Drug Guide
Budesonide; Formoterol Fumarate
Classification
Therapeutic: Asthma and COPD maintenance therapy
Pharmacological: Combo inhaled corticosteroid and long-acting beta2-agonist
FDA Approved Indications
- Maintenance treatment of airflow obstruction in patients with asthma and COPD
Mechanism of Action
Budesonide is an inhaled corticosteroid that suppresses airway inflammation. Formoterol is a long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle, leading to bronchodilation.
Dosage and Administration
Adult: 2 inhalations twice daily, as prescribed by healthcare provider
Pediatric: Typically for children aged 6 years and older, dosage adjusted by healthcare provider
Geriatric: Adjust dose based on patient response and tolerability; no specific age-related contraindications, but caution advised
Renal Impairment: No specific dose adjustment required; use with caution
Hepatic Impairment: Use with caution; no specific dose adjustment established
Pharmacokinetics
Absorption: Rapid absorption from the lungs; systemic absorption minimal for local effects
Distribution: Selective distribution to the lungs; systemic binding of corticosteroid and beta2-agonist is limited
Metabolism: Budesonide undergoes extensive first-pass metabolism in the liver; formoterol metabolized via COMT and CYP pathways
Excretion: Renal and fecal routes
Half Life: Budesonide ~2-4 hours; Formoterol ~12 hours
Contraindications
- Hypersensitivity to budesonide, formoterol, or other corticosteroids/beta2-agonists
Precautions
- History of hypersensitivity reactions, cardiovascular disorders, hyperthyroidism, diabetes, osteoporosis, glaucoma, or infections like tuberculosis
Adverse Reactions - Common
- Throat irritation (Common)
- Hoarseness (Common)
- Headache (Common)
Adverse Reactions - Serious
- Worsening of asthma or COPD exacerbation (Uncommon)
- Cardiac arrhythmias or tachycardia (Uncommon)
- Oral candidiasis (Less common)
Drug-Drug Interactions
- Other beta2-agonists, MAO inhibitors, tricyclic antidepressants, beta-blockers, CYP3A4 inhibitors like ketoconazole
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor respiratory status, breath sounds, and for signs of allergic reactions or infections
Diagnoses:
- Ineffective airway clearance
- Risk for infection
- Impaired gas exchange
Implementation: Administer via inhaler as prescribed; educate patient on inhaler technique; monitor for adverse effects
Evaluation: Assess improvement in symptoms, lung function tests, and adherence to therapy
Patient/Family Teaching
- Use inhaler correctly to ensure medication delivery
- Rinse mouth after inhalation to prevent thrush
- Report worsening symptoms or adverse effects
- Do not stop medication abruptly
Special Considerations
Black Box Warnings:
- Potential for severe asthma episodes if used improperly
Genetic Factors: Genetic variations in CYP2D6 and CYP3A4 can affect metabolism of formoterol
Lab Test Interference: None noted
Overdose Management
Signs/Symptoms: Severe nausea, vomiting, tremors, tachycardia, hypokalemia, hyperglycemia
Treatment: Supportive care,Monitor vital signs, Manage symptoms; activated charcoal if ingestion occurred recently; seek emergency care
Storage and Handling
Storage: Store at room temperature, away from moisture and heat
Stability: Stable up to manufacture's expiration date when stored properly