Drug Class Description
Urinary antispasmodic

Generic Name
Oxybutynin hydrochloride

Drug Description
Prolonged release tablet.Lyrinel XL 5 mg: Round yellow coloured tablet printed “5 XL" with black ink.Lyrinel XL 10 mg: Round pink coloured tablet printed “10 XL" with black ink.

Presentation
Lyrinel XL™ 5 mg prolonged release tablet - Each tablet contains oxybutynin hydrochloride 5 mg.Lyrinel XL™ 10 mg prolonged release tablet - Each tablet contains oxybutynin hydrochloride 10 mg.

Indications
Adults and Elderly: For the symptomatic treatment of urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder.Children over the age of 6 years: The symptomatic treatment of detrusor hyperreflexia secondary to a neurogenic condition.

Adult Dosage
DosageAdults and ElderlyStarting 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 Lyrinel XL. 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.

Child Dosage
Children over the age of 6 yearsInitial dose of 5 mg once a day increased in 5 mg increments up to a maximum of 15 mg once a day.Lyrinel XL is not recommended for use in children below age of 6 years, due to a lack of data on safety and efficacy.Method of administrationLyrinel XL must be swallowed whole with the aid of liquid, and must not be chewed, divided, or crushed.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.Lyrinel XL may be administered with or without food.

Elderly Dosage
See Adult Dosage

Contra Indications
- Hypersensitivity to oxybutynin or any of the excipients- 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

Special Precautions
Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.Oxybutynin should be given with caution in patients with the following conditions:- hepatic or renal impairment- clinically significant bladder outflow obstruction since anticholinergic drugs may aggravate bladder outflow and cause retention- gastrointestinal motility disorders- gastroesophageal reflux and/or who are currently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis- 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.If urinary tract infection is present, an appropriate antibacterial therapy should be started.Oxybutynin may aggravate the symptoms of hyperthyroidism, congestive heart failure, cardiac arrhythmia, tachycardia, hypertension and 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.Oxybutynin may lead to decreased salivary secretions, which could result in tooth caries, periodontitis, or oral candidiasis.As oxybutynin may trigger angle-closure glaucoma, visual acuity and intraocular pressure should be monitored periodically during therapy. Patients should be advised to seek advice immediately if they are aware of a sudden loss of visual acuity.

Interactions
The concomitant use of oxybutynin with other anticholinergic medicinal products or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics, dipyridamole, may increase the frequency or severity of dry mouth, constipation and drowsiness.Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. They may also antagonize the gastrointestinal prokinetic effects of metoclopramide and domperidone. However, the interaction between prokinetics and oxybutynin has not been established.Sublingual nitrates may fail to dissolve under the tongue owing to dry mouth, resulting in reduced therapeutic effect.Oxybutynin is metabolised by cytochrome P450 isoenzyme CYP3A4. Mean oxybutynin chloride concentrations were approximately 2 fold higher when Lyrinel XL was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g. itraconazole and fluconazole) or macrolide antibiotics (e.g. erythromycin), may alter oxybutynin pharmacokinetics. The clinical relevance of such potential interaction is not known. Caution should be used when such drugs are coadministered.

Adverse Reactions
The table below reflects the data obtained with Lyrinel XL in clinical trials and from postmarketing experience. In clinical trials with Lyrinel XL (n=1006), adverse events were associated mainly with the anticholinergic actions of oxybutynin. Adverse events were generally dose related. As with other oxybutynin formulations, dry mouth was the most frequently reported adverse reaction. However, in clinical studies, dry mouth has been less frequently reported with Lyrinel XL than with oxybutynin immediate release formulations. For patients who required final doses of 5 or 10 mg of Lyrinel XL, the relative incidence of dry mouth that occurred at any dose level was 1.8 times lower compared with patients who required final doses > 10 mg. Very Common 1/10 Common 1/100 to <1/10 Uncommon 1/1,000 to <1/100 Rare 1/10,000 to <1/1000Not Known*Infections and infestationsurinary tract infection, cystitis, pharyngitis, nasopharyngitis, upper respiratory tract infection,, bronchitis, sinusitis,Blood and Lymphatic system disorders: leukopenia, thrombocytopenia Immune System Disorders hypersensitivity Metabolism & Nutrition Disorders anorexia, dehydration, hyperglycaemia appetite increased Psychiatric disorders insomnia, depression, nervousness, confusional state anxiety, abnormal dreams hallucinations, night terror, psychotic disorder, agitation Nervous System Disorders somnolence, headache, dizziness, dysgeusia paraesthesia, vertigo hypertonia, tremor, tinnitus convulsions Eye disorders vision blurred, dry eye, kerato-conjunctivitis sicca conjunctivitis diplopia, glaucoma, photophobia Cardiac disorders palpitations atrial arrhythmia, bradycardia, bundle branch block, nodal arrhythmia, supraventricular extrasystoles arrhythmia tachycardia Vascular disorders hypertension vasodilatation, migraine hypotension, phlebitis, ecchymosis flushing Respiratory, thoracic and mediastinal disorders nasal dryness, mucosal dryness, cough, pharyngo-laryngeal pain, dry throat rhinitis, hoarseness, epistaxis, dyspnoea laryngitis, laryngeal oedema, respiratory disorder, sputum increased Gastrointestinal Disorders Dry mouth constipation, diarrhoea, nausea, dyspepsia, abdominal pain, flatulence, gastroesophageal reflux disease, loose stools, vomiting dysphagia, mouth ulceration, abdominal distension, glossitis, stomatitis faecal abnormality, oesophageal stenosis acquired, gastritis, gastroenteritis viral, hernia, rectal disorder, gastric atony, tongue disorder, tongue oedema Skin and subcutaneous tissue disorders dry skin, pruritus acne, urticaria, face oedema, alopecia, eczema, nail disorder, skin discolouration, anhidrosis hair disorder, rash maculo-papular, granuloma, sweating increased, photosensitivity reaction rash Musculoskeletal and connective tissue disorders pain in extremity, back pain, arthralgia muscle cramps, myalgia arthritis Renal and urinary disorders micturition disorder, residual urine volume, urinary retention, dysuria, urinary hesitation urinary frequency, urinary tract disorder, haematuria, nocturia, pyuria, micturition urgency urinary incontinence, urine abnormal, urogenital disorder impotence, erectile dysfunctionReproductive system and breast disorders breast pain, vaginitis vulvovaginal disorder, uterine cervical disorder, genital discharge General disorders and administration site conditions asthenia, oedema peripheral, fatigue, chest pain pain, thirst, oedema rigor, pyrexia, influenza like illness, malaise, pelvic pain Investigations blood pressure increased electro-cardiogram abnormal, blood urea increased, blood creatinine increased blood alkaline phosphatase increased, blood lactase dehydrogenase increased, blood aspartate, aminotransferase increased, blood alanine aminotransferase increased Injury, poisoning and procedural complications fall *Cannot be estimated from the available clinical data. Undesirable effects noted with other oxybutynin hydrochloride formulations:In addition, cyclopegia, mydriasis and suppression of lactation have been reported with the use of other oxybutynin hydrochloride formulations.

Manufacturer
Janssen-Cilag

Drug Availability
(POM)

Updated
12 August 2009