Rx PredniSONE, 2.5 mg, Single Tablet

The keystone of satisfactory therapeutic management with prednisonetablets, as with other steroid predecessors, isindividualization of dosage in reference to the severity of thedisease, the anticipated duration of steroid therapy, and the animalpatient's threshold or tolerance for steroid excess. The primeobjective of steroid therapy should be to achieve a satisfactory degreeof control with a minimum effective daily dose.

The dosage recommendations are suggested average total daily dosesand are intended as guides. As with other orally administeredcorticosteroids, the total daily dose of prednisone should be givenin equally divided doses. The initial suppressive dose level iscontinued until a satisfactory clinical response is obtained, a periodusually of 2 to 7 days in the case of musculoskeletal diseases,allergic conditions affecting the skin or respiratory tract, and ocularinflammatory diseases. If a satisfactory response is not obtained in 7days, reevaluation of the case to confirm the original diagnosis shouldbe made. As soon as a satisfactory clinical response is obtained, thedaily dose should be reduced gradually, either to termination oftreatment in the case of acute conditions (e.g., seasonal asthma,dermatitis, acute ocular inflammations) or to the minimal effectivemaintenance dose level in the case of chronic conditions (e.g.,rheumatoid arthritis). In chronic conditions, and in rheumatoidarthritis especially, it is important that the reduction in dosage frominitial to maintenance dose levels be accomplished slowly. Themaintenance dose level should be adjusted from time to time as requiredby fluctuation in the activity of the disease and the animal's generalstatus. Accumulated experience has shown that the long-term benefits tobe gained from continued steroid maintenance are probably greater thelower the maintenance dose level. In rheumatoid arthritis inparticular, maintenance steroid therapy should be at the lowestpossible level.

Important: In the therapeutic management of animal patientswith chronic diseases such as rheumatoid arthritis, prednisone shouldbe regarded as a highly valuable adjunct, to be used in conjunctionwith, but not as replacement for, standard therapeutic measures.

2.5 mg per 10 lb (4.5 kg) body weight per day. Average total daily oraldoses for dogs as follows:

The total daily dose should be given in divided doses, 6 to 10 hours apart.

Federal law restricts this drug to use by or on the order of alicensedveterinarian.

Because of its inhibitory effect on fibroplasia, prednisone maymask the signs of infection and enhance dissemination of the infectingorganism. Hence, all animal patients receiving prednisone should bewatched for evidence of intercurrent infection. Should infection occur,it must be brought under control by use of appropriate antibacterialmeasures, or administration of prednisone should be discontinued.

Not for human use. Clinical and experimental data have demonstratedthat corticosteroids administered orally or by injection to animals mayinduce the first stage of parturition if used during the last trimesterof pregnancy and may precipitate premature parturition followed bydystocia, fetal death, retained placenta, and metritis.Additionally, corticosteroids administered to dogs, rabbits, androdents during pregnancy have resulted in cleft palate in offspring.Corticosteroids administered to dogs during pregnancy have alsoresulted in other congenital anomalies, including deformed forelegs,phocomelia, and anasarca.

PRECAUTIONS

Prednisone is a potent therapeutic agent influencing the biochemicalbehavior of most, if not all, tissues of the body. Because thisanti-inflammatory steroid manifests little sodium-retaining activity,the usual early sign of cortisone or hydrocortisone overdosage (i.e.,increase in body weight due to fluid retention) is not a reliable indexof overdosage. Hence, recommended dose levels should not be exceeded,and all animal patients receiving prednisone should be under closemedical supervision. All precautions pertinent to the use ofmethylprednisolone apply to prednisone. Moreover, the veterinarianshould endeavor to keep informed of current studies of corticosteroidsas they are reported in the veterinary literature.Use of corticosteroids, depending on dose, duration and specificsteroid, may result in inhibition of endogenous steroid productionfollowing drug withdrawal. In patients presently receiving or recentlywithdrawn from systemic corticosteroid treatments, therapy with arapid-acting corticosteroid should be considered in unusually stressfulsituations.

Store at controlled room temperature 15°- 30° C (59° - 86° F).

CONTRAINDICATIONS

Do not use in viral infections. Prednisone, like methylprednisolone,is contraindicated in animals with peptic ulcer, corneal ulcer, andCushingoid syndrome. The presence of diabetes, osteoporosis,predisposition to thrombophlebitis, hypertension, congestive heartfailure, renal insufficiency, and active tuberculosis necessitatescarefully controlled use. Some of the above conditions occur onlyrarely in dogs but should be kept in mind.

Prednisone is similar to methylprednisolone in regard to kinds ofside effects and metabolic alterations to be anticipated when treatmentis intensive or prolonged. In animal patients with diabetes mellitus,use of prednisone may be associated with an increase in the insulinrequirement. Negative nitrogen balance may occur, particularly inanimals that require protracted maintenance therapy; measures tocounteract persistent nitrogen loss include a high protein intake andthe administration, when indicated, of a suitable anabolic agent.Excessive loss of potassium, like excessive retention of sodium, is notlikely to be induced by effective maintenance doses of prednisone.However, these effects should be kept in mind and the usual regulatorymeasures employed as indicated. Ecchymotic manifestations in dogs mayoccur. If such reactions do occur and are serious, reduction in dose ordiscontinuance of prednisone therapy may be indicated.Side effects, such as SAP and SALT enzyme elevations, weight loss,anorexia, polydipsia and polyuria have occurred following the use ofsynthetic cortico-steroids in dogs. Vomiting and diarrhea (occasionallybloody) have also been observed. Cushing's syndrome in dogs has beenreported in association with prolonged or repeated steroid therapy.

Since prednisone, like methylprednisolone, suppresses endogenousadrenocortical activity, it is highly important that the animalpatient receiving prednisone be under careful observation, not onlyduring the course of treatment but for some time after treatment isterminated. Adequate adrenocortical supportive therapy with cortisoneor hydrocortisone, and including ACTH, must be employed promptly if theanimal is subjected to any unusual stress such as surgery, trauma, orsevere infection.

Prescription

This item requires a valid prescription from a licensed veterinarian.