Label Changes for:

Arcapta Neohaler (indacaterol maleate) Inhalation Powder 75 mcg

September 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012

 

4 CONTRAINDICATIONS

ARCAPTA NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients. [see Warnings and Precautions (5.4)]

5 WARNINGS AND PRECAUTIONS

5.4 Immediate Hypersensitivity Reactions
  • Immediate hypersensitivity reactions may occur after administration of ARCAPTA NEOHALER. If signs suggesting allergic reactions (in particular, difficulties in rash) occur, ARCAPTA NEOHALER should be discontinued immediately and alternative therapy instituted.

6 ADVERSE REACTIONS

6.3 Postmarketing Experience
  • added ..... paradoxical bronchospasm
  • added ..... hypersentivity

MEDICATION GUIDE

  • information on hypersentivity reactions added
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