Dulera is a prescription inhaler used to treat asthma in patients 5 years of age and older. It combines two medications in one device: an anti-inflammatory corticosteroid and a long-acting bronchodilator. Together, these components reduce airway swelling and keep the airways open for up to 12 hours, making it a daily maintenance treatment rather than a rescue inhaler.
How Dulera Works
Dulera delivers two active ingredients with each puff. The first is a corticosteroid that reduces inflammation inside the airways. It works by suppressing the immune cells and chemical signals that drive the swelling, mucus production, and tightening associated with asthma. This component addresses the underlying cause of asthma symptoms over time.
The second ingredient is a long-acting bronchodilator that relaxes the smooth muscle lining your airways, opening them wider so air flows more easily. It begins working relatively quickly and lasts about 12 hours, which is why the inhaler is taken twice daily. In lab studies, this bronchodilator showed more than 200 times greater activity on lung receptors compared to heart receptors, meaning it targets the lungs with minimal effect on heart rate.
Neither ingredient alone is as effective as the combination. In clinical trials, patients using both components together gained a 135 mL improvement in lung function over 12 weeks compared to those using only the bronchodilator. The bronchodilator also contributed meaningfully: two hours after dosing, patients on the combination showed 148 to 208 mL better airflow than those on the corticosteroid alone. Those numbers translate into noticeably easier breathing for most people with moderate to severe asthma.
Who Can Use Dulera
Dulera is FDA-approved for patients aged 5 and older. It is not approved for COPD or any condition other than asthma, and its safety and effectiveness have not been established in children younger than 5.
The inhaler comes in three strengths. Adults and adolescents 12 and older can be prescribed either the 100 mcg/5 mcg or 200 mcg/5 mcg strength, depending on asthma severity. Children aged 5 to 11 use a lower 50 mcg/5 mcg strength. Your prescriber will choose the appropriate dose based on how well your asthma is currently controlled.
Dulera Is Not a Rescue Inhaler
This is one of the most important things to understand about Dulera. It is a maintenance inhaler, meaning you take it every day on a schedule to prevent symptoms. It does not work fast enough to stop an asthma attack that’s already happening. You still need a separate short-acting rescue inhaler for sudden breathing difficulty or flare-ups. Keep your rescue inhaler accessible at all times, even if Dulera is controlling your symptoms well day to day.
How to Take It
The standard regimen is two puffs twice a day, once in the morning and once in the evening. This schedule stays the same regardless of which strength you’re prescribed. The maximum daily dose for adults and adolescents is two inhalations of the 200 mcg/5 mcg strength twice daily, totaling 800 mcg of the corticosteroid and 20 mcg of the bronchodilator per day. For children 5 to 11, the maximum is 200 mcg/20 mcg per day.
Before using Dulera for the first time, you need to prime the inhaler by releasing 4 test sprays into the air, away from your face, shaking well before each spray. If you haven’t used it for more than 5 days, prime it again the same way. This ensures you get a full, consistent dose when you inhale. Store the canister at room temperature, between 68 and 77°F.
Common Side Effects
In clinical trials involving nearly 700 patients using Dulera over 12 to 26 weeks, the most frequently reported side effects were mild. Nasal and throat irritation (nasopharyngitis) occurred in about 4.7% of patients. Headache affected roughly 2% to 4.5%, depending on the dose. Sinus inflammation (sinusitis) was reported in about 2% to 3.3% of users. These rates were broadly similar to what patients experienced on either component alone.
Like all inhaled corticosteroids, Dulera can cause oral thrush, a yeast infection in the mouth and throat. Rinsing your mouth with water after each use and spitting it out (rather than swallowing) helps reduce this risk.
Safety of the Long-Acting Bronchodilator
Long-acting bronchodilators were once the subject of serious safety concerns. When used alone, without a corticosteroid, they were linked to an increased risk of severe asthma events, including hospitalizations and, rarely, death. This led the FDA to place a boxed warning on products containing this class of medication.
That warning was removed from Dulera in December 2017. Large clinical trials showed that when a long-acting bronchodilator is combined with a corticosteroid in a single inhaler, as it is in Dulera, there is no significant increase in serious asthma-related events compared to using a corticosteroid inhaler alone. The key risk factor was using the bronchodilator without anti-inflammatory protection, which Dulera’s fixed combination prevents.