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ULTIBRO BREEZHALER is a brand name for Indacaterol, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
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
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).
). 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.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
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 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 […]