Indacaterol is an active pharmaceutical ingredient in the Selective Beta-2-Adrenoreceptor Agonists group (R03AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised March 13, 2026[1]
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
How to take
GB
EUEuropean Union· EMA
10 products
Uses
EUOfficial regulatory label· revised November 20, 2025[2]
Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short- acting beta2-agonists.
How to take
EU
CACanada· Health Canada
5 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
ULTIBRO BREEZHALER (indacaterol maleate and glycopyrronium bromide) is a combination of a long- acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), 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, and for the reduction of exacerbations of COPD in patients with a history of exacerbations.
ULTIBRO BREEZHALER is not indicated for the treatment of acute episodes of bronchospasm. ULTIBRO BREEZHALER is not indicated for asthma use. The safety and effectiveness of ULTIBRO BREEZHALER in asthma have not been established. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): No dosage adjustment is required in patients over 65 years of age.
Drug interactions
Known interactions involving Indacaterol. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB001011157 · revised March 13, 2026
[2]European Medicines Agency · EMEA/H/C/005067 · revised November 20, 2025
[3]Health Canada (DPD) · 02418282 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler. Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day.
Patients should be instructed not to take more than one dose in a day. Special populations Elderly population Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). Renal impairment Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
2). Hepatic impairment Ultibro Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. 2). Paediatric population There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD.
The safety and efficacy of Ultibro Breezhaler in children have not been established. No data are available. Method of administration For inhalation use only. The capsules must not be swallowed. 6). The inhaler provided with each new prescription should be used.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 13, 2026[1]
The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances. Summary of the safety profile The safety experience with Ultibro Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Ultibro Breezhaler showed similar adverse reactions to the individual components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination. Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ultibro Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Tabulated summary of adverse reactions Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 1). Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Adverse reactions Adverse reactions Frequency category Infections and infestations Upper respiratory tract infection Very common Nasopharyngitis Common Urinary tract infection Common Sinusitis Common Rhinitis Common Immune system disorders Hypersensitivity Common Angioedema2 Uncommon Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus Common Psychiatric disorders Insomnia Uncommon Nervous system disorders Dizziness Common Headache Common Paraesthesia Rare Eye disorders Glaucoma1 Uncommon Cardiac disorders Ischaemic heart disease Uncommon Atrial fibrillation Uncommon Tachycardia Uncommon Palpitations Uncommon Respiratory, thoracic and mediastinal disorders Cough Common Oropharyngeal pain including throat irritation Common Paradoxical bronchospasm Uncommon Dysphonia2 Uncommon Epistaxis Uncommon Gastrointestinal disorders Dyspepsia Common Dental caries Common Gastroenteritis Uncommon Dry mouth Uncommon Skin and subcutaneous tissue disorders Pruritus/rash Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain Uncommon Muscle spasm Uncommon Myalgia Uncommon Pain in extremity Uncommon Renal and urinary disorders Bladder obstruction and urinary retention Common General disorders and administration site conditions Pyrexia1 Common Chest pain Common Oedema peripheral Uncommon Fatigue Uncommon 1 Adverse reaction observed with Ultibro Breezhaler, but not with the individual components.
2 Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data. Description of selected adverse reactions Cough was common, but usually of mild intensity. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 13, 2026[1]
5). Asthma Ultibro Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Not for acute use Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm. Hypersensitivity Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler.
If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm Administration of Ultibro Breezhaler may result in paradoxical bronchospasm which can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium Narrow-angle glaucoma No data are available in patients with narrow-angle glaucoma, therefore Ultibro Breezhaler should be used with caution in these patients.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ultibro Breezhaler should any of these signs or symptoms develop. Urinary retention No data are available in patients with urinary retention, therefore Ultibro Breezhaler should be used with caution in these patients.
2-fold in subjects with severe renal impairment and end-stage renal disease. 2). These patients should be monitored closely for potential adverse reactions. Cardiovascular effects Ultibro Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Beta2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur with this medicinal product, treatment may need to be discontinued.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 13, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
Posology Adults and adolescents aged 12 years and over The recommended dose is one capsule to be inhaled once daily. Patients should be given the strength containing the appropriate mometasone furoate dose for the severity of their disease and should be regularly reassessed by a healthcare professional.
The maximum recommended dose is 125 mcg/260 mcg once daily. Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible.
Patients should be instructed not to take more than one dose in a day. 2). 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The posology in patients 12 years of age and older is the same posology as in adults.
