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Detrusitol/Detrusitol SR

Detrusitol/Detrusitol SR Overdosage

tolterodine

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Full Prescribing Info
Overdosage
Detrusitol: Symptoms: The highest dose given to human volunteers of tolterodine L-tartrate is 12.8 mg as single dose. The most severe adverse events observed were accommodation disturbances and micturition difficulties.
Management: In the event of tolterodine overdose, treat with gastric lavage and give activated charcoal. Treat symptoms as follows: Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine.
Convulsions or pronounced excitation: treat with benzodiazepines.
Respiratory insufficiency: treat with artificial respiration.
Tachycardia: treat with beta-blockers.
Urinary retention: treat with catheterization.
Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room.
An increase in QT interval was observed at a total daily dose of 8 mg immediate release tolterodine (twice the recommended daily dose of the immediate release formulation and equivalent to three times the peak exposure of the prolonged release capsule formulation) administered over four days. In the event of tolterodine overdose, standard supportive measures for managing QT prolongation should be adopted.
Detrusitol SR: Overdosage with DETRUSITOL SR Capsules can potentially result in severe central anticholinergic effects and should be treated accordingly.
ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate release at doses up to 8 mg (4 mg bid) and higher doses were not evaluated [see Precautions and Pharmacology under Actions].
A 27-month-old child who ingested 5 to 7 tolterodine immediate release 2 mg tablets was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.
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