§ 520.1615. Omeprazole.
214 words·~1 min read·
/us/cfr/t21/s§ 520.1615·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Specifications. Each gram of paste contains 0.37 gram omeprazole.
(b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c)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.”
(d)Conditions of use in horses—(1) Amount.
(i)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.
(ii)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.
(2)Indications for use.
(i)For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
(ii)For prevention of gastric ulcers in horses.
(3)Limitations. Do not use in horses intended for human consumption. [69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]
Connections2 cite this
Cited by 2 sections
Citation graph
cites case law
§ 520.1615
Omeprazole.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source