21 C.F.R. § 522.775   Doxapram hydrochloride injection.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.775   Doxapram hydrochloride injection.

(a) Specifications. The drug is a sterile aqueous solution containing 20 milligrams doxapram hydrochloride per milliliter.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Administer to dogs, cats, and horses to stimulate respiration during and after general anesthesia; to speed awakening and return of reflexes after anesthesia. Administer to neonate dogs and cats to initiate respiration following dystocia or caesarean section; to stimulate respiration following dystocia or caesarean section.

(2) For intravenous use in dogs and cats at a dose of 21/2 to 5 milligrams of doxapram hydrochloride per pound of body weight in barbiturate anesthesia, 0.5 mg per lb. in gas anesthesia; for intravenous use in horses at 0.25 mg per lb. of body weight in barbiturate anesthesia, 0.2 mg per lb. in inhalation anesthesia, 0.25 mg per 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.

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

[40 FR 17838, Apr. 23, 1975, as amended at 67 FR 67521, Nov. 6, 2002]

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