(a)Specifications. Triflupromazine hydrochloride injection contains 20 milligrams of triflupromazine hydrochloride in each milliliter of sterile aqueous solution.
(b)Sponsor. See No. 053501 in § 510.600(c) of this chapter.
(c)Conditions of use.
(1) The drug is used in dogs, cats, and horses to relieve anxiety and to help control psychomotor overactivity as well as to increase the tolerance of animals to pain and pruritus. The drug is indicated in various office and clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic.1
(2) The drug is administered to dogs either intravenously at a dosage level of 0.5 to 1 milligram per pound of body weight daily, or intramuscularly at a dosage level of 1 to 2 milligrams per pound of body weight daily. It is administered to cats intramuscularly at a dosage level of 2 to 4 milligrams per pound of body weight daily. It is administered to horses intravenously or intramuscularly at a dosage level of 10 to 15 milligrams per 100 pounds of body weight daily to a maximum dose of 100 milligrams. 1
1 These conditions are NAS/NRC reviewed and are deemed effective. Applications for these uses need not include the effectiveness data specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(3) Not for use in horses intended for food. 1
(4) Do not use in conjunction with organophosphates and/or procaine hydrochloride, because phenothiazines may potentitate the toxicity of organophosphates and the activity of procaine hydrochloride. 1
(5) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985]
Title 21 published on 2014-04-01
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