Phenylbutazone

This drug is used for the relief of inflammatory conditions associated with the musculoskeletal system.

Do not exceed a daily dosage of 4 grams per day. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level the lowest dosage maintained at the level capable of producing the desired clinical response. Not for use in animals intended for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets

For the relief of inflammatory conditions associated with the musculoskeletal system in horses.

Do not use in horses intended for human consumption. Federal law prohibits extra label use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets, USP 1 gram

For the treatment of inflammatory conditions associated with the musculoskeletal system.

Administer orally by adding to a portion of the usual grain ration. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Treated animals should not be slaughtered for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butazolidin® Granules

The drug is used for the relief of inflammatory conditions associated with a musculoskeletal system.

Administer in three divided doses daily. Do not exceed a total daily dose of 800 milligrams regardless of body weight. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets

For the relief of inflammatory conditions associated with the musculoskeletal system.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butatron®

ACTIONS AND USES: Kuzell (1,2,3), Payne (4), Flemming (5) and Denko (6), demonstrated clinical effectiveness of phenylbutazone in acute rheumatism, gout, gouty arthritis and various other rheumatoid diseases in man. Anti-inflammatory activity has been well established by Fabre (7), Domenjoz (8), Wilhelmi (9), and Yourish (10). Lieberman (11) reported on the effective use of phenylbutazone in the treatment of conditions of the musculoskeletal system in dogs, including posterior paralysis associated with intervertebral disc syndrome, fractures, arthritis and injuries to the limbs and joints. Joshua (12) observed objective improvement without toxicity following long-term therapy of two aged arthritic dogs. Ogilvie and Sutter (13) reported rapid response to phenylbutazone therapy in a review of 19 clinical cases including posterior paralysis, posterior weakness, arthritis, rheumatism and other conditions associated with lameness and musculoskeletal weakness. Camberos (14) reported favorable results with phenylbutazone following intermittent treatment of thoroughbred horses and arthritis and chronic arthrosis (e.g. osteoarthritis of medical and distal bones of the hock, arthritis of the stifle and hip, arthrosis of the spine and generalized arthritis). Results were less favorable in cases of traumatism, muscle rupture, strains and inflammatory conditions of the third phalanx. Sutter (15) reported favorable responses in chronic equine arthritis, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx. INDICATIONS: Phenylbutazone possesses non-hormonal, anti-inflammatory activity of value in the management of musculoskeletal conditions in dogs and horses such as the arthritides, including osteoarthritis, and as an aid in the relief of inflammation associated with intervertebral disc syndrome in dogs.

FDA application 044-756

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.

PHENYLBUTAZONE 20% INJECTION 200 mg/mL

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. Store in a refrigerator between 2oC and 8oC (36oF and 46oF).

Phenylbutazone

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.

PHENYLBUTE (phenylbutazone) Powder

Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses.

PhenylbutazoneBoluses

For relief of inflammatory conditions associated with the musculoskeletal system in horses.

Phenylbute® Injection 20% (Phenylbutazone)

For Oral Use in Horses Only. Non-steroidal anti-inflammatory drug (NSAID)

Pributazone® (phenylbutazone boluses)

Kuzell, 1, 2, 3 Payne,4 Fleming,5 and Denko6 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,7 Domenjoz,8 Wilhelmi,9 and Yourish.10 Lieberman 11 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. Joshua12 observed objective improvement without toxicity following long-term therapy of two aged arthritic dogs. Ogilvie and Sutter13 reported rapid response to phenylbutazone therapy in a review of 19 clinical cases including posterior paralysis, posterior weakness, arthritis, rheumatism, and other conditions associated with lameness and musculoskeletal weakness. Camberos14 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, arthrosis of the spine, chronic hip pains, chronic pain in the trapezius muscles, and generalized arthritis). Results were less favorable in cases of traumatism, muscle rupture, strains and inflammations of the third phalanx. Sutter15 reported favorable response in chronic equine arthritis, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx

PHENYLBUTAZONE 20% INJECTION 200 mg/mL

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.

