Dilbro UniCap110 mcg+50 mcg

Dilbro UniCap is an inhaled combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), indicated for the following uses:

Established / Approved Use

• Long-term maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations

• Dilbro UniCap is not indicated for the treatment of asthma. LABA-containing medicines used without an inhaled corticosteroid are associated with an increased risk of asthma-related death.
• Dilbro UniCap is not a rescue inhaler and must not be used to treat acute symptoms of COPD or acute bronchospasm. A separate short-acting bronchodilator should be prescribed and kept on hand for acute relief.

Dilbro UniCap is intended for once-daily, regular maintenance use, not for as-needed symptom relief.

Indacaterol + Glycopyrronium inhalation capsules (for use with a dedicated dry-powder inhaler device) typically contain a fixed-dose combination of:

• Indacaterol (as indacaterol maleate) - a long-acting beta2-adrenergic agonist (LABA)
• Glycopyrronium (as glycopyrronium bromide) - a long-acting muscarinic antagonist (LAMA)

Each hard capsule also contains excipients, including lactose monohydrate (which may contain trace milk proteins). Strength combinations and exact excipients vary by manufacturer and market; always check the product label of the specific brand dispensed.

Dilbro UniCap is a fixed-dose combination inhaled medicine used in adults for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). It combines two complementary bronchodilators - an ultra-long-acting beta2-agonist and a long-acting anticholinergic (antimuscarinic) agent - delivered together once daily via a dry-powder inhaler device using hard capsules.

By combining two different bronchodilator mechanisms, Dilbro UniCap produces greater and more sustained improvement in airflow and symptom control than either component used alone, and is intended for regular, ongoing use rather than occasional or emergency use.

Dilbro UniCap belongs to the therapeutic class of inhaled bronchodilators for obstructive airway disease, specifically a fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), used for COPD maintenance therapy.

Indacaterol + Glycopyrronium combines two bronchodilators with complementary mechanisms of action:

Indacaterol (LABA component)

Indacaterol selectively stimulates beta2-adrenergic receptors on airway smooth muscle, activating adenylate cyclase and increasing intracellular cyclic AMP (cAMP). This leads to relaxation of bronchial smooth muscle and bronchodilation. Its effect is long-acting, supporting once-daily dosing.

Glycopyrronium (LAMA component)

Glycopyrronium is a competitive, reversible antagonist of muscarinic acetylcholine receptors, particularly the M3 subtype found on airway smooth muscle. By blocking acetylcholine's bronchoconstrictor action, it produces sustained bronchodilation and reduces airway resistance.

Used together, the two components act on different receptor pathways, producing additive bronchodilation and improved lung function compared with either agent alone.

Dilbro UniCap is administered by oral inhalation only, using the dry-powder inhaler device provided with the pack. The capsule must not be swallowed. Each capsule is loaded into the inhaler immediately before use, pierced, and its powder contents inhaled through the mouthpiece in one or two deep breaths, followed by breath-holding for a few seconds. Patients should be trained on correct inhaler technique, as inadequate technique reduces the amount of drug delivered to the lungs.

Dilbro UniCap has been studied for the following clinically significant drug interactions:

• Other LABA- or anticholinergic-containing medicines: Concomitant use of other long-acting beta2-agonists or other anticholinergic/antimuscarinic agents (including other inhaled bronchodilators) should generally be avoided, as it increases the risk of additive adverse effects without added benefit.
• Beta-blockers: Non-selective beta-blockers may antagonize the bronchodilator effect of the indacaterol component and should generally be avoided in patients with obstructive airway disease; if a beta-blocker is required for another condition, a cardioselective agent may be considered with caution and monitoring.
• MAO inhibitors, tricyclic antidepressants, and other drugs known to prolong the QT interval: These may potentiate the cardiovascular effects (e.g., tachycardia, arrhythmia) of the beta-agonist component; Dilbro UniCap should be used with caution in patients receiving such drugs.
• Sympathomimetic agents: Concomitant use with other sympathomimetic medicines may potentiate cardiovascular side effects.
• Non-potassium-sparing diuretics: The ECG changes and/or hypokalemia associated with beta-agonists may worsen with concomitant loop or thiazide diuretics; monitor potassium levels if used together.

Side effects reported with Dilbro UniCap are generally related to its two components (a LABA and a LAMA):

Common

• Dry mouth
• Cough
• Headache
• Nasopharyngitis (common cold-type symptoms)
• Dizziness
• Oropharyngeal pain
• Muscle spasms or pain in extremities

Cardiovascular (beta-agonist related)

• Tachycardia and palpitations
• Hypertension
• Rarely, cardiac arrhythmias (including atrial fibrillation)

Anticholinergic-related

• Urinary retention or difficulty urinating, particularly in patients with pre-existing bladder outlet obstruction or prostatic hyperplasia
• Constipation

Uncommon/Rare but Important

• Paradoxical bronchospasm (immediately after inhalation - discontinue and seek urgent medical attention if this occurs)
• Hypersensitivity reactions (rash, urticaria, angioedema)
• Blurred vision or eye pain suggestive of acute narrow-angle glaucoma

Patients experiencing severe or persistent side effects should contact their physician promptly.

