Temaril-P

Manufacturer
Zoetis Inc.
Effective date
2023-01-12
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:41:51

Label at a glance#

ProductTemaril-P
Active ingredientTRIMEPRAZINE TARTRATE, PREDNISOLONE
Label structure14 sections

Indications and uses

Temaril-P 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 ...

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 ...

Storage and handling

Store in a Dry, Cool Place at Temperatures Not Above 25°C (77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Temaril-P®
(trimeprazine with prednisolone)
Tablets

Antipruritic–Antitussive–Anti-inflammatory

For use in dogs

CAUTION

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

DESCRIPTION SECTION

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

MECHANISM OF ACTION SECTION

The exclusive Temaril-P 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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

1. Antipruritic

SPL UNCLASSIFIED SECTION

Temaril-P 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

SPL UNCLASSIFIED SECTION

Temaril-P has been found to be effective therapy and adjunctive therapy in various cough conditions of dogs. Therefore, in addition to its antipruritic action, Temaril-P 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 Temaril-P 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: Temaril-P may be administered to animals suffering from acute or chronic bacterial infections provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.

WARNING

WARNINGS SECTION

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.

PRECAUTIONS AND SIDE EFFECTS

PRECAUTIONS SECTION

All the precautions applicable to cortisone and to phenothiazine derivatives apply also to Temaril-P. 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 Temaril-P should be reduced and discontinued unless the severity of the condition being treated makes its relief paramount.

Prolonged treatment with Temaril-P 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The same dosage schedule may be followed for both antipruritic and antitussive therapy.

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.

STORAGE AND HANDLING SECTION

Store in a Dry, Cool Place at Temperatures Not Above 25°C (77°F)

HOW SUPPLIED

HOW SUPPLIED SECTION

100- and 1000-tablet bottles.

REFERENCES

REFERENCES SECTION

1. Knowles JO, Knowles RP: Preliminary reports on an effective antipruritic agent. Vet Med 55(8):67–68, 1960.
2. Candlin FT: An agent to aid in control of pruritus. Vet Med 56(5):207–208, 1961.
3. Yoxall AT, Hird JRF: Pharmacological Basis of Small Animal Medicine. Blackwell Scientific Publications, London, pp. 99–102, 1979.
4. Booth N, McDonald LE: Veterinary Pharmacology and Therapeutics, 5th ed. Iowa State University Press, Ames, pp. 564–570, 1982.
5. Davis L: Handbook of Small Animal Therapeutics.Churchill Livingstone, New York, pp. 140–142; 459–461; 468–469, 1985.
6. Scott D: Systemic glucocorticoid therapy. Current Veterinary Therapy, Kirk WV Saunders, ed., Philadelphia, pp. 988–994, 1980.
7. Lecture: “Rational Steroid Therapy” Duncan C. Ferguson, VMD, PhD, Department of Pharmacology, Cornell University.
8. Kemppianen RJ, Lorenz MD, Thompson FN: Adrenocortical suppression in the dog given a single intramuscular dose of prednisolone or triamcinolone acetonide. Am J Vet Res 42(2):204–206, 1982.
9. Rogers WA, Ruebner BH: A retrospective study of probable glucocorticoid induced hepatopathy in dogs. JAVMA 1977;170(6): 603-605.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 012-437

zoetis

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

40031413

Revised: May 2020

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40031414

PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40031415

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
897059prednisoLONE 2 MG / trimeprazine tartrate 5 MG Oral TabletPSN7
897063Temaril-P 5 MG / 2 MG Oral TabletPSN7
897063prednisolone 2 MG / trimeprazine tartrate 5 MG Oral Tablet [Temaril-P]SBD7
897059prednisolone 2 MG / trimeprazine tartrate 5 MG Oral TabletSCD7
897063Temaril-P (prednisolone 2 MG / trimeprazine tartrate 5 MG) Oral TabletSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-8550-1Temaril-P100 in 1 BOTTLETABLET1007
54771-8550-2Temaril-P1000 in 1 BOTTLETABLET10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-8550TEMARIL-P (TRIMEPRAZINE TARTRATE AND PREDNISOLONE) TABLET [ZOETIS INC.]72 package rows20230113_9de07d0d-44df-47da-b4b7-24f5fc803b46.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
prednisoloneACTIVE INGREDIENT9PHQ9Y1OLM1
trimeprazine tartrateACTIVE INGREDIENT362NW1LD6Z1
prednisoloneACTIVE MOIETY9PHQ9Y1OLM1
trimeprazineACTIVE MOIETY76H78MJJ521

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-855054771-8550-1, 54771-8550-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIMEPRAZINE TARTRATE362NW1LD6ZACTIM
PREDNISOLONE9PHQ9Y1OLMACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.