Label Changes for:

Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol

July 2013

Changes have been made to the 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)

 

July 2013

WARNINGS AND PRECAUTIONS

Coexisting Conditions
  • DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with aneurysm, pheochromocytoma, ….

ADVERSE REACTIONS

DRUG INTERACTIONS

Halogenated Hydrocarbons
  • There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
Postmarketing Experience
  • cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia

 

 

January 2013

MEDICATION GUIDE

How Should I Use Dulera?
  • Remove the cap from the mouthpiece of the actuator before using DULERA.

 

 

August 2012

ADVERSE REACTIONS

Postmarketing Experience
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