21 C.F.R. § 522.161 Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.
Title 21 - Food and Drugs
(a) Chemical names. Betamethasone acetate: 9-α-Fluoro-16-β-methylprednisolone - 21 - acetate (C24H31FO6). Betamethasone disodium phosphate: 9-α-Fluoro-16-β-methylprednisolone-21-disodium phosphate (C22H28FNa2O8P). (b) Specifications. The drug is a sterile aqueous suspension and each cubic centimeter contains: 12 milligrams of betamethasone acetate (equivalent to 10.8 milligrams of betamethasone), 3.9 milligrams of betamethasone disodium phosphate (equivalent to 3 milligrams of betamethasone), 2 milligrams of dibasic sodium phosphate, 5 milligrams of sodium chloride, 0.1 milligram of disodium EDTA, 0.5 milligram of polysorbate 80, 9 milligrams of benzyl alcohol, 5 milligrams of sodium carboxymethylcellulose, 1.8 milligrams of methylparaben, 0.2 milligram of propylparaben, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection q.s. (c) Sponsor. See No. 000061 in §510.600(c) of this chapter. (d) Conditions of use. It is used or intended for use by intra-articular injection of horses for the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints. Administer from 2.5 to 5 cubic centimeters per dose. Dose may be repeated when necessary depending upon the duration of relief obtained. Not for use in horses intended for food. For use only by or on the order of a licensed veterinarian. [40 FR13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.161 Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.
