Formoterol / Mometasone

Formoterol / mometasone is a combination inhaled medicine approved to treat asthma.

• Dulera is indicated for the twice-daily maintenance treatment of asthma in patients 5 years of age and older
• Dulera is for patients whose asthma is not adequately controlled with an inhaled corticosteroid alone, or whose asthma severity warrants starting both an inhaled corticosteroid and a long-acting bronchodilator together
• Dulera is not indicated for the relief of acute bronchospasm — it does not replace a rescue inhaler

Dulera works through two separate but complementary actions. Mometasone is a potent corticosteroid that damps down airway inflammation — it inhibits multiple cell types (including mast cells and eosinophils) and chemical messengers (such as histamine and leukotrienes) that drive the asthmatic response. Formoterol is a long-acting beta-2 agonist that relaxes the smooth muscle wrapped around the airways, allowing them to widen and making breathing easier; it also helps suppress the release of inflammatory substances from mast cells. Together, they address both the underlying inflammation and the airway narrowing that cause asthma symptoms.

Dulera is taken by oral inhalation only — breathed in through the mouth using its pressurized inhaler. The standard schedule is two inhalations twice daily, every morning and every evening. Some improvement in breathing can occur within 5 minutes, but the full benefit may take a week or longer to develop. If symptoms flare between doses, use a separate short-acting rescue inhaler — do not take extra doses of Dulera.

• Shake the inhaler well before every use
• Rinse your mouth with water and spit after each dose
• Prime the inhaler before first use and if unused for more than 5 days
• Follow your prescriber's instructions on strength and frequency exactly

The most common side effects reported with Dulera include:

• Nasopharyngitis (runny or stuffy nose, sore throat)
• Sinusitis (sinus pain or congestion)
• Headache
• Hoarse voice (dysphonia), more common with longer-term use
• Oral candidiasis (yeast infection in the mouth or throat) — rinsing your mouth after each dose greatly reduces this risk
• In children: flu, upper respiratory infections, and headache

More serious reactions — including heart rhythm problems, severe allergic reactions, worsening asthma, adrenal suppression, or vision changes — are less common but require prompt medical attention if they occur.

• LABA risk: Formoterol, the bronchodilator component, is associated with increased risk of serious asthma-related events (including death) when used alone. Dulera delivers it with mometasone, which significantly reduces this risk — but Dulera must never replace a rescue inhaler or be overused.
• Not for acute attacks: Dulera must not be used to treat a sudden or severe asthma attack. Always have a short-acting rescue inhaler available.
• Immune suppression: The corticosteroid component can weaken immune defenses. Chickenpox and measles can become severe or life-threatening in susceptible people using corticosteroids — avoid exposure and tell your doctor immediately if you are exposed.
• Adrenal suppression: Switching from oral corticosteroids to Dulera requires careful, slow tapering under medical supervision — abrupt withdrawal can cause adrenal insufficiency (extreme fatigue, weakness, nausea, low blood pressure).
• Eye effects: Long-term use raises the risk of glaucoma (increased eye pressure) and cataracts (clouding of the eye lens). Report any new eye symptoms to your doctor.
• Growth in children: Inhaled corticosteroids can slow growth velocity in children. Pediatric patients should be monitored regularly.
• Bone density: Long-term use may decrease bone mineral density. Patients with risk factors for osteoporosis should be monitored.

Dulera can interact with several types of medicines — always tell your prescriber and pharmacist everything you take:

• Strong CYP3A4 inhibitors (ritonavir, ketoconazole, clarithromycin, itraconazole, and others) — slow the breakdown of mometasone, potentially raising steroid levels in the blood and increasing the risk of systemic steroid side effects
• Other long-acting beta-2 agonists (salmeterol, arformoterol, formoterol products) — do not use with Dulera; overlapping doses risk overdose and serious heart effects
• Beta-blockers (propranolol, metoprolol, atenolol) — can block the bronchodilator effect of formoterol and may trigger severe airway narrowing
• MAO inhibitors and tricyclic antidepressants — can amplify formoterol's cardiovascular effects; avoid use within 2 weeks of stopping these medicines
• QTc-prolonging drugs (certain heart rhythm medicines, some antibiotics, some antipsychotics) — combined use increases the risk of dangerous heart rhythm disturbances
• Diuretics and xanthine derivatives (theophylline) — can worsen low blood potassium (hypokalemia) when combined with formoterol
• Halogenated anesthetic gases — raise the risk of arrhythmias during surgery; inform your anesthesiologist you use Dulera

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not use Dulera if you are allergic to mometasone furoate, formoterol fumarate, or any ingredient in the inhaler
• Do not use Dulera as the primary treatment for status asthmaticus (a severe, life-threatening asthma attack)
• Tell your doctor if you have any heart condition, high blood pressure, irregular heartbeat, or an aneurysm
• Tell your doctor if you have diabetes, a seizure disorder, thyroid disease, or low potassium levels
• Tell your doctor about any active infections — including tuberculosis, eye herpes, or any fungal, bacterial, or parasitic infection — since Dulera suppresses immune defenses
• If you are switching from oral corticosteroids (such as prednisone), your doctor must taper you off slowly to prevent adrenal insufficiency
• Pregnancy: No randomized clinical studies exist in pregnant women; poorly controlled asthma poses its own risks to the pregnancy, so discuss the benefits and risks with your doctor
• Breastfeeding: It is unknown whether Dulera components pass into human milk; weigh the benefits of breastfeeding against any potential risk with your doctor
• Children under 5: Safety and effectiveness have not been established in children younger than 5 years of age
• Liver impairment: Monitor for signs of increased drug exposure if you have liver problems, as the corticosteroid is processed by the liver

Taking too much Dulera can cause symptoms from excess formoterol (the bronchodilator), including rapid or irregular heartbeat, high or low blood pressure, tremor, headache, nervousness, nausea, dizziness, muscle cramps, low potassium, high blood sugar, and in severe cases, seizures or cardiac arrest. Chronic overuse of the corticosteroid component (mometasone) can lead to signs of too much steroid in the body (hypercorticism), such as weight gain and easy bruising. If you suspect an overdose, stop using Dulera and seek immediate medical care; cardiac monitoring is recommended.

In clinical studies, Dulera produced bronchodilation (airway opening) that was detectable within 5 minutes and lasted through 12 hours after dosing — comparable to formoterol delivered alone. Studies in adults and children found no clinically meaningful changes in heart rate, blood pressure, blood sugar, or potassium levels at recommended doses. However, the corticosteroid component (mometasone) can partially suppress the body's natural cortisol production (HPA-axis suppression), an effect seen with inhaled corticosteroids generally and more pronounced at higher doses.

After inhalation, mometasone is absorbed into the bloodstream, reaching peak levels within 30 minutes to 4 hours; oral bioavailability (the amount absorbed if accidentally swallowed) is negligible, meaning nearly all systemic exposure comes from lung absorption. Formoterol acts locally in the lungs as a bronchodilator after inhalation. The main route of metabolism for mometasone is through liver enzymes (specifically CYP3A4), which is why medicines that block those enzymes can raise mometasone blood levels. Systemic exposure to mometasone from Dulera is similar to or lower than that from equivalent doses delivered via dry powder inhalers.

Store at controlled room temperature 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F) . store the inhaler with the mouthpiece down or in a horizontal position. Keep out of reach of children.