ADEQUAN
® I.M.
Luitpold
Brand of Polysulfated Glycosaminoglycan (PSGAG)
Solution 500 mg/5 mL
For Intramuscular Use In Horses
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
Each 5 milliliters of Adequan® i.m. contains 500 mg of Polysulfated Glycosaminoglycan and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH. Sodium Chloride may be added to adjust tonicity.
PHARMACOLOGY
Polysulfated Glycosaminoglycan is chemically similar to the glycosaminoglycans in articular cartilage matrix. PSGAG is a potent proteolytic enzyme inhibitor and diminishes or reverses the pathologic processes of traumatic or degenerative joint disease which result in a net loss of cartilage matrix components. PSGAG improves joint function by reducing synovial fluid protein levels and increasing synovial fluid hyaluronic acid concentration in traumatized equine carpal and hock joints.
TOXICITY
Toxicity studies were conducted in horses. Doses as high as 2,500 mg were administered intramuscularly to 6 horses twice a week for 12 weeks. This dosage is 5 times the recommended dosage and 3 times the recommended therapeutic regimen. Clinical observations revealed no soreness or swelling at the injection site or in the affected joint. No animal had any clinical or laboratory evidence of toxicity.
INDICATIONS
Adequan® i.m. is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
CONTRAINDICATIONS
There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan.
WARNING
Do not use in horses intended for human consumption.
DOSAGE AND ADMINISTRATION
The recommended dose of Adequan® i.m. in horses is 500 mg every 4 days for 28 days intramuscularly. The injection site must be thoroughly cleansed prior to injection. Do not mix Adequan® i.m. with other drugs or solvents.
REPRODUCTIVE SAFETY
Studies have not been conducted to establish safety in breeding horses.
Dispose of spent needles in accordance with all federal, state and local environmental laws.
WARNING
Keep this and all medications out of the reach of children.
HOW SUPPLIED
Adequan® i.m. solution, 500 mg/5 mL is available in 5 mL glass vials, packaged in boxes of 7.
STORAGE CONDITIONS
Store at controlled room temperature up to 25°C (77°F) (See USP). Discard unused portion.
LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, NY 11967
(631) 924-4000
(800) 458-0163
Made in U.S.A.
IN 99501
Rev. 8/07
MG #7560
NADA #140-901, Approved by FDA
NAC No.: 10390026