Ultivent-M150 mcg+50 mcg+160 mcg

Ultivent-M is a fixed-dose triple combination inhaled therapy containing a long-acting beta2-agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS), delivered once daily via a single dry-powder inhaler.

Established / Approved Use

• Maintenance treatment of asthma: Ultivent-M is indicated for the maintenance treatment of asthma in adult patients who are not adequately controlled on a maintenance combination of a long-acting beta2-agonist and a high-dose inhaled corticosteroid, and who have experienced one or more asthma exacerbations in the previous year.

Important Notes

• Ultivent-M is a maintenance (controller) therapy only and must be taken regularly, once daily, even when the patient feels well.
• Ultivent-M is not indicated for the initial or first-line treatment of asthma, and is not intended for patients whose asthma is controlled on lower-intensity therapy.
• Ultivent-M is not a rescue medication and must never be used for the relief of acute bronchospasm or an acute asthma attack; a separate short-acting bronchodilator must be available for such episodes.
• Ultivent-M is not indicated for chronic obstructive pulmonary disease (COPD) or other respiratory conditions outside its approved asthma indication.

Each single-dose inhalation capsule of Indacaterol + Glycopyrronium + Mometasone Furoate for use with its dedicated inhaler device delivers a fixed combination of three active ingredients per actuation: an indacaterol component (as indacaterol acetate, a long-acting beta2-agonist), a glycopyrronium component (as glycopyrronium bromide, a long-acting muscarinic antagonist), and mometasone furoate (an inhaled corticosteroid), formulated as a dry powder for oral inhalation. Strength combinations are specified per approved product labeling (e.g., a mid- and a high-strength presentation), and the capsules also contain formulation excipients such as lactose monohydrate and magnesium stearate.

Ultivent-M is a once-daily, single-inhaler triple combination therapy for asthma, combining three complementary mechanisms of bronchodilation and anti-inflammatory action in one device: indacaterol (a long-acting beta2-adrenergic agonist, LABA), glycopyrronium (a long-acting muscarinic antagonist, LAMA), and mometasone furoate (an inhaled corticosteroid, ICS).

Ultivent-M is delivered as a dry powder from a single capsule inhaled once daily using its dedicated breath-actuated inhaler device. It is intended for patients with asthma that remains inadequately controlled despite treatment with an ICS/LABA combination, offering additional bronchodilation from the LAMA component alongside continued anti-inflammatory control from the ICS component.

Ultivent-M belongs to the therapeutic class of triple combination inhaled respiratory therapy, specifically a fixed-dose combination of a long-acting beta2-agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS), used in the maintenance treatment of asthma.

Indacaterol + Glycopyrronium + Mometasone Furoate combines three distinct and complementary pharmacological mechanisms:

• Indacaterol (LABA): selectively stimulates beta2-adrenergic receptors in bronchial smooth muscle, activating adenylyl cyclase and increasing intracellular cyclic AMP, which produces sustained relaxation of airway smooth muscle and bronchodilation lasting 24 hours.
• Glycopyrronium (LAMA): competitively and reversibly blocks acetylcholine at M3 muscarinic receptors on airway smooth muscle, inhibiting cholinergically-mediated bronchoconstriction and providing additional, complementary bronchodilation over 24 hours.
• Mometasone furoate (ICS): a synthetic corticosteroid with potent local anti-inflammatory activity in the airway, reducing airway inflammation, mucosal edema, and mucus secretion that underlie asthma symptoms and exacerbations, while co-formulation with a LABA also mitigates the increased risk of asthma-related death associated with LABA monotherapy.

After oral inhalation, all three components are absorbed systemically to a variable extent, are subject to hepatic metabolism (indacaterol and mometasone furoate via CYP3A4), and are eliminated mainly via feces with a minor renal contribution; each component has a pharmacokinetic profile consistent with once-daily dosing.

