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indacaterol and glycopyrronium bromide

R03AL04

Forms & Strengths

Inhalation powder, capsules containing indacaterol 110 mcg / glycopyrronium 50 mcg (Ultibro Breezhaler)

Adult Dosing

COPD maintenance: Inhale the contents of one capsule (110/50 mcg) once daily at the same time of day using the Breezhaler device

Pediatric Dosing

Safety and efficacy in pediatric patients (< 18 years) have not been established; not indicated for pediatric use

Indications

Long-term once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)

Mechanism of Action

Indacaterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates intracellular adenylate cyclase, causing smooth muscle relaxation
Glycopyrronium is a long-acting muscarinic antagonist (LAMA) that blocks bronchoconstrictive action of acetylcholine on airway smooth muscle
Combination provides complementary bronchodilation through dual distinct pharmacological pathways

Contraindications

Hypersensitivity to indacaterol, glycopyrronium, or any excipients (e.g., lactose)
History of severe hypersensitivity to milk proteins
Primary treatment of asthma (due to LABA safety warnings)

Adverse Reactions

Nasopharyngitis
Upper respiratory tract infection
Urinary tract infection
Headache
Cough
Paradoxical bronchospasm
Anticholinergic effects (dry mouth, constipation, urinary retention)

Drug Interactions

Other long-acting sympathomimetic agents or anticholinergics may potentiate adverse effects
Strong CYP3A4 and P-glycoprotein inhibitors (e.g., ketoconazole) may increase systemic exposure to indacaterol
Beta-blockers can weaken or antagonize the effect of indacaterol and may induce severe bronchospasm in COPD patients

Curated Content: Needs Vetting Before Put to Clinical Use