PHENYLBUTAZONE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sparhawk Laboratories, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

    For relief of inflammatory conditions associated with the musculoskeletal system in horses. Treated animals should not be slaughtered for food purposes. Parenteral injections should be made intravenously only; do not inject subcutaneously or intramuscularly. Use with caution in patients who have a history of drug allergy. For relief of inflammatory conditions associated with the musculoskeletal system in horses. Intravenous dosage (not subcutaneous or intramuscular use) : Horses : 1 to 2 g per 1,000 lb body weight (5 to 10 mL/1,000 lb) daily. Not for use in Horses intended for food. See package outsert for additional information. Approved by FDA under ANADA 200-371 Each mL contains: Phenylbutazone ............................. 200 mg Benzyl Alcohol Preservative .........10.45 mg Sodium hydroxide to adjust pH to 9.5 to 10.0 Water For Injection ...............................q.s.

Product summary:

INJECTABLE : For Horses only: 100 mL vials, 200 mg/mL (1 g/5 mL) Each mL contians 200 mg of phenylbutazone, 10.45 mg of benzyl alcohol as preservative, sodium hydroxide to adjust pH to 9.5 to 10.0, and water for injection, Q.S.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PHENYLBUTAZONE- PHENYLBUTAZONE INJECTION
SPARHAWK LABORATORIES, INC.
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PHENYLBUTAZONE 20% INJECTION (PHENYLBUTAZONE)
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
FOR HORSES ONLY
APPROVED BY FDA UNDER ANADA # 200-371
DESCRIPTION: Phenylbutazone 20% Injection (phenylbutazone) is a
synthetic,
nonhormonal anti-inflammatory, antipyretic compound useful in the
management of
inflammatory conditions. The apparent analgesic effect is probably
related mainly to the
compound's anti-inflammatory properties. Chemically, phenylbutazone is
4-butyl-1,2-
diphenyl-3,5-pyrazolidinedione. It is a pyrazolon derivative entirely
unrelated to the
steroid hormones, and has the following structural formula:
BACKGROUND PHARMACOLOGY
Kuzell,
Payne,
Fleming,
and Denko demonstrated clinical effectiveness of
phenylbutazone in acute rheumatism, gout, gouty arthritis and various
other rheumatoid
disorders in man. Anti-rheumatic and anti-inflammatory activity has
been well established
by Fabre,
Domenjoz,
Wilhelmi,
and Yourish.
Lieberman
reported on the effective
use of phenylbutazone in the treatment of painful conditions of the
musculoskeletal
system in dogs; including posterior paralysis associated with
intervertebral disc
syndrome, painful fractures, arthritis, and painful injuries to the
limbs and joints.
Joshua
observed objective improvement without toxicity following long-term
therapy
of two aged arthritic dogs. Ogilvie and Sutter
reported rapid response to
phenylbutazone therapy in a review of 19 clinical cases including
posterior paralysis,
1, 2, 3
4
5
6
7
8
9
10
11
12
13
posterior weakness, arthritis, rheumatism, and other conditions
associated with
lameness and musculoskeletal weakness.
Camberos
reported favorable results with phenylbutazone following intermittent
treatment of Thoroughbred horses for arthritis and chronic arthrosis
(e.g.,
osteoarthritis of medial and distal bones of the hock, arthritis of
stifle and hip, arthros