Ultivent-M is for oral inhalation only using its dedicated inhaler device — capsules must never be swallowed. Load one capsule into the inhaler immediately before use, pierce it as instructed, and inhale forcefully and deeply through the mouthpiece to disperse and inhale the full dose. Rinse the mouth with water and spit it out (do not swallow) after each dose to reduce the risk of oral thrush.

The following clinically significant interactions have been well established for Ultivent-M:

• Other LABAs, LAMAs, or inhaled corticosteroids: Co-administration with other medicines containing a long-acting beta2-agonist, a long-acting muscarinic antagonist, or an inhaled corticosteroid should be avoided, as this would result in therapeutic duplication and increased risk of additive adverse effects.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase systemic exposure to the indacaterol and mometasone furoate components, increasing the risk of systemic corticosteroid and cardiovascular/LABA-related adverse effects; concurrent use should be avoided or undertaken with caution and monitoring.
• Non-selective beta-blockers: May reduce the bronchodilator effect of the indacaterol component and can provoke bronchospasm; non-selective beta-blockers should generally be avoided in patients using Ultivent-M, and if a beta-blocker is required, a cardioselective agent should be considered with caution.
• Other anticholinergic (antimuscarinic) medicines: Concurrent use with other anticholinergic agents may result in additive anticholinergic effects (e.g., dry mouth, urinary retention, constipation) and should generally be avoided.
• Medicines that prolong the QT interval, MAO inhibitors, and tricyclic antidepressants: May potentiate the cardiovascular effects (e.g., effects on heart rate/rhythm) of the indacaterol component; use with caution.
• Xanthine derivatives, other beta-adrenergic agents, and diuretics: May increase the risk of hypokalemia and/or cardiovascular effects when used concurrently with the LABA component; monitor as clinically indicated.

The following adverse effects have been reported with Ultivent-M:

Common

• Nasopharyngitis and upper respiratory tract infection
• Headache
• Oral or oropharyngeal candidiasis (thrush)
• Cough and dysphonia (hoarseness/voice changes)
• Urinary tract infection
• Tachycardia (fast heartbeat)
• Musculoskeletal pain
• Asthma exacerbation

Uncommon

• Hyperglycemia
• Dry mouth
• Rash and other hypersensitivity reactions
• Cataracts (with prolonged use)
• Dysuria and urinary retention
• Palpitations and other cardiac rhythm disturbances

Patients should seek prompt medical attention for worsening breathing difficulty immediately after a dose (paradoxical bronchospasm), chest pain, palpitations, visual disturbance, or any severe or persistent adverse effect while using Ultivent-M.

Pregnancy

Data on the use of Ultivent-M in pregnant women are limited. Animal reproduction studies have not shown teratogenic effects with the indacaterol and glycopyrronium components at clinically relevant exposures, but corticosteroids such as mometasone furoate have produced fetal malformations in animal studies at high systemic exposures. Ultivent-M should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus; a physician should be consulted before use in pregnancy, and uncontrolled asthma itself carries risk to both mother and fetus.

Lactation

It is not known whether the components of Ultivent-M are excreted in human breast milk, though inhaled corticosteroids and related compounds are known to pass into milk in small amounts. A decision on whether to continue or discontinue breastfeeding, or to continue or discontinue Ultivent-M, should be made by weighing the benefit of breastfeeding to the infant against the mother's clinical need for therapy, in consultation with a physician.

The following precautions and warnings apply to the use of Ultivent-M:

