Drug Guide
Formoterol Fumarate and Mometasone Furoate
Classification
Therapeutic: Asthma and COPD maintenance therapy
Pharmacological: Beta2-adrenergic agonist and inhaled corticosteroid combination
FDA Approved Indications
- Management of asthma in patients aged 12 years and older
- Management of airflow obstruction in COPD (less common for this specific combination)
Mechanism of Action
Formoterol is a long-acting beta2-adrenergic receptor agonist that relaxes airway smooth muscle, resulting in bronchodilation. Mometasone is an inhaled corticosteroid that reduces inflammation by inhibiting multiple types of inflammatory cells and decreasing cytokine production.
Dosage and Administration
Adult: Two inhalations (each containing 4.5 mcg formoterol and 200 mcg mometasone) twice daily
Pediatric: Not approved for children under 12 years.
Geriatric: No specific dosage adjustment; monitor for cardiovascular effects.
Renal Impairment: No specific dosage adjustment recommended.
Hepatic Impairment: No specific dosage adjustment recommended.
Pharmacokinetics
Absorption: Rapid absorption for both components when inhaled.
Distribution: Systemic distribution mostly in plasma and tissues.
Metabolism: Formoterol is metabolized via CYP2D6 and CYP2C19 pathways; Mometasone undergoes extensive first-pass metabolism via hepatic enzymes.
Excretion: Renal and fecal excretion of metabolites.
Half Life: Formoterol approximately 12 hours; Mometasone approximately 12 hours (systemic half-life).
Contraindications
- Hypersensitivity to mometasone or formoterol or other beta2-agonists or corticosteroids
- Status asthmaticus or other acute episodes of asthma
Precautions
- Use with caution in patients with cardiovascular disorders, hypertension, hyperthyroidism, diabetes, or seizures
- Monitor for paradoxical bronchospasm
Adverse Reactions - Common
- Throat irritation (Common)
- Headache (Common)
- Pharyngitis (Common)
- Oral candidiasis (Less common)
Adverse Reactions - Serious
- Paradoxical bronchospasm (Uncommon)
- Cardiovascular effects (tachycardia, palpitations) (Uncommon)
- Hypersensitivity reactions including angioedema (Rare)
Drug-Drug Interactions
- Other beta-agonists, monoamine oxidase inhibitors, tricyclic antidepressants (may increase cardiovascular effects)
- CYP2D6 or CYP2C19 inhibitors (may affect formoterol metabolism)
Drug-Food Interactions
- Avoid potent CYP2D6 inhibitors like fluoxetine, paroxetine
Drug-Herb Interactions
N/ANursing Implications
Assessment: Assess respiratory status, lung sounds, and pulse before and periodically during therapy.
Diagnoses:
- Ineffective Airway Clearance related to bronchospasm or inflammation
- Risk for Infection related to inhaled corticosteroid use
Implementation: Educate patient on proper inhaler technique, adherence, and symptom monitoring.
Evaluation: Monitor for symptom control, adverse effects, and adherence.
Patient/Family Teaching
- Instruct on correct inhaler technique.
- Rinse mouth after inhalation to prevent oropharyngeal candidiasis.
- Do not use for acute bronchospasm; carry a rescue inhaler.
- Report any signs of adverse reactions to healthcare provider.
Special Considerations
Black Box Warnings:
- Potential risk of severe asthma episodes or death with LABA monotherapy, always combine with ICS as prescribed.
Genetic Factors: Genetic polymorphisms in CYP2D6 may affect metabolism of formoterol.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Severe tachycardia, hypokalemia, hyperglycemia, tremors, seizures.
Treatment: Provide supportive care, monitor cardiac and respiratory status, administer beta-blockers cautiously if needed, and correct electrolyte disturbances.
Storage and Handling
Storage: Store at room temperature, away from moisture and direct heat.
Stability: Stable for prescribed shelf life, check packaging for expiration date.