Formoterol and mometasone

Generic name: Formoterol And Mometasone
Brand names: Dulera
Dosage form: inhalation aerosol (5 mcg-100 mcg/inh; 5 mcg-200 mcg/inh; 5 mcg-50 mcg/inh)
Drug class: Bronchodilator combinations

Usage of Formoterol and mometasone

Formoterol is a long-acting bronchodilator. Mometasone is a steroid.

Formoterol and mometasone is a combination medicine used to control and prevent the symptoms of asthma in adults and children at least 5 years old.

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.

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.

Formoterol and mometasone may cause serious side effects. 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 formoterol and mometasone.

Common side effects of formoterol and mometasone 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 Formoterol and mometasone

You should not use formoterol and mometasone 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.

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 this medicine 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 breast-feed while using this medicine. Ask your doctor about any risk.

Formoterol and mometasone is not approved for use by anyone younger than 5 years old.

Relate drugs

How to use Formoterol and mometasone

Usual Adult Dose for Asthma -- Maintenance:

5 to 11 years: 2 inhalations of 50 mcg mometasone/5 mcg formoterol twice a day Maximum dose: 200 mcg mometasone/20 mcg formoterol per day12 years and older: Two inhalations twice daily (morning and evening). -Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.Maximum Dose: 800 mcg of mometasone/20 mcg of formoterol per dayComments: -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 formoterolComments: -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

Formoterol and mometasone is not a rescue medicine for asthma attacks. 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 Formoterol and mometasone

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 affect 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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