Formoterol and Mometasone furoate

DULERA 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.

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.

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.

Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. Hypersensitivity to any of the ingredients of DULERA.

LABA 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. Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

LABA use may result in the following: Serious asthma-related events – hospitalizations, intubations, and death. Cardiovascular and central nervous system effects. Systemic and local corticosteroid use may result in the following: Candida albicans infection Immunosuppression Hypercorticism and adrenal suppression Growth effects in pediatrics Glaucoma and cataracts Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (reported in ≥3% in any treatment arm and greater than placebo) included: Nasopharyngitis, sinusitis and headache.

In clinical trials, concurrent administration of DULERA and other drugs, such as short-acting beta 2 -agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with DULERA. The drug interactions of the combination are expected to reflect those of the individual components. Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. Adrenergic agents: Use with caution. Additional adrenergic drugs may potentiate sympathetic effects. Xanthine derivatives and diuretics: Use with caution. May potentiate ECG changes and/or hypokalemia. MAO inhibitors, tricyclic antidepressants, macrolides, and drugs that prolong QTc interval: Use with extreme caution. May potentiate effect on the cardiovascular system.

Store at controlled room temperature 20°C–25°C (68°F–77°F), excursions permitted to 15°C–30°C (59°F–86°F). For best results, keep the canister at room temperature before use. Exposure to temperatures above 120°F may cause bursting. After priming, store the inhaler with the mouthpiece down or in a horizontal position. Do not use or store near heat or open flame.