Spiriva氣適靈

Spiriva Overdosage

tiotropium bromide

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Overdosage
High doses of tiotropium bromide may lead to anticholinergic signs and symptoms.
However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide for Spiriva and 282 micrograms tiotropium for Spiriva Respimat in healthy volunteers. Additionally, no relevant adverse effects, beyond dry mouth, were observed following 7 day dosing of up to 170 microgram tiotropium bromide for Spiriva and up to 141 micrograms tiotropium for Spiriva Respimat in healthy volunteers. In a multiple dose study in COPD patients with a maximum daily dose of 43 microgram tiotropium bromide for Spiriva and 36 micrograms tiotrpium for Spiriva Respimat over four weeks no significant undesirable effects have been observed.
Spiriva: Acute intoxication by inadvertent oral ingestion of tiotropium bromide capsules is unlikely due to low oral bioavailability.
Spiriva Respimat: No relevant adverse events, beyond dry mouth/throat and dry nasal mucosa, were observed following 14-day dosing of up to 40 micrograms tiotropium solution for inhalation in healthy subjects with the exception of pronounced reduction in salivary flow from day 7 onwards. No significant undesirable effects have been observed in six long-term studies in patients with COPD when a daily dose of 10 micrograms tiotropium solution for inhalation was given over 4-48 weeks.
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