Home Drug Guide Budesonide; Formoterol Fumarate; Glycopyrrolate

Drug Guide

Generic Name

Budesonide; Formoterol Fumarate; Glycopyrrolate

Brand Names Breztri Aerosphere

Classification

Therapeutic: Bronchodilator, Anti-inflammatory, Combination inhaler for COPD

Pharmacological: Inhaled corticosteroid, Long-acting beta-agonist, Anticholinergic

FDA Approved Indications

Treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema

Mechanism of Action

Budesonide reduces airway inflammation via corticosteroid effects; Formoterol is a long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle; Glycopyrrolate is an anticholinergic that blocks parasympathetic bronchoconstriction, leading to bronchodilation.

Dosage and Administration

Adult: Two inhalations twice daily inhalation of Breztri Aerosphere via the provided inhaler.

Pediatric: Not approved for pediatric use; safety and efficacy have not been established.

Geriatric: Use with caution, considering potential increased risk of side effects from all components.

Renal Impairment: No specific dosage adjustment recommended.

Hepatic Impairment: Use with caution; no specific dosage adjustments established.

Pharmacokinetics

Absorption: Systemic absorption occurs; bioavailability varies by component.

Distribution: Widely distributed; high pulmonary absorption.

Metabolism: Budesonide is extensively metabolized in the liver; Formoterol primarily metabolized hepatically; Glycopyrrolate undergoes minimal hepatic metabolism.

Excretion: Metabolites excreted primarily in urine and feces.

Half Life: Budesonide: approx. 2-4 hours; Formoterol: approx. 10 hours; Glycopyrrolate: approx. 2 hours.

Contraindications

Hypersensitivity to any component.
History of hypersensitivity to milk proteins (for inhaled corticosteroids).

Precautions

Use caution in patients with infections, tachyarrhythmias, severe cardiac disease, or with a history of hypersensitivity reactions. Not for acute bronchospasm.

Adverse Reactions - Common

Oral thrush (candidiasis) (Common)
Tachycardia, palpitations (Common)
Dry mouth (Common)

Adverse Reactions - Serious

Paradoxical bronchospasm (Rare)
Hypokalemia, hypotension (Rare)
Cardiac arrhythmias (Rare)

Drug-Drug Interactions

Other beta2-agonists, monoamine oxidase inhibitors, tricyclic antidepressants, other corticosteroids.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor lung function, assess for signs of infections or adverse effects.

Diagnoses:

Impaired gas exchange
Risk for infection
Ineffective airway clearance

Implementation: Instruct patient on correct inhaler technique, monitor for side effects, evaluate effectiveness.

Evaluation: Assess improvement in respiratory symptoms, lung function tests, and adverse effects.

Patient/Family Teaching

Use inhaler as prescribed, rinse mouth after corticosteroid use, report signs of infection or worsening symptoms.
Avoid allergens or irritants that worsen COPD.
Adherence to medication schedule is crucial.

Special Considerations

Black Box Warnings:

Oral corticosteroids may increase the risk of pneumonia in COPD patients.

Genetic Factors: None specified.

Lab Test Interference: None noted.

Overdose Management

Signs/Symptoms: Severe allergic reactions, tachycardia, tremors, hypokalemia.

Treatment: Discontinue medication, supportive care, and symptomatic treatment as needed.

Storage and Handling

Storage: Store at room temperature away from moisture and heat.

Stability: Stable as per manufacturer guidelines until expiration date.