The safety and efficacy in paediatric patients below 12 years of age have not been established. No data are available. Method of administration For inhalation use only. The capsules must not be swallowed. 6) with each new prescription.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. The capsules must only be removed from the blister immediately before use.
6). 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised November 20, 2025[2]
8%). Tabulated list of adverse reactions Adverse reactions are listed by MedDRA system organ class (Table 1). The frequency of the adverse reactions is based on the PALLADIUM study. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000).
8 Table 1 Adverse reactions System organ class Adverse reactions Frequency category Infections and infestations Nasopharyngitis Very common Upper respiratory tract infection Common Candidiasis*1 Uncommon Immune system disorders Hypersensitivity*2 Common Angioedema*3 Uncommon Metabolism and nutrition disorders Hyperglycaemia*4 Uncommon Nervous system disorders Headache*5 Common Eye disorders Vision blurred Uncommon Cataract*6 Uncommon Cardiac disorders Tachycardia*7 Uncommon Respiratory, thoracic and mediastinal disorders Asthma (exacerbation) Very common Oropharyngeal pain*8 Common Dysphonia Common Skin and subcutaneous tissue disorders Rash*9 Uncommon Pruritus*10 Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain*11 Common Muscle spasms Uncommon * Indicates grouping of preferred terms (PTs): 1 Oral candidiasis, oropharyngeal candidiasis.
2 Drug eruption, drug hypersensitivity, hypersensitivity, rash, rash erythematous, rash pruritic, urticaria. 3 Allergic oedema, angioedema, periorbital swelling, swelling of eyelid. 4 Blood glucose increased, hyperglycaemia. 5 Headache, tension headache.
10 Anal pruritus, eye pruritus, nasal pruritus, pruritus, pruritus genital. 11 Back pain, musculoskeletal pain, myalgia, neck pain, musculoskeletal chest pain. Paediatric population The safety profile of the medicinal product was assessed in the phase III study in adolescents (12 years and older) and adults.
Frequency, type and severity of adverse reactions in adolescents are similar to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised November 20, 2025[2]
Deterioration of disease This medicinal product should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Patients should not stop treatment without physician supervision since symptoms may recur after discontinuation. It is recommended that treatment with this medicinal product should not be stopped abruptly. If patients find the treatment ineffective, they should continue treatment but must seek medical attention.
Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy. Sudden and progressive deterioration in the symptoms of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Hypersensitivity Immediate hypersensitivity reactions have been observed after administration of this medicinal product. If signs suggesting allergic reactions occur, in particular angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm As with other inhalation therapy, administration of this medicinal product may result in paradoxical bronchospasm, which can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Cardiovascular effects of beta agonists Like other medicinal products containing beta2-adrenergic agonists, this medicinal product may produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure and/or symptoms.
If such effects occur, treatment may need to be discontinued. This medicinal product should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised November 20, 2025[2]
1.
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[3]
e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. • As with other inhaled drugs containing beta2-adrenergic agents, ULTIBRO BREEZHALER should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA and/or LAMA, as an overdose may result.
d) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking ULTIBRO BREEZHALER. • Patients should be made aware that for optimum benefit, ULTIBRO BREEZHALER must be used regularly, even when asymptomatic.
2 Recommended Dose and Dosage Adjustment The recommended dosage of ULTIBRO BREEZHALER for patients 18 years and older is once-daily oral inhalation of the content of one 110/50 mcg capsule using the ULTIBRO BREEZHALER inhaler. Dosing in special populations Renal impairment ULTIBRO BREEZHALER can be used at the recommended dose in patients with mild to moderate renal impairment.
3 Pharmacokinetics, Special Populations and Conditions). Hepatic impairment ULTIBRO BREEZHALER can be used at the recommended dose in patients with mild and moderate hepatic impairment. No data are available for subjects with severe hepatic impairment (See also 10 CLINICAL PHARMACOLOGY).
Geriatrics (≥ 65 years of age) ULTIBRO BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and ULTIBRO® BREEZHALER® – Product Monograph Page 6 of 46 older. Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use.
4 Administration For inhalation use only. ULTIBRO BREEZHALER capsules must not be swallowed (see also
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
1 Adverse Reaction Overview Long-acting beta2-adrenergic agonists such as indacaterol, one of the active ingredients of ULTIBRO BREEZHALER increase the risk of asthma-related death. ULTIBRO BREEZHALER is not indicated for the treatment of asthma (See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 1 INDICATIONS, 2 CONTRAINDICATIONS, and 7 WARNING AND PRECAUTIONS).
