Oxybutynin oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release tablets containing oxybutynin hydrochloride.
Drugs List
Therapeutic Indications
Uses
Neurogenic bladder disorder
Nocturnal enuresis
Unstable bladder treatment.Symptoms of urgency/frequency/urge incontinence
Dosage
Adults
Starting dose
5 mg once daily for at least one week.
Maintenance dose
The dose may be increased to 10 mg once daily in order to achieve optimum efficacy and tolerability. Subsequent increases or decreases should be made in increments of 5 mg per day at intervals of at least 1 week.
The total daily dose should not exceed 20 mg.
Children
Children over 5 years of age
Initial dose of 5 mg once daily. This may be increased in 5 mg increments at intervals of at least 1 week up to a maximum of 15 mg once daily.
Additional Dosage Information
Missed tablet
In the case of a missed dose, the patient should wait and take the next dose at the regular time.
Transferring from standard release formulations
For patients changing from standard release presentations, clinical judgement should be used in determining the correct modified release dose. Dose should be adjusted to the minimum dose that achieves optimum efficacy and tolerability, taking into account the current dose of standard release presentations.
Contraindications
Children under 5 years
Acute porphyria
Breastfeeding
Galactosaemia
Gastrointestinal atony
Gastrointestinal obstruction
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Pregnancy
Severe ulcerative colitis
Shallow anterior chamber of eye
Toxic megacolon
Urinary frequency and nocturia secondary to cardiac failure
Urinary frequency and nocturia secondary to renal failure
Urinary retention
Precautions and Warnings
Children aged 5 to 18 years
Frail elderly patients
Predisposition to narrow angle glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Cardiac arrhythmias
Congestive cardiac failure
Decreased gastrointestinal motility
Gastroesophageal reflux
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Parkinson's disease
Renal impairment
Tachycardia
Ulcerative colitis
Advise ability to drive/operate machinery may be affected by side effects
Treat urinary tract infection concomitantly
Contains lactose
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
Advise patient to report new visual problems and symptoms
Children may experience increased frequency of certain side effects
Decreased salivary secretions may lead to dental caries
May cause heat prostration when used in high environmental temperatures
Discontinue immediately if angioedema of the tongue/glottis/larynx occurs
Outer membrane of tablet is not digested
Pregnancy and Lactation
Pregnancy
Oxybutynin is contraindicated during pregnancy.
The manufacturer does not recommend the use of oxybutynin during pregnancy. Animal studies have shown minor reproductive toxicity. At the time of writing, there is limited information on the use of oxybutynin in human pregnancy. Briggs (2015) and Schaefer (2015) suggest that based on animal data, that the risk to the foetus is low.
Lactation
Oxybutynin is contraindicated during breastfeeding.
The manufacturer does not recommend the use of oxybutynin during breastfeeding as 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 (2015) suggests that its use for bladder incontinence is acceptable, although antimuscarinics may reduce lactation. Usage is preferred to be at the end of breastfeeding with a waiting period of 3 to 4 hours.
Side Effects
Agitation
Allergic reaction
Angioedema
Anhidrosis
Anorexia
Anxiety
Arrhythmias
Asthenia
Blood pressure changes
CNS stimulation
Confusion
Convulsions
Cough
Decreased appetite
Dehydration
Depression
Disturbances in sweating
Dizziness
Dream abnormalities
Drowsiness
Dry eyes
Dry mouth
Dry mucous membranes
Dysgeusia
Dysphagia
Epistaxis
Flushing
Gastro-enteritis
Gastro-intestinal disturbances
Glaucoma
Glossitis
Haematuria
Hallucinations
Headache
Hernia
Hoarseness
Hypertonia
Impaired memory
Increased sputum
Influenza-like symptoms
Insomnia
Laryngeal oedema
Malaise
Mouth ulcers
Nervousness
Nightmares
Oedema
Oesophageal stricture
Pain
Palpitations
Paraesthesia
Pharyngitis
Photosensitivity
Pruritus
Psychotic symptoms
Pyrexia
Rectal disorders
Respiratory disorders
Rhinitis
Rigors
Skin reactions
Somnolence
Stomatitis
Tachycardia
Thirst
Tongue disorder
Tremor
Upper respiratory tract infection
Urinary abnormalities
Urinary tract disorders
Vertigo
Visual disturbances
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 2014
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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: Lyrinel XL prolonged release tablet. Janssen-Cilag Ltd. Revised July 2014.
Summary of Product Characteristics: Oxybutynin hydrochloride XL 10mg & 5mg prolonged release tablets. Accord-UK Ltd. Revised September 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 October 2022
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