[Title 21 CFR 520.1100] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)] [Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS] [Part 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS] [Sec. 520.1100 - Griseofulvin.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 6 1996-04-01 1996-04-01 false Griseofulvin. 520.1100 Sec. 520.1100 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS Sec. 520.1100 Griseofulvin. (a) Chemical name. 7-Chloro-2',4,6-trimethoxy-6'-methylspiro [benzofuran-2(3H), 1'-[2]-cyclohexene]-3,4'-dione. (b) Specifications. Complies with U.S.P. for griseofulvin microsize. (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. (d) Conditions of use. (1) As a soluble powder for horses, it is administered as a drench or as a top dressing on feed. It is used for equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum. Administer for not less than 10 days a daily dose as follows: Adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams. Not for use in horses intended for food. For use only by or on the order of a licensed veterinarian. (2)(i) Boluses containing 2.5 grams of griseofulvin are used in horses for treating ringworm infection caused by Trichophyton equinum. It is administered to adult horses at a level of one bolus per day, to yearlings at one-half to one bolus per day, and to foals at one-half bolus per day. All three dosage levels should be administered for a period of not less than 10 days. In responsive cases, treatment should be continued until all infected areas are proven negative by appropriate culture. Not for use in horses intended for food. (ii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows: [[Page 170]] (a) Daily (single or divided) dose: ------------------------------------------------------------------------ Dosage Body weight (pounds) (milligrams) ------------------------------------------------------------------------ Up to 6................................................... 62.5 6 to 18................................................... 125 18 to 36.................................................. 250 36 to 48.................................................. 375 48 to 75.................................................. 500 ------------------------------------------------------------------------ (b) Weekly (single) dose: If experience indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body weight x body weight x number of days between treatments. Dosage should be adjusted according to response. Administer additional dose after the animal is free of infection. (ii) Indications for use. For treatment of fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini. (iii) Limitations. For satisfactory diagnosis, a microscopic tissue examination or culture is recommended prior to treatment. Treatment should be continued for 3 to 4 weeks in skin and hair infections, and up to 4 months for infections involving nails or claws. Clipping of hair, nails, and claws to help remove any remaining viable fungi is indicated. Safety for use of griseofulvin for pregnant animals has not been established. 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 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 19, 1989] Sec. 520.1120 Haloxon oral dosage forms.