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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.622b]



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. 520.622b Diethylcarbamazine citrate syrup.

(a)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.

(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(3) Conditions of use. (i) The drug is indicated for use in dogs for the prevention of infection with Dirofilaria immitis and T. canis and T. leonina. It is also indicated for treatment of ascarid infections of T. canis and T. leonina in dogs and T. cati in cats.

(ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dosage rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably administered immediately after feeding.

(iii) Older dogs should be proven negative for the presence of Dirofilaria immitis infection before administration of the drug. Those with proven infection of Dirofilaria immitis should be rendered negative using adulticidal and microfilaricidal drugs before administration of this drug.

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b) [Reserved]

(c)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.

(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.

(3) Conditions of use. (i) The drug is used in dogs between 4 weeks and 8 months of age for the removal of ascarids (Toxacara canis ) and in animals over 4 weeks of age for the prevention of heartworm disease (Dirofilaria immitis ).

(ii) The drug is administered (a ) for removal of ascarids at a dosage of 50 milligrams per pound of body weight divided into two equal doses and administered 8 to 12 hours apart (morning and night), orally or mixed with either dry or wet food, and (b ) for prevention of heartworm disease at a dosage of 3 milligrams per pound of body weight daily, orally or in food, in heartworm endemic areas, from the beginning of mosquito activity, during the mosquito season, and for 2 months following the end thereof.

(iii) Dogs older than 8 months of age may be infected with Dirofilaria immitis. Use of the drug is contraindicated in dogs with active D. immitis infections.

(iv) 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 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018]

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