Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.1315 - Maropitant.
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§ 520.1315 Maropitant.
(a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs -
(1) Indications for use and amount.
(i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.
(ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.
(iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 9243, Mar. 1, 2007, as amended at 78 FR 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015]