Prednisolone, Trimeprazine Tartrate: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Prednisolone, Trimeprazine Tartrate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Trimeprazine with Prednisolone (NADA/ANADA 200-784)
Trimeprazine with Prednisolone NADA 200-784, Original approval, June 20, 2024; sponsor ZyVet Animal Health, Inc.; species: Dogs; foi_id 15546; FDA PDF
Indication
Antipruritic (relief of itching and inflammation associated with skin disorders of dogs) and antitussive (kennel cough/tracheobronchitis, bronchitis, and coughs of nonspecific origin).
Dose regimen
Up to 10 lb: ½ tablet; 11-20 lb: 1 tablet; 21-40 lb: 2 tablets; over 40 lb: 3 tablets, Oral, Twice daily (initial dosage), After 4 days reduce to half the initial dose or an amount sufficient to maintain remission; each tablet contains 5 mg trimeprazine (as tartrate) and 2 mg prednisolone.
Weight of Dog Initial Dosage Up to 10 lb ½ tablet, twice daily 11 – 20 lb 1 tablet, twice daily 21 – 40 lb 2 tablets, twice daily Over 40 lb 3 tablets, twice daily
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 332.5 (ng/mL)*hour (prednisolone, generic) | Prednisolone analyte; single oral dose of one 5 mg trimeprazine/2 mg prednisolone tablet, 28 fasted dogs, four-period crossover; Table II.2 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | AUC (ng/mL)*hour 332.5† 352.9† 0.94 0.81 1.10 |
| auc | 352.9 (ng/mL)*hour (prednisolone, RLNAD Temaril-P) | Prednisolone analyte; single oral dose of one 5 mg trimeprazine/2 mg prednisolone tablet, 28 fasted dogs, four-period crossover; Table II.2 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | AUC (ng/mL)*hour 332.5† 352.9† 0.94 0.81 1.10 |
| cmax | 164.2 ng/mL (prednisolone, generic) | Prednisolone analyte; single oral dose of one 5 mg trimeprazine/2 mg prednisolone tablet, 28 fasted dogs, four-period crossover; Table II.2 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | CMAX (ng/mL) 164.2† 163.0† 1.01 0.85 1.19 |
| cmax | 163.0 ng/mL (prednisolone, RLNAD Temaril-P) | Prednisolone analyte; single oral dose of one 5 mg trimeprazine/2 mg prednisolone tablet, 28 fasted dogs, four-period crossover; Table II.2 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | CMAX (ng/mL) 164.2† 163.0† 1.01 0.85 1.19 |
| tmax | 0.75 (0.49) hours (prednisolone, generic; arithmetic mean (SD)) | Prednisolone analyte; single oral dose of one 5 mg trimeprazine/2 mg prednisolone tablet, 28 fasted dogs, four-period crossover; Table II.2 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | TMAX (hours) (SD)‡ 0.75 (0.49)‡ 0.74 (0.57)‡ NE NE NE |
| auc | 6.61 (ng/mL)*hour (trimeprazine, generic) | Trimeprazine analyte (reference-scaled average bioequivalence); Table II.1 columns: sWR, generic mean, RLNAD mean, ratio, 95% upper bound, 90% CI (geometric means) | AUC (ng/mL)*hour 0.3780 6.61† 6.51† 1.04 -0.0701 NE |
| cmax | 2.44 ng/mL (trimeprazine, generic) | Trimeprazine analyte (reference-scaled average bioequivalence); Table II.1 columns: sWR, generic mean, RLNAD mean, ratio, 95% upper bound, 90% CI (geometric means) | CMAX (ng/mL) 0.4721 2.44† 2.25† 1.13 -0.0660 NE |
| tmax | 0.74 (0.51) hours (trimeprazine, generic; arithmetic mean (SD)) | Trimeprazine analyte (reference-scaled average bioequivalence); Table II.1 columns: sWR, generic mean, RLNAD mean, ratio, 95% upper bound, 90% CI (geometric means) | TMAX (hours) (SD)‡ NE 0.74 (0.51)‡ 0.77 (0.54)‡ NE NE NE |
Effectiveness
Pivotal blood-level bioequivalence study (Study No. 113-BC-3422): masked, randomized, four-period, two-sequence, single oral dose crossover in healthy fasted dogs, generic vs Temaril-P tablets, 14-day washout.; n = 28; primary endpoint: CMAX and AUC for trimeprazine (reference-scaled average bioequivalence) and prednisolone (average bioequivalence, 90% CI within 0.80-1.25); result: Bioequivalence demonstrated for both analytes (prednisolone AUC ratio 0.94, CMAX ratio 1.01; trimeprazine AUC ratio 1.04, CMAX ratio 1.13 with 95% upper bounds < 0).
The in vivo blood-level study was conducted in 28 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: First generic of Temaril-P; the bioequivalence study is recorded as effectiveness. No target animal safety or field studies required. PK rows quoted from Tables II.1/II.2 as flattened by PDF extraction.
Reproduce: foi_structured_search(query="Prednisolone, Trimeprazine Tartrate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).