Pregnancy: There are no adequate and well-controlled studies of Dilbro UniCap in pregnant women. Dilbro UniCap should be used during pregnancy only if the potential benefit to the mother clearly justifies the potential risk to the fetus, and only under the direct advice and supervision of a physician.

Lactation: It is not known whether the components of Dilbro UniCap are excreted in human breast milk. Because many drugs are excreted in breast milk, caution should be exercised, and a decision should be made whether to discontinue breastfeeding or discontinue the medicine, taking into account the importance of the drug to the mother - a physician should be consulted before use while breastfeeding.

• Not a rescue medicine: Dilbro UniCap must not be used to treat acute episodes of breathlessness or acute bronchospasm. Patients should be prescribed and should carry a separate short-acting bronchodilator for acute relief.
• Not for asthma: Dilbro UniCap is not approved for asthma; LABA-containing medicines used without a concomitant inhaled corticosteroid may increase the risk of serious asthma-related events.
• Cardiovascular disease: Use with caution in patients with coronary artery disease, arrhythmias, hypertension, or other cardiovascular disorders, as beta-agonists can produce cardiovascular effects (tachycardia, palpitations, blood pressure changes) and, rarely, ECG changes.
• Narrow-angle glaucoma: Use with caution due to the anticholinergic (glycopyrronium) component; instruct patients to seek immediate medical advice if they develop eye pain, blurred vision, visual halos, or red eyes.
• Urinary retention: Use with caution in patients with bladder outlet obstruction, prostatic hyperplasia, or urinary retention, due to the anticholinergic component.
• Convulsive disorders, thyrotoxicosis, and diabetes mellitus: Use with caution, as beta-agonists may unmask or worsen these conditions.
• Hypokalemia and hyperglycemia: Beta-agonists can occasionally produce clinically significant hypokalemia and transient hyperglycemia; monitor in susceptible patients (e.g., those on diuretics, or with diabetes).
• Paradoxical bronchospasm: If this occurs, discontinue Dilbro UniCap immediately and institute alternative therapy.
• Immediate hypersensitivity reactions: Discontinue Dilbro UniCap if signs of an allergic reaction occur.
• Co-administration with similar drug classes: Avoid using other LABA- or anticholinergic-containing medicines concurrently (see Interactions).

Overdose with Dilbro UniCap may be expected to produce exaggerated effects of its two components, such as excessive beta-adrenergic stimulation (tachycardia, palpitations, arrhythmias, tremor, headache, nausea, hypokalemia, hyperglycemia) and/or anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).

There is no specific antidote. If overdose is suspected, seek immediate medical attention or contact emergency services/a poison control center. Treatment is supportive and symptomatic; cardiac monitoring is advised, and cardioselective beta-blockers may be considered by a physician with caution, given the risk of bronchospasm. Do not attempt to manage a suspected overdose at home without medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep capsules in the sealed blister and remove only immediately before use. Do not refrigerate or freeze. Keep out of reach of children.

Elderly

No dose adjustment is generally required in elderly patients; however, they may be more susceptible to cardiovascular and anticholinergic side effects, so monitor accordingly.

Renal Impairment

No dose adjustment needed in mild-to-moderate renal impairment. Use with caution and close monitoring in severe renal impairment or end-stage renal disease, including patients on dialysis, as clinical data are limited.

Hepatic Impairment

No dose adjustment needed in mild-to-moderate hepatic impairment. Use with caution in severe hepatic impairment due to limited clinical data.

Pediatric Population

Dilbro UniCap is not indicated for use in children or adolescents; safety and efficacy have not been established (see Pediatric Uses).

Pregnancy and Breastfeeding

See Pregnancy and Lactation section for detailed guidance.

Dilbro UniCap is intended for long-term, continuous maintenance treatment of COPD rather than short courses or as-needed use. It should be taken regularly, once daily, for as long as prescribed by the treating physician, who will periodically reassess the need for continued therapy, response to treatment, and any emerging side effects.

Indacaterol + Glycopyrronium is a fixed-dose combination of a long-acting beta2-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA), classified as an inhaled dual bronchodilator for obstructive airway disease.

Indacaterol + Glycopyrronium works through two complementary bronchodilator mechanisms: the indacaterol component stimulates beta2-adrenergic receptors on airway smooth muscle, raising intracellular cAMP and causing relaxation of the airways, while the glycopyrronium component blocks M3 muscarinic acetylcholine receptors, preventing acetylcholine-driven bronchoconstriction. Together, these actions produce greater and more sustained bronchodilation than either mechanism alone, improving airflow and reducing COPD symptoms.

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Dilbro UniCap is not indicated for use in children or adolescents. The safety and efficacy of Dilbro UniCap in patients under 18 years of age have not been established, and it should not be prescribed for pediatric patients outside of a clinical trial setting.