21 C.F.R. § 522.1680 Oxytocin injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin. (b) Sponsors. See Nos. 000010, 000856, 059130, 058639, 059130, and 061623 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount—(i) Obstetrical. Administer drug intravenously, intramuscularly, or subcutaneously under aseptic conditions as indicated. The following dosages are recommended and may be repeated as conditions require: (ii) Milk letdown. Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require: (2) Indications for use. Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980, as amended at 52 FR 18691, May 19, 1987; 52 FR 25212, July 6, 1987; 52 FR 36023, Sept. 25, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11, 1991, 56 FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, 1994; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 65 FR 45877, July 26, 2000; 66 FR 22117, May 3, 2001; 68 FR 36913, June 20, 2003]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1680 Oxytocin injection.
------------------------------------------------------------------------ mL U.S.P. units------------------------------------------------------------------------Cats............................ 0.25 to 0.5....... 5 to 10.Dogs............................ 0.25 to 1.5....... 5 to 30.Ewes, Sows...................... 1.5 to 2.5........ 30 to 50.Cows, Horses.................... 5.0............... 100.------------------------------------------------------------------------
------------------------------------------------------------------------ mL U.S.P. units------------------------------------------------------------------------Cows............................ 0.5 to 1.0........ 10 to 20.Sows............................ 0.25 to 1.0....... 5 to 20.------------------------------------------------------------------------
