[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR520.260] [Page 109-110] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents Sec. 520.260 n-Butyl chloride capsules. (a)(1) Specifications. n-Butyl chloride capsules, veterinary contain 272 milligrams or 816 milligrams of n-butyl chloride in each capsule. (2) Sponsor. See No. 021091 in Sec. 510.600(c) of this chapter. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme) from cats. (ii)(a) Animals should not be fed for 18 to 24 hours before being given the drug. Puppies and kittens should be wormed at 6 weeks of age. However, if heavily infested, they may be wormed at 4 or 5 weeks of age. Administration of the drug should be followed in \1/2\ to 1 hour with a teaspoonful to a tablespoonful of milk of magnesia or 1 or 2 milk of magnesia tablets. Normal rations may be resumed 4 to 8 hours after treatment. Puppies and kittens should be given a repeat treatment in a week or 10 days. After that they should be treated every 2 months (or as symptoms reappear) until a year old. When the puppy or kitten is a year old, one treatment every 3 to 6 months is sufficient. (b) For dogs or cats that have been wormed regularly, treatment every 3 to 6 months will be sufficient. If a dog or cat has not been wormed previously and has the symptoms of large roundworms a dose should be given and repeated in 10 days. Removal of hookworms may require 3 or 4 doses at 10-day intervals. (c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be given 2 capsules per dose which contain 272 milligrams of n-butyl chloride each. Such animals weighing 4 to 5 pounds should be given 3 such capsules. Animals weighing 6 to 7 pounds should be given 4 such capsules and animals weighing 8 to 9 pounds should be given 5 such capsules. Animals weighing 10 to 20 pounds should be given 3 capsules which contain 816 milligrams of n-butyl chloride each, animals weighing 20 to 40 pounds should be given 4 such capsules and animals weighing over 40 pounds should be given 5 such capsules with the maximum dosage being 5 capsules, each of which contains 816 milligrams of n-butyl chloride. (iii) A veterinarian should be consulted before using in severely debilitated dogs or cats and also prior to repeated use in cases which present signs of persistent parasitism. [[Page 110]] (b)(1) Specifications. n-Butyl chloride capsules contain 221, 442, 884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each capsule. \1\ --------------------------------------------------------------------------- \1\ These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by Sec. 514.111 of this chapter. --------------------------------------------------------------------------- (2) Sponsors. See No. 023851 in Sec. 510.600(c) of this chapter for 221, 442, 884, or 1,768 milligram or 4.42 gram capsules; No. 000115 or 038782 for 884 or 1,768 milligram or 4.42 gram capsules; and No. 000069 for 221 milligram capsules. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs. \1\ (ii)(a) Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in \1/2\ to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. \1\ (b) The drug is administered orally to dogs. Capsules containing 221 milligrams of n-butyl chloride are administered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 1\1/4\ pound of body weight. Capsules containing 442 milligrams of n-butyl chloride are administered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 2\1/ 2\ pounds body weight. Capsules containing 884 milligrams of n-butyl chloride are administered to dogs as follows: Weighing under 5 pounds, 1 capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds, 3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing 1,768 milligrams of n-butyl chloride are administered at a dosage level of 1 capsule per dog weighing 5 to 10 pounds. Capsules containing 4.42 grams of n-butyl chloride are administered at a dosage level of 1 capsule per dog weighing 40 pounds or over. \1\ (iii) A veterinarian should be consulted before using in severely debilitated dogs. \1\ (c)(1) Specifications. n-Butyl chloride capsules, veterinary contain 884 or 1,768 milligrams or 4.42 grams of n-butyl chloride in each capsule. (2) Sponsor. See No. 000115 in Sec. 510.600(c) of this chapter. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancyclostoma caninum, Ancyclostoma braziliense, and Uncinaria stenocephala) from dogs. (ii)(a) Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in \1/2\ to 1 hour with a mild cathartic. Normal rations may be resumed 4 to 8 hours after treatment. (b) The drug is administered orally to dogs. Capsules containing 884 milligrams of n-butyl chloride are administered to dogs as follows: weighing under 5 pounds, 1 capsule; weighing 5-10 pounds, 2 capsules; weighing 10-20 pounds, 3 capsules; weighing 20-40 pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing 1,768 milligrams of n- butyl chloride are administered at a dosage level of 1 capsule per dogs to dogs weighing 5-10 pounds and 2 capsules per dog to dogs weighing 20- 40 pounds. Capsules containing 4.42 grams of n-butyl chloride are administered at dosage level of 1 capsule per dog to dogs weighing 40 pounds or over. (iii) A veterinarian should be consulted before using in severely debilitated dogs. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, June 18, 1990; 64 FR 15684, Apr. 1, 1999]