Trioson(200 mcg+6 mcg+10 mcg)/puff

Trioson is a fixed-dose triple inhaler combining an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).

Established/Approved Use

• Maintenance treatment of chronic obstructive pulmonary disease (COPD): Trioson is indicated for the long-term maintenance treatment of COPD in adult patients who are not adequately controlled by a combination of an inhaled corticosteroid with a long-acting beta2-agonist, or by two long-acting bronchodilators (a LABA and a LAMA).

Not Indicated For

• Trioson is not a rescue medication and must not be used to treat acute episodes of bronchospasm or acute exacerbations of COPD; a separate fast-acting bronchodilator should always be available for such episodes.
• Trioson is not approved for the treatment of asthma as a fixed triple combination; its safety and efficacy in asthma have not been established for this specific product.

Each actuation of Beclometasone + Formoterol + Glycopyrronium pressurized metered-dose inhaler delivers a fixed combination of beclometasone dipropionate (an inhaled corticosteroid), formoterol fumarate dihydrate (a long-acting beta2-agonist), and glycopyrronium (as glycopyrronium bromide, a long-acting muscarinic antagonist) in an extrafine aerosol formulation.

Trioson is a triple fixed-dose combination inhaler used for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It combines three complementary mechanisms of action in a single extrafine-particle inhaler: an inhaled corticosteroid to reduce airway inflammation, a long-acting beta2-agonist to relax airway smooth muscle, and a long-acting muscarinic antagonist to block bronchoconstriction mediated by acetylcholine. Trioson helps improve lung function, reduce COPD exacerbations, and improve symptom control in patients whose disease is not adequately managed with dual therapy.

Trioson is a triple fixed-dose combination inhaler: Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA) + Long-Acting Muscarinic Antagonist (LAMA), used in the management of chronic obstructive pulmonary disease (COPD).

Beclometasone + Formoterol + Glycopyrronium exerts its therapeutic effect in COPD through three complementary pharmacological mechanisms delivered together as an extrafine aerosol that reaches both the large and small airways.

Beclometasone (Inhaled Corticosteroid component)

Beclometasone dipropionate reduces airway inflammation by inhibiting the release of inflammatory mediators and reducing the infiltration and activation of inflammatory cells in the airway, helping to reduce the frequency of COPD exacerbations.

Formoterol (Long-Acting Beta2-Agonist component)

Formoterol fumarate is a selective long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle by stimulating beta2-receptors, producing bronchodilation with an onset of action within minutes and a duration of effect of approximately 12 hours.

Glycopyrronium (Long-Acting Muscarinic Antagonist component)

Glycopyrronium is a long-acting anticholinergic agent that blocks the bronchoconstrictor effects of acetylcholine on airway smooth muscle by antagonizing muscarinic (M3) receptors, producing sustained bronchodilation.

Together, these three components of Beclometasone + Formoterol + Glycopyrronium produce complementary bronchodilation and anti-inflammatory effects in patients with COPD.

Trioson is for oral inhalation only, using the supplied pressurized metered-dose inhaler. It is not for oral ingestion, injection, or nebulization. See Dosage and Administration for full technique guidance.

Other LABA- or LAMA-Containing Medicines

Trioson should not be used concurrently with other medicines containing a long-acting beta2-agonist or a long-acting muscarinic antagonist, as this increases the risk of additive cardiovascular and anticholinergic adverse effects without added therapeutic benefit.

Beta-Blockers

Beta-adrenergic blocking agents (including eye drops) may reduce or antagonize the bronchodilator effect of the formoterol component of Trioson and should generally be avoided in patients with COPD unless there are compelling reasons for their use.

CYP3A4 Inhibitors

Strong inhibitors of CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole) may increase systemic exposure to the beclometasone component of Trioson and increase the risk of systemic corticosteroid effects; concurrent use should be approached with caution.

Diuretics, Xanthines and QT-Prolonging Drugs

Non-potassium-sparing diuretics, xanthine derivatives, and other steroids may potentiate hypokalemia associated with the formoterol component of Trioson. Monoamine oxidase inhibitors, tricyclic antidepressants, and other drugs known to prolong the QT interval may increase the risk of ventricular arrhythmias when used with Trioson.

Other Anticholinergic Medicines

Concomitant use of other anticholinergic-containing medicines with Trioson may lead to additive anticholinergic effects; caution is advised.

Common Side Effects

• Oral candidiasis (thrush) and hoarseness (dysphonia)
• Headache
• Nasopharyngitis and upper respiratory tract infection
• Dry mouth
• Tremor and palpitations
• Urinary tract infection

Less Common but Serious Side Effects

• Pneumonia (see Precautions and Warnings)
• Paradoxical bronchospasm (see Precautions and Warnings)
• Cardiovascular effects including tachycardia and arrhythmias (see Precautions and Warnings)
• Hypersensitivity reactions including rash, urticaria, and angioedema
• Urinary retention and worsening narrow-angle glaucoma (see Precautions and Warnings)

Patients experiencing any of these effects while using Trioson should contact their physician promptly.

