• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Dulera (Mometasone Furoate and Formoterol Fumarate Dihydrate) Inhalation Aerosol

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

 

July 2013

Summary View

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

Summary View

MEDICATION GUIDE

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

 

 

August 2012

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • angioedema