Bupactin

Each tablet contains Phenylbutazone 1 g. Inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, and Sodium Starch Glycolate.

Bupactin Indications And Usage

Bupactin tablets have non-hormonal anti-inflammatory properties in the management of musculoskeletal conditions in horses, such as generalized arthritis.

Contraindications

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

Warning

Treated animals should not be slaughtered for food purposes.

Precautions

Stop medication at first sign of gastrointestinal upset, blood dyscrasia, jaundice, or black or tarry stools. Agranulocytosis associated with the drug has occurred in man and was reversible upon discontinuance of treatment. Fatal reactions, although rare, have been reported in dogs after long-term therapy. Routine blood counts should be made at weekly intervals during the early phase of therapy and thereafter at intervals of two weeks. A significant fall in total white count, or a relative decrease in granulocytes, or black or tarry stools indicate that therapy with Bupactin tablets should be immediately discontinued. In the treatment of inflammatory conditions associated with infection specific anti-infective therapy is required. Caution should be observed when administering to patients with a history of drug allergy.

Bupactin Dosage And Administration

Horses: 2 to 4 mg per lb of body weight (equivalent to 1 to 2 grams per 500 lb of body weight) or 2 to 4 Bupactin tablets, for 1000 lb of body weight per day. Do not exceed 4 grams per animal per day. As symptoms regress, reduce dosage 25% to 50% of initial dose as needed to control symptoms. If there is no improvement in 5 days discontinue treatment. Infective conditions should be treated concurrently with the proper anti-infectives. Response to treatment is variable, as is also the tolerance for the drug. Withdrawal of the drug may be followed by reappearance of symptoms, after which it may be given intermittently to control symptoms. The drug is symptomatic in action and not curative.

Recommendations

Use up to the maximum recommended dose for the first 48 hours. As symptoms regress, reduce dosage 25% to 50% of the initial “loading dose” as needed to control symptoms.

Because of the more rapid metabolism in animals, administer Bupactin tablets in 3 divided daily doses (at 8-hour intervals) to maintain therapeutic blood level. Response to treatment with Bupactin tablets usually occurs within 24 hours after the initial dose. If no response is evident after 5 days of dosing, treatment should be discontinued.

While many chronic conditions, such as chronic osteoarthritis, will respond to phenylbutazone therapy, no permanent cure can be affected owing to the advance tissue changes. In such cases discontinuance of treatment often will result in recurrence of symptoms. However, intermittent therapy may be extremely valuable to alleviate symptoms of chronic inflammatory lesions.

How Supplied

Bupactin tablets are supplied as white, round, scored tablets, embossed “WW 462” on scored side and plain on the other side. Bottles of 100 tablets.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Bupactin Caution

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

Keep Out Of The Reach Of Children.

For use in animals only.

References

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

2. Kuzell,W.C.; Schaffarzick, R.W.; Brown, B.; and Mankle, E. A. JAMA 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. AMA Arch. Ophth. 53:264 (1955)

11. Lieberman. L. L. Jour. Amer. Vet. Med. Assoc. 125:128 (1954)

12. Joshua, J. 0. Vet. Rec. 68:60 (Jan. 21, 1956)

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

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

15. Sutter, M. D. Vet. Med. 58:83 (Feb., 1958)

Manufactured for Apical Pharmaceutical Corp. Miami, FL USA

Bupactin™ is a trademark of Apical Pharmaceutical, Inc.

C-2

Nac No.

12970010