PHENYLBUTAZONE BOLUSES- phenylbutazone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Butler Animal health Supply, LLC dba Covetrus North America

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

For oral use in horses only Non-steroidal anti-inflammatory drug (NSAID) Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses. Use with caution in patients who have a history of drug allergy.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PHENYLBUTAZONE BOLUSES- PHENYLBUTAZONE TABLET
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
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PHENYLBUTAZONE
BOLUSES
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 extra-label use of this product in female
dairy cattle 20 months
of age or older.
APPROVED BY FDA UNDER ANADA # 200-433
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
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, Kuzell
, Payne , Fleming , and Denko , demonstrated the clinical
effectiveness
of phenylbutazone in gout, gouty arthritis, acute arthritis, acute
rheumatism and various
other rheumatoid disorders in humans. Fabre , Domenjoz , Wilhelmi
, and Yourish
,
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
, Ogilvie and
Sutter
, 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 Camberos
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
respo