Dilbro UniCap Inhalation Capsule

This is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It should not be used in acute episodes of bronchospasm. This is not indicated for asthma.

This is a once daily fxed dose combination of Glycopyrronium, a long-acting muscarinic receptor antagonist (LAMA) and Indacaterol, a long-acting β 2 receptor agonist (LABA). When Glycopyrronium & Indacaterol are administered together, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve bronchial smooth muscle relaxation.

The recommended dose is one inhalation capsule once-daily administration at the same time each day. This inhalation capsule must be administered only by the oral inhalation route and only using the inhaler device. This capsule must not be swallowed. If a dose is missed, it should be taken as soon as possible. Patients should not take more than one dose in a day.

Geriatric: This can be used at the recommended dose in elderly patients (65 years of age and older).

Pediatric: The safety and efficacy in pediatric populations under 18 years of age have not been established.

Renal impairment: This can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis (estimated glomerular filtration rate below 30 ml/min/1.73 m2), it should be used only if the expected benefit outweighs the potential risk.

Hepatic impairment: This can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of this inhalation capsule in patients with severe hepatic impairment, therefore caution should be observed in these patients.

No specific interaction studies were conducted for Glycopyrronium and Indacaterol combination. Information on the potential for interactions is based on the potential for each individual component. The concomitant use of Glycopyrronium and Indacaterol with β-adrenergic blockers, anticholinergics or sympathomimetic agents is not recommended. Sympathomimetic agents may potentiate the adverse events of Indacaterol. Caution is required with the concomitant use of hypokalemic treatment.

It is contraindicated in patients with hypersensitivity to Glycopyrronium or Indacaterol, or to any other component of this combination; Patients with severe hypersensitivity to milk proteins and All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication.

Adverse reactions that have been associated with muscarinic antagonists include cardiovascular effects (atrial arrhythmias and tachycardia), ocular disorders (e.g., blurred vision), urinary retention, gastrointestinal disorders, dry mouth and cough. Adverse reactions that have been associated with β2-agonists include immediate hypersensitivity reactions (urticaria, rash, bronchospasm, edema and angioedema), cardiovascular effects (tachycardia, arrhythmia, palpitations, myocardial ischaemia, hypertension or. hypotension), hypokalemia, hyperglycemia, headache, nervousness, insomnia, muscle spasms, fatigue, malaise and tremor. The most common adverse drug reactions related to the drug product (reported >3% and greater than placebo) were cough and oropharyngeal pain (including throat irritation).

Pregnancy category C. There are no data from the use of this combination in pregnant women available. Therefore, this combination should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus. It is not known whether Indacaterol, Glycopyrronium and their metabolites are excreted in human milk. The use of this combination by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.

Long-acting β2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma. This combination should be used with caution in patients with narrow-angle glaucoma or urinary retention. β2-adrenergic agonists may produce signifcant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects.

Administration of this combination Cozycap may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, this combination Cozycap should be discontinued immediately and alternative therapy instituted. β2 receptor agonists may produce significant hypokalemia is some patients, which has the potential to produce adverse cardiovascular effects. Inhalation of high doses of β2 agonists may produce increases in plasma glucose. Upon initiation of treatment with this combination plasma glucose should be monitored more closely in diabetic patients.

There is no information on clinically relevant overdosing with this combination. An overdose could lead to exaggerated efects typical of β2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia & hyperglycemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalized.

Combined bronchodilators

Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.