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Formoterol and mometasone

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

Medically reviewed: December 26, 2017

What is formoterol and mometasone?

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.

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

Formoterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when formoterol and mometasone are used together as a combination product.

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

Important Information

Formoterol and mometasone is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Before taking this medicine

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

Mometasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure formoterol and mometasone is safe for you, tell your doctor if you have ever had:

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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether formoterol and mometasone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Formoterol and mometasone is not approved for use by anyone younger than 12 years old.

How should I use formoterol and mometasone?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using too much of this medicine can cause life-threatening side effects. Tell your doctor if you think your medications are not working as well.

Formoterol and mometasone is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast-acting inhalation medicine for an asthma attack.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Shake the inhaler for at least 5 seconds before each use.

Rinse your mouth with water after each use of your inhaler.

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.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Store at room temperature away from moisture and heat.

Store the 60-inhalation canister upright with the mouthpiece down, or on its side. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

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.

What happens if I miss a dose?

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?

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

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

What should I avoid while using formoterol and mometasone?

Do not use a second form of formoterol (Bevespi, Perforomist, Symbicort) or other long-acting inhaled bronchodilator unless your doctor tells you to. This includes arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), salmeterol (Advair, Serevent), or vilanterol (Breo Ellipta, Anoro Ellipta).

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 such as mometasone.

Formoterol and mometasone side effects

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

Call your doctor at once if you have:

  • 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);

  • chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • worsening asthma symptoms.

Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

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.

See also: Side effects (in more detail)

Formoterol and mometasone dosing information

Usual Adult Dose for Asthma -- Maintenance:

Two inhalations inhaled orally twice daily (morning and evening).

Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol

Comments:
-The starting dose should be determined based on patient's previous asthma therapy.
-Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
-Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
-Not for use in treatment of acute bronchospasm.

Usual Pediatric Dose for Asthma -- Maintenance:

For children 12 years of age and older:
Two inhalations inhaled orally twice daily (morning and evening).

Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol

Comments:
-The starting dose should be determined based on patient's previous asthma therapy.
-Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
-Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
-Not for use in treatment of acute bronchospasm.

Use: Indicated for patients 12 years of age and older who have inadequate control on a long-term asthma control medication or whose disease severity requires initiation of an inhaled corticosteroid and long-acting beta2-adrenergic agonist

What other drugs will affect formoterol and mometasone?

Many drugs can interact with formoterol and mometasone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete and many other drugs can interact with formoterol and mometasone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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