Home Drug Guide Budesonide; Formoterol Fumarate Dihydrate

Drug Guide

Generic Name

Budesonide; Formoterol Fumarate Dihydrate

Brand Names Symbicort, Breyna

Classification

Therapeutic: Bronchodilator and anti-inflammatory agent combination for asthma and COPD

Pharmacological: Combination of inhaled corticosteroid (Budesonide) and long-acting beta-agonist (Formoterol)

FDA Approved Indications

Asthma in patients 6 years and older
Maintenance treatment of airflow obstruction in COPD including chronic bronchitis and emphysema

Mechanism of Action

Budesonide reduces airway inflammation by inhibiting multiple types of inflammatory cells and decreasing airway hyperresponsiveness; Formoterol stimulates beta2-adrenergic receptors leading to bronchodilation, with a longer onset of action suitable for maintenance therapy.

Dosage and Administration

Adult: Two inhalations twice daily (total of 160 mcg Budesonide and 4.5 mcg Formoterol per inhalation)

Pediatric: For ages 6-17: Two inhalations twice daily; dosage may be adjusted based on severity and response

Geriatric: Use with caution; no specific dosage adjustments needed, but monitor for adverse effects

Renal Impairment: No specific dose adjustment recommended

Hepatic Impairment: Use with caution; no specific dose adjustment available

Pharmacokinetics

Absorption: Budesonide has high first-pass metabolism, with low systemic bioavailability (~10-20%). Formoterol has good inhalation absorption.

Distribution: Wide tissue distribution for both drugs.

Metabolism: Budesonide is extensively metabolized in the liver via CYP3A4; Formoterol is metabolized primarily by glucuronidation.

Excretion: Budesonide metabolites are excreted mainly in feces; Formoterol metabolites are excreted in urine.

Half Life: Budesonide approximately 2-4 hours; Formoterol approximately 12 hours.

Contraindications

Hypersensitivity to budesonide, formoterol, or any component of the formulation

Precautions

History of hypersensitivity reactions, including to other beta-agonists or corticosteroids; do not use for acute asthma attacks; use with caution in cardiovascular disease, seizures, or diabetes. Monitor for paradoxical bronchospasm.

Adverse Reactions - Common

Oral candidiasis (thrush) (Common)
Hoarseness (Common)
Headache (Common)
Muscle or joint pain (Common)

Adverse Reactions - Serious

Paradoxical bronchospasm (Rare)
Hypersensitivity reactions, including anaphylaxis (Rare)
Severe asthma exacerbation (Rare)

Drug-Drug Interactions

Other beta-agonists or corticosteroids, CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) which can increase systemic levels of formulations.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor respiratory status, lung function tests, and for signs of adverse reactions, especially oral thrush.

Diagnoses:

Impaired gas exchange
Risk for infections
Ineffective airway clearance

Implementation: Instruct patient on correct inhaler technique, rinse mouth after using inhaler, and adhere to prescribed dosing schedule.

Evaluation: Assess symptom control, lung function, and monitor for adverse effects.

Patient/Family Teaching

Use inhaler exactly as prescribed.
Rinse mouth after inhalation to prevent thrush.
Report worsening symptoms or side effects.
Do not discontinue without consulting healthcare provider.

Special Considerations

Black Box Warnings:

Will not relieve acute bronchospasm or asthma attack; use for maintenance only.

Genetic Factors: Genetic variations can affect beta-adrenergic response, but not routinely tested.

Lab Test Interference: None significant.

Overdose Management

Signs/Symptoms: Severe tachycardia, hypokalemia, tremor, hypoxia, paradoxical bronchospasm, severe allergic reactions.

Treatment: Discontinue medication; provide symptomatic and supportive care, oxygen, and monitor cardiovascular status.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F). Protect from moisture.

Stability: Stable until expiration date printed on the packaging.