DETRUSITOL

What it is

Detrusitol tablets contain tolterodine tartrate, a competitive muscarinic receptor antagonist. Detrusitol is available in 1 mg and 2 mg tablet strengths.

Approved indications

— Treatment of patients with overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.

Dosing overview

The recommended oral dose for tolterodine tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. For patients with significantly reduced hepatic function or severely impaired renal function (GFR ≤30 mL/min), the recommended dose is 1 mg twice daily.

Key safety warnings

Detrusitol should be used with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Detrusitol should be used with caution in patients with gastrointestinal obstructive disorders such as pyloric stenosis and in patients with autonomic neuropathy, hiatus hernia or decreased gastrointestinal motility. Patients should be informed that antimuscarinic agents may produce blurred vision or dizziness. Caution should be used in patients with known risk factors for QT prolongation (such as congenital or documented acquired QT prolongation, hypokalaemia, hypomagnesaemia, hypocalcaemia, bradycardia, concurrent administration of drugs known to prolong the QT interval) and relevant pre-existing cardiac diseases (such as myocardial ischaemia, arrhythmia, congestive heart failure, cardiomyopathy). Since this drug may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.

Contraindications

Detrusitol is contraindicated in patients with urinary retention; gastric retention; uncontrolled narrow angle glaucoma; myasthenia gravis; severe ulcerative colitis; toxic megacolon. Detrusitol is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Regulatory history

Detrusitol (tolterodine tartrate 1 mg and 2 mg tablet blister packs) were first listed on the ARTG on 15 December 2004. The product was first approved on 18 October 2005.