formoterol and mometasone

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

What is 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.

What should I discuss with my healthcare provider before using formoterol and 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.

How should I use formoterol and mometasone?

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water without swallowing after each use of your inhaler.

Do not allow a young child to use this medicine without help from an adult.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Your vision and your bone mineral density may need to be checked often.

Store the 60-inhalation canister on its side, or with the mouthpiece down.

Once your asthma is under control, your doctor may want you to stop using this medicine. Do not stop using the medicine unless your doctor tells you to.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

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?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains mometasone (a steroid).

What are the possible side effects of formoterol and mometasone?

• 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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about formoterol and mometasone.