Indacaterol + Glycopyrronium

• Chronic Obstructive Pulmonary Disease (COPD):
  Indicated for the maintenance treatment of airflow obstruction and reduction of exacerbations in adult patients with moderate to very severe COPD.
• Symptom Relief:
  Used to improve lung function and relieve symptoms such as breathlessness in COPD patients.
• Not for Acute Relief:
  This combination is not indicated for the treatment of acute bronchospasm or sudden worsening of COPD symptoms.
• Off-label Uses:
  Not commonly used off-label; use outside approved indications should be under specialist guidance.

• Adults:
• One inhalation containing 110 mcg indacaterol and 50 mcg glycopyrronium once daily via the dry powder inhaler.
• Elderly:
• No dose adjustment required.
• Pediatrics:
• Safety and efficacy have not been established in patients under 18 years; use is not recommended.
• Renal or Hepatic Impairment:
• No dose adjustment necessary for mild to moderate impairment.
• Use with caution in severe renal impairment due to limited data.
• Route:
• Inhalation via dry powder inhaler only.
• Duration:
• Continuous once-daily maintenance therapy.

Indacaterol is a long-acting beta2-adrenergic receptor agonist (LABA) that binds selectively to beta2 receptors on airway smooth muscle, causing sustained muscle relaxation and bronchodilation. Glycopyrronium is a long-acting muscarinic antagonist (LAMA) that competitively inhibits acetylcholine at M3 muscarinic receptors in the airway smooth muscle, preventing bronchoconstriction. Together, these agents produce prolonged bronchodilation through complementary mechanisms, improving airflow and reducing COPD symptoms.

• Absorption: Rapid local absorption in the lungs after inhalation with minimal systemic exposure.
• Distribution: Limited systemic distribution; plasma protein binding moderate.
• Metabolism:
• Indacaterol is metabolized primarily by direct glucuronidation and cytochrome P450 3A4 (CYP3A4) oxidation.
• Glycopyrronium undergoes minimal metabolism; mainly excreted unchanged.
• Elimination:
• Indacaterol half-life approximately 40–56 hours.
• Glycopyrronium half-life approximately 13–57 hours; primarily renal excretion.
• Onset of Action: Bronchodilation occurs within 5 minutes of inhalation.
• Duration: Effects last at least 24 hours, allowing once-daily dosing.

• Pregnancy:
  There are no adequate and well-controlled studies in pregnant women. Use only if potential benefit justifies potential risk to the fetus.
• Lactation:
  It is unknown whether either drug is excreted in human milk; caution is advised when administered to breastfeeding mothers.

• Primary Class: Bronchodilator Combination
• Subclass: Long-Acting Beta2-Agonist (LABA) + Long-Acting Muscarinic Antagonist (LAMA)

• Known hypersensitivity to indacaterol, glycopyrronium, or any excipients.
• Use in patients experiencing acute COPD exacerbation or acute bronchospasm.
• Severe hypersensitivity to lactose or milk proteins if present in inhaler formulation.

• Not for acute symptom relief; patients should have a short-acting bronchodilator available.
• Use with caution in patients with cardiovascular diseases such as arrhythmias, ischemic heart disease, or hypertension.
• Monitor for paradoxical bronchospasm; discontinue drug if it occurs.
• Caution in patients with narrow-angle glaucoma or urinary retention due to anticholinergic effects.
• Avoid excessive use or use beyond prescribed dose.
• No black box warnings are associated with this medication.

• Common:
• Upper respiratory tract infections
• Cough
• Headache
• Nasopharyngitis
• Dry mouth
• Less Common:
• Tremor
• Palpitations
• Dizziness
• Urinary retention
• Glaucoma exacerbation
• Serious (Rare):
• Paradoxical bronchospasm
• Cardiovascular events (tachycardia, arrhythmias)
• Hypersensitivity reactions such as angioedema, rash

• Beta-blockers may reduce effectiveness and increase risk of bronchospasm.
• Concurrent use with other anticholinergic drugs may increase anticholinergic adverse effects.
• CYP3A4 inhibitors (e.g., ketoconazole) may increase indacaterol plasma levels; monitor for toxicity.
• Monoamine oxidase inhibitors and tricyclic antidepressants may potentiate cardiovascular effects.
• No known significant interactions with food or alcohol.

• GOLD guidelines recommend LABA/LAMA combinations like indacaterol + glycopyrronium as preferred maintenance therapy in COPD patients with persistent symptoms or high exacerbation risk.
• New inhaler devices have improved ease of use and drug delivery.
• Safety data continues to support once-daily dosing with a favorable benefit-risk profile.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from heat, moisture, and direct sunlight.
• Do not freeze.
• Keep inhaler dry and in original packaging until use.