21 CFR 522.542 - Dexamethasone-21-isonicotinate suspension.

Code of Federal Regulations - Title 21: Food and Drugs

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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 522: IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

522.542 - Dexamethasone-21-isonicotinate suspension.

(a) Specifications. Each milliliter of sterile suspension contains 1 milligram of dexamethasone-21-isonicotinate.

(b) Sponsor. No. 000010 in ? 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in the treatment of various inflammatory conditions associated with the musculoskeletal system in dogs, cats, and horses.

(2) It is recommended for intramuscular administration as follows: Dogs?0.25 to 1 milligram; cats?0.125 to 0.5 milligram; horses?5 to 20 milligrams. Dosage may be repeated.

(3) Clinical and experimental data have demonstrated that corticosteriods administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition following by dystocia, fetal death, retained placenta, and metritis.

(4) Not for use in horses intended for food.

(5) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[42 FR 37543, July 22, 1977, as amended at 47 FR 14703, Apr. 6, 1982]

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