Trimeprazine and prednisolone

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Trimeprazine with Prednisolone Tablets, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for Trimeprazine with Prednisolone Tablets by ZYVET ANIMAL HEALTH INC, a trimeprazine and prednisolone product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 3 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: Trimeprazine with Prednisolone Tablets. Manufacturer: ZYVET ANIMAL HEALTH INC. FDA Structured Product Label set id 38872971-1154-45e1-a5e9-ff0b68bba60a. Label effective 2024-07-12. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

1. Antipruritic: Trimeprazine with Prednisolone is recommended for the relief of itching regardless of cause. Its usefulness has been demonstrated for the relief of itching and the reduction of inflammation commonly associated with most skin disorders of dogs such as the eczema caused by internal disorders, otitis, and dermatitis (allergic, parasitic, pustular, and nonspecific). It often relieves pruritus which does not respond to other therapy. With any pruritus treatment, the cause should be determined and corrected; otherwise, signs are likely to recur following discontinuance of therapy. 2. Antitussive: Trimeprazine with Prednisolone has been found to be effective therapy and adjunctive therapy in various cough conditions of dogs. Therefore, in addition to its anti pruritic action, Trimeprazine with Prednisolone is recommended for the treatment of "kennel cough" or tracheobronchitis, bronchitis including all allergic bronchitis, and infections and coughs of nonspecific origin. (Coughs due to cardiac insufficiencies would not be expected to respond to Trimeprazine with Prednisolone therapy.) As with any antitussive treatment, the etiology of the cough should be determined and eliminated if possible. Otherwise, symptoms are likely to recur following discontinuance of therapy. Note: Trimeprazine with Prednisolone may be administered to animals suffering from acute or chronic bacterial infections provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.

Dosage and Administration

The same dosage schedule may be followed for both antipruritic and antitussive therapy. Weight of Dog Initial Dosage Up to 10 lb 1/2 tablet, twice daily 11–20 lb 1 tablet, twice daily 21–40 lb 2 tablets, twice daily Over 40 lb 3 tablets, twice daily After 4 days, reduce dosage to 1/2 of the initial dose or to an amount just sufficient to maintain remission of symptoms. Individual animal response will vary and dosage should be adjusted until proper response is obtained. Store at 20° to 25°C (68° to 77°F), excursions permitted to 40°C (104°F). Protect from light.

Warnings

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. If a vasoconstrictor is needed, norepinephrine should be used in lieu of epinephrine. Phenothiazine derivatives may reverse the usual elevating action of epinephrine causing a further lowering of blood pressure. Keep Trimeprazine with Prednisolone Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. CONTACT INFORMATIONS: To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact ZyVet Animal Health Inc. at 1-877-779-9838. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae PRECAUTIONS AND SIDE EFFECTS: All the precautions applicable to cortisone and to phenothiazine derivatives apply also to Trimeprazine with Prednisolone. Possible side effects attributable to corticosteroids include sodium retention and potassium loss, negative nitrogen balance, suppressed adrenal cortical function, delayed wound healing, osteoporosis, elevated levels of SGPT and SAP, and vomiting and diarrhea (occasionally bloody). Cushings syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Possible increased susceptibility to bacterial invasion and/or the exacerbation of preexisting bacterial infection may occur in patients receiving corticosteroids. As noted above, however, this problem can be avoided by concomitant use of appropriate anti-infective agents. Possible side effects attributable to phenothiazine derivatives include sedation; protruding nictitating membrane; blood dyscrasias; intensification and prolongation of the action of analgesics, sedatives and general anesthetics; and potentiation of organophosphate toxicity and the activity of procaine hydrochloride. It should be remembered that the premonitory signs of cortisone overdosage, such as sodium retention and edema, may not occur with prednisolone. Therefore, the veterinarians must be alert to detect less obvious side effects, such as blood dyscrasias, polydipsia, and polyuria. The appearance and severity of side effects are dose related and are minimal at the recommended dosage level. If troublesome side effects are encountered, the dosage of Trimeprazine with Prednisolone should be reduced and discontinued unless the severity of the condition being treated makes its relief paramount. Prolonged treatment with Trimeprazine with Prednisolone must be withdrawn gradually. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic steroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.

Description

Each tablet contains trimeprazine tartrate (USP) 10-[3-(Dimethylamino)-2-methylpropyl]phenothiazine tartrate (2:1) equivalent to trimeprazine, 5 mg, and prednisolone, 2 mg. Action: The exclusive Trimeprazine with Prednisolone formula combines the antipruritic and antitussive action of trimeprazine with the anti-inflammatory action of prednisolone. A therapeutic effect is attained by administering the tablets twice daily.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming trimeprazine and prednisolone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 2,088 reports

Reactions most often coded in dogs, 2,088 reports
VeDDRA reaction termReports
Lack of efficacy - NOS295
Vomiting280
Emesis225
Lethargy (see also Central nervous system depression in 'Neurological')217
Elevated serum alkaline phosphatase (SAP)159
Diarrhoea152
Anorexia143
Other abnormal test result NOS133
Polydipsia123
Elevated alanine aminotransferase (ALT)112
Polyuria109
INEFFECTIVE, LOSS OF EFFECT106
INEFFECTIVE, ATOPY CONTROL96
Death by euthanasia86
Depression82

Outcome as recorded by the reporter: Ongoing 741; Recovered/Normal 507; Outcome Unknown 332; Died 101; Euthanized 69; Recovered with Sequela 43.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Cats: 18 reports

Reactions most often coded in cats, 18 reports
VeDDRA reaction termReports
Accidental exposure5
Depression3
Systemic disorder NOS3
Vomiting3
Ataxia2
Blood in vomit2
Diarrhoea2
Lethargy (see also Central nervous system depression in 'Neurological')2
No sign2
Other abnormal test result NOS2
Proteinuria2
Weight loss2
Abdominal effusion1
Abnormal pupil light reflex1
Abnormal ultrasound finding1

Outcome as recorded by the reporter: Ongoing 4; Outcome Unknown 2; Died 1; Euthanized 1; Recovered/Normal 1.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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