ADEQUAN CANINE 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:

Elanco US Inc.

INN (International Name):

POLYSULFATED GLYCOSAMINOGLYCAN

Composition:

POLYSULFATED GLYCOSAMINOGLYCAN 100 mg in 1 mL

Prescription type:

PRESCRIPTION

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ADEQUAN CANINE- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION
ELANCO US INC.
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ADEQUAN CANINE
Brand of Polysulfated Glycosaminoglycan
Solution 100 mg/mL in a 5 mL preserved
Multiple dose vial for intramuscular use in dogs
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION:
The active ingredient in Adequan® Canine is polysulfated
glycosaminoglycan (PSGAG). Polysulfated
glycosaminoglycan is a semi-synthetic glycosaminoglycan prepared by
extracting glycosaminoglycans
(GAGs) from bovine tracheal cartilage. GAGs are polysaccharides
composed of repeating
disaccharide units. The GAG present in PSGAG is principally
chondroitin sulfate containing 3 to 4
sulfate esters per disaccharide unit. The molecular weight for PSGAG
used in the manufacture of
Adequan® is 3,000 to 15,000 daltons.
Each mL of Adequan® Canine contains 100 mg of PSGAG, 0.9% v/v benzyl
alcohol as a preservative,
and water for injection q.s. to 1 mL. Sodium hydroxide and/or
hydrochloric acid added when necessary
to adjust pH. The solution is clear, colorless to slightly yellow.
PHARMACOLOGY:
The specific mechanism of action of Adequan® in canine joints is not
known. PSGAG is characterized
as a “disease modifying osteoarthritis drug”. Experiments
conducted _in vitro_ have shown PSGAG to
inhibit certain catabolic enzymes which have increased activity in
inflamed joints, and to enhance the
activity of some anabolic enzymes. For example, PSGAG has been shown
to significantly inhibit serine
proteinases. Serine proteinases have been demonstrated to play a role
in the Interleukin-l mediated
degradation of cartilage proteoglycans and collagen. PSGAG is reported
to be an inhibitor of
Prostaglandin E2 (PGE2) synthesis. PGE2 has been shown to increase the
loss of proteoglycan from
cartilage. PSGAG has been reported to inhibit some catabolic enzymes
such as elastase, stromelysin,
metalloproteases, cathepsin B1, and hyaluronidases, which degrade
collagen, proteoglycans, and
hyaluronic acid in