PHENYLBUTAZONE powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S)

Available from:

MWI/VetOne

Administration route:

ORAL

Prescription type:

PRESCRIPTION

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

Product summary:

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.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PHENYLBUTAZONE- PHENYLBUTAZONE POWDER
MWI/VETONE
----------
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.
DESCRIPTION
Phenylbutazone chemically is
4-butyl-1,2-diphenyl-3,5-pyrazolidinedione.
C
H
N O
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.
19
20
2
2
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