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]