520.622b—Diethylcarbamazine citrate syrup.

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

(2) Sponsor. See No. 053501 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) (1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.

(2) Sponsors. (i) See No. 017030 for use as in paragraphs (b)(3)(ii)(a) and (b)(3)(ii)(c) of this section.

(ii) See No. 017030 for use as in paragraphs (b)(3)(ii) (a) and (c) of this section.

(3) Conditions of use— (i) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and as an aid in control of large roundworms; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.

(ii) Indications for use. (a) For prevention of heartworm disease (Dirofilaria immitis) in dogs.

(b) As an aid in control of large roundworms (T. canis) in dogs.

(iii) Limitations. The drug may be placed on the daily ration or given directly by mouth. 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. Older dogs should be proven negative for presence of Dirofilaria immitis infections before administering the drug. 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 1 month before the mosquito season and be continued daily throughout the mosquito season and for 2 months thereafter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Sponsor. See No. 000010 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.

Code of Federal Regulations

[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]

CFR

520.622b—Diethylcarbamazine citrate syrup.

Code of Federal Regulations