Pregnancy

There are limited data on the use of Trioson in pregnant women. Trioson should be used during pregnancy only if the anticipated benefit to the mother justifies the potential risk to the fetus, and only under close medical supervision.

Lactation

It is not known whether the components of Trioson are excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue Trioson, taking into account the benefit of breastfeeding to the child and the benefit of treatment to the mother; consult a physician before use while breastfeeding.

Not for Acute Symptoms

Trioson is not indicated for the relief of acute symptoms; a separate, fast-acting inhaled bronchodilator must be available at all times for treatment of acute symptoms.

Paradoxical Bronchospasm

As with other inhaled therapies, Trioson may cause paradoxical bronchospasm that can be life-threatening; if this occurs, Trioson should be discontinued immediately and alternative therapy instituted.

Cardiovascular Effects

The formoterol component of Trioson can produce clinically significant cardiovascular effects, including increased heart rate and blood pressure changes in some patients. Use Trioson with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Anticholinergic Effects (Glycopyrronium Component)

Use Trioson with caution in patients with narrow-angle glaucoma, urinary retention, or symptomatic prostatic hyperplasia or bladder-neck obstruction, as the glycopyrronium component may worsen these conditions. Patients should seek immediate medical attention for worsening eye pain, blurred vision, or difficulty urinating while on Trioson.

Pneumonia Risk

An increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroid-containing products such as Trioson; physicians should remain vigilant for signs and symptoms of pneumonia, as these can overlap with COPD exacerbations.

Reduction in Bone Mineral Density

Long-term use of inhaled corticosteroid-containing products such as Trioson may be associated with a reduction in bone mineral density; monitor patients with major risk factors for decreased bone mineral content.

Hypercorticism and Adrenal Suppression

Trioson contains an inhaled corticosteroid; caution should be exercised when transferring patients from systemic corticosteroid therapy, and patients should be monitored for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression.

Concomitant LABA/LAMA Products

Do not use Trioson with other medicines containing a long-acting beta2-agonist or long-acting muscarinic antagonist (see Drug Interactions).

Hypokalemia and Hyperglycemia

The formoterol component of Trioson may produce significant hypokalemia and transient hyperglycemia in some patients; caution is advised, particularly in patients on concomitant diuretics.

Overdose with Trioson may present with exaggerated pharmacological effects such as tachycardia, tremor, palpitations, headache, nausea, hyperglycemia, hypokalemia, dry mouth, urinary retention, and, with excess corticosteroid exposure, symptoms of hypercorticism. If overdose of Trioson is suspected, seek immediate medical attention or contact a poison control center; supportive and symptomatic treatment should be provided under medical supervision, including cardiac monitoring where indicated. There is no specific antidote for Trioson overdose.

Store Trioson below 25°C, protected from direct sunlight and frost. Do not expose the canister to temperatures above 50°C. The canister contains a pressurized liquid; do not puncture, break, or burn the canister even when apparently empty. Keep out of reach and sight of children.

Elderly

No dose adjustment of Trioson is required in elderly patients; however, elderly patients with cardiovascular disease should be monitored closely for cardiovascular effects.

Renal Impairment

Trioson has not been specifically studied in patients with renal impairment; use with caution, particularly in severe renal impairment, given the potential for accumulation of the glycopyrronium component.

Hepatic Impairment

Trioson has not been specifically studied in patients with hepatic impairment; use with caution.

Pediatric Population

Trioson is not indicated for use in patients under 18 years of age (see Pediatric Uses).

Trioson is intended for long-term maintenance treatment of COPD and is generally continued indefinitely as part of ongoing COPD management, as directed by the treating physician; it should be used continuously, not intermittently, for optimal benefit. The physician will periodically reassess the need for continued treatment with Trioson.

Inhaled Corticosteroid (ICS) / Long-Acting Beta2-Agonist (LABA) / Long-Acting Muscarinic Antagonist (LAMA) triple combination

Beclometasone + Formoterol + Glycopyrronium combines three mechanisms: beclometasone (an inhaled corticosteroid) reduces airway inflammation; formoterol (a long-acting beta2-agonist) stimulates beta2-adrenergic receptors to relax bronchial smooth muscle; and glycopyrronium (a long-acting muscarinic antagonist) blocks acetylcholine-mediated bronchoconstriction at M3 muscarinic receptors. Together, these complementary actions in Beclometasone + Formoterol + Glycopyrronium produce sustained bronchodilation and reduced airway inflammation in COPD.

Trioson is not approved for use in children or adolescents below 18 years of age. Safety and efficacy of Trioson in the pediatric population have not been established, and it should not be used in this age group.