Toxicity: In a subacute toxicity study, 32 adult beagle dogs (4 males and 4 females per treatment group) received either 0.9% saline solution or PSGAG at a dose of
5 mg, 15 mg, or 50 mg per kg of body weight (approximately 2.3, 6.8, or 22.7 mg/lb), via intramuscular injection twice weekly for 13 weeks. PSGAG doses represent approximately
1X, 3X, and 10X the recommended dosage of 2 mg/lb, and more than 3 times the recommended 4-week duration of treatment. Necropsies were performed 24 hours after the final
treatment. During week 12, one dog in the 50 mg/kg dosage group developed a large hematoma at the injection site which necessitated euthanasia. No other mortalities occurred
during the treatment period. Statistically significant changes in the 50 mg/kg group included increased prothrombin time, reduced platelet count, an increase in ALT and
cholesterol, and increased liver and kidney weights. Increased cholesterol and kidney weights were also noted in the 15 mg/kg group. Microscopic lesions were noted in the
liver (Kupffer cells containing eosinophilic foamy cytoplasm), kidneys (swollen, foamy cells in the proximal convoluted tubules), and lymph nodes (macrophages with
eosinophilic foamy cytoplasm) in the 15 mg/kg and 50 mg/kg groups. Intramuscular inflammation, hemorrhage, and degeneration were seen in all 3 PSGAG treated groups;
the incidence and severity appeared dose related.
Contraindications: 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.
Precautions: The safe use of Adequan® Canine used in breeding, pregnant, or lactating dogs has not been evaluated. Use with caution in
dogs with renal or hepatic impairment.
Adverse Reactions: In the clinical efficacy trial, 24 dogs were treated with Adequan® Canine twice weekly for 4 weeks. Possible adverse reactions were
reported after 2.1% of the injections. These included transient pain at the injection site (1 incident), transient diarrhea (1 incident each in 2 dogs), and
abnormal bleeding (1 incident). These effects were mild and self-limiting and did not require interruption of therapy.
Post Approval Experience (2014)
The following adverse events are based on voluntary, post-approval reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably
estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The signs reported are listed in decreasing order of
reporting frequency.
Vomiting, anorexia, depression/lethargy, diarrhea.
In some cases, death has been reported.
To report suspected adverse drug events, contact American Regent, Inc. at 1-800-458-0163. For additional information about adverse drug
experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/AnimalVeterinary/SafetyHealth .
Warnings: Not for use in humans. Keep this and all medications out of reach of children.
For the Adequan® Canine full prescribing information, click here.
To view the Safety Data Sheet, click here.