Pentosan Polysulfate Sodium — Active Pharmaceutical Ingredient

Pentosan Polysulfate Sodium is an active pharmaceutical ingredient found in 1 FDA-approved drug product. Forms: CAPSULE. Routes: ORAL.

Drug Ingredients A–Z 2 min read
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Pentosan Polysulfate Sodium (1 brand name, 1 dosage form, 1 route)

Available dosage forms: CAPSULE.

Routes of administration: ORAL.

Brand Names

  • ELMIRON

Dosage and Administration

Administer 3 mg/kg (1.4 mg/lb) by intramuscular injection once weekly for four weeks (for a total of four doses). Zycosan is provided in a single use vial and does not contain a preservative. Discard unused vial contents.

Contraindications

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 (see Warnings and Precautions).

Adverse Reactions

In a clinical field effectiveness study, two hundred thirty-seven horses (120 Zycosan and 117 saline control) were evaluated for field safety (see Effectiveness ). 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. Table 1: Adverse Reactions Adverse Reaction Number (%) of Zycosan™ treated horses (N=120) Number (%) of Saline treated horses (N=117) Immediate or Peri-Dosing Injection Site ReactionOccurring 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. 21 (18%) 4 (3%) Delayed Injection Site ReactionOccurring more than 3 hours post-injection; observations included pain, heat, swelling, edema, redness, or neck muscle cramping. Pain was exhibited local to the injection site and as reluctance to eat, drink, or move the neck or head. Horses may have experienced more than one episode. 13 (11%) 3 (3%) Prolonged aPTT(post-treatment) 18 (15%) 1 (1%) Prolonged PT(post-treatment) 5 (4%) 1 (1%) Lethargy 14 (12%) 7 (6%) Behavior Change Observations included aggression, stomping, pawing, agitation, anxiousness, overactivity, quietness and/or depression, or unsettledness. 10 (8%) 8 (7%) Colic 2 (2%) 0 (0%) Elevated Sorbitol Dehydrogenase (SDH) 1 (1%) 0 (0%) Stiffness 1 (1%) 0 (0%) 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

⚠ Caution
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