Drug Guide

Generic Name

Budesonide; Formoterol Fumarate

Brand Names Symbicort Aerosphere

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/A

Drug-Herb Interactions

N/A

Nursing 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

This guide is for educational purposes only and is not intended for clinical use.