21 CFR § 522.1680 - Oxytocin.
(a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin.
(b) Sponsors. See Nos. 054771 and 061133 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:
| 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. |
(ii) Milk letdown. Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require:
| mL | U.S.P. units | |
|---|---|---|
| Cows | 0.5 to 1.0 | 10 to 20. |
| Sows | 0.25 to 1.0 | 5 to 20. |
(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.