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:

American Regent, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Adequan® Canine is recommended for intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints. Do not use in dogs showing hypersensitivity to PSGAG. PSGAG is a synthetic heparinoid; do not use in dogs with known or suspected bleeding disorders.

Product summary:

Adequan® Canine Solution 100 mg/mL in a 5 mL preserved multiple dose vial. NDC 10797-975-02       5 mL Multiple Dose Vials           Packaged 2 vials per box AMERICAN REGENT, INC. ANIMAL HEALTH Shirley, NY  11967 (1-888-354-4857) Approved by FDA under NADA # 141-038 Made in U.S.A. Rev. 9/2021 IN975 MG #44454

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ADEQUAN CANINE- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION
AMERICAN REGENT, INC.
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ADEQUAN CANINE
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.
DESCRIPTION:
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