CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.622c—Diethylcarbamazine citrate chewable tablets.

520.622c—Diethylcarbamazine citrate chewable tablets.

(a) Specifications. Each chewable tablet contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine citrate.
(b) Sponsors. See drug listing nos. in § 510.600(c) of this chapter for identification of sponsors as follows:
(1) For 015579, use of 30 or 120 milligram tablets as in paragraph (c)(2)(i) of this section.
(2) For 000069, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section.
(3) For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section.
(4) For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section.
(5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section.
(6) For 000010, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.
(7) [Reserved]
(c) Conditions of use— (1) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.
(2) Indications for use. (i) For prevention of heartworm disease (Dirofilaria immitis) in dogs; as an aid in control of ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs and cats.
(ii) For prevention of infection with Dirofilaria immitis (heartworm disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs.
(iii) For prevention of heartworm disease (Dirofilaria immitis) in dogs.
(3) Limitations. Tablets are administered orally or pulverized and given in the feed. For treatment of ascarid infections, a repeat dose should be given in 10 to 20 days to remove immature worms which may enter the intestine from the lungs after the first dose. Dogs with established heartworm infections should not receive the drug until they have been converted to a negative status by the use of adulticidal and microfilaricidal drugs. Inadvertent administration to heartworm-infected dogs may cause adverse reactions due to pulmonary occlusion. Overdosage may cause emesis. For prevention of heartworm disease in heartworm-endemic areas, administration of the drug should start at the beginning of mosquito activity and be continued daily throughout the mosquito season and for approximately a month thereafter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[43 FR 6941, Feb. 17, 1978]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 520.622c , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Code of Federal Regulations

Effective Date Note: At 76 FR 17777, Mar. 31, 2011, § 520.622c was amended by removing and reserving paragraph (b)(1); removing reserved paragraph (b)(7); and revising paragraph (c)(3), effective April 11, 2011. For the convenience of the user, the revised text is set forth as follows: § 520.622c Diethylcarbamazine citrate chewable tablets. (c) * * * (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.