ADEQUAN I.A.- polysulfated glycosaminoglycan injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)

Available from:

American Regent, Inc.

INN (International Name):

POLYSULFATED GLYCOSAMINOGLYCAN

Composition:

POLYSULFATED GLYCOSAMINOGLYCAN 250 mg in 1 mL

Administration route:

INTRA-ARTICULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Adequan is recommended for the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses. Do not use in horses showing hypersensitivity to Polysulfated Glycosaminoglycan. Do not administer Adequan in the face of joint sepsis.

Product summary:

Adequan solution, 250 mg/mL is available as: NDC 10797-991-72       1 mL single dose vials           Packaged in boxes of 6 Store at controlled room temperature up to 25°C (77°F) (See USP).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ADEQUAN I.A.- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION
AMERICAN REGENT, INC.
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ADEQUAN I.A.
(POLYSULFATED GLYCOSAMINOGLYCAN) (PSGAG)
Solution 250 mg/mL
For intra-articular (I.A.) use in horses
DESCRIPTION
Each milliliter of Adequan contains 250 mg of Polysulfated
Glycosaminoglycan and Water for Injection
q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to
adjust pH.
PHARMACOLOGY
Polysulfated Glycosaminoglycan is chemically similar to the
mucopolysaccharides of cartilaginous
tissue. It is a potent proteolytic enzyme inhibitor and diminishes or
reverses the processes which result
in the loss of cartilaginous mucopolysaccharides. PSGAG improves joint
function by stimulating
synovial membrane activity, reducing synovial protein levels and
increasing synovial fluid viscosity in
traumatized equine carpal joints.
TOXICITY
Toxicity studies were conducted in horses. Doses as high as 1,250 mg
were administered intracarpally
to 6 horses once a week for 18 weeks. This dosage is 5 times the
recommended dosage and 3.6 times
the recommended therapeutic regimen. Clinical observations revealed
soreness and swelling in 1.8% (2
of 109 animals) at the injection site which was mild, self limiting
and lasted less than one day. There
was a dose related evaluation on partial thromboplastin time,
creatinine and glucose. No animal had any
clinical illness during the trial and none showed clinical evidence of
toxicity except transient swelling
at the injection site, possibly due to mechanical invasion of the
joint.
INDICATIONS
Adequan is recommended for the treatment of non-infectious
degenerative and/or traumatic joint
dysfunction and associated lameness of the carpal joint in horses.
CONTRAINDICATIONS
Do not use in horses showing hypersensitivity to Polysulfated
Glycosaminoglycan. Do not administer
Adequan in the face of joint sepsis.
WARNING
Do not use in horses intended for human consumption.
DOSAGE AND ADMINISTRATION
The recommended dose of Adequan in horses is 250 mg (1 vial) once a
week for five