The U.S. Food and Drug

Administration (FDA) has approved Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a fixed-dose combination asthma treatment for patients 12 years of age and older.

 

Dulera Medication Guide

 

Read the Medication Guide that comes with Dulera before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

 

Important information about Dulera

 

Dulera can cause serious side effects, including:

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in Dulera), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in Dulera, reduces the risk of death from asthma problems seen with formoterol.

   • Call your healthcare provider if breathing problems worsen over time while using Dulera. You may need different treatment.

   • Get emergency medical care if:

     • breathing problems worsen quickly, and

     • you use your rescue inhaler medicine, but it does not relieve your breathing problems.

2. Dulera should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking Dulera. Your healthcare provider will decide if you can stop Dulera without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.