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 18 years
Gastrointestinal atony
Hereditary fructose intolerance
Myasthenia gravis
Narrow angle glaucoma
Renal impairment
Severe gastrointestinal disorder
Severe hepatic impairment
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Frail elderly patients
Predisposition to glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Congestive cardiac failure
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Pregnancy
Reflux oesophagitis

Advise visual disturbances may affect ability to drive or operate machinery
Preparation contains sucrose
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 with caution in pregnancy.

No clinical data on human pregnancies exposed to trospium chloride is available.

Animal studies have shown placenta transfer of trospium chloride and have not indicated any direct or indirect adverse effects on pregnancy, embryo or foetal development, parturition, or postnatal development in rats.

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

Lactation

Use trospium with caution in breastfeeding.

Animal studies have shown that trospium chloride passes in maternal milk.

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 distension
Abdominal pain
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chest pain
Constipation
Diarrhoea
Dizziness
Dry eyes
Dry mouth
Dyspepsia
Dyspnoea
Flatulence
Headache
Impaired vision
Increase in serum transaminases
Micturition disorders
Myalgia
Nasal dryness
Nausea
Rash
Stevens-Johnson syndrome
Tachyarrhythmia
Tachycardia
Toxic epidermal necrolysis
Urinary retention
Urinary tract infections

Presentation

Modified release capsule 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

Contraindications

Children under 18 years
Gastrointestinal atony
Hereditary fructose intolerance
Myasthenia gravis
Narrow angle glaucoma
Renal impairment
Severe gastrointestinal disorder
Severe hepatic impairment
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Frail elderly patients
Predisposition to glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Congestive cardiac failure
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Pregnancy
Reflux oesophagitis

Advise visual disturbances may affect ability to drive or operate machinery
Preparation contains sucrose
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 with caution in pregnancy.

No clinical data on human pregnancies exposed to trospium chloride is available.

Animal studies have shown placenta transfer of trospium chloride and have not indicated any direct or indirect adverse effects on pregnancy, embryo or foetal development, parturition, or postnatal development in rats.

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

Lactation

Use trospium with caution in breastfeeding.

Animal studies have shown that trospium chloride passes in maternal milk.

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

Modified release capsules should be swallowed whole with water on an empty stomach one hour before meal.

Advise patients that if affected by visual disturbances they should not drive or operate machinery.

Side Effects

Abdominal distension
Abdominal pain
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chest pain
Constipation
Diarrhoea
Dizziness
Dry eyes
Dry mouth
Dyspepsia
Dyspnoea
Flatulence
Headache
Impaired vision
Increase in serum transaminases
Micturition disorders
Myalgia
Nasal dryness
Nausea
Rash
Stevens-Johnson syndrome
Tachyarrhythmia
Tachycardia
Toxic epidermal necrolysis
Urinary retention
Urinary tract infections

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: September 2015

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 18 September 2015.

Summary of Product Characteristics: Regurin XL 60mg prolonged-release capsule. Speciality European Pharma Ltd. Revised January 2012.