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
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