21 CFR 522.775 - Doxapram.

§ 522.775 Doxapram.

(a)Specifications. Each milliliter of solution contains 20 milligrams (mg) doxapram hydrochloride.

(b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount. For intravenous use in dogs and cats at a dose of 2 1/2 to 5 mg per pound (/lb) body weight in barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for intravenous use in horses at 0.25 mg/lb body weight in barbiturate anesthesia, 0.2 mg/lb in inhalation anesthesia, 0.25 mg/lb with chloral hydrate with or without magnesium sulfate; for subcutaneous, sublingual, or umbilical vein administration in neonate puppies at a dose rate of 1 to 5 mg; for subcutaneous or sublingual use in neonate kittens at 1 to 2 mg. Dosage may be repeated in 15 to 20 minutes if necessary.

(2)Indications for use. Administer to dogs, cats, and horses to stimulate respiration during and after general anesthesia; or to speed awakening and return of reflexes after anesthesia. Administer to neonate dogs and cats to initiate respiration following dystocia or caesarean section; or to stimulate respiration following dystocia or caesarean section.

(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 72 FR 261, Jan. 4, 2007, as amended at 75 FR 10167, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 09-Nov-2018 03:23

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2018-09-28; vol. 83 # 189 - Friday, September 28, 2018
    1. 83 FR 48940 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective September 28, 2018, except for amendatory instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
      21 CFR Parts 510, 520, 522, 524, 529, 556, and 558