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520.2605—Trimeprazine tartrate and prednisolone capsules.
(a) Specifications.
Each capsule contains 3.75 milligrams of trimeprazine in sustained released form (as the tartrate) and 1 milligram of prednisolone (capsule no. 1) or 7.5 milligrams of trimeprazine in sustained release form (as the tartrate) and 2 milligrams of prednisolone (capsule no. 2).
| Animal weight (pounds) | Number of capsules per dose | |
|---|---|---|
| Capsule No. 1 | Capsule No. 2 | |
| Up to 10 | 1 | |
| 11 to 20 | 2 | 1 |
| 21 to 40 | 4 | 2 |
| Over 40 | 6 | 3 |
(2) Indications for use.
For the relief of itching regardless of cause, 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). It is also used in dogs as adjunctive therapy in various cough conditions including treatment of “kennel cough” or tracheobronchitis, bronchitis including allergic bronchitis, tonsillitis, acute upper respiratory infections, and coughs of nonspecific origin. The product may also be administered to dogs suffering from acute or chronic bacterial infections, provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.
(3) Limitations.
After 4 days, reduce dosage to one-half the initial dose or to an amount sufficient to maintain remission of symptoms. Dosages in individual cases may vary and should be adjusted until proper response is obtained. Do not use the drug in cases of viral infections involving corneal ulceration or dendritic ulceration of the cornea. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Code of Federal Regulations
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