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Dose regimens1
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Adverse effects52
Effectiveness In a clinical field effectiveness study, two hundred thirty-seven horses (120 Zycosan and 117 saline control) were evaluated for field safety (see). All doses of Zycosan were administered in the neck muscle. Injection site reactions were the most frequently reported adverse reactions during the study. Injection site reactions were associated with clinicopathology changes in some cases. Other adverse reactions reported in more than one horse were prolongation of coagulation parameters (activated partial thromboplastin time (aPTT) and prothrombin time (PT)), lethargy, behavior changes, and colic. Adverse reactions are summarized in Table 1. Horses may have experienced more than one of the observed adverse reactions. Injection site reactions (heat, pain, swelling/edema, or redness) occurred more frequently and were generally more severe in Zycosan treated horses as compared to control horses over the course of the study. Several Zycosan treated horses had injection site reactions following more than one injection. The onset of reactions ranged from 0 hours to 3 days post injection. The duration of the reactions ranged from 1 to 5 days. Most reactions resolved without treatment. Injection site reactions in Zycosan treated horses were predominantly characterized by swelling/edema ranging in size from 0.2 cm to 15 cm at their widest point. Pain was the most commonly observed concurrent clinical sign associated with the swelling/edema in Zycosan treated horses. Pain was generally exhibited local to the injection site and as reluctance to eat, drink, or move the neck or head. Lethargy or depression were reported concurrently in some horses. One Zycosan treated horse had neck muscle cramping observed concurrently. One Zycosan treated horse experienced swelling accompanied by heat and pain at the injection site along with mild hyperglycemia, an increase in its white blood cell count and neutrophilia. This horse recovered without treatment. Two Zycosan treated horses developed large (15 cm) swellings along with pain and heat at the injection site beginning 1 to 2 days following injection. Both horses concurrently showed mild hyperbilirubinemia, mild hyperglycemia, mild neutrophilia, and mild monocytosis on clinical pathology. One of these horses was reluctant to move its head or neck and was noted to be tachypneic the day following injection. The second horse showed concurrent clinical signs of anorexia, depression, and fever. Both horses were removed from the study and treated with flunixin meglumine. The horse with concurrent fever was also treated with an oral antibiotic for 5 days. Both horses recovered within 5 days from the onset of clinical signs. Coagulation parameters were evaluated pre-treatment and 3 hours post-treatment following the first (study day 0), third (study day 14) and fourth (study day 21) injection. Mean post-treatment values for aPTT in the Zycosan treated group increased by approximately 19 seconds at each study timepoint but remained within the laboratory reference range. Clinically relevant prolongation of aPTT values occurred post-treatment in 18 Zycosan treated horses, with some horses experiencing prolongation of aPTT at multiple timepoints. Clinically relevant prolongation in PT occurred post-treatment in 5 Zycosan treated horses. Three Zycosan treated horses showed concurrent clinically relevant prolongation in aPTT and PT at study day 0 (N=1) or study day 14 (N=2). One of the horses with post-treatment prolongation of aPTT and PT at study day 14 was concurrently reported to have an injection site reaction. Clinical signs of bleeding or thrombocytopenia were not observed in any horses with prolongation of coagulation parameters. Two Zycosan treated horses developed clinical signs of colic (lethargy, generalized discomfort, decreased appetite, decreased water intake, and/or decreased manure output) within 12 hours following treatment after the third injection. One horse was diagnosed with a pelvic flexure impaction. One horse was noted to display a markedly lowered head position prior to colic signs and was removed from the study. In both cases, colic signs resolved within 24 hours with symptomatic treatment. One Zycosan treated horse showed an increase in SDH in conjunction with trending increases in aspartate aminotransferase (AST) and alanine transaminase (ALT) that did not exceed the reference range. Concurrent clinically relevant changes in γ-glutamyl transferase (GGT) or clinical signs were not observed in this horse. Table 1: Adverse Reactions Adverse Reaction Number (%) of Zycosan™ treated horses (N=120) Number (%) of Saline treated horses (N=117) Occurring 0-3 hours post-injection; clinical signs included pain, heat, swelling, edema, redness, or neck muscle cramping. Horses may have experienced more than one episode. Immediate or Peri-Dosing Injection Site Reaction 21 (18%) 4 (3%) Occurring more than 3 hours post-injection; observations included pain, heat, swelli… [truncated]
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Diarrhoea3 reports
- Elevated serum alkaline phosphatase (SAP)2 reports
- Emesis (multiple)2 reports
- Lethargy (see also Central nervous system depression in 'Neurological')2 reports
- Neutrophilia2 reports
- Pain NOS2 reports
- Vomiting2 reports
- Abnormal posture NOS1 reports
- Acidosis1 reports
- Administration error NOS1 reports
- Anaemia NOS1 reports
- Anorexia1 reports
Contraindications1
Warnings and Precautions (see). Horses with hypersensitivity to pentosan polysulfate sodium or any of the inactive ingredients in Zycosan should not receive Zycosan. Do not use Zycosan concurrently with other anticoagulant drugs. Do not use in horses with clotting disorders or within 24 hours of surgical procedures
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It is chemically and structurally similar to heparin and other glycosaminoglycans (GAG). Pentosan polysulfate sodium has anticoagulant and fibrinolytic effects. The mechanism of action for pentosan polysulfate sodium is unknown but is thought to include stimulation of hyaluronic acid and GAG synthesis in damaged joints, inhibition of proteolytic enzymes (including metalloproteinases), and scavenging of free radicals. Pentosan polysulfate sodium may also modulate receptor-mediated binding of cytokines.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references6
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Effects of pentosan polysulfate sodium on joint structure and function out to six months in naturally-occurring canine osteoarthritis.
Study summary not available in the imported record. Open the original citation to review the study.
- Pentosan polysulfate sodium promotes redifferentiation to the original phenotype in micromass-cultured canine articular chondrocytes and exerts molecular weight-dependent effects.
Study summary not available in the imported record. Open the original citation to review the study.
- Acute and severe haemorrhage following pentosan polysulfate injection in a Cornish Rex.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy of intravesical pentosan polysulfate sodium in cats with obstructive feline idiopathic cystitis.
Study summary not available in the imported record. Open the original citation to review the study.
- Inhibitory effects of pentosan polysulfate sodium on MAP-kinase pathway and NF-κB nuclear translocation in canine chondrocytes in vitro.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.
Available products
Products listed in the Health Canada Drug Product Database for this active ingredient. A listing does not establish that a product is authorized for the clinical uses described on this page.