RESPIMAT is a soft mist inhaler

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SAFETY INFORMATION

INSPIOLTO RESPIMAT

Indication and clinical use: 
INSPIOLTO RESPIMAT (tiotropium bromide monohydrate and olodaterol hydrochloride) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta₂-adrenergic agonist (LABA) 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. Not indicated for the relief of acute deterioration of COPD or asthma use. Should not be used in patients under 18 years of age.

Contraindications: 
Contraindications in patients with hypersensitivity to tiotropium bromide monohydrate or olodaterol hydrochloride or to any of the excipients and patients with a history of hypersensitivity to atropine or its derivatives, e.g., ipratropium.

Most serious warnings and precautions: 
Asthma-related death: Long-acting beta₂-adrenergic agonists (LABA) increase the risk of asthma-related death. This was shown in a salmeterol study and is considered a class effect of LABA, including olodaterol.

Other relevant warnings and precautions:

• Should not be used more than once daily
• Should not be used in asthma
• Should not be used for treatment of acute episodes of bronchospasm
• Should not be initiated in patients with acutely deteriorating COPD
• Should not be used in conjunction with other long-acting beta₂-adrenergic agonists or short- or long-acting muscarinic antagonists or at higher doses than recommended
• Patients with narrow-angle glaucoma or urinary retention
• Avoid getting mist into eyes
• Patients predisposed to low levels of serum potassium
• Patients with known history of QTc prolongation, risk factors for torsade de pointes or patients taking medications known to prolong the QTc interval
• Patients with convulsive disorders or thyrotoxicosis and patients who are unusually responsive to sympathomimetic amines
• Patients with preexisting diabetes mellitus or ketoacidosis
• Occurrence of dizziness or blurred vision may influence ability to use machinery
• Cardiovascular effects such as increase in pulse rate, systolic or diastolic blood pressure or cardiac arrhythmias
• Contains benzalkonium chloride, which may cause wheezing and breathing difficulties especially in asthma patients (bronchospasm)
• Paradoxical bronchospasm that may be life-threatening
• Pregnant and nursing women
• Can be used in patients with mild and moderate hepatic impairment; no data available for use in patients with severe hepatic impairment
• Can only be used in patients with moderate to severe renal impairment if the expected benefit outweighs the potential risk

For more information: 
Please consult the Product Monograph at https://InspioltoRespimatPM.ca for information relating to adverse reactions, drug interactions, and dosing information not discussed in this piece. The Product Monograph is also available by calling us at 1-800-263-5103 ext. 84633.

SPIRIVA RESPIMAT

Indications and clinical use: 
SPIRIVA RESPIMAT (tiotropium bromide monohydrate) is indicated as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema, and for the reduction of exacerbations. 

SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator treatment in adult patients with asthma who remain symptomatic on a combination of inhaled corticosteroid (equivalent to, but not limited to ≥500 mcg fluticasone/day or ≥800 mcg budesonide/day) and a long-acting β₂-agonist and who experienced one or more severe exacerbations in the previous year. 

SPIRIVA RESPIMAT is not indicated as rescue medication for the relief of acute bronchospasm in COPD or asthma. Safety and efficacy in patients less than 18 years of age have not been established.

Contraindications: 
Patients with a history of hypersensitivity to tiotropium bromide, atropine or its derivatives (e.g., ipratropium).

Other relevant warnings and precautions:

• Should not be used for initial treatment of acute episodes of bronchospasm or for the relief of acute symptoms
• Should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition
• Should not be used as a first-line treatment or monotherapy for asthma
• Immediate hypersensitivity reactions may occur
• Should not be used more frequently than two inhalations once daily
• Patients with narrow-angle glaucoma, urinary retention (prostatic hyperplasia or bladder neck obstruction)
• Avoid getting mist into eyes
• Patients with cardiovascular disorders
• Should not be used with other medicine containing a short- or long-acting muscarinic antagonist
• Occurrence of dizziness or blurred vision may influence ability to drive and use machinery
• Cardiovascular effects, such as cardiac arrhythmias (e.g., atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists
• Should be used cautiously in patients with moderate to severe renal impairment
• Contains benzalkonium chloride, which may cause wheezing and breathing difficulties especially in asthma patients
• Discontinue immediately if inhalation-induced bronchospasm occurs
• Should not be used in pregnant and nursing women

For more information: 
Please consult the Product Monograph at https://SpirivaRespimatPM.ca for important information relating to adverse reactions, interactions, and dosing information not discussed in this piece. The Product Monograph is also available by calling us at 1-800-263-5103 ext. 84633.

