21 C.F.R. § 520.622a Diethylcarbamazine citrate tablets.
Title 21 - Food and Drugs
(a) Sponsors. (1) See 015579 in §510.600(c) of this chapter for use of 50, 200, and 400 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs and cats. (2) See 053501 in §510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs. (3) See 061623 in §510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (4) See 017030 in §510.600(c) of this chapter for use of 50, 100, 200, 300, and 400 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs and cats. (5) See 000081 in §510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (6) See No. 000010 in §510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (b) Conditions of use—(1) Dosage/indications for use. (i) Three milligrams per pound of body weight daily for prevention of heartworm disease (Dirofilaria immitis) in dogs. (ii) Three milligrams per pound of body weight daily as an aid in the control of ascarid infections (Toxocara canis) in dogs. (iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs (Toxocara canis) and cats (Toxocara canis and Toxascaris leonina). (2) Limitations. Administer orally either pulverized and given in feed or water or directly by mouth. For the treatment of ascarid infections, repeat in 10 to 20 days to remove immature worms that may enter the intestine from the lungs after the first dose. Do not treat dogs with established heartworm infections 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 because of 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. [46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.622a Diethylcarbamazine citrate tablets.
