Chemical formula: C₁₀H₁₈O₂₁S₄ Molecular mass: 602.497 g/mol PubChem compound: 37720
Pentosan polysulfate interacts in the following cases:
Pentosan polysulfate sodium is a weak anticoagulant. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to treatment with other medicinal products influencing coagulation such as anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal antiinflammatory medicinal products should be evaluated for haemorrhagic events. Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use. Visual symptoms might include complaints of difficulty when reading, visual distortions, altered colour vision and/or slow adjustment to low or reduced light environments.
All patients should have an ophthalmologic examination after 6 months of use of PPS for early detection of pigmentary maculopathy, and, if there are no pathologic findings, regularly after 5 years of use (or earlier, in case of visual complaints). However, in case of relevant ophthalmologic findings, a yearly examination should be conducted. In such situations, treatment cessation should be considered.
There are no data from the use of pentosan polysulfate sodium in pregnant women. Animal studies with respect to reproductive toxicity were not conducted. Pentosan polysulfate sodium is not recommended during pregnancy.
It is unknown whether pentosan polysulfate sodium or metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Therefore, pentosan polysulfate sodium should not be used during breast-feeding.
No information on a potential impact of pentosan polysulfate sodium on fertility is available.
Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.
The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium. The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
The most common adverse events reported from the clinical studies are headache, dizziness and gastro-intestinal events like diarrhoea, nausea, abdominal pain and rectal bleeding.
The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity.
Adverse events are listed below by MedDRA body system organ class and by frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Common: Infections, influenza
Uncommon: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Not known: Coagulation disorders
Uncommon: Photosensitivity
Not known: Allergic reactions
Uncommon: Anorexia, weight gain, weight loss
Uncommon: Severe Emotional Lability/Depression
Common: Headache, dizziness
Uncommon: Increased sweating, insomnia, hyperkinesia, paraesthesia
Uncommon: Lacrimation, amblyopia
Uncommon: Tinnitus
Uncommon: Dyspnoea
Common: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Uncommon: Indigestion, vomiting, mouth ulcer, flatulence, constipation
Common: Peripheral oedema, alopecia
Uncommon: Rash, increased mole size
Common: Back pain
Uncommon: Myalgia, Arthralgia
Common: Urinary frequency
Common: Asthenia, pelvic pain
Not known: Liver function abnormalities
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