21 C.F.R. § 520.763a Dithiazanine iodide tablets.
Title 21 - Food and Drugs
(a) Chemical name. 3-Ethyl-2-[5-(3-ethyl - 2 - benzothiazolinylidene) - 1,3 - pentadienyl]-benzothiazolium iodide. (b) Specifications. Dithiazanine iodide tablets contain 10 milligrams, 50 milligrams, 100 milligrams, or 200 milligrams of dithiazanine iodide in each tablet. (c) Sponsor. See No. 000010 in §510.600(c) of this chapter. (d) Conditions of use. (1) The tablets are administered orally to dogs immediately after feeding using the following dosage schedule for various parasite infestations: (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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.763a Dithiazanine iodide tablets.
------------------------------------------------------------------------ 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)................ 10Strongyloides (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.
