AmTech Phenylbutazone Tablets, USP 1 gram

Manufacturer: IVX Animal Health

Anti-inflammatory

For Oral Use In Horses Only

Keep Out Of Reach Of Children

Nada 91-818, Approved By Fda

AmTech Phenylbutazone Tablets, USP 1 gram Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra label use of this product in female dairy cattle 20 months of age or older.

Description

Phenylbutazone chemically is 4-butyl-1, 2 diphenyl-3, 5-pyrazolidinedione.

C₁₉H₂₀N₂O₂

Mol. Wt. 308.38

Each tablet contains 1 g of phenylbutazone

Background Pharmacology

Phenylbutazone was first synthesized in 1948 and introduced into human medicine in 1949. Kuzell (1), (2), (3), Payne, (4), Fleming, (5) and Denko, (6) demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre (7), Domenjoz, (8), Wilhelmi, (9) and Yourish, (10), have established the anti-rheumatic and anti-inflammatory activity of phenylbutazone. It is entirely unrelated to the steroid hormones.

Toxicity of phenylbutazone has been investigated in rats and mice (11), and dogs (12).

Phenylbutazone has been used by Camberos (13), in thoroughbred horses. Favorable results were reported in cases of traumatism, muscle rupture, strains and inflammations of the third phalanx. Results were not as favorable in the periodic treatment of osteoarthritis of the stifle and hip, arthrosis of the trapezious muscles and general arthritis. Sutter, (14) reported a favorable response in chronic equine arthritis of long duration, fair results in severely bruised mare and poor results in two cases where the condition was limited to the third phalanx.

AmTech Phenylbutazone Tablets, USP 1 gram Indications

Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses.

AmTech Phenylbutazone Tablets, USP 1 gram Dosage And Administration

For Horses Only: Orally 1 to 2 tablets per 500 pounds of body weight, but not to exceed 4 g per animal daily. Use high dose for the first 48 hours, then gradually reduce to a maintenance dose.

Contraindications

Use with caution in patients who have history of drug allergy.

Precaution

In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.

Warning

Do not use in horses intended for human consumption.

How Supplied

Tablets containing 1 gram of phenylbutazone are supplied in bottles of 100 tablets.

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

References

1. Kuzell, WC, Schaffarzick, RW, Naughler, WE, Gandia, C and Mankle, EA: A.M.A. Arch. Inst. Med., 92,646 (1953).

2. Kuzell, WC, Schaffarzick, RW, Brown, B and Mankle, EA: J.A.M.A. 149; 729 (1952).

3. Kuzell, WC and Schaffarzick, RW: Calif. Med. 77; 319 (1952).

4. Payne, RW, Shelter, MR, Farr, CH, Hellbaum, AA and Ishmall, WK: J. Lab. Clin. Med. 45; 331 (1955).

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

6. Denko, CW and Rumi, D: American Pract. 6; 1865 (1955).

7. Fabre, J, et al: Semain. Hop. (Paris) 31; 87 (1955).

8. Domenjoz, R, et al: Arzneimittel-Forsch, 5; 488 (1955).

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

10. Yourish, W, Paton, B, Brodie, B, Burns, J: A.M.A. Arch. Ophth., 53: 264 (1955).

11. Hazelton, LW, Tusing, TW and Hollana, EG: J. Pharmacol, Exper. Ther., 109; 387 (1953).

12. Ogilvie, FB and Sutter, MD: Vet. Med 52; 492-4 (1957).

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

14. Sutter, MD: Vet. Med., 53; 83 (Feb. 1958).

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

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

801021 Rev0406

NET CONTENTS:	NDC
100 Tablets	59130-715-34	801021-34 Rev1207

Nac No.

10740364