(a) Sponsors. (1) [Reserved]
(1) [Reserved]
(2) See 054771 in Sec. 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 Sec. 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) [Reserved]
(5) See No. 000061 in Sec. 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. 054628 in Sec. 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.
(1) Dosage/indications for use. (i) Three milligrams per pound of body weight daily for prevention of heartworm disease (Dirofilaria immitis) in dogs.
(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. 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; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, May 20, 2014] Sec. 520.622b Diethylcarbamazine citrate syrup.
(a)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 054771 in Sec. 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.
(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.
(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 054628 in Sec. 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).
(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] Sec. 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 Sec. 510.600(c) of this chapter for identification of sponsors as follows:
(1) [Reserved]
(2) For 054771, 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 054628, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.
(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.
(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.
(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [43 FR 6941, Feb. 17, 1978]
Editorial Note: For Federal Register citations affecting Sec. 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.