PHENYLBUTE (phenylbutazone) Powder

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.

Phenylbute® Injection 20% (Phenylbutazone)

CONTRAINDICATIONS: Phenylbutazone should not be administered to animals with serious hepatic, renal or cardiac pathology, or those with a history of blood dyscrasia.

FDA application 044-756

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

BUTEQUINE™ (phenylbutazone) Paste for Horses

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

PhenylbutazoneBoluses

HAZARDS AND PRECAUTIONS: 1. Use with caution in animals with a history of drug allergy. 2. Stop medication at the first sign of gastrointestinal upset, jaundice or blood dyscrasia. Authenticated cases of agranulocytosis associated with phenylbutazone have occured in man. Phenylbutazone induced blood dyscrasias have been reported in dogs. Throbocytopenia and leukopenia are early manifestations followed by nonregenerative anemia. The occurrence of this reaction is not dose depended and is unpredictable. To guard against this possibility, conduct routine blood counts at not more than 7 day intervals during the early course of therapy, and at intervals of not more than 14 days throughout the course of therapy. Any significant fall in the total white count, relative decrease in granulocytes or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate treatment. 3. When treating inflammatory conditions associated with infection, specific anti-infective therapy is required. 4. Response to phenylbutazone therapy is prompt, usually occurring within 24 hours. If no significant clinical response is evident after 5 days of therapy, re-evaluate diagnosis and therapeutic regimen.

FDA application 044-756

Not for use in humans. Keep out of reach of children. Keep Phenylbutazone Boluses in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. Do not use in horses intended for human consumption.

PhenylbutazoneBoluses

WARNING: PHENYLBUTAZONE SHOULD NOT BE ADMINISTERED TO MEAT, EGG OR MILK PRODUCING ANIMALS BECAUSE THE STATUS OF RESIDUES OF DRUG REMAINING IN EDIBLE TISSUES HAS NOT BEEN DETERMINED.

FDA application 044-756

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

PHENYLBUTE (phenylbutazone) Powder

WARNING: Do not use in horses intended for human consumption.

BUTEQUINE™ (phenylbutazone) Paste for Horses

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

PhenylbutazoneBoluses

One to two grams per 500 pounds weight daily. Do not exceed a daily dosage of 4 grams per day. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level the lowest dosage maintained at the level capable of producing the desired clinical response.

Oral

Not for use in animals intended for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butazolidin® Bolus

It is administered intravenously at a dosage level of 1 to 2 grams per 1,000 pounds of body weight daily in 3 divided doses, not to exceed 4 grams daily. Limit intravenous administration to not more than 5 successive days.

Intravenous

Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone 20% Injection

Administer by intravenous injection 1 to 2 grams (g) per 1,000 pounds of body weight daily in three divided doses, not to exceed 4 g daily. Limit intravenous administration to not more than 5 successive days.

Intravenous

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

EquiBute Injection

1 to 2 tablets per 500 pounds of body weight, but not to exceed 4 g per animal daily. Use high dose for the first 48 hours, then gradually reduce to a maintenance dose.

Oral

Do not use in horses intended for human consumption. Federal law prohibits extra label use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets, USP 1 gram

Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed, not exceed 4 g per animal daily.

Oral

Do not use in horses intended for human consumption. Do not exceed a daily dosage of 4 grams per day. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Superiorbute®

It is administered intravenously at a dosage level of 1 to 2 grams per 1,000 pounds of body weight daily in 3 divided doses, not to exceed 4 grams daily.

Intravenous

Limit intravenous administration to not more than 5 successive days. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Bizolin Injection 20%

Administer 1 to 2 boluses per 500 lb body weight, but not to exceed 4 g daily. Reduce dosage as symptoms regress.

Oral

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. Do not use in horses intended for human consumption.

Pributazone®

Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight.

Oral

Do not exceed 4 g per animal daily. Administer at a relatively high dosage level for the first 48 hours, then reduce gradually to a maintenance dosage level with the lowest dosage maintained at the level capable of producing the desired clinical response. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Equizone 100™

1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.

