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Dulera

Last reviewed on RxList: 7/14/2017
Dulera Patient Information Including Side Effects

Brand Names: Dulera

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

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.

Read the Dulera (mometasone furoate, formoterol fumarate dihydrate inhalation) Side Effects Center for a complete guide to possible side effects

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

Do not use formoterol and mometasone to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast acting inhalation medication. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

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.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Dulera Patient Information including How Should I Take

What should I discuss with my healthcare provider before using formoterol and mometasone (Dulera)?

You should not use this medication if you are allergic to formoterol (Foradil, Perforomist, Symbicort) or mometasone (Asmanex).

To make sure you can safely use this medication, tell your doctor if you have any of the following conditions:

  • tuberculosis;
  • an active infection of any kind;
  • herpes infection of the eye;
  • heart disease;
  • liver disease;
  • low bone mineral density;
  • glaucoma or cataracts;
  • epilepsy or other seizure disorder;
  • diabetes; or
  • a thyroid disorder.

FDA pregnancy category C. It is not known whether formoterol and mometasone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether formoterol and mometasone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Mometasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 12 years old without the advice of a doctor.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use 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.

This medication comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use formoterol and mometasone to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

The usual dose is 2 inhalations twice each day, morning and evening. Follow your doctor's instructions.

Shake the inhaler canister well before each use.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using the inhaler. Do not swallow.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Store at room temperature away from moisture and heat.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Dulera Patient Information including If I Miss a Dose

What happens if I miss a dose (Dulera)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Dulera)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, muscle cramps, chest pain, fast or pounding heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

What should I avoid while using formoterol and mometasone (Dulera)?

Do not use a second form of formoterol (such as Foradil, Perforomist, or Symbicort) or use another similar long-acting inhaled bronchodilator (LABA) such as salmeterol (Advair, Serevent) or arformoterol (Brovana).

Mometasone can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

What other drugs will affect formoterol and mometasone (Dulera)?

Many drugs can interact with formoterol and mometasone. Below is just a partial list. Tell your doctor if you are using:

  • a diuretic (water pill);
  • caffeine, diet pills, cold medicine, or a stimulant medication;
  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);
  • anti-malaria medication;
  • heart or blood pressure medication;
  • heart rhythm medicine;
  • HIV/AIDS medications;
  • medicines to treat psychiatric disorders;
  • migraine headache medicine;
  • narcotic medication;
  • an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), levofloxacin (Levaquin), and others;
  • antifungal medication such as ketoconazole (Nizoral), and others;
  • an antidepressant such as amitriptylline (Elavil, Vanatrip), protriptyline (Vivactil), and others;
  • an MAO inhibitor such as phenelzine (Nardil), selegiline (Eldepryl, Emsam), tranylcypromine (Parnate), and others; or
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran).

This list is not complete and there are many other drugs that can interact with formoterol and mometasone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about formoterol and mometasone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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