21 C.F.R. § 520.960   Flumethasone tablets.


Title 21 - Food and Drugs


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

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§ 520.960   Flumethasone tablets.

(a) Specifications. Each tablet contains 0.0625 milligram of flumethasone.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. (i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses.

(ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in divided doses.

(2) Indications for use. (i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis.

(ii) Dogs and cats: It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

(3) Limitations. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996]

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