Dulera

Generic name: Formoterol And Mometasone
Brand names: Dulera
Drug class: Bronchodilator combinations

Usage of Dulera

Dulera inhalers contain a combination of formoterol and mometasone. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.< Mometasone is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Dulera is used to control and prevent the symptoms of asthma in adults and children who are at least 5 years old.

Dulera is not for use in treating an asthma or bronchospasm attack.

Dulera side effects

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

Call your doctor at once if you have:

worsening asthma symptoms;

tremors, nervousness, chest pain, fast or pounding heartbeats;

fever, chills, cough with mucus, feeling short of breath;

wheezing, choking, or other breathing problems after using this medication;

blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

signs of thrush (a fungal infection) - sores or white patches in your mouth or throat, trouble swallowing;

high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

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

signs of a hormonal disorder - tiredness or weakness, feeling light-headed, nausea, vomiting.

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

Common Dulera side effects may include:

runny or stuffy nose, sinus pain;

headache; or

cough, sore throat.

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.

Before taking Dulera

You should not use Dulera if you are allergic to formoterol or mometasone.

Mometasone can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.

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

heart disease, high blood pressure;

a seizure;

a weak immune system;

liver disease;

osteoporosis;

glaucoma, cataracts, or other vision problems;

diabetes;

a drug allergy;

pheochromocytoma (tumor of the adrenal gland);

a thyroid disorder; or

an aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding).

Tell your doctor if you are pregnant. It is not known whether formoterol and mometasone will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Dulera is not approved for use by anyone younger than 5 years old.

Relate drugs

How to use Dulera

Usual Adult Dose of Dulera 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

Warnings

Dulera is not a rescue medicine for asthma attacks. It will not work fast enough to treat 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.

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

What other drugs will affect Dulera

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

antifungal medicine such as ketoconazole; or

medicine to treat HIV (especially if it contains cobicistat, lopinavir, or ritonavir).

This list is not complete. Other drugs may interact with formoterol and mometasone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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