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Formoterol and mometasone 

Generic name: formoterol and mometasone [for-MOE-ter-ol-and-moe-MET-a-sone]
Brand name: Dulera
Dosage form: inhalation aerosol (5 mcg–100 mcg/inh; 5 mcg–200 mcg/inh; 5 mcg–50 mcg/inh)
Drug class: bronchodilator combinations

What is Formoterol and mometasone?

Formoterol acts as a bronchodilator. Mometasone is a steroid. Combination medicine Formoterol/Mometasone helps control asthma symptoms in children and adults over the age of 5 years. When used alone, formoterol can increase the death risk of asthmatics. This risk does not increase when mometasone and formoterol are combined. This medication guide does not list all possible uses for mometasone and formoterol.

Side effects of Formoterol and mometasone

If you experience symptoms such as difficulty breathing, hives or swelling on the lips, face, throat or tongue that indicate allergies then seek medical assistance immediately.

Side effects from mometasone and formoterol can be serious. If you experience:

  • Asthma symptoms are getting worse.
  • Tremors, nervousness, chest pain, or fast or pounding heartbeats;
  • Feeling short of breath, fever, chills, and a cough that produces mucus;
  • If you experience wheezing or breathing difficulties after taking this medicine,
  • Blurred vision or tunnel vision; eye redness or pain; or seeing halos around lights
  • Signs of Thrush: white patches or sores in the mouth and throat; difficulty swallowing.
  • High blood sugar: increased thirst, frequent urination and fruity breath smell are signs of high blood sugar;
  • Constipation; leg cramps.
  • Signs of hormonal disorders: fatigue or weakness; feeling lightheaded; nausea and vomiting.

Mometasone can affect the growth of children. If your child's growth isn't normal while taking formoterol or mometasone, tell your doctor.

Side effects that may occur from formoterol or mometasone include:

  • Runny or stuffy nasal congestion, sinus pain
  • Headache;
  • Cough, sore throat

There may be other side effects.Call your doctor if experiencing side effects; otherwise contact the FDA by dialing 1-800-FDA-1088 and report the incident(s).

Similar/related drugs

Nucala, prednisone, Symbicort, Ventolin, Breo Ellipta, Ventolin HFA, and Dupixent

Warnings

Do not use formoterol or mometasone to treat asthma. If your symptoms worsen quickly, you should seek medical help.

Before you take this drug

If you have an allergy to mometasone or formoterol, then do not use the formoterol.

Your immune system can be weakened by mometasone. Inform your doctor of any illnesses or infections you have had in the last few weeks.

If you've ever:

  • Hypertension and coronary heart disease.
  • A seizure;
  • A weak immune system
  • Liver disease
  • Osteoporosis;
  • Other vision disorders, such as glaucoma or cataracts,
  • Diabetes;
  • Drug allergy
  • Pheochromocytoma
  • A thyroid condition;
  • An aneurysm is a weak or damaged blood vessel that could rupture and cause serious bleeding.

Inform your doctor immediately if you become pregnant. This medicine is not known to harm an unborn child. Untreated or uncontrolled asthma during pregnancy can cause serious complications, such as low birth weight, preterm birth, or eclampsia, which is dangerously high blood pressure and may lead to health problems for both the mother and child. Treatment of asthma can be beneficial to both mother and baby. Breast-feeding may be unsafe while taking this medication. You should consult your physician about possible risks. Anyone younger than five years of age is not allowed to use mometasone or formoterol.

How to take Formoterol and mometasone?

Read all instructions listed on your medication's label carefully and heed its directions exactly.Follow the directions on your prescription label. Too much medicine may cause dangerous side effects. Do not use formoterol or mometasone to treat asthma. Only inhalation medicines with rapid action should be used for attacks. If your asthma symptoms worsen quickly or you feel that your medications are not helping, seek medical help. Please read and follow all instructions for use that come with your medication. Unless the instructions are clear, if you don't understand them please ask your pharmacist or doctor for clarification. After each inhaler use, rinse your mouth out with water. Never let a child under the age of 12 use this medication without adult supervision. Your symptoms may improve in 1 to 2 weeks. Continue to take the medicine as prescribed, and let your doctor know if you do not see improvement in your symptoms. Once your asthma has been well controlled, you may be told by your doctor to stop taking formoterol or mometasone.

Your dose needs may change due to surgery, illness, stress or an asthma attack.You should not alter your dose of medication or your schedule without consulting your doctor. Tell your doctor about any numbers that are below normal if you have a peak-flow meter. You may want to have your vision and bone mineral density checked regularly. Keep away from high temperatures and moisture.If the canister heats up too quickly, it may burst.You should not burn or puncture an empty inhaler. The 60-inhalation cartridge can be stored on its side or with the mouthpiece facing down. Your doctor might want you to discontinue using the medicine once your asthma has been controlled. You should not stop taking the medication unless you are told to by your doctor.

What happens if I miss the dose?

Adult dose for asthma maintenance:
From 5 to 11 years old: twice daily, 2 inhalations each of mometasone or formoterol, 50 mg or 5 mg
Maximum dose: 200 mcg mometasone/20 mcg formoterol per day
Twelve years of age and older: two inhalations daily, morning and evening.
Each inhalation contains 100 mg, 200 mg of mometasone, and 5 mg of formoterol.
The maximum dose is 800 mg of mometasone and 20 mg of formoterol each day.
Comments:
The starting dose is determined by the patient's prior asthma treatment.
Patients who have previously been on medium-dose corticosteroids should start on 100 mcg/5 mcg.
Patients who have previously been on high-dose corticosteroids inhaled should start on 200 mcg/5 mcg.
Not for the treatment of acute bronchospasm.
The usual pediatric dose for asthma maintenance is:
Children 12 and over:
Orally, inhale two inhalations twice a day (morning and evening).
Inhalation of either mometasone or formoterol in doses of 100 or 200 mg is available.
Dosage Maximum: 800 mg mometasone and 20 mg formoterol
Comments:
The starting dose is determined by the patient's prior asthma treatment.
Patients who have previously been on medium-dose corticosteroids inhaled should start on 100 mcg/5 mcg.
Patients who have previously been on high-dose corticosteroids inhaled should start on 200 mcg/5 mcg.
Not for the treatment of acute bronchospasm.
Usage: For patients aged 12 and over who are not controlled by a long-term asthma medication, or for those whose condition is severe enough to require an inhaled beta2-adrenergic antagonist and corticosteroid.

What happens if I miss the dose?

Do not take the dose you missed. Use your next dose as usual. Use only one dose at a time.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention. The symptoms of an overdose include pain in the chest, a fast heartbeat, and feeling short of breath or shaky.

What should be avoided?

Avoid using a second inhaled medicine that contains formoterol (such as arformoterol, indacaterol, or other similar medicines such as olodaterol, salmeterol, or vilanterol). Stay away from people with infections or illnesses. If you have been exposed to measles or chickenpox, call your doctor immediately for treatment. If you are taking a medication that contains the steroid mometasone, these conditions may be severe or fatal.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Combining certain drugs can increase the risks for adverse side effects or make other medicines less effective.

Inform your doctor of all other medications you are taking, including:

  • Antifungal medicines such as ketoconazole.
  • Medicine to treat HIV, especially if it contains lopinavir or cobicistat.

The list below is not exhaustive. Formoterol or mometasone may be affected by other drugs, such as vitamins, herbal products, prescription medicines, and over-the-counter medicines. This list does not include all possible drug-drug interactions.