SPIRIVA Safety Information
IMPORTANT PRODUCT INFORMATION
SPIRIVA® HandiHaler®
(tiotropium bromide inhalation powder)
SPIRIVA HandiHaler is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, ie, ipratropium, or to any component of this product. SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, ie, rescue therapy.
Immediate hypersensitivity reactions, including angioedema (swelling of the lips, tongue or throat), itching, and rash, may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If either of these occurs, treatment with SPIRIVA should be stopped and other treatments considered. As an anticholinergic drug, SPIRIVA may potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction, and should be used with caution in patients with any of these conditions.
As SPIRIVA is a predominantly renally excreted drug, SPIRIVA use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of <50 mL/min). SPIRIVA has been used concomitantly with other drugs commonly used in COPD (these include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids) without increases in adverse drug reactions. However, the coadministration of SPIRIVA with other anticholinergic-containing drugs (eg, ipratropium) has not been studied and is therefore not recommended. The most commonly reported adverse drug reaction with SPIRIVA was dry mouth, which was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects
included constipation, increased heart rate, blurred vision, glaucoma (new onset or worsening), urinary difficulty and urinary retention.