a prescription medicine that may help control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older.
DULERA combines an inhaled corticosteroid medicine (ICS), mometasone furoate, and a long-acting beta2-adrenergic agonist medicine (LABA), formoterol.
DULERA is not
used to relieve sudden breathing problems and will not replace a rescue inhaler.
DULERA is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and children with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.
MEDICINES
IN
ONE INHALER
DULERA is taken twice daily every day. DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening.
DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
Learn about a Savings Offer
SAVINGS OFFER FOR DULERA** Not all patients are eligible. Certain restrictions apply. Please see the Terms and Conditions.
Learn about a Savings Offer
SAVINGS OFFER FOR DULERA** Not all patients are eligible. Certain restrictions apply. Please see the Terms and Conditions.
3 dosage strengths available
50 mcg/5 mcg
Approved in 2019 for pediatric patients aged 5 to less than 12 years
100 mcg/5 mcg
or
200 mcg/5 mcg
Approved in 2010 for adult and adolescent patients aged 12 years and older
For pediatric patients aged 5 to 12 years
DULERA helps significantly improve lung function. Pediatric patients 5 to less than 12 years old taking DULERA had a greater measure of air exhaled during a forced breath in 1 second compared to those taking mometasone furoate alone*.
*The study involved pediatric patients 5 to less than 12 years old whose asthma was previously controlled on an ICS/LABA for at least 4 weeks.
For adult and adolescent patients aged 12 years and older
DULERA helps significantly improve lung function. Fewer adults and adolescents 12 years and older taking DULERA had an asthma flare-up† compared to people taking formoterol alone*.
*The study involved patients 12 years of age and older whose asthma was not under control while using medium-dose inhaled corticosteroids.
†Flare-up defined as an important reduction in lung function that may last 2 or more consecutive days, emergency treatment, hospitalization or treatment with certain additional asthma medications.
DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures, electrocardiogram (ECG) changes, or death. Tell your doctor about medicines you take and about all of your medical conditions.
People taking DULERA may experience
If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.
The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, headache, flu, and upper respiratory infection.
You are encouraged to report the negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.