PRIBUTAZONE- phenylbutazone tablet

PRIBUTAZONE by

Drug Labeling and Warnings

PRIBUTAZONE by is a Animal medication manufactured, distributed, or labeled by FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Phenylbutazone Boluses

For Oral Use in Horses Only

Non-steroidal anti-inflammatory drug (NSAID)

DESCRIPTION & PHARMACOLOGY:

Phenylbutazone chemically is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It has the following structural formula:

Phenylbutazone was first synthesized in 1948 and introduced into human medicine in 1949, Kuzell1,2,3, Payne4, Fleming5, and Denko6, demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre7, Domenjoz8, Wilhelmi9, and Yourish10, 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 mice11, Ogilvie and Sutter12, have also made a study on the chronic toxicity of phenylbutazone in dogs. They have shown that dogs receiving 10 mg. and 100 mg. per Kg. body weight, per day for 90 days, maintain good appetites, excrete normal feces, gain weight and maintain a normal blood picture. They also report no abnormal macroscopic or microscopic changes in sacrificed animals which could have been attributed to the drug. Phenylbutazone has been used by Camberos13 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 osteo-arthritis of medial and distal bones of the hock, arthritis of the stifle and hip, arthrosis of the trapezious muscles, and generalized arthritis. Sutter14 reported a favorable response in chronic equine arthritis of long duration, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx.

INDICATIONS:

Phenylbutazone is for the relief of inflammatory conditons associated withthe musculoskeletal system in horses.

DOSAGE & ADMINISTRATION:

For horses only.

HORSES: Orally - 1 to 2 boluses pr 500 lb. body weight. Do not exceed 4 grams daily. Reduce dosage as symptoms regress. Intermittent treatment given only when symptoms appear may be indicated.

CONTRAINDICATIONS:

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

PRECAUTION:

Concomitant use with other antiinflammatory drugs, such as NSAIDS or corticosterioids, should be avoided or closely monitored. 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.

CAUTION:

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

AVAILABILITY:

Available in 1 gm. boluses - 100 boluses per bottle.

REFERENCES:

1. Kuzell, W.C., Schafferzick, R.W., Naughler, W.E., Gandia, G. and Mankle, E.A.: A.M.A. Arch. Inst. Med., 92; 646 (1953).

2. Kuzell, W.C., Schafferzick, R.W., Brown, B. and Mankle, E.A.: J.A.M.A. 149; 729 (1952).

3. Kuzell, W.C., and Schafferzick, R.W.: Calif. Med. 77; 319 (1952).

4. Payne, R.W., Shelter, M.R., Farr, C.H., Hellbaum, A.A. and Ishmall, W.K.: J. Lab. Clin. Med., 45; 331 (1955).

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

6. Denko, C.W., and Rumi, D.: American Pract. 6; 1865 (1956).

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, L.W., Tusing, T.W. and Hollana,E.G.: J. Pharmacol. Exper. Ther., 109; 387 (1953).

12. Ogilvie, F.B. and Sutter, M.D.: Vet. Med. 52;492-4 (1957).

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

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

Iss. 05-09

IMAGE OF LABEL

image of label

INGREDIENTS AND APPEARANCE

PRIBUTAZONE  
phenylbutazone tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58829-334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S)	PHENYLBUTAZONE	1 g

Product Characteristics
Color	white (WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	18mm
Flavor		Imprint Code	BUTE;1GM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58829-334-10	12 in 1 CASE
1		100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200433	09/01/2009

Labeler - FIRST PRIORITY INCORPORATED (179925722)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture