Indications And Dose
Bladder pain syndrome ▶BY MOUTH ▶Adult: 100 mg 3 times a day, review treatment after 6 months and discontinue if no response
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Drug reference
Bladder pain syndrome ▶BY MOUTH ▶Adult: 100 mg 3 times a day, review treatment after 6 months and discontinue if no response
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Active bleeding
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Patients at increased risk of bleeding
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NICE decisions ▶Pentosan polysulfate sodium for treating bladder pain syndrome (November 2019) NICE TA610 Pentosan polysulfate sodium (Elmiron ®) is recommended as an option for treating bladder pain syndrome with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if: . their condition has not responded to an adequate trial of standard oral treatments, and . it is not offered in combination with bladder instillations, and . any previous treatment with bladder instillations was not stopped because of lack of response, and . it is used in secondary care, and . the manufacturer provides pentosan polysulfate sodium according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta610 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2194 The Scottish Medicines Consortium has advised (November 2019) that pentosan polysulfate sodium (Elmiron ®) is accepted for use within NHS Scotland for the treatment of bladder pain syndrome characterised by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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MHRA/CHM ADVICE (UPDATED SEPTEMBER 2019): ELMIRON ® (PENTOSAN POLYSULFATE SODIUM): RARE RISK OF PIGMENTARY MACULOPATHY Cases of pigmentary maculopathy have been reported rarely with pentosan polysulfate sodium, especially after long-term use at high doses. Healthcare professionals are advised that patients should have regular ophthalmic examinations during treatment, and to consider stopping treatment if pigmentary maculopathy develops. Patients should be advised to seek immediate medical attention if visual changes occur.
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▶Common or very common Alopecia. asthenia. back pain. diarrhoea. dizziness. gastrointestinal discomfort. haemorrhage. headache. increased risk of infection. nausea. pelvic pain. peripheral oedema ▶Uncommon Amblyopia. anaemia. appetite decreased. arthralgia. constipation. depression. dyspnoea. emotional lability. eye disorders. flatulence. hyperhidrosis. hyperkinesia. insomnia. leucopenia. melanocytic naevus size increased. myalgia. oral ulceration. paraesthesia. photosensitivity reaction. skin reactions. thrombocytopenia. tinnitus. vomiting. weight changes ▶Frequency not known Coagulation disorder. hepatic function abnormal
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid—no information available.
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Manufacturer advises caution— evidence of hepatic involvement in elimination.
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Manufacturer advises caution— evidence of renal involvement in elimination. Genito-urinary system
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Manufacturer advises careful monitoring in patients with history of heparin or pentosan polysulfate sodium induced thrombocytopenia.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 23 ▶Fibrase (Imported (Italy)) Pentosan polysulfate sodium 50 mg Fibrase 50mg capsules | 50 capsule P s ▶Elmiron (Sovereign Medical Ltd, Consilient Health Ltd) Pentosan polysulfate sodium 100 mg Elmiron 100mg capsules | 90 capsule P £450.00–£699.40 DT = £450.00 TERPENES
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100 mg 3 times a day, review treatment after
First-line fragment. Read the complete Indications and Dose section above.
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