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OXYBUTYNIN HYDROCHLORIDE ASPIRE is a brand name for Oxybutynin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Oxybutynin is indicated in adults for the symptomatic treatment of urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder. Paediatric population Oxybutynin hydrochloride is indicated in children over 5 years of age for: - Urinary incontinence,…
Verbatim from this product's MHRA label. Tap a section to expand.
2). Adults Starting dose: the recommended starting dose is one 5 mg tablet once daily.
Maintenance dose/dose adjustment:
In order to achieve a maintenance dose giving an optimal balance of efficacy and tolerability, after at least one week on 5 mg daily, the dose may be increased to 10 mg once daily, with subsequent incremental increases or decreases of 5 mg/day.
There should be an interval of at least one week between dose changes. Maximum dose: in patients requiring a higher dose, the total daily dose should not exceed 20 mg. For patients currently taking oxybutynin immediate release, clinical judgement should be exercised in selecting the appropriate dose of Oxybutynin.
The dosage should be adjusted to the minimum dose that achieves an optimal balance of efficacy and tolerability, taking into account the current immediate- release dose. In case of a missed dose, the patient should wait and take the next dose at the regular time.
Elderly No dosage adjustment is necessary in elderly patients. Paediatric population Children over the age of 5 years Initial dose of 5 mg once a day increased in 5 mg increments up to a maximum of 15 mg once a day. 2). Method of administration Oxybutynin must be swallowed whole with the aid of liquid, and must not be chewed, divided, or crushed because the tablet is formulated to provide prolonged release.
Patients should be advised that the tablet membrane may pass through the gastrointestinal tract unchanged. This has no bearing on the efficacy of the product.
Summary of the safety profile The most common adverse reactions reported during clinical trials by > 5% of patients were dry mouth, constipation, diarrhoea, headache, somnolence and dizziness. 4). , placebo or active comparator) clinical trials for the management of overactive bladder, in which 759 adult subjects received doses ranging from 5 to 20 mg/day.
, active comparator) clinical trial, in which 60 paediatric subjects received doses of 10 or 15 mg/day. Table 1 below reflects the adverse drug reactions reported with Oxybutynin XL in clinical trials in adults and from postmarketing experience.
Adverse drug reactions reported in the paediatric clinical trial are shown in Table 2.
Table 1:
Adverse drug reactions reported in clinical trials in adults and from postmarketing experience Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1000 Not Known* Infections and infestations Urinary tract infection Immune System Disorders Hypersensitivity Anaphylactic reaction Metabolism and nutrition disorders Anorexia, Fluid retention, Decreased appetite Psychiatric disorders Insomnia Hallucinations, Confusional state, Agitation, Memory impairment Psychotic disorder, Anxiety, Nightmares, and Paranoia, symptoms of depression, dependence (in patients with history of drug or substance abuse) Nervous system disorders Somnolence, Dizziness, Headache, Dysgeusia Convulsions Cognitive disorders Eye disorders Vision blurred, Dry eye Angle closure glaucoma Mydriasis, Ocular hypertension Cardiac disorders Palpitations Arrhythmia, Tachycardia Vascular disorders Hypertension, Flushing Respiratory, thoracic and mediastinal disorders Oropharyngeal pain, Cough, Nasal dryness, Dry throat Dysphonia, Nasal congestion, Throat irritation Gastrointestinal disorders Dry mouth Gastro-oesophageal reflux disease, Abdominal pain, Dyspepsia, Constipation, Diarrhoea, Nausea, Flatulence Dysphagia, Abdominal discomfort, Frequent bowel movements, Vomiting Pseudo- obstruction in patients at risk (elderly or patients with constipation and treated with other medicinal products that decrease intestinal motility) Skin and subcutaneous tissue disorders Dry skin, Pruritus Urticaria, Rash Angioedema, Hypohidrosis Renal and urinary disorders Dysuria, Urinary hesitation Urinary retention, Residual urine Impotence General disorders and administration site conditions Fatigue Chest discomfort, Mucosal dryness, Thirst Investigations Residual urine volume+ Injury, poisoning and procedural complications Fall Heat stroke *Cannot be estimated from the available clinical data.
8). g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapy or increasing the dose; consider discontinuing therapy or reducing the dose if anticholinergic CNS effects develop.
Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling has the potential to become life-threatening.
If involvement of tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. 3) - anticholinergic medicinal products should be used with caution in patients who have hiatal hernia/gastro-oesophageal reflux disease and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
- pre-existing dementia treated with cholinesterase inhibitors due to risk of aggravation of symptoms. Oxybutynin should be used with caution in the frail elderly who may be more sensitive to the effects of oxybutynin. Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.
If urinary tract infection is present, an appropriate antibacterial therapy should be started. Oxybutynin may aggravate tachycardia (and thus the symptoms of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive disorders and symptoms of prostatic hypertrophy.
When oxybutynin is used in patients with fever or in high environmental temperatures, this can cause heat prostration, or heat stroke, due to decreased sweating. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1 - Narrow-angle glaucoma or shallow anterior chamber - Myasthenia gravis - Urinary retention - Gastrointestinal obstructive disorder, paralytic ileus or intestinal atony - Severe ulcerative colitis - Toxic megacolon - Urinary frequency and nocturia due to heart or renal failure - Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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+The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased. Description of selected adverse reactions The following postmarketing adverse reactions listed in Table 1 are from postmarketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data comprising 759 patients: hallucinations, agitation, memory impairment, and convulsions.
These estimates represent the upper limit of the 95% CI. As with other oxybutynin formulations, dry mouth was the most frequently reported adverse drug reaction. However, in clinical studies, dry mouth has been less frequently reported with Oxybutynin than with oxybutynin immediate release formulations.
8 times lower compared with patients who required final doses > 10 mg. Paediatric population The safety of Oxybutynin was evaluated in 60 paediatric subjects (age range 5 to 15 years; dose range 10-15 mg/day) who participated in an open-label, active control, three-arm clinical trial.
Adverse drug reactions reported by Oxybutynin-treated paediatric subjects in this clinical trial are shown in Table 2 Table 2: Adverse drug reactions reported in clinical trials with paediatric subjects Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1000 Metabolism and nutrition disorders Anorexia Psychiatric disorders Insomnia Nervous system disorders Headache Vascular disorders Flushing Gastrointestinal disorders Constipation Diarrhoea Skin and subcutaneous tissue disorders Rash, Pruritus 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).
Oxybutynin may reduce salivary secretions, which could result in dental caries, parodontitis, or oral candidiasis. As oxybutynin can cause angle-closure glaucoma, visual acuity and intraocular pressure should be monitored periodically during therapy.
Patients should be advised to contact a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain. Paediatric population Oxybutynin hydrochloride is not recommended for use in children below age 5 years due to insufficient data on safety and efficacy.
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.