1. Home
  2. Animal Drug Index - P
  3. Pributazone

Animal NDC 58829-334-10 Pributazone

Phenylbutazone

Animal Product Information

Field Name Field Value
Animal NDC Code 58829-334-10
Proprietary Name Pributazone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Phenylbutazone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name First Priority Incorporated
Product Type Prescription Animal Drug
Usage Information
    For Oral Use in Horses Only.Non-steroidal anti-inflammatory drug (NSAID)
Active Ingredient(s)
  • Phenylbutazone
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200433 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Pributazone Images

Pributazone Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications & Usage



For Oral Use in Horses Only.

Non-steroidal anti-inflammatory drug (NSAID)


Caution:



Federal law restricts this drug to use by closed when not in use. 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.

Not for Use in Humans • Keep Out of Reach of Children

Approved by FDA under ANADA # 200-433

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.


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, Kuzell1,2,3, Payne4, Fleming5, and Denko6, demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre7, Domenjoz8, Wilhelmi9, and Yourish10, 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 mice11, Ogilvie and Sutter12, 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 Camberos13 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 response in chronic equine arthritis of long duration, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx.


Indications:



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


Dosage & Administration:



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.


Ingredients:



Each bolus contains:
Phenylbutazone, U.S.P. ............................. 1 gram
Plus excipients.


Contraindications:



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


Precaution:



Concomitant use with other antiinflammatory drugs, such as NSAIDS or corticosteroids, should be avoided or closely monitored. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.


Warning:



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.


Contact Information:



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


Availability:



Available in 1 gm. boluses - 100 boluses per bottle.

Reorder No. OM036PC


Storage:



Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use.

Lot No. Exp. Date


References



1. Kuzell, W.C., Schafferzick, R.W., Naughler, W.E., Gandia, G. and Mankle, E.A.: A.M.A. Arch. Inst. Med., 92; 646 (1953).
2. Kuzell, W.C., Schafferzick, R.W., Brown, B. and Mankle, E.A.: J.A.M.A. 149; 729 (1952).
3. Kuzell, W.C., and Schafferzick, R.W.: Calif. Med. 77; 319 (1952).
4. Payne, R.W., Shelter, M.R., Farr, C.H., Hellbaum, A.A. and Ishmall, W.K.: J. Lab. Clin. Med., 45; 331 (1955).
5. Fleming, J., and Will, G.: Ann. Rheumat. Dist., 12; 95 (1953).
6. Denko, C.W., and Rumi, D.: American Pract. 6; 1865 (1956).
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., Burns, J.: A.M.A. Arch. Ophth., 53; 264 (1955).
11. Hazelton, L.W., Tusing, T.W. and Hollana, E.G.: J. Pharmacol. Exper. Ther., 109; 387 (1953).
12. Ogilvie, F.B. and Sutter, M.D.: Vet. Med. 52; 492-4 (1957).
13. Camberos, H.R.: Rev. Med. Vet. (Buenos Aires) 38; 9 (1956).
14. Sutter, M.D.: Vet. Med., 53; 83 (Feb. 1958).


Information For Owners/Caregivers



Priority Care and Pributazone are registered trademarks of First Priority, Inc.

Rev. 10-22

Made in U.S.A.

Manufactured By: FIRST PRIORITY, INC., Elgin, IL 60123

www.prioritycare.com

NOT RETURNABLE IF OUTDATED


Net Contents: 100 Boluses




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.