Formoterol Fumarate/ Mometasone Furoate

Formoterol Fumarate and Mometasone Furoate is a fixed-dose combination inhaler therapy prescribed for the long-term management of chronic airway disorders. This dual-action formulation synergizes a bronchodilator and an anti-inflammatory agent to improve pulmonary function and prevent respiratory symptoms.

The medication belongs to two pharmacologic classes:

• Formoterol Fumarate: a long-acting beta2-adrenergic receptor agonist (LABA)
• Mometasone Furoate: an inhaled corticosteroid (ICS)

Marketed under various brand names such as Dulera, Zenhale, and Elifor, it is available in both metered-dose and dry powder inhaler formats. The combination is indicated for the maintenance treatment of asthma and COPD, particularly in patients requiring both LABA and ICS therapy.

This combination is approved as a maintenance therapy for moderate to severe persistent asthma. It is beneficial in patients whose asthma remains uncontrolled on ICS alone, offering a step-up treatment approach to reduce daily symptoms and future exacerbations.

In moderate to severe COPD, especially those with a history of exacerbations, this therapy helps reduce the frequency of flare-ups and improves airflow limitation. It is used in conjunction with long-acting muscarinic antagonists (LAMAs) or alone when LAMAs are not tolerated.

While not approved for acute EIB prevention, regular use of the combination may provide baseline protection by stabilizing the airway and reducing hyperresponsiveness associated with exertion.

• Treatment of eosinophilic bronchitis resistant to monotherapy
• Supportive therapy in allergic airway syndromes, including asthma-COPD overlap syndrome (ACOS)
• Adjunct in chronic cough linked to airway eosinophilia and inflammation

Formoterol binds selectively to beta2-receptors on bronchial smooth muscle, inducing muscle relaxation and bronchodilation. Its rapid onset (within minutes) and prolonged duration (up to 12 hours) make it suitable for both symptom relief and maintenance therapy.

Mometasone suppresses airway inflammation by inhibiting cytokine production, reducing eosinophilic infiltration, and limiting hyperresponsiveness. It minimizes airway remodeling over long-term use, improving respiratory stability.

• Improves asthma control more effectively than ICS alone
• Reduces exacerbations and hospitalizations
• Allows for lower corticosteroid doses while maintaining efficacy

Available in metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), common strengths include:

• Formoterol 5 mcg + Mometasone 100 mcg per inhalation
• Formoterol 5 mcg + Mometasone 200 mcg per inhalation

Dosage is individualized based on age, disease severity, and previous control:

• Adults: 2 inhalations twice daily
• Children (age-dependent): typically 1-2 inhalations twice daily

Adjustments are made based on clinical response and exacerbation history.

• Demonstrate correct inhaler usage (MDI or DPI-specific)
• Rinse mouth after each use to reduce risk of oropharyngeal candidiasis
• Stress the importance of daily adherence for effective control

• Active ingredients: Formoterol Fumarate and Mometasone Furoate per actuation
• Inactive components: Propellants (HFA), lactose monohydrate (in DPI), surfactants, stabilizers
• Lactose content: Important for patients with severe lactose intolerance or galactosemia

The combination of budesonide and formoterol is used to help manage and alleviate asthma symptoms, including breathing issues such as wheezing and shortness of breath, as well as coughs and chest tightness, in adults and children aged 6 years or older.

Glycopyrrolate and formoterol fumarate inhalation is a combination drug used to manage chronic obstructive pulmonary disease (COPD) in the long term, which includes conditions such as chronic bronchitis and emphysema. It is important to note that this medication is not intended for relief during breathing difficulties.

Albuterol works quickly but only lasts for 6 hours, whereas formoterol fumarate has a longer-lasting effect of 6 to 12 hours.

In terms of Mometasone, it is seen as a potent topical corticosteroid. On the other hand, Triamcinolone's potency varies between medium and low based on its formulation and concentration.

