Label Changes for:
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol
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)
WARNINGS AND PRECAUTIONS
- DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with aneurysm, pheochromocytoma, ….
- There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
- cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia
How Should I Use Dulera?
- Remove the cap from the mouthpiece of the actuator before using DULERA.