Dulera® (mometasone furoate/formoterol)

Dulera® (mometasone furoate/formoterol) is approved for the long-term treatment of asthma for people 5 years of age and up.^1-3

Dulera is a combination of an inhaled corticosteroid and a long-acting beta-agonist (LABA). It comes as a metered-dose inhaler.^1-3

Do not take Dulera if you are having an asthma attack. Use a rescue inhaler instead.^1-3

What are the ingredients in Dulera?

Dulera contains 2 active ingredients;^1-3

• Mometasone furoate, which is a synthetic corticosteroid. Corticosteroids are natural body chemicals that reduce inflammation.
• Formoterol, which is a LABA

How does Dulera work?

The 2 ingredients in Dulera work in different ways to treat asthma. Mometasone furoate is an inhaled corticosteroid that reduces airway inflammation. It does this by blocking pro-inflammatory processes involved in allergic reactions.^1-3

Formoterol is a type of LABA. It binds a protein in your cells called the beta-adrenergic receptor. This relaxes airway muscles and opens up the airway. It also blocks the activity of chemicals that increase inflammation. Its effects are longer acting, which makes it different from a rescue inhaler, which is a short-acting beta agonist. LABAs are never used as a solo medicine and should always be in combination with an inhaled corticosteroid.^1-3

What are the possible side effects of Dulera?

Possible side effects of Dulera include:^1-3

• Allergic reactions
• Increased wheezing (bronchospasm)
• Low bone density
• Slow growth in children
• Eye problems, such as glaucoma and cataracts
• Low blood sugar and potassium levels
• Inflammation of the nose, throat, and sinuses
• Headache

Inhaled corticosteroids like Dulera can cause thrush. This is a fungal infection in the mouth and throat. Rinse your mouth and regularly clean your inhaler after taking Dulera to help prevent thrush. Contact your doctor if you notice symptoms of thrush, such as:^1-3

• Throat discomfort or pain
• Hoarse voice
• Red or white patches in your mouth

Corticosteroids can weaken your immune system and increase your risk of infection. This risk is lower with inhaled corticosteroids. Avoid contact with people who have chickenpox, measles, or other contagious diseases. Call your doctor if you show symptoms of an infection, such as:^1-3

• Fever
• Fatigue
• Aches and pains
• Chills
• Nausea and vomiting

Dulera can also worsen current infections. Tell your doctor if you have any active infections, including tuberculosis or herpes simplex virus.^1-3

Switching to Dulera from oral corticosteroids increases your risk of adrenal insufficiency. This is a potentially life-threatening condition. It happens when your adrenal glands do not make enough steroid hormones. Talk to your doctor if you notice symptoms of adrenal insufficiency, including:^1-3

• Tiredness
• Weakness
• Nausea and vomiting
• Low blood pressure

LABAs such as formoterol increase the risk of asthma-related death when taken alone. The FDA says that LABAs should only be taken in combination with an inhaled corticosteroid. Dulera is a combined drug with an inhaled steroid and a LABA, and is safe. Get emergency help if:^1-3

• Breathing problems worsen quickly
• Your rescue inhaler does not relieve breathing problems

These are not all the possible side effects of Dulera. Talk to your doctor about what to expect when taking Dulera. You also should call your doctor if you have any changes that concern you when taking Dulera.

Things to know about Dulera

Take Dulera as your doctor describes. It comes as a metered-dose inhaler. Your doctor will teach you how to use, store, and clean your inhaler.^1-3

Your doctor will determine your dose based on age, asthma severity, and other medicines. You may not notice improvement in symptoms for a few weeks after starting treatment. Once symptoms stabilize, your doctor may switch you from Dulera to a medicine that has only an inhaled corticosteroid. This can help prevent side effects from LABAs.^1-3

If symptoms do not improve after 2 weeks, your doctor may increase your dosage. Do not stop using Dulera unless your doctor tells you to. If you miss a dose, just take your next scheduled dose when it is due. Do not take Dulera more than twice a day.^1-3

Dulera may interfere with other medicines or worsen certain conditions. Tell your doctor if you:^1-3

• Have any heart problems, seizures, high blood pressure, or diabetes
• Have had any problems with your liver, thyroid, eyes, immune system, or bone health
• Have any current infections
• Are planning to have surgery
• Are pregnant or breastfeeding

Before beginning treatment for asthma, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Dulera.