ULTIBRO BREEZHALER is a combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA). Adverse reactions to ULTIBRO BREEZHALER are expected to be similar in nature to other beta2-agonists and muscarinic antagonists.
, blurred vision), urinary retention, gastrointestinal disorders, dry mouth and cough. Adverse reactions that have been associated with beta2-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 (≥3% and greater than placebo) were headache, cough, and oropharyngeal pain (including throat irritation). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The safety profile of ULTIBRO BREEZHALER is based on 1882 patients with a clinical diagnosis of moderate to very severe COPD who have received at least one dose of ULTIBRO BREEZHALER 110/50 mcg once- daily. This includes 1710 patients exposed to ULTIBRO BREEZHALER for 12 weeks (3 months) or longer (up to 15 months).
Patients with clinically significant cardiovascular abnormalities and significant ECG findings at baseline were excluded from these studies. The presentation of the safety profile of ULTIBRO BREEZHALER takes into account on the experience with ULTIBRO BREEZHALER in its pivotal clinical trial program as well as the clinical and post-marketing experience with the individual monotherapy components.
6-Month Safety Data: To evaluate the safety of ULTIBRO BREEZHALER compared to placebo the first 6-month data for Study A2307 was pooled with the data from Study A2303 as these 2 studies had similar designs and patient populations. The adverse drug reactions from the 6-month safety data presented below are listed by MedDRA system organ class.
6) ^new adverse drug reaction observed with the combination ULTIBRO BREEZHALER but not with the monotherapy components. 3 Less Common Clinical Trial Adverse Reactions Cardiac disorders: ischaemic heart disease, atrial fibrillation Eye disorders: glaucoma* Gastrointestinal disorders: dry mouth General disorders: fatigue Immune system disorders: hypersensitivity Musculoskeletal and connective tissue disorders: muscle spasm, myalgia Nervous system disorders: paresthesia Psychiatric disorders: insomnia Renal and urinary disorders: bladder obstruction and urinary retention Respiratory, thoracic and mediastinal disorders: epistaxis Skin and subcutaneous tissue disorders: pruritus/rash *adverse drug reaction observed with the combination ULTIBRO BREEZHALER but not with the monotherapy components.
12-Month Trials For the 12-month trial A2307 comparing ULTIBRO BREEZHALER (n=226) and placebo (n=113), there were no notable differences in demographics across treatment groups. 6 years. 1% of the total population. 5% of patients, respectively.
The proportion of patients in each age group (< 65 years, 65 years to < 75 years, and ≥ 75 years) was similar across treatment groups. 6%, respectively). 0% vs. 7%). Viral upper respiratory tract infection, upper respiratory tract infection, and hypertension adverse events were reported for a lower percentage of patients in the ULTIBRO BREEZHALER group than the placebo group.
Cough, lower respiratory tract infections and pyrexia were reported for a slightly higher percentage of patients in the ULTIBRO BREEZHALER group compared with placebo. The percentage of patients with pneumonia […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
). ULTIBRO BREEZHALER is not indicated for the treatment of asthma. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions WARNING: ASTHMA RELATED DEATH Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death.
Data from a large placebo controlled US study that compared the safety of another LABA (salmeterol) or placebo added to patients’ usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including indacaterol maleate, one of the active ingredients of ULTBRO BREEZHALER.
ULTIBRO® BREEZHALER® – Product Monograph Page 5 of 46 ULTIBRO BREEZHALER is only indicated for COPD. The safety and efficacy of ULTIBRO BREEZHALER in patients with asthma have not been established. ULTIBRO BREEZHALER is not indicated for the treatment of asthma.
e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. • As with other inhaled drugs containing beta2-adrenergic agents, ULTIBRO BREEZHALER should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA and/or LAMA, as an overdose may result.
d) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking ULTIBRO BREEZHALER. • Patients should be made aware that for optimum benefit, ULTIBRO BREEZHALER must be used regularly, even when asymptomatic.
2 Recommended Dose and Dosage Adjustment The recommended dosage of ULTIBRO BREEZHALER for patients 18 years and older is once-daily oral inhalation of the content of one 110/50 mcg capsule using the ULTIBRO BREEZHALER inhaler. Dosing in special populations Renal impairment ULTIBRO BREEZHALER can be used at the recommended dose in patients with mild to moderate renal impairment.
