Contraindications
Urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis, uncontrolled narrow-angle glaucoma.
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Special Precautions
Patient at risk of QT prolongation (e.g. congenital prolonged QT, concurrent class Ia or III antiarrhythmics therapy, electrolyte imbalance, bradycardia, pre-existing cardiac disease), bladder flow obstruction (e.g. benign prostatic hypertrophy); decreased gastrointestinal motility (e.g. intestinal atony) or obstructive disorder (e.g. pyloric stenosis); controlled or treated narrow-angle glaucoma, Alzheimer's disease, autonomic neuropathy, hiatus hernia. Hepatic and renal impairment. Elderly. Pregnancy and lactation. Patient taking potent CYP3A4 inhibitors. CYP2D6 poor metabolisers. Patient Counselling This drug may cause dizziness, drowsiness, or blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs and renal function (e.g. BUN, creatinine); postvoid residual urine volume prior to treatment initiation. Assess for signs of anticholinergic effects (e.g. dry mouth, dizziness, constipation).
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Adverse Reactions
Significant: Angioedema, QT prolongation (high doses, CYP2D6 poor metabolisers), urinary or gastric retention, decreased gastrointestinal motility, CNS effects (e.g. dizziness, drowsiness, blurred vision), anaphylaxis.
Cardiac disorders: Palpitations, tachycardia.
Eye disorders: Dry eyes, abnormal vision and accommodation.
Gastrointestinal disorders: Dry mouth, dyspepsia, constipation, abdominal pain, diarrhoea, flatulence.
General disorders and administration site conditions: Fatigue, flu-like symptoms.
Investigations: Increased weight.
Metabolism and nutrition disorders: Peripheral oedema.
Nervous system disorders: Headache, somnolence.
Renal and urinary disorders: Dysuria.
Respiratory, thoracic and mediastinal disorders: Sinusitis, chest pain.
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Drug Interactions
Increased risk of QT prolongation with class IA (e.g. quinidine, procainamide) and Class III (e.g. amiodarone, sotalol) antiarrhythmics. Increased serum concentrations thereby greater risk of overdosage with potent CYP3A4 inhibitors (e.g. erythromycin, clarithromycin, ketoconazole, itraconazole, protease inhibitors), especially in CYP2D6 poor metabolisers. May decrease prokinetic effects of metoclopramide and cisapride. Additive therapeutic and adverse effects with other antimuscarinic drugs. Reduced therapeutic effects with muscarinic/cholinergic receptor agonists. May increase exposure of tolterodine (immediate-release) with potent CYP2D6 inhibitor (e.g. fluoxetine), especially in CYP2D6 extensive metabolisers.
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CIMS Class
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ATC Classification
G04BD07 - tolterodine ; Belongs to the class of urinary antispasmodics.
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