doses of tiotropium may lead to anticholinergic signs and symptoms. However,
there were no systemic anticholinergic adverse effects following a single
inhaled dose of up to 282 mcg tiotropium in 6 healthy volunteers. In a study of
12 healthy volunteers, bilateral conjunctivitis and dry mouth were seen
following repeated once-daily inhalation of 141 mcg of tiotropium.
by inadvertent oral ingestion of SPIRIVA capsules is unlikely since it is not
case of overdose has been reported from postmarketing experience. A female
patient was reported to have inhaled 30 capsules over a 2.5 day period, and
developed altered mental status, tremors, abdominal pain, and severe
constipation. The patient was hospitalized, SPIRIVA HandiHaler was
discontinued, and the constipation was treated with an enema. The patient
recovered and was discharged on the same day.
mortality was observed at inhalation tiotropium doses up to 32.4 mg/kg in mice,
267.7 mg/kg in rats, and 0.6 mg/kg in dogs. These doses correspond to 7300,
120,000, and 850 times the recommended human daily inhalation dose on a mg/m2
basis, respectively. These dose multiples may be over-estimated due to
difficulties in measuring deposited doses in animal inhalation studies.