Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Lyrinel XL 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.
Oxybutynin hydrochloride is indicated in children over 5 years of age for:
Lyrinel XL may be administered with or without food (see section 5.2).
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 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.
In case of a missed dose, the patient should wait and take the next dose at the regular time.
No dosage adjustment is necessary in elderly patients.
Initial dose of 5 mg once a day increased in 5 mg increments up to a maximum of 15 mg once a day.
Lyrinel XL should not be used in children below age of 5 years, because safety and efficacy have not been established (see sections 5.1 and 5.2).
Lyrinel XL 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.
The symptoms of overdose with oxybutynin progress from an intensification of the usual CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes (flushing, fall in blood pressure, circulatory failure etc.), respiratory failure, paralysis and coma.
Measures to be taken include administration of physostigmine by slow intravenous injection.
Fever should be treated symptomatically with tepid sponging or ice packs.
In pronounced restlessness or excitation, diazepam may be given by intravenous injection. Tachycardia may be treated with intravenous propranolol and urinary retention managed by bladder catheterisation.
In the event of progression of curare-like effects to paralysis of the respiratory muscles, mechanical ventilation will be required.
The continuous release of oxybutynin from Lyrinel XL should be considered in the treatment of overdose. Patients should be monitored for at least 24 hours.
Lyrinel XL 5mg: 2 years.
Lyrinel XL 10mg: 18 months.
Keep the container tightly closed in order to protect from moisture. Do not store above 25°C.
High density polyethylene bottles with child resistant closure (polypropylene) and desiccant.
Pack sizes 3, 7, 10, 14, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Do not remove or swallow the sachet of granules in the bottle. This contains desiccant, which keeps the tablets dry.
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