Drugs List

Therapeutic Indications

Uses

Interstitial cystitis

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.

Contraindications

Children under 18 years
Haemorrhage
Breastfeeding
Pregnancy

Precautions and Warnings

Elderly
Predisposition to bleeding complications
Coagulopathy
Hepatic impairment
History of heparin-induced thrombocytopenia
Renal impairment

Exclude bladder carcinoma before treatment
Exclude urinary tract infection before treatment
Monitor ophthalmic function before and during long-term use
Review treatment every 6 months
Consider discontinuing if pigmentary maculopathy occurs
Discontinue if an adequate response is not achieved within 6 months

Pentosan polysulfate sodium is a weak anticoagulant. Patients undergoing invasive procedures or having signs of underlying coagulopathy or other increased risk of bleeding 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.

Pregnancy and Lactation

Pregnancy

Pentosan polysulfate sodium is contraindicated in pregnancy.

The high molecular weight (4000 to 6000) and low oral absorption suggest that pentosan dose not reach the embryo or the foetus. However, there is limited data regarding the use of pentosan polysulfate sodium in pregnancy and it is therefore not recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pentosan polysulfate sodium is contraindicated in breastfeeding.

It is unknown whether pentosan polysulfate sodium is excreted in human breast milk.

A risk to newborns and infants cannot be excluded, thus the manufacturer recommends not using pentosan polysulfate sodium in breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal enlargement
Abdominal pain
Allergic reaction
Alopecia
Altered liver function tests
Amblyopia
Anaemia
Anorexia
Arthralgia
Asthenia
Back pain
Coagulation disorders
Constipation
Depression
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Ecchymosis
Emotional lability
Flatulence
Haemorrhage
Headache
Hepatic impairment
Hyperkinesia
Increase in mole size
Increased sweating
Indigestion
Infections
Influenza
Insomnia
Lacrimation
Leukopenia
Mouth ulcers
Myalgia
Nausea
Paraesthesia
Pelvic pain
Peripheral oedema
Photosensitivity
Rash
Rectal bleeding
Thrombocytopenia
Tinnitus
Urinary frequency
Vomiting
Weight changes

Presentation

Oral formulations of pentosan polysulfate sodium.

Drugs List

Therapeutic Indications

Uses

Interstitial cystitis

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.

Dosage

Adults

Contraindications

Children under 18 years
Haemorrhage
Breastfeeding
Pregnancy

Precautions and Warnings

Elderly
Predisposition to bleeding complications
Coagulopathy
Hepatic impairment
History of heparin-induced thrombocytopenia
Renal impairment

Exclude bladder carcinoma before treatment
Exclude urinary tract infection before treatment
Monitor ophthalmic function before and during long-term use
Review treatment every 6 months
Consider discontinuing if pigmentary maculopathy occurs
Discontinue if an adequate response is not achieved within 6 months

Pentosan polysulfate sodium is a weak anticoagulant. Patients undergoing invasive procedures or having signs of underlying coagulopathy or other increased risk of bleeding 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.

Pregnancy and Lactation

Pregnancy

Pentosan polysulfate sodium is contraindicated in pregnancy.

The high molecular weight (4000 to 6000) and low oral absorption suggest that pentosan dose not reach the embryo or the foetus. However, there is limited data regarding the use of pentosan polysulfate sodium in pregnancy and it is therefore not recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pentosan polysulfate sodium is contraindicated in breastfeeding.

It is unknown whether pentosan polysulfate sodium is excreted in human breast milk.

A risk to newborns and infants cannot be excluded, thus the manufacturer recommends not using pentosan polysulfate sodium in breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal enlargement
Abdominal pain
Allergic reaction
Alopecia
Altered liver function tests
Amblyopia
Anaemia
Anorexia
Arthralgia
Asthenia
Back pain
Coagulation disorders
Constipation
Depression
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Ecchymosis
Emotional lability
Flatulence
Haemorrhage
Headache
Hepatic impairment
Hyperkinesia
Increase in mole size
Increased sweating
Indigestion
Infections
Influenza
Insomnia
Lacrimation
Leukopenia
Mouth ulcers
Myalgia
Nausea
Paraesthesia
Pelvic pain
Peripheral oedema
Photosensitivity
Rash
Rectal bleeding
Thrombocytopenia
Tinnitus
Urinary frequency
Vomiting
Weight changes

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Elmiron 100mg hard capsules. Consilient Health Ltd. Revised July 2019.