Drugs List

Therapeutic Indications

Uses

Neurogenic bladder disorder
Overactive bladder syndrome

Treatment of urinary incontinence and/or urinary urgency and urinary frequency in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries.

Administration

A high fat meal increases the bioavailability of propiverine hydrochloride. The manufacturer recommends that propiverine should be taken before a meal, especially in patients with renal or hepatic impairment.

Contraindications

Children under 18 years
Bladder outflow obstruction
Breastfeeding
Galactosaemia
Gastrointestinal atony
Gastrointestinal obstruction
Hereditary fructose intolerance
Moderate hepatic impairment
Myasthenia gravis
Narrow angle glaucoma
Pregnancy
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Predisposition to narrow angle glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Cardiac arrhythmias
Glucose-galactose malabsorption syndrome
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
New York Heart Association class IV failure
Reflux oesophagitis
Renal impairment - creatinine clearance below 30 ml/minute
Tachycardia

Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Contains glucose
Contains lactose
Preparation contains sucrose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Consider residual urinary volume, in patients with urinary tract infections
Monitor hepatic function on long term therapy
Monitor patients at risk of glaucoma for increases in intraocular pressure
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Propiverine is contraindicated in pregnancy.

At the time of writing there no adequate reports of its use in pregnant women. The potential risk for humans is unknown.

Animal studies have shown reproductive toxicity.

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

Propiverine is contraindicated in breastfeeding.

Propiverine is secreted into the milk of lactating mammals. 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 propiverine 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
Alterations in hepatic enzymes
Blurred vision
Confusion
Constipation
Decrease in blood pressure
Decreased sweating
Difficulty in micturition
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Fatigue
Flushing
Hallucinations
Headache
Hypersensitivity reactions
Mydriasis
Nausea
Palpitations
Rash
Restlessness
Tremor
Urinary retention
Vomiting

Presentation

Tablets containing propiverine hydrochloride

Drugs List

Therapeutic Indications

Uses

Neurogenic bladder disorder
Overactive bladder syndrome

Treatment of urinary incontinence and/or urinary urgency and urinary frequency in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries.

Dosage

Adults

Elderly

Patients with Renal Impairment

Administration

A high fat meal increases the bioavailability of propiverine hydrochloride. The manufacturer recommends that propiverine should be taken before a meal, especially in patients with renal or hepatic impairment.

Contraindications

Children under 18 years
Bladder outflow obstruction
Breastfeeding
Galactosaemia
Gastrointestinal atony
Gastrointestinal obstruction
Hereditary fructose intolerance
Moderate hepatic impairment
Myasthenia gravis
Narrow angle glaucoma
Pregnancy
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention

Precautions and Warnings

Predisposition to narrow angle glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Cardiac arrhythmias
Glucose-galactose malabsorption syndrome
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
New York Heart Association class IV failure
Reflux oesophagitis
Renal impairment - creatinine clearance below 30 ml/minute
Tachycardia

Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Contains glucose
Contains lactose
Preparation contains sucrose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Consider residual urinary volume, in patients with urinary tract infections
Monitor hepatic function on long term therapy
Monitor patients at risk of glaucoma for increases in intraocular pressure
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Propiverine is contraindicated in pregnancy.

At the time of writing there no adequate reports of its use in pregnant women. The potential risk for humans is unknown.

Animal studies have shown reproductive toxicity.

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

Propiverine is contraindicated in breastfeeding.

Propiverine is secreted into the milk of lactating mammals. 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 propiverine 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
Alterations in hepatic enzymes
Blurred vision
Confusion
Constipation
Decrease in blood pressure
Decreased sweating
Difficulty in micturition
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Fatigue
Flushing
Hallucinations
Headache
Hypersensitivity reactions
Mydriasis
Nausea
Palpitations
Rash
Restlessness
Tremor
Urinary retention
Vomiting

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: December 2014

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 05 December 2014.

Summary of Product Characteristics: Detrunorm 15 mg tablets. Amdipharm Mercury Company Ltd. Revised December 2013.

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 05 December 2014