COMBIVENT RESPIMAT

Indication and clinical use: 
COMBIVENT RESPIMAT (ipratropium bromide and salbutamol sulfate) inhalation solution is indicated for treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

Contraindications:

• Patients with a history of hypersensitivity to ipratropium bromide or salbutamol sulfate or to atropine or its derivatives
• Patients with cardiac tachyarrhythmias, and hypertrophic obstructive cardiomyopathy

Other relevant warnings and precautions:

• Should only be used after careful risk/benefit assessment: uncontrolled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy, urinary retention
• Care should be taken with patients suffering from coronary insufficiency, arrhythmias and hypertension, convulsive disorders and in patients who are unusually responsive to sympathomimetic amines
• Fatalities have been reported following excessive use of inhaled sympathomimetic amines, the exact cause of which is unknown
• Concomitant use of COMBIVENT RESPIMAT with other sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. COMBIVENT RESPIMAT should not be administered concomitantly with other medicines containing a muscarinic antagonist, as this has not been studied, and an overdose may result
• Special care and supervision are required in patients with idiopathic hypertrophic subvalvular aortic stenosis, in whom an increase in the pressure gradient between the left ventricle and the aorta may occur, causing increased strain on the left ventricle
• Caution in patients with cardiovascular disorders; especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Potentially serious hypokalemia has been reported and can be aggravated by hypoxia. Hypokalemia will increase the susceptibility of digitalis-treated patients to cardiac arrhythmias. It is recommended that serum potassium levels be monitored in such situations
• Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances
• Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur
• Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm). Patients with asthma are at an increased risk for these adverse events
• Severe life-threatening paradoxical bronchospasm has been reported in patients receiving beta₂-agonists
• The patient should be instructed to consult a doctor immediately in the event of acute, rapidly worsening dyspnea. In addition, the patient should be warned to seek medical advice should a reduced response become apparent
• The safety of COMBIVENT RESPIMAT in pregnancy has not been established
• Caution should be exercised when COMBIVENT RESPIMAT is administered to nursing mothers
• The efficacy and safety in children and adolescents under 18 years has not been established
• Caution should be exercised when COMBIVENT RESPIMAT is administered at the recommended dose to elderly patients, as they experienced a higher total adverse event frequency compared to patients who were less than 65 years old
• Caution is recommended when driving a car or operating machinery. Patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment

For more information: 
Please consult the Product Monograph at https://CombiventRespimatPM.ca for important information relating to adverse reactions, interactions, and dosing information not discussed in this piece. The Product Monograph is also available by calling us at 1-800-263-5103 ext. 84633.

SPIRIVA HANDIHALER

Indication and clinical use: 
SPIRIVA (tiotropium bromide monohydrate) is indicated as a long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema. 

SPIRIVA is not indicated as rescue medication for the relief of acute bronchospasm in COPD. Safety and efficacy in patients less than 18 years of age have not been established.

Contraindications:

• In patients with a history of hypersensitivity to tiotropium bromide, atropine or its derivatives (e.g., ipratropium), or to any component of this product

Other relevant warnings and precautions:

• Should not be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
• Should not be used in patients with acute deteriorating COPD
• Should not be used for the initial treatment of acute episodes of bronchospasm or for the relief of acute symptoms
• Should not be used more frequently than once daily or at higher doses than recommended
• Should not be administered concomitantly with other medicines containing a long-acting muscarinic antagonist
• Should be used with caution in patients with symptomatic prