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U.S. Department of Health and Human Services

Safety

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Dulera (Mometasone Furoate and Formoterol Fumarate Dihydrate) Inhalation Aerosol

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

 

April 2014

Summary View

17 PATIENT COUNSELLING INFORMATION

17.6 Instructions for Use

Patients should be instructed regarding the following:

  • Read the Medication Guide before use and follow the Instructions for Use carefully. 

Patients should be reminded to:

  • Remove the cap from the mouthpiece of the actuator before use. 
  • Not remove the canister from the actuator.
  • Not wash inhaler in water. The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

MEDICATION GUIDE

How Should I Use DULERA?

DO NOT remove the canister from the actuator because:

  • You may not receive the correct amount of medication.
  • The dose counter may not function properly.
  • Reinsertion may cause the dose counter to count down by 1 and may discharge a puff.

Patient Instructions For Use

You should not remove the canister from the actuator because:

  • You may not receive the correct amount of medication.
  • The dose counter may not function properly.
  • Reinsertion may cause the counter to count down by 1 and may discharge a puff. 

 

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