Food and Drug Administration, HHS § 520.804
Strongylus vulgaris; and pinworms, Milligrams Length of per pound Oxyuris equi. of body treatmentÐ weight days (3) Limitations. Administer by drench or mixed with the daily ration as a sin- Hookworms (Ancylostoma caninum, Uncinaria gle dose. Treatment is recommended in stenocephala) ...... 10 7 spring and fall. In a heavily infested Whipworms (Trichuris vulpis) ...... 10 7 environment, treatment may be re- Strongyloides (Strongyloides canis, Strongyloides stercoralis) 10 10±12 peated every 30 days. Not for use in Heartworm microfilariae horses intended for food purposes. Se- (Dirofilaria immitus) ...... 3±5 7±10 verely debilitated animals should not Note: Treatment with dithiazanine iodide for heartworm be wormed except on the advice of a microfilariae should follow 6 weeks after therapy for adult veterinarian. If the drug is for adminis- worms. tration by stomach tube, it shall be la- (2) The drug is contraindicated in beled: ‘‘Federal law restricts this drug animals sensitive to dithiazanine io- to use by or on the order of a licensed dide and should be used cautiously, if veterinarian.’’ at all, in dogs with reduced renal func- tion. [47 FR 52696, Nov. 23, 1982, as amended at 48 (3) Federal law restricts this drug to FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988] use by or on the order of a licensed vet- erinarian. § 520.784 Doxylamine succinate tab- (e) Use for treating dogs for large lets. roundworms, hookworms, whipworms, and strongyloides as provided for in (a) Specifications. The drug is in tab- this section has been NAS/NRC re- let form and contains doxylamine suc- viewed and deemed effective. Applica- cinate as the active drug ingredient. tions for these uses need not include ef- (b) Sponsor. See No. 011716 in fectiveness data as specified by § 514.111 § 510.600(c) of this chapter. of this chapter, but may require bio- (c) Conditions of use. (1) The drug is equivalency and safety information. used in conditions in which antihis- taminic therapy may be expected to al- [40 FR 13838, Mar. 27, 1975, as amended at 47 leviate some signs of disease in horses, FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, dogs, and cats.1 1983; 53 FR 40727, Oct. 18, 1988] (2) It is administered orally to horses § 520.763c Dithiazanine iodide and pi- at a dosage level of 1 to 2 milligrams perazine citrate suspension. per pound of body weight per day di- vided into 3 or 4 equal doses. It is ad- (a) Specifications. Each milliliter of ministered orally to dogs and cats at a the drug contains 69 milligrams of dosage level of 2 to 3 milligrams per dithiazanine iodide and 83 milligrams pound of body weight per day divided of piperazine base (as piperazine cit- into 3 or 4 equal doses.1 rate). (3) Not for use in horses intended for (b) Sponsor. See 054273 in § 510.600(c) of food.1 this chapter. (c) NAS/NRC status. The conditions of (4) Federal law restricts this drug to use are NAS/NRC reviewed and found use by or on the order of a licensed vet- 1 effective. Applications for these uses erinarian. need not include effectiveness data as [40 FR 13838, Mar. 27, 1975, as amended at 42 specified by § 514.111 of this chapter, FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, but may require bioequivalency and 1981; 61 FR 8873, Mar. 6, 1996] safety information. (d) Conditions of use—(1) Amount. 1 § 520.804 Enalapril tablets. ounce (30 milliliters) per 100 pounds of (a) Specifications. Each tablet con- body weight for the first 500 pounds; 3⁄4 tains either 1.0, 2.5, 5.0, 10.0, or 20.0 mil- ounce for each 100 pounds thereafter, ligrams of enalapril maleate. up to 1,200 pounds; 101⁄4 ounces to ani- mals over 1,200 pounds. 1 These conditions are NAS/NRC reviewed (2) Indications for use. For control of and deemed effective. Applications for these large roundworms, Parascaris equorum; uses need not include effectiveness data as small strongyles; large strongyles, specified by § 514.111 of this chapter.
159
VerDate 29