AmTech Phenylbutazone Tablets, USP 100 mg

Background Pharmacology

Kuzell, (1,2,3) Payne, (4) Fleming, (5) and Denko, (6) demonstrated clinical effectiveness of Phenylbutazone in acute rheumatism, gout, gouty, arthritis, and various other rheumatoid disorders in man. Anti-inflammatory activity has been well established by Fabre, (7), Domenjoz, (8) Wilhelmi, (9) and Yourish, (10).

Lieberman (11) reported on the effective use of phenylbutazone in the treatment of painful conditions of the musculoskeletal system in dogs. Joshua (12) observed objective improvement without toxicity following long term therapy of two aged arthritic dogs. Ogilvie and Sutter (13) reported rapid response to phenylbutazone therapy in a review of 19 clinical cases including arthritis, rheumatism, and other conditions associated with lameness and musculoskeletal weakness. Camberos (14) reported favorable results with phenylbutazone following intermittent treatment of Thoroughbred horses for arthritis and chronic arthrosis (e.g., osteoarthritis of medial, and distal bones of the hock, arthritis of stifle and hip, arthrosis of the spine, chronic hip pains, chronic pain in trapezius muscles, and generalized arthritis). Results were less favorable in cases of traumatism, muscle rupture, strains, and inflammations of the third phalanx. Sutter (15) reported favorable response in chronic equine arthritis, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx.

AmTech Phenylbutazone Tablets, USP 100 mg Indications

For relief of inflammatory conditions associated with the musculoskeletal system in dogs.

Contraindications

Animals showing evidence of cardiac, hepatic, or renal damage or a history of blood dyscrasia, or those with signs or history of anemia.

Precautions

Stop medication at first sign of gastrointestinal upset, jaundice, or blood dyscrasia. Authenticated cases of agranulocytosis associated with the drug have occurred in man; fatal reactions, although rare, have been reported in dogs after long-term therapy. To guard against this possibility, conduct routine blood counts at weekly intervals during the early phase of therapy and at intervals of two weeks thereafter. Any significant fall in the total white count, relative decrease in granulocytes, or black or tarry stools, should be regarded as a signal for immediate cessation of therapy and institution of appropriate counter measures.

In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy is required.

Administration And Dosage

ORALLY-20 mg per lb of body weight (100 mg/5 lb) in three divided doses daily. Maximum dose is 800 mg per day regardless of weight. Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing desired clinical response.

Guidelines To Successful Therapy

1. Response to Phenylbutazone therapy is prompt, usually occurring within 24 hours. If no significant clinical response is evident after 5 days, re-evalutate diagnosis and therapeutic approach.

2. In animals, Phenylbutazone is largely metabolized in 8 hours. It is recommended that a third of the daily dose be administered at 8 hour intervals. Reduce dosage as symptoms regress. In some cases, treatment may be given only when symptoms appear with no need for continuous medication. If long term therapy is planned, oral administration is suggested.

3. In many cases, tablets may be crushed and given with feed.

4. Many chronic conditions will respond to Phenylbutazone therapy, but discontinuance of treatment may result in recurrence of symptoms.

5. The duration of treatment will depend upon the degree of severity of the condition and generally ranges from 6 to 14 days with retreatment given only to control recurring symptoms. If there is no improvement in 5 days, discontinue treatment.

How Supplied

Phenylbutazone Tablets, USP 100 mg are supplied in bottles of 1000 tablets.

Store At Controlled Room Temperature, 20° To 25°c (68° To 77°f).

Dispense In A Tight Container With Child-resistant Closure.

references

1. Kuzell, W.C., Schaffarzick, R.W., Naugler, W.G., and Mankle, E.A.: A.M.A. Arch. Int. Med. 92:646, 1953

2. Kuzell, W.C., Schaffarzick, R.W., Brown, B., and Mankle, E.A.: Jour. Amer. Med. Assoc. 149:729, 1952

3. Kuzell, W.C., and Schaffarzick, R.W.: Calif. Med. 77:319, 1952

4. Payne, R.W., Sheltlar, M.R., Farr, C., Hellbaum, A.A. and Ishmael, W.K.T.: J. Lab. Clin. Med. 45:331, 1955

5. Fleming, J., and Will, G.: Ann. Rheumat. Dis. 12:95, 1953

6. Denko, C.W., and Ruml, D.: Amer. Practit. 6:1865, 1955

7. Fabre, J., and Berger, A.: Semaine Hop. (Paris) 31:87, 1955

8. Domenjoz, R., Theobald, W. and Morsdorf, K.: Arzneimittel-Forsch. 5:488, 1955

9. Wilhelmi, G., and Pulver, R.: Arzneimittel-Forsch. 5:221, 1955

10. Yourish, N., Paton, B., Brodie, B.B., and Burns, J.J.: A.M.A. Arch. Ophth. 53:264, 1955

11. Lieberman, L.L.: Jour. Amer. Vet. Assoc. 125:128, 1954

12. Joshua, J.O.: Vet. Rec. 68:60 (Jan. 21), 1956

13. Ogilvie, F.B., and Sutter, M.D.: Vet. Med. 52:492-494, 1957

13. Camberos, H.R.: Rev. Med. Vet. (Buenos Aires), 38:9, 1956

14. Sutter, M.D.: Vet. Med. 53:83 (Feb.), 1958

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Manufactured By IVX Animal Health, Inc., St. Joseph, MO 64503

AmTech^® is a registered trademark of IVX Animal Health, Inc.

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