SPIRIVA Safety Information
IMPORTANT PRODUCT INFORMATION
SPIRIVA Handihaler is contraindicated in patients with a history of hypersensitivity to ipratropium or tiotropium (atropine derivatives).
SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.
Immediate hypersensitivity reactions, including angioedema (swelling of lips, tongue or throat), itching, and rash, may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA should be stopped and other treatments considered.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA.
Use with caution in patients with severe hypersensitivity to milk proteins.
SPIRIVA HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.
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 HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions. The co-administration of SPIRIVA HandiHaler with other anticholinergic-containing drugs (e.g., ipratropium) has not been studied and is therefore not recommended.
The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia and arthralgia.