Label Changes for:
Spiriva HandiHaler (tiotropium bromide inhalation powder)
July 2011
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011
7 DRUG INTERACTIONS
7.2 Anticholinergics
- There is potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of SPIRIVA HandiHaler with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions (5.4, 5.5) and Adverse Reactions (6)]
17 PATIENT COUNSELING INFORMATION
- See changes in INSTRUCTIONS FOR USE
