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OXYBUTYNIN HYDROCHLORIDE is a brand name for Oxybutynin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oxybutynin hydrochloride is indicated for the symptomatic treatment of urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage should be determined individually.
Adults:
The usual dose is 5mg (5ml) two or three times a day. This may be increased to a maximum of 5mg (5ml) four times a day to obtain a clinical response provided that the side effects are tolerated.
Elderly (including frail elderly):
The elimination half-life is increased in the elderly. 5ml) twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg (5ml) twice a day to obtain a clinical response provided that the side effects are tolerated.
Paediatric population Children (under 5 years of age):
Oxybutynin Hydrochloride is not recommended in children under 5 years of age due to the absence of data. 5ml) twice a day. This dose may be titrated upwards to 5mg (5ml) two or three times a day to obtain a clinical response provided that the side effects are tolerated.
5ml) twice a day. This dose may be titrated upwards to 5mg (5ml) two or three times a day to obtain a clinical response provided that the side effects are tolerated. The last dose should be given before bedtime. Method of administration For oral use
Like all medicines, oxybutynin can cause undesirable effects, although not everybody gets them. The frequency of possible undesirable effects listed below are currently defined as: very common (≥ 1 / 10), common (≥ 1/ 100 to <1 / 10), uncommon (≥ 1 /1000 to <1 / 100), rare (≥ 1 / 10, 000 to <1 /1000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1:
Adverse effects and their frequencies Infection and infestations: Not known: urinary tract infection. Immune system disorders Not known: hypersensitivity.
Psychiatric disorders:
Common: confusional state. Not known: agitation, anxiety, cognitive disorders in elderly, hallucinations, nightmares, paranoia, , symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse).
Nervous system disorders:
Very common: dizziness, headache, somnolence. Not known: cognitive disorders, convulsions, drowsiness, disorientation.
Eye disorders:
Very Common: vision blurred. Common: dry eyes. Not known: angle closure glaucoma, increased intraocular pressure, mydriasis.
Cardiac disorders:
Common: palpitation Not known: arrhythmia, tachycardia.
Vascular disorders:
Common: flushing (which may be more marked in children). Respiratory, thoracis and mediastinal disorders Not known: epistaxis Gastro-intestinal disorders: Very common: constipation, nausea, dry mouth. Common: diarrhoea, vomiting. Uncommon: abdominal discomfort, anorexia, decreased appetite, dysphagia.
• Oxybutynin Hydrochloride should be used with caution in patients with Parkinson’s disease who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy (such as those with Parkinson’s disease), severe gastro-intestinal motility disorders, hepatic or renal impairment.
• Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis. • Oxybutynin Hydrochloride may aggravate cognitive disorders, symptoms of prostatic hypertrophy and tachycardia (thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension).
• Anticholinergic CNS effects (such as hallucinations, agitation, confusion, somnolence) have been reported. Monitoring recommended, particularly in first few months after initiating therapy or increasing the dose. If anticholinergic CNS effects develop, termination of treatment or dose reduction may be considered.
• Since Oxybutynin Hydrochloride can cause narrow-angle glaucoma, patients should be advised to contact a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain. • Oxybutynin Hydrochloride may reduce salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
• Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
• When Oxybutynin Hydrochloride is used in high environmental temperatures, this can cause heat prostration due to decreased sweating. Elderly Anticholinergic medicinal products should be used with caution in elderly patients due to the risk of cognitive impairment.
1. • Myasthenia gravis. • Narrow-angle glaucoma or shallow anterior chamber. • Gastrointestinal obstruction including paralytic ileus, intestinal atony. • Toxic megacolon. • Severe ulcerative colitis. • Bladder outflow obstruction where urinary retention may be precipitated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Oxybutynin in United Kingdom.
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Not known: gastroesophageal reflux, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility) Skin and subcutaneous tissue disorders: Very common: dry skin.
Not known: angioedema, hypohidrosis, rash, urticaria, photosensitivity. Musculoskeletal and connective tissue disorders Not known: muscle disorders manifested as muscle weakness, myalgia and/or muscle spasms.
Renal and urinary disorders:
Common: urinary retention. Not known: difficulty in micturition.
Injury, poisoning and procedural complications:
Not known: heat stroke.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
They also have a higher risk of occurrence of adverse reactions to the product. Paediatric population The use of Oxybutynin Hydrochloride in children under 5 years of age is not recommended; it has not been established whether oxybutynin can be safely used in this age group.
There is limited evidence supporting the use of Oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor overactivity). In children over 5 years of age, Oxybutynin Hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Excipient warning:
This product contains: Sorbitol (E420): This medicine contains 182 mg sorbitol in each ml which is equivalent to 910 mg per dose of 5ml dose. 8 mg propylene glycol in each ml which is equivalent to 4 mg per dose of 5ml dose.
Methyl Parahydroxybenzoate (E218):
This medicine contains 1 mg methyl parahydroxybenzoate in each ml which is equivalent to 5 mg per 5 ml dose.