Formoterol-Mometasone

Formoterol and Mometasone is a combination prescription medication used to control and prevent the symptoms of asthma. 

• Formoterol and Mometasone are available under various brand names: Dulera

Common side effects of Formoterol and Mometasone include:

• runny or stuffy nose, sinus pain.
• headache; or
• cough, sore throat.

Serious side effects of Formoterol and Mometasone include:

• hives. 
• difficulty breathing. 
• swelling of the face, lips, tongue, or throat.
• 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 the 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 the chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Rare side effects of Formoterol and Mometasone include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Aerosol

• (50 mcg/5 mcg)/actuation
• (100 mcg/5 mcg)/actuation
• (200 mcg/5 mcg)/actuation

Asthma

Adult dosage

Metered-dose inhaler: 

• Oral inhalation: 2 inhalations twice daily of mometasone 100 mcg/formoterol 5 mcg or mometasone 200 mcg/formoterol 5 mcg (maximum dose: mometasone 200 mcg/formoterol 5 mcg [2 inhalations] twice daily).

Pediatric dosage

Children 5 years to below 12 years:

• Mometasone 50 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.

Children above 12 years and Adolescents:

• Mometasone 100 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.
• Mometasone 200 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Formoterol and Mometasone have severe interactions with no other drugs.
• Formoterol and Mometasone have serious interactions with at least 42 other drugs.
• Formoterol and Mometasone have moderate interactions with at least 310 other drugs.
• Formoterol and Mometasone have minor interactions with at least 17 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to formoterol or mometasone.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Formoterol and Mometasone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Formoterol and Mometasone?”

Cautions

• Formoterol and mometasone are not rescuing 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.
• Mometasone can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.
• Formoterol and mometasone is not approved for use by anyone younger than 5 years old.
• 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).

Pregnancy and Lactation

• Tell your doctor if you are pregnant. It is not known whether this 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.
• Lactation
  • It may not be safe to breastfeed while using Formoterol and Mometasone. Ask your doctor about any risks.