Detrusitol

Detrusitol Special Precautions

tolterodine

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Tolterodine shall be used with caution in patients with: Significant bladder outlet obstruction at risk of urinary retention; Gastrointestinal obstructive disorders, e.g. pyloric stenosis; Renal impairment (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions); Hepatic disease (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions); Autonomic neuropathy; Hiatus hernia; Risk for decreased gastrointestinal motility.
Multiple oral total daily doses of immediate release 4 mg (therapeutic) and 8 mg (supratherapeutic) tolterodine have been shown to prolong the QTc interval (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of these findings is unclear and will depend on individual patient risk factors and susceptibilities present. Tolterodine should be used with caution in patients with risk factors for QT-prolongation including: Congenital or documented acquired QT prolongation; Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia; Bradycardia; Relevant pre-existing cardiac diseases (i.e. cardiomyopathy, myocardial ischaemia, arrhythmia, congestive heart failure); Concomitant administration of drugs known to prolong QT-interval including Class IA (e.g. quinidine, procainamide) and Class III (e.g. amiodarone, sotalol) anti-arrhythmics.
This especially holds true when taking potent CYP3A4 inhibitors (see Pharmacology: Pharmacodynamics under Actions).
Concomitant treatment with potent CYP3A4 inhibitors should be avoided (see Interactions).
Urinary retention: As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment.
Excipient information: Detrusitol 2 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium free'.
Effects on Ability to Drive and Use Machines: Since this drug may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.
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