Drugs List

Therapeutic Indications

Uses

Neurogenic bladder disorder
Nocturnal enuresis
Unstable bladder treatment.Symptoms of urgency/frequency/urge incontinence

Management of urinary incontinence, urgency and frequency in unstable bladder conditions. Unstable bladder may be due to idiopathic detrusor instability or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as spina bifida and multiple sclerosis.

Oxybutynin may also be used for children to manage nocturnal enuresis in conjunction with non-drug therapy. It should only be used in these patients when non-drug therapy alone or in conjunction with other drug treatment has failed.

Contraindications

Children under 2 years
Bladder outflow obstruction
Gastrointestinal atony
Gastrointestinal obstruction
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Porphyria
Severe ulcerative colitis
Shallow anterior chamber of eye
Toxic megacolon
Urinary retention

Precautions and Warnings

Children aged 2 to 5 years
Frail elderly patients
Autonomic neuropathy
Benign prostatic hyperplasia
Breastfeeding
Cardiac arrhythmias
Congestive cardiac failure
Decreased gastrointestinal motility
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Pregnancy
Reflux oesophagitis
Renal impairment
Tachycardia

Advise ability to drive/operate machinery may be affected by side effects
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
May precipitate glaucoma
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor patients at risk of glaucoma for increases in intraocular pressure
Monitor visual status
Reassess need for continued treatment at regular intervals of 3-6 months
Advise patient to report new visual problems and symptoms
Decreased salivary secretions may lead to dental caries
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Use oxybutynin with caution in pregnancy.

Oxybutynin should only be used during pregnancy if considered essential and there is no safer alternative.

At the time of writing, no reports of the use of oxybutynin in human pregnancy were available. However, Briggs (2011) and Schaefer (2007) suggest that based on animal data, that the risk to the foetus is low.

Foetal toxicity and fertility studies in animals showed effects on reproductive processes only at maternally toxic doses.

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 oxybutynin with caution in breastfeeding.

A small amount of oxybutynin is excreted in human breast milk. At the time of writing there is limited published information regarding the use of oxybutynin during breastfeeding, therefore the effect on the newborn/infant is unknown. Schaefer (2007) suggests that its use for bladder incontinence is acceptable, although antimuscarinics may reduce lactation. The UK drugs in Lactation Advisory Service suggests oxybutynin may be used with caution in breastfeeding provided the infant is monitored for anticholinergic affects, e.g. urinary retention, colic, constipation and poor weight gain.

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 discomfort
Agitation
Allergic reaction
Angioedema
Anorexia
Anxiety
Arrhythmias
Blurred vision
Cognitive impairment
Confusion
Constipation
Convulsions
Decreased appetite
Decreased sweating
Diarrhoea
Difficulty in micturition
Disorientation
Dizziness
Drowsiness
Dry eyes
Dry mouth
Dry skin
Dysphagia
Facial flushing
Gastroesophageal reflux
Glaucoma
Hallucinations
Headache
Heat stroke
Mydriasis
Nausea
Nightmares
Ocular hypertension
Paranoia
Photosensitivity
Rash
Restlessness
Skin reactions
Somnolence
Tachycardia
Urinary retention
Urinary tract infections
Urticaria
Vomiting

Presentation

Immediate release oral formulations of oxybutynin hydrochloride.

Drugs List

Therapeutic Indications

Uses

Neurogenic bladder disorder
Nocturnal enuresis
Unstable bladder treatment.Symptoms of urgency/frequency/urge incontinence

Management of urinary incontinence, urgency and frequency in unstable bladder conditions. Unstable bladder may be due to idiopathic detrusor instability or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as spina bifida and multiple sclerosis.

Oxybutynin may also be used for children to manage nocturnal enuresis in conjunction with non-drug therapy. It should only be used in these patients when non-drug therapy alone or in conjunction with other drug treatment has failed.

Dosage

The licensed doses for different brands may be different.

Adults

Elderly

Children

Contraindications

Children under 2 years
Bladder outflow obstruction
Gastrointestinal atony
Gastrointestinal obstruction
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Porphyria
Severe ulcerative colitis
Shallow anterior chamber of eye
Toxic megacolon
Urinary retention

Precautions and Warnings

Children aged 2 to 5 years
Frail elderly patients
Autonomic neuropathy
Benign prostatic hyperplasia
Breastfeeding
Cardiac arrhythmias
Congestive cardiac failure
Decreased gastrointestinal motility
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Pregnancy
Reflux oesophagitis
Renal impairment
Tachycardia

Advise ability to drive/operate machinery may be affected by side effects
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
May precipitate glaucoma
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor patients at risk of glaucoma for increases in intraocular pressure
Monitor visual status
Reassess need for continued treatment at regular intervals of 3-6 months
Advise patient to report new visual problems and symptoms
Decreased salivary secretions may lead to dental caries
May cause heat prostration when used in high environmental temperatures

Pregnancy and Lactation

Pregnancy

Use oxybutynin with caution in pregnancy.

Oxybutynin should only be used during pregnancy if considered essential and there is no safer alternative.

At the time of writing, no reports of the use of oxybutynin in human pregnancy were available. However, Briggs (2011) and Schaefer (2007) suggest that based on animal data, that the risk to the foetus is low.

Foetal toxicity and fertility studies in animals showed effects on reproductive processes only at maternally toxic doses.

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 oxybutynin with caution in breastfeeding.

A small amount of oxybutynin is excreted in human breast milk. At the time of writing there is limited published information regarding the use of oxybutynin during breastfeeding, therefore the effect on the newborn/infant is unknown. Schaefer (2007) suggests that its use for bladder incontinence is acceptable, although antimuscarinics may reduce lactation. The UK drugs in Lactation Advisory Service suggests oxybutynin may be used with caution in breastfeeding provided the infant is monitored for anticholinergic affects, e.g. urinary retention, colic, constipation and poor weight gain.

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

Advise patients that side effects such as drowsiness and dizziness may affect their ability to drive or operate machinery.

Advise patients to seek immediate medical advice if visual disturbances occur.

Side Effects

Abdominal discomfort
Agitation
Allergic reaction
Angioedema
Anorexia
Anxiety
Arrhythmias
Blurred vision
Cognitive impairment
Confusion
Constipation
Convulsions
Decreased appetite
Decreased sweating
Diarrhoea
Difficulty in micturition
Disorientation
Dizziness
Drowsiness
Dry eyes
Dry mouth
Dry skin
Dysphagia
Facial flushing
Gastroesophageal reflux
Glaucoma
Hallucinations
Headache
Heat stroke
Mydriasis
Nausea
Nightmares
Ocular hypertension
Paranoia
Photosensitivity
Rash
Restlessness
Skin reactions
Somnolence
Tachycardia
Urinary retention
Urinary tract infections
Urticaria
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: May 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Summary of Product Characteristics: Cystrin 5mg tablets. Zentiva. Revised March 2015.
Summary of Product Characteristics: Ditropan Elixir. SANOFI. Revised September 2014.
Summary of Product Characteristics: Ditropan 2.5mg Tablets. SANOFI. Revised September 2014.
Summary of Product Characteristics: Ditropan 5mg Tablets. SANOFI. Revised September 2014.
Summary of Product Characteristics: Oxybutynin hydrochloride 2.5mg/5ml Oral Solution. Thame Laboratories. Revised March 2015.
Summary of Product Characteristics: Oxybutynin hydrochloride 5mg/5ml Oral Solution. Thame Laboratories. Revised March 2015.

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

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017