21 C.F.R. § 520.763b   Dithiazanine iodide powder.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.763b   Dithiazanine iodide powder.

(a) Chemical name. 3-Ethyl-2-[5-(3-ethyl-2-benzothiazolinylidene)-1,3-pentadienyl]-benzothiazoliumiodide.

(b) Specifications. Dithiazanine iodide powder contains 200 milligrams of dithiazanine iodide per level standard tablespoon.

(c) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(d) Conditions of use. (1) Dithiazanine iodide powder is administered to dogs by mixing the proper dosage in the dog's food, using the following dosage schedule for various parasite infestations:

 ------------------------------------------------------------------------                                              Milligrams                                               per pound     Length of                                                of body   treatment_days                                                weight------------------------------------------------------------------------Large roundworms (Toxocara canis, Toxascaris          10           3-5 leonina)...................................Hookworms (Ancylostoma caninum, Uncinaria             10             7 stenocephala)..............................Whipworms (Trichuris vulpis)................          10             7Strongyloides (Strongyloides canis,                   10         10-12 Strongyloides stercoralis).................Heartworm microfilariae (Dirofilaria                 3-5          7-10 immitus)...................................------------------------------------------------------------------------Note: Treatment with dithiazanine iodide for heartworm microfilariae  should follow 6 weeks after therapy for adult worms.

(2) The drug is contraindicated in animals sensitive to dithiazanine iodide and should be used cautiously, if at all, in dogs with reduced renal function.

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

(e) Use for treating dogs for large roundworms, hookworms, whipworms, and strongyloides as provided for in this section has been NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]

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