• Store below 25°C (77°F), away from direct sunlight and heat sources
• Keep inhalers dry and capped when not in use
• Discard after the labeled number of doses or expiration date

• Throat irritation, hoarseness
• Dry mouth, dysphonia
• Headache, nasal congestion, palpitations, and tremors

• Paradoxical bronchospasm requiring immediate discontinuation
• Systemic corticosteroid effects such as adrenal suppression or stunted growth (in children)
• Increased pneumonia risk, particularly in older COPD patients

• Potential reduction in bone mineral density with prolonged use
• Risk of ocular complications including glaucoma and cataracts

• Beta-blockers may reduce the bronchodilatory effects of formoterol
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) can increase mometasone exposure
• Use with diuretics may potentiate risk of hypokalemia

• Hypersensitivity to formoterol, mometasone, or formulation components
• Acute episodes of asthma or COPD (not suitable for rescue use)
• Primary therapy for status asthmaticus or other acute airway compromise

Formoterol Fumarate/Mometasone Furoate inhalers are effective in managing chronic airway diseases, but their use necessitates adherence to strict safety protocols due to potential systemic and respiratory risks.

• LABA-Related Asthma Mortality Warning: Long-acting beta2-agonists (LABAs), including formoterol, carry a boxed warning regarding the risk of asthma-related deaths. Monotherapy with a LABA is contraindicated in asthma. This risk is significantly reduced when combined with an inhaled corticosteroid, such as mometasone.
• Adrenal Suppression with High-Dose Corticosteroids: Prolonged use of high-dose inhaled corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis. This suppression can result in signs of adrenal insufficiency, particularly during times of physiological stress such as surgery or infection.
• Immunosuppressive Effects of Long-Term ICS Use: Chronic exposure to inhaled corticosteroids may increase susceptibility to localized or systemic infections, including oral candidiasis, tuberculosis reactivation, or other opportunistic pathogens. Patients with weakened immune systems should be monitored closely.

Elderly patients may exhibit heightened sensitivity to both pharmacologic agents due to age-related changes in pharmacokinetics and comorbidities.

• Initiate therapy at the lower end of the dosing spectrum.
• Monitor for cardiovascular complications such as arrhythmias, hypertension, or myocardial ischemia, especially in those with pre-existing conditions.
• Assess for signs of glucose intolerance or electrolyte disturbances.

The safety profile in pregnancy and lactation is not fully established, requiring careful evaluation of maternal benefits versus fetal or neonatal risks.

• Classified as FDA Pregnancy Category C, use only if the expected benefit justifies potential risk.
• Animal studies suggest possible fetal harm at high systemic exposures; human data are limited.
• Mometasone and formoterol may be excreted in breast milk. Consider potential effects on the nursing infant, such as adrenal suppression or growth retardation.

Pediatric administration should be guided by age-appropriate formulations and close clinical supervision.

• Approved use typically starts from age 5 or 12 years, depending on the specific product.
• ICS therapy, particularly at higher doses or prolonged use, may lead to growth velocity suppression. Routine growth monitoring is advised.

Overuse or accidental overdose of this combination inhaler can lead to systemic complications requiring immediate medical attention.

• LABA Overdose: Symptoms may include tachycardia, tremors, nervousness, chest pain, arrhythmia, or significant hypokalemia. Beta-agonist toxicity may also result in elevated blood glucose and lactic acidosis.
• Corticosteroid Overdose: High systemic exposure may induce Cushingoid features, weight gain, moon face, and HPA axis suppression. In extreme cases, adrenal crisis may occur, particularly in patients on long-term therapy.
• Treatment Protocols: Discontinue the medication, provide supportive care, correct electrolyte imbalances, and monitor cardiovascular and metabolic status. In severe cases, hospital admission and endocrinology consultation may be necessary.

Safe handling and disposal of inhalers are crucial for patient safety and environmental sustainability.

• Do not spray near eyes, open flames, or sources of ignition. Contents are pressurized and may be flammable.
• Store the inhaler with the cap on, and avoid puncturing or incinerating even when empty.
• Dispose of used inhalers per local regulations. Some regions offer pharmaceutical take-back programs to safely handle devices containing propellants or residual medication.