3 Pharmacokinetics, Special Populations and Conditions). Hepatic impairment ULTIBRO BREEZHALER can be used at the recommended dose in patients with mild and moderate hepatic impairment. No data are available for subjects with severe hepatic impairment (See also 10 CLINICAL PHARMACOLOGY).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[3]
ULTIBRO BREEZHALER (indacaterol maleate and glycopyrronium bromide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING of the product monograph. • Patients with severe hypersensitivity to milk proteins. • All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication (see 7 WARNINGS AND PRECAUTIONS).
ULTIBRO BREEZHALER is not indicated for the treatment of asthma.
This is not medical advice. Consult a qualified healthcare professional.
In addition, beta-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Therefore, long-acting beta2-adrenergic agonists (LABA) or LABA-containing combination products such as Ultibro Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms) were excluded from the clinical trials, and therefore there is no experience in these patient groups.
Ultibro Breezhaler should be used with caution in these patient groups. Hypokalaemia Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
The decrease in serum potassium is usually transient, not requiring supplementation. 5). 1). Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients.
7%). Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients. General disorders Ultibro Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Patients with unstable ischaemic heart disease, a history of myocardial infarction in last 12 months, New York Heart Association (NYHA) class III/IV left ventricular failure, arrhythmia, uncontrolled hypertension, cerebrovascular disease or history of long QT syndrome and patients being treated with medicinal products known to prolong QTc were excluded from studies in the indacaterol/mometasone furoate clinical development programme.
Thus safety outcomes in these populations are considered unknown. 5 While beta2-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, the clinical significance of these observations is unknown.
Long-acting beta2-adrenergic agonists (LABA) or LABA-containing combination products such as Atectura Breezhaler should therefore be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicinal products affecting the QT interval.
Hypokalaemia with beta agonists Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
5). Clinically relevant hypokalaemia has not been observed in clinical studies of indacaterol/mometasone furoate at the recommended therapeutic dose. Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists and corticosteroids may produce increases in plasma glucose.
Upon initiation of treatment, plasma glucose should be monitored more closely in diabetic patients. This medicinal product has not been investigated in patients with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus.
Prevention of oropharyngeal infections In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.
Systemic effects of corticosteroids Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Possible systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, glaucoma, and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
It is therefore important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use.
Patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
This medicinal product should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated […]
Geriatrics (≥ 65 years of age) ULTIBRO BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and ULTIBRO® BREEZHALER® – Product Monograph Page 6 of 46 older. Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use.
4 Administration For inhalation use only. ULTIBRO BREEZHALER capsules must not be swallowed (see also 5 OVERDOSAGE). The capsules must be administered only using the ULTIBRO BREEZHALER inhaler. ULTIBRO BREEZHALER should be administered at the same time each day.
ULTIBRO BREEZHALER capsules must always be stored in the blister to protect from moisture and light, and only removed IMMEDIATELY BEFORE USE (see also 11 STORAGE, STABILITY AND DISPOSAL and 12 SPECIAL HANDLING INSTRUCTIONS). When prescribing ULTIBRO BREEZHALER, patients should be instructed on the correct use of the inhaler.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it. 5 Missed Dose If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
5 OVERDOSAGE In a single dose study in healthy volunteers the 4-fold of the therapeutic dose of ULTIBRO BREEZHALER (four dose steps of 110/50 mcg separated by one hour, each) was well tolerated with no relevant effects on heart rate, QTc-interval, serum potassium or blood glucose.
In COPD patients, doses of up to 600/100 mcg indacaterol/glycopyrronium were inhaled over two weeks and there were no relevant effects on heart rate, QTc-interval, blood glucose or serum potassium. There was an increase in ventricular ectopies after 14 days of dosing with 300/100 and 600/100 mcg indacaterol/glycopyrronium.
In four patients, non-sustained ventricular tachycardia was recorded with the longest episode recorded being 9 beats (4 seconds). ULTIBRO BREEZHALER contains both indacaterol and glycopyrronium; therefore, the risks associated with overdosage for the individual monotherapy components described below apply to ULTIBRO BREEZHALER.
If overdose occurs, discontinue ULTIBRO BREEZHALER and initiate appropriate symptomatic and/or supportive therapy. In serious cases, patients should be hospitalised. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm.
Cardiac monitoring (including electrocardiography) is recommended in cases of overdosage. There is insufficient evidence to determine if dialysis is beneficial for overdosage of ULTIBRO BREEZHALER. , angina, hypertension or hypotension, tachycardia with rates up to 200 bpm, tremor, palpitations, nervousness, headache, nausea, dry mouth, vomiting, drowsiness, muscle cramps, ventricular arrhythmias, metabolic acidosis, fatigue, malaise, insomnia, hypokalaemia […]