§520.1615. Omeprazole.
21 C.F.R. § 520.1615
Specifications. Each gram of paste contains 0.37 gram omeprazole.
Sponsor. See No. 000010 in § 510.600(c) of this chapter.
Special considerations. When labeled for use as in paragraph (d)(2)(i) of this section, product labeling shall bear: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
Conditions of use in horses—
Amount.
For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once daily for at least an additional 4 weeks.
For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day.
Indications for use.
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
For prevention of gastric ulcers in horses.
Limitations. Do not use in horses intended for human consumption.
Notes, amendments, and revision history
Amendments
[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]