Beclometasone + Formoterol + Glycopyrronium

• Chronic Obstructive Pulmonary Disease (COPD):
  Indicated for maintenance treatment to improve lung function and reduce exacerbations in adult patients with moderate to severe COPD, including chronic bronchitis and emphysema.
• Asthma:
  Used as maintenance therapy for moderate to severe asthma inadequately controlled with inhaled corticosteroids and long-acting beta2-agonists.
• Off-label:
  Occasionally employed in asthma-COPD overlap syndrome (ACOS) under specialist guidance.

• Route: Inhalation via metered-dose inhaler or dry powder inhaler.
• Adults:
  Typically, two inhalations twice daily (morning and evening).
• Pediatrics:
  Safety and efficacy not established in children under 18 years.
• Elderly:
  No dosage adjustment required; monitor for adverse effects.
• Renal/Hepatic Impairment:
  No dose adjustment needed; exercise caution and monitor clinical response.
• Administration instructions:
  Patients should be instructed on proper inhaler technique. Rinse mouth after inhalation to minimize risk of oral candidiasis.

Beclometasone dipropionate is an inhaled corticosteroid that suppresses airway inflammation by inhibiting multiple inflammatory cells and mediators. Formoterol fumarate is a long-acting beta2-adrenergic receptor agonist that relaxes bronchial smooth muscle, causing bronchodilation. Glycopyrronium bromide is a long-acting muscarinic antagonist that blocks M3 receptors in airway smooth muscle, preventing acetylcholine-induced bronchoconstriction. The combined action results in sustained bronchodilation, reduced airway inflammation, and improved airflow.

• Absorption: Beclometasone is rapidly converted to its active metabolite after inhalation; formoterol and glycopyrronium are absorbed through pulmonary tissue with systemic bioavailability.
• Distribution: Moderate plasma protein binding; lung tissue concentration significant for therapeutic effect.
• Metabolism: Beclometasone and formoterol metabolized in liver primarily via CYP3A4; glycopyrronium undergoes minimal metabolism.
• Elimination: Metabolites and unchanged drugs eliminated via renal and biliary routes.
• Half-life: Formoterol ~10 hours; glycopyrronium ~33 hours; beclometasone active metabolite approximately 2.7 hours.
• Onset & Duration: Bronchodilation onset within minutes for formoterol and glycopyrronium; beclometasone effects develop over days to weeks; effects last ~12 hours or longer.

• Pregnancy: No well-controlled studies in humans; use only if potential benefit justifies potential risk. Animal studies do not indicate direct teratogenicity.
• Lactation: Unknown if excreted in human milk; caution advised during breastfeeding.

• Combination inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), and long-acting muscarinic antagonist (LAMA).

• Known hypersensitivity to beclometasone, formoterol, glycopyrronium, or formulation excipients.
• Acute bronchospasm requiring immediate relief.
• Hypersensitivity to milk proteins if applicable (due to lactose excipient).

• Not for acute bronchospasm treatment.
• Use cautiously in patients with cardiovascular diseases.
• Monitor for paradoxical bronchospasm.
• Possible systemic corticosteroid effects with high doses.
• Monitor for glaucoma and urinary retention due to anticholinergic effects.
• Increased risk of pneumonia in COPD patients on ICS-containing regimens.

• Common: Headache, throat irritation, oral candidiasis, cough, dry mouth.
• Respiratory: Upper respiratory infections, bronchospasm (rare), nasopharyngitis.
• Cardiovascular: Palpitations, tachycardia (rare).
• Others: Nervousness, tremor, muscle cramps, urinary retention (rare).
• Serious/Rare: Hypersensitivity reactions, glaucoma, increased intraocular pressure.

• Beta-blockers may reduce bronchodilator effect.
• Concomitant anticholinergics may increase anticholinergic side effects.
• CYP3A4 inhibitors may increase corticosteroid systemic exposure.
• Avoid use with MAO inhibitors or tricyclic antidepressants due to cardiovascular risks.
• No significant interaction with alcohol.

• GOLD and GINA recommend triple therapy for severe COPD or asthma inadequately controlled by dual therapy.
• Emphasis on minimizing corticosteroid exposure while maintaining control.
• Recent clinical trials affirm triple therapy’s efficacy in symptom control and exacerbation reduction.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from heat, moisture, and light.
• Do not freeze or puncture inhaler.
• Keep inhaler dry and out of reach of children.