Phenylbutazone by MWI/VetOne PHENYLBUTAZONE powder

Phenylbutazone by

Drug Labeling and Warnings

Phenylbutazone by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel 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 10 grams of powder contains 1 gram phenylbutazone

INDICATIONS

Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.

DOSAGE AND ADMINISTRATION

For Horses Only: Administer orally (using the 0.6  ounce (18 mL) scoop provided) on a small amount of palatable feed and mix well. Give 1 to 2 level scoops per 500 pounds of body weight, but do not exceed 4 scoops per animal daily. Use the high dose for the first 48 hours, then gradually reduce to a maintenance dose.

CONTRAINDICATIONS

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

WARNING

Do not use in horses intended for human consumption.

HUMAN WARNING

Keep this and all medications out of the reach of children. Dispense in tight, child resistant containers.

PRECAUTION

Concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.

CLINICAL 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 period 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.

HOW SUPPLIED

Phenylbutazone Powder is supplied in 1.1 lb (0.5 kg) jars and 2.2 lb (1 kg) jars each containing a dispensing scoop. One level scoop delivers 10 grams of powder containing 1 gram of phenylbutazone.

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, and 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 (1957).
13. Camberos, HR: Rev. Med. Vet. (Buenos Aries), 38:9 (1956).
14. Sutter, MD: Vet. Med., 53:83 (1958).

Approved by FDA under ANADA # 200-334

Principal Display Panel - Phenylbutazone Powder (1.1 lb jar)

​NDC: 13985-991-11

VETONE

Phenylbutazone

Powder

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

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

Approved by FDA under ANADA # 200-334

Net Contents: 1.1 lb (0.5 kg)

Principal Display Panel - Phenylbutazone Powder (2.2 lb jar)

NDC: 13985-991-22

VETONE™

Phenylbutazone

Powder

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID).

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

Approved by FDA under ANADA # 200-334

Net Contents: 2.2 lb (1 kg)

INGREDIENTS AND APPEARANCE

PHENYLBUTAZONE 
phenylbutazone powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-991
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S)	PHENYLBUTAZONE	1 g  in 10 g

Product Characteristics
Color	orange (Light orange powder)	Score
Shape		Size
Flavor	ORANGE (ORANGE FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-991-11	500 g in 1 JAR
2	NDC: 13985-991-22	1000 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200334	05/01/2009

Labeler - MWI/VetOne (019926120)