourth stage larvae) and adult hookworms (Ancylostoma caninum, A. braziliense, andUncinaria stenocephala ) and ascarids (Toxocara canis ) from weaned pups and adult dogs.

(3)Limitations. Do not use this product to treat dogs weighing less than 2 pounds, unweaned pups, or pups under 5 weeks of age. Maximum efficacy against hookworms necessitates two doses in 1 day of treatment. The interval between the doses should be not less than 4 hours or more than 24 hours. Administer the first dose in the morning before feeding. Do not permit dog to chew tablet. Feed the dog between doses. Do not feed milk or other fatty foods during treatment. Retreatment may be needed in 7 to 28 days as determined by laboratory fecal examinations or in animals kept in known contaminated quarters. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

Database Updated April 1, 2008

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