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 asthma symptoms in adults and children who are at least 5 years old.

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

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

Follow all instructions 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.

Formoterol and mometasone is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems worsen quickly, or if you think your asthma medications are not working as well.

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 let a young child use this medicine without help from an adult.

It may take 1 or 2 weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve. Your doctor may tell you to stop using formoterol and mometasone once your asthma is well controlled.

Your dose may need to 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 bone mineral density may need to be checked often.

Store at room temperature away from moisture and high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

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.

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.

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 in 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 for 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.

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.

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

Skip the missed dose and take your next dose at the usual time. Do not take two doses at the same time.

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.

Do not use a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

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).

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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.