Oral

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butequine™

100 mg or 1 g tablet: 1-2 grams per 500 lbs. body weight, not to exceed 4 grams daily.

Oral

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butatron®

1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily as required.

Oral

Administer orally by adding to a portion of the usual grain ration. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Treated animals should not be slaughtered for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butazolidin® Granules

One to two grams per 500 pounds weight daily.

Oral

Do not exceed a daily dosage of 4 grams per day. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level the lowest dosage maintained at the level capable of producing the desired clinical response. Not for use in animals intended for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets

1 to 2 g per 500 pounds of body weight daily.

Oral

Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

EquiBute Tablets 100 mg

20 milligrams per pound of body weight daily. Administer in three divided doses daily. Do not exceed a total daily dose of 800 milligrams regardless of body weight. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butazolidin® Bolus

Administer twenty milligrams per pound of body weight in three divided doses daily. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response.

Oral

Do not exceed a total daily dose of 800 milligrams regardless of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets, USP 100 mg

It is administered intravenously at a dosage level of 10 milligrams per pound of body weight daily in 3 divided doses, not to exceed 800 milligrams daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.

Intravenous

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone 20% Injection

Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.

Intravenous

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

EquiBute Injection

100 mg tablet: 20 mg per pound body weight (100 mg/5 lbs.) daily in 3 divided doses, not to exceed 800 mg daily regardless of body weight.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butatron®

Twenty milligrams per pound of body weight daily.

Oral

Administer in three divided doses daily. Do not exceed a total daily dose of 800 milligrams regardless of body weight. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Phenylbutazone Tablets

20 mg per pound of body weight daily.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

EquiBute Tablets 100 mg

HORSES INTRAVENOUSLY : 1 to 2 g per 1,000 lbs of body weight (5 to 10 mL/1,000 lbs) daily. Injection should be given slowly and with care. Limit intravenous administration to a maximum of 5 successive days, which may be followed by oral phenylbutazone dosage forms. GUIDELINES TO SUCCESSFUL THERAPY 1. Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing desired clinical response. 2. Response to phenylbutazone therapy is prompt, usually occurring within 24 hours. If no significant clinical response is evident after 5 days, reevaluate diagnosis and therapeutic approach. 3. In animals, phenylbutazone is largely metabolized in 8 hours. It is recommended that a third of the daily dose be administered at 8 hour intervals. Reduce dosage as symptoms regress. In some cases, treatment may be given only when symptoms appear with no need for continuous medication. If long-term therapy is planned, oral administration is suggested. 4. Many chronic conditions will respond to phenylbutazone therapy, but discontinuance of treatment may result in recurrence of symptoms.

INTRAVENOUS

Phenylbute® Injection 20% (Phenylbutazone)

DOSAGE-DOGS: ORALLY 20 mg per pound body weight (100 mg/5 lbs.) daily in 3 divided doses, not to exceed 800 mg daily regardless of body weight. DOSAGE-HORSES: ORALLY 1-2 grams per 500 lbs. body weight, not to exceed 4 grams daily. ADMINISTRATION: 1. Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing the desired clinical response. 2. In many cases tablets may be crushed and given with feed. Reduce the dosage as symptoms regress. In some cases treatment may be given only when symptoms appear with no need for continuous medication. 3. In animals, phenylbutazone is largely metabolized in 8 hours. It is recommended that a third of the daily dose be administered at 8 hour intervals. 4. Many chronic conditions will respond to phenylbutazone therapy but discontinuance of treatment may result in the recurrence of symptoms.

ORAL

FDA application 044-756

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.

ORAL

PHENYLBUTE (phenylbutazone) Powder

ADMINISTRATION AND DOSAGE: Orally – 1 to 2 g of phenylbutazone per 500 lb. (227 kg) of body weight daily. Do not exceed 4 g daily. Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing desired clinical response.

ORAL

BUTEQUINE™ (phenylbutazone) Paste for Horses

For horses only. HORSES: Orally - 1 to 2 boluses per 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. Lot No. / Exp. Date

ORAL

PhenylbutazoneBoluses