21 C.F.R. § 520.2604

Current through October 31, 2024
Section 520.2604 - Trimeprazine and prednisolone tablets
(a)Specifications. Each tablet contains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone.
(b)Sponsors. See Nos. 054771 and 086117 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Amount. Administer orally an initial dosage: for dogs weighing up to 10 pounds, 1/2 tablet twice daily; for dogs weighing 11 to 20 pounds, 1 tablet twice daily; for dogs weighing 21 to 40 pounds, 2 tablets twice daily; and for dogs weighing over 40 pounds, 3 tablets twice daily. After 4 days, reduce dosage to one-half the initial dose or to an amount sufficient to maintain remission of symptoms.
(2)Indications for use. For the relief of itching regardless of cause; and for reduction of inflammation commonly associated with most skin disorders of dogs such as eczema, caused by internal disorders, otitis, and dermatitis, allergic, parasitic, pustular, and nonspecific origins. As adjunctive therapy in various cough conditions including treatment of "kennel cough" or tracheobronchitis, bronchitis including allergic bronchitis, infections, and coughs of nonspecific origin.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.2604

79 FR 28833 , May 20, 2014, as amended at 87 FR 10969 , Feb. 28, 2022; 89 FR 85426 , Oct. 28, 2024
As amended at 87 FR 10969 , 2/28/2022; 89 FR 85426 , 10/28/2024