Mometasone Furoate/ Formoterol Fumarate

What it is and how it works

Mechanism of Action DULERA: DULERA contains both mometasone furoate and formoterol fumarate; therefore, the mechanisms of actions described below for the individual components apply to DULERA. These drugs represent two different classes of medications (a synthetic corticosteroid and a selective long-acting beta 2 -adrenergic receptor agonist) that have different effects on clinical, physiological, and inflammatory indices of asthma. Mometasone furoate : Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma.

Indications

is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. Important Limitation of Use: Not indicated for the relief of acute bronchospasm. Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use: DULERA is NOT indicated for the relief of acute bronchospasm.

Dosage and administration (summary)

For oral inhalation only. Treatment of asthma in patients 12 years of age and older: 2 inhalations twice daily of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg. Starting dosage is based on disease severity. Treatment of asthma in patients aged 5 to less than 12 years: 2 inhalations twice daily of DULERA 50 mcg/5 mcg. Administration Information Administer DULERA as two inhalations twice daily every day (morning and evening) by the orally inhaled route (see Patient Instructions for Use in the Patient Information leaflet). Do not use more than two inhalations twice daily of the prescribed strength of DULERA as some patients are more likely to experience adverse effects with higher doses of formoterol.

Contraindications

Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. Hypersensitivity to any of the ingredients of DULERA. Status Asthmaticus DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity DULERA is contraindicated in patients with known hypersensitivity to mometasone furoate, formoterol fumarate, or any of the ingredients in DULERA .

Warnings and precautions

monotherapy increases the risk of serious asthma-related events. Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms. Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing.

Pregnancy

Pregnancy Risk Summary There are no randomized clinical studies of DULERA, mometasone furoate, or formoterol fumarate in pregnant women. There are clinical considerations with the use of DULERA in pregnant women . Animal reproduction studies with DULERA are not available.

Storage and supply

Storage and Handling Only use the DULERA canister with the DULERA actuator. Do not use the DULERA actuator with any other inhalation drug product. Do not use actuators from other products with the DULERA canister. Do not remove the canister from the actuator because the correct amount of medication may not be discharged.

Source: Mometasone Furoate And Formoterol Fumarate Dihydrate (Dulera) — US FDA prescribing information, 2026-07-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.