21 C.F.R. § 522.960b Flumethasone acetate injection.
Title 21 - Food and Drugs
(a) Chemical name. 6-alpha,9-alpha-difluoro - 16 - alpha - methylprednisolone 21-acetate. (b) Specifications. Flumethasone injection is sterile and contains per cubic centimeter: 2 milligrams of flumethasone acetate; 20 milligrams of propylene glycol; 9 milligrams of benzyl alcohol (as preservative); 8 milligrams of sodium chloride; 1 milligram of polysorbate 80; 0.1 milligram of citric acid; water for injection q.s. (c) Sponsor. See No. 000856 in §510.600(c) of this chapter. (d) Conditions of use. (1) It is recommended in certain acute and chronic canine dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions. (2) The drug is administered intramuscularly at the following recommended daily dosage: Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 milligram per animal. (3) For use only by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.960b Flumethasone acetate injection.
------------------------------------------------------------------------ Dosage in Weight of animal in pounds milligrams------------------------------------------------------------------------Up to 10.................................................... 1.010 to 25.................................................... 2.025 and over................................................. 4.0------------------------------------------------------------------------
