Drugs List

Therapeutic Indications

Uses

Symptomatic treatment of urinary urgency, frequency or urge incontinence

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).

Contraindications

Children under 12 years
Galactosaemia
Gastrointestinal atony
Myasthenia gravis
Narrow angle glaucoma
Severe gastrointestinal disorder
Severe hepatic impairment
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Children aged 12 to 18 years
Frail elderly patients
Predisposition to glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Congestive cardiac failure
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Pregnancy
Reflux oesophagitis
Renal impairment - creatinine clearance below 30 ml/minute

Advise visual disturbances may affect ability to drive or operate machinery
Contains lactose
Some formulations contain sucrose
Some formulations contain wheat starch
Reassess need for continued treatment at regular intervals of 3-6 months
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Use trospium chloride with caution in pregnancy.

At the time of writing no clinical data on human pregnancies exposed to trospium has been located.

In animal studies, placenta transfer of trospium was seen but did not indicate any direct or indirect adverse effects on pregnancy, embryo or foetal development, parturition, or postnatal development in rats.

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

Use trospium chloride with caution in breastfeeding.

At the time of writing there is no data to show if trospium is excreted in human breast milk.

Animal studies have shown that trospium chloride passes in maternal milk, therefore, a risk to the newborn cannot be excluded.

The UK Drugs in Lactation Advisory Service states that due to the long half-life of trospium chloride there is an increased risk of accumulation in breastfed infants. It also recommends that breastfed infants should be monitored for anticholinergic effects e.g. urinary retention, colic and constipation.

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 pain
Agitation
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chest pain
Confusion
Constipation
Diarrhoea
Disturbances in accommodation
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Flatulence
Hallucinations
Headache
Impaired vision
Increase in serum transaminases
Micturition disorders
Myalgia
Nausea
Pruritus
Rash
Stevens-Johnson syndrome
Tachyarrhythmia
Tachycardia
Toxic epidermal necrolysis
Urinary retention
Urticaria

Presentation

Tablets containing trospium chloride

Drugs List

Therapeutic Indications

Uses

Symptomatic treatment of urinary urgency, frequency or urge incontinence

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Children under 12 years
Galactosaemia
Gastrointestinal atony
Myasthenia gravis
Narrow angle glaucoma
Severe gastrointestinal disorder
Severe hepatic impairment
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Children aged 12 to 18 years
Frail elderly patients
Predisposition to glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Congestive cardiac failure
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Pregnancy
Reflux oesophagitis
Renal impairment - creatinine clearance below 30 ml/minute

Advise visual disturbances may affect ability to drive or operate machinery
Contains lactose
Some formulations contain sucrose
Some formulations contain wheat starch
Reassess need for continued treatment at regular intervals of 3-6 months
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Use trospium chloride with caution in pregnancy.

At the time of writing no clinical data on human pregnancies exposed to trospium has been located.

In animal studies, placenta transfer of trospium was seen but did not indicate any direct or indirect adverse effects on pregnancy, embryo or foetal development, parturition, or postnatal development in rats.

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

Use trospium chloride with caution in breastfeeding.

At the time of writing there is no data to show if trospium is excreted in human breast milk.

Animal studies have shown that trospium chloride passes in maternal milk, therefore, a risk to the newborn cannot be excluded.

The UK Drugs in Lactation Advisory Service states that due to the long half-life of trospium chloride there is an increased risk of accumulation in breastfed infants. It also recommends that breastfed infants should be monitored for anticholinergic effects e.g. urinary retention, colic and constipation.

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

Counselling

The tablets should be swallowed whole with water before meals (on an empty stomach).

Advise patient that if side effects affecting their vision occur they should not drive and operate machinery.

Side Effects

Abdominal pain
Agitation
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chest pain
Confusion
Constipation
Diarrhoea
Disturbances in accommodation
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Flatulence
Hallucinations
Headache
Impaired vision
Increase in serum transaminases
Micturition disorders
Myalgia
Nausea
Pruritus
Rash
Stevens-Johnson syndrome
Tachyarrhythmia
Tachycardia
Toxic epidermal necrolysis
Urinary retention
Urticaria

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: October 2015

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 26 October 2015.

Summary of Product Characteristics: Flotros 20mg film-coated tablets. Galen Limited. Revised July 2015.

Summary of Product Characteristics: Regurin 20g tablets. Speciality European Pharma. Revised October 2010.

Summary of Product Characteristics: Uraplex 20g coated tablets. Speciality European Pharma. Revised August 2011.

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 26 October 2015