• Not for acute symptoms: Ultivent-M is a maintenance therapy only and must not be used to treat acute asthma symptoms or an acute exacerbation; a separate short-acting rescue bronchodilator should always be available.
• Paradoxical bronchospasm: As with other inhaled therapies, Ultivent-M may produce paradoxical bronchospasm that can be life-threatening; if this occurs, discontinue Ultivent-M immediately and treat with a rescue bronchodilator.
• Do not stop abruptly: Ultivent-M should not be stopped or the dose reduced abruptly without physician guidance, as this may lead to worsening asthma symptoms; dose reduction should be undertaken gradually under medical supervision.
• Cardiovascular effects (LABA component): The indacaterol component can produce clinically significant cardiovascular effects, including increases in heart rate, blood pressure, or ECG changes; use with caution in patients with cardiovascular disease, arrhythmias, or hypertension.
• Anticholinergic effects (LAMA component): Use with caution in patients with narrow-angle glaucoma (may worsen or precipitate an attack) or urinary retention/bladder outlet obstruction (may worsen these conditions), and instruct patients to seek immediate medical attention for eye pain, blurred vision, or visual halos, or for difficulty urinating.
• Local and systemic corticosteroid effects (ICS component): Oropharyngeal candidiasis and hoarseness may occur; rinsing the mouth after each dose reduces this risk. Prolonged use of inhaled corticosteroids may increase the risk of pneumonia (particularly in COPD, though Ultivent-M is not indicated for COPD), and may cause systemic corticosteroid effects such as adrenal suppression, reduced bone mineral density, growth effects in adolescents, cataracts, and glaucoma, especially at higher doses or with prolonged use; monitor accordingly.
• Hypokalemia and hyperglycemia: Beta2-agonists may produce clinically significant hypokalemia and transient hyperglycemia; use with caution in patients predisposed to these conditions.
• Immunosuppression/infections: As with other corticosteroid-containing therapies, caution is warranted regarding exposure to infections such as chickenpox or measles in non-immune patients.

There is limited clinical experience with overdose of Ultivent-M. Overdose is likely to produce exaggerated effects of the individual components, such as tachycardia, palpitations, tremor, headache, arrhythmias, hypokalemia, and hyperglycemia (from the LABA component), dry mouth, blurred vision, or urinary retention (from the LAMA component), and, with prolonged excessive exposure, systemic corticosteroid effects (from the ICS component). In the event of a suspected overdose, seek immediate medical attention or contact a poison control center right away. Management should be supportive and symptomatic, with cardiac monitoring as appropriate, guided by a physician or emergency medical personnel; there is no specific antidote.

Store at room temperature (below 30°C), away from light and moisture. Keep the capsules in the blister until immediately before use, and keep out of reach of children.

• Pediatric patients: Safety and efficacy of Ultivent-M have not been established in patients under 18 years of age; not recommended for use in this population.
• Elderly patients: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients, but elderly patients may have a higher likelihood of cardiovascular comorbidity, so use with routine clinical monitoring.
• Renal impairment: Use with caution in patients with severe renal impairment or end-stage renal disease requiring dialysis, as systemic exposure to the glycopyrronium component may be increased (see Dosage and Administration).
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment, as systemic exposure to the components may be increased (see Dosage and Administration).
• Pregnant and breastfeeding women: See Pregnancy and Lactation.

Ultivent-M is intended for long-term, ongoing maintenance treatment of asthma and should be continued regularly, once daily, for as long as prescribed. It is not intended for short-term or as-needed use. The prescribing physician should periodically reassess asthma control and the continued need for therapy, and any change in dose or discontinuation should be done gradually and under medical supervision.

Triple combination inhaled respiratory therapy; Long-acting beta2-agonist (LABA); Long-acting muscarinic antagonist (LAMA); Inhaled corticosteroid (ICS)

Indacaterol + Glycopyrronium + Mometasone Furoate acts through three complementary mechanisms delivered from a single inhaler: the indacaterol component relaxes airway smooth muscle via beta2-adrenergic receptor stimulation (bronchodilation), the glycopyrronium component blocks M3 muscarinic receptors to inhibit cholinergically-mediated bronchoconstriction (additional bronchodilation), and the mometasone furoate component exerts potent local anti-inflammatory activity in the airway to reduce inflammation, edema, and mucus hypersecretion underlying asthma symptoms and exacerbations (see Pharmacology).

The safety and efficacy of Ultivent-M have not been established in pediatric patients under 18 years of age. Its use is therefore not recommended in children and adolescents, and alternative asthma therapies with established pediatric data should be used in this age group under specialist guidance.