Usage
Budesonide + Indacaterol is prescribed for the maintenance treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
This combination drug falls under the pharmacological classifications:
- Corticosteroid (Budesonide): Reduces airway inflammation.
- Long-acting beta2-adrenergic agonist (LABA) (Indacaterol): Relaxes and opens the airways.
The mechanism of action involves two components: Budesonide reduces inflammation in the airways, while Indacaterol relaxes the smooth muscles around the airways, leading to bronchodilation and improved airflow.
Alternate Names
There is no officially recognized alternate generic name. A common combination of these medications is marketed under the brand name Atectura Breezhaler.
How It Works
Pharmacodynamics: Budesonide, a glucocorticoid, binds to glucocorticoid receptors in the cytoplasm, translocates to the nucleus, and modulates gene transcription. This leads to decreased inflammation by inhibiting the production of inflammatory mediators. Indacaterol, a LABA, stimulates beta2-adrenergic receptors on airway smooth muscle, activating adenylate cyclase and increasing intracellular cyclic AMP levels. This results in smooth muscle relaxation and bronchodilation.
Pharmacokinetics:
- Budesonide: Administered via inhalation, Budesonide is absorbed into the lungs with limited systemic absorption. It undergoes extensive first-pass metabolism in the liver via CYP3A4 enzymes. Excretion is primarily through the feces.
- Indacaterol: Also inhaled, Indacaterol has a longer duration of action compared to other LABAs. It is metabolized primarily by uridine 5’-diphospho-glucuronosyltransferase (UGT) enzymes and eliminated through the feces and urine.
Receptor binding: Budesonide binds to glucocorticoid receptors. Indacaterol binds to beta2-adrenergic receptors.
Elimination pathways: Budesonide is eliminated through hepatic metabolism and fecal excretion. Indacaterol is eliminated via UGT metabolism and both fecal and renal excretion.
Dosage
Standard Dosage
Adults:
The standard dose for Atectura Breezhaler is one inhalation (containing 110 mcg budesonide, 110 mcg glycopyrrolate, and 55 mcg indacaterol) once daily, administered at the same time each day.
Children:
This combination is not recommended for use in children.
Special Cases:
- Elderly Patients: No dosage adjustment is necessary.
- Patients with Renal Impairment: No dose adjustment is required in patients with mild to moderate renal impairment. For patients with severe renal impairment or end-stage renal disease requiring dialysis, the drug can be used at the recommended dose only if the expected benefit outweighs the potential risk.
- Patients with Hepatic Dysfunction: No dose adjustment is required in patients with mild to moderate hepatic impairment. Use with caution in patients with severe hepatic impairment.
- Patients with Comorbid Conditions: Use with caution in patients with cardiovascular disorders, diabetes, hyperthyroidism, hypokalemia, narrow-angle glaucoma, prostatic hyperplasia, seizure disorders, and urinary retention.
Clinical Use Cases
Budesonide + Indacaterol (Atectura Breezhaler) is specifically indicated for the maintenance treatment of COPD and not for the clinical use cases listed (Intubation, Surgical Procedures, Mechanical Ventilation, ICU Use, Emergency Situations). Short-acting bronchodilators or other appropriate therapies should be used in these acute scenarios.
Dosage Adjustments
No specific dosage adjustments are indicated beyond those mentioned for special populations.
Side Effects
Common Side Effects
Upper respiratory tract infection, nasopharyngitis, cough, headache, back pain, and muscle spasms.
Rare but Serious Side Effects
Pneumonia, paradoxical bronchospasm, angioedema, hypersensitivity reactions, arrhythmias, hyperglycemia, hypokalemia, and glaucoma.
Long-Term Effects
Increased risk of osteoporosis, cataracts, adrenal suppression with prolonged use of inhaled corticosteroids.
Adverse Drug Reactions (ADR)
Severe allergic reactions, severe bronchospasm, and significant cardiovascular events.
Contraindications
Hypersensitivity to budesonide, indacaterol, or any component of the formulation. Primary treatment of status asthmaticus or other acute episodes of COPD. Co-administration with other long-acting beta2-agonists.
Drug Interactions
Beta-adrenergic blockers, strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), and some anticholinergics may interact with Budesonide + Indacaterol. Consult a drug interaction database for a complete list.
Pregnancy and Breastfeeding
Budesonide + Indacaterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited information is available regarding breastfeeding. However, budesonide is present in human milk at low levels. Caution is advised.
Drug Profile Summary
- Mechanism of Action: Budesonide: Anti-inflammatory (corticosteroid). Indacaterol: Bronchodilator (LABA).
- Side Effects: Common: Upper respiratory tract infection, cough, headache. Serious: Paradoxical bronchospasm, angioedema, arrhythmias.
- Contraindications: Hypersensitivity, acute bronchospasm, concomitant LABA use.
- Drug Interactions: Beta-blockers, strong CYP3A4 inhibitors, some anticholinergics.
- Pregnancy & Breastfeeding: Use with caution. Consult specialist.
- Dosage: One inhalation once daily.
- Monitoring Parameters: Lung function (FEV1), blood glucose, potassium levels, eye examinations (for long-term use).
Popular Combinations
Not applicable, as this is already a fixed-dose combination.
Precautions
Patients should be monitored for signs and symptoms of hypercorticism, paradoxical bronchospasm, cardiovascular effects, and worsening of underlying conditions (e.g., diabetes, glaucoma).
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Budesonide + Indacaterol (Atectura Breezhaler)?
A: One inhalation once daily.
Q2: Can Budesonide + Indacaterol be used to treat acute exacerbations of COPD?
A: No, it is for maintenance treatment only. Use a short-acting bronchodilator (SABA) for acute exacerbations.
Q3: Can this combination be used in asthmatic patients?
A: No, Atectura Breezhaler is not indicated for the treatment of asthma.
Q4: What are the most common side effects?
A: Upper respiratory tract infection, nasopharyngitis, cough, headache.
Q5: Are there any serious side effects to be aware of?
A: Yes, paradoxical bronchospasm, angioedema, arrhythmias, hypokalemia. Patients should seek immediate medical attention if these occur.
Q6: What are the drug interactions to consider?
A: Beta-blockers, strong CYP3A4 inhibitors, some anticholinergics. Consult a comprehensive drug interaction resource for a complete list.
Q7: Can Budesonide + Indacaterol be used during pregnancy or breastfeeding?
A: Only if the potential benefit outweighs the risk. Discuss with a specialist.
Q8: How should patients be monitored during long-term therapy?
A: Monitor lung function (FEV1), blood glucose, potassium levels, and perform periodic eye examinations to check for cataracts or glaucoma.
Q9: What should a patient do if they miss a dose?
A: Take the missed dose as soon as possible, but do not take two doses on the same day. Resume regular dosing schedule the next day.
