Medications and Drugs

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Brand Names: Dulera

Generic Name: formoterol and mometasone (Pronunciation: for MOE ter ol and moe MET a sone)

• What is formoterol and mometasone (Dulera)?
• What are the possible side effects of formoterol and mometasone (Dulera)?
• What is the most important information I should know about formoterol and mometasone (Dulera)?
• What should I discuss with my healthcare provider before using formoterol and mometasone (Dulera)?
• How should I use formoterol and mometasone (Dulera)?
• What happens if I miss a dose (Dulera)?
• What happens if I overdose (Dulera)?
• What should I avoid while using formoterol and mometasone (Dulera)?
• What other drugs will affect formoterol (Dulera)?
• Where can I get more information?

What is formoterol and mometasone (Dulera)?

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

The combination of formoterol and mometasone is used as a maintenance treatment for asthma in adults and children who are at least 12 years old. This medication is not for use in treating an asthma or bronchospasm attack.

Formoterol and mometasone is usually given after other asthma medications have been tried without successful treatment of symptoms.

Formoterol and mometasone may also be used for purposes not listed in this medication guide.

What are the possible side effects of formoterol and mometasone (Dulera)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• sores or white patches in your mouth or throat;
• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, eye pain, or seeing halos around lights;
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;
• chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;
• increased thirst or hunger, urinating more than usual; or
• worsening asthma symptoms.

Less serious side effects may include:

• headache;
• stuffy nose, sinus pain, sore throat;
• changes in menstrual periods;
• hoarseness or deepened voice;
• dizziness, anxiety, headache;
• sleep problems (insomnia);
• back pain, muscle cramps;
• sore throat, dry mouth, cough, stuffy nose; or
• skin rash, itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about formoterol and mometasone (Dulera)?

Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using formoterol and mometasone.

Asthma is often treated with a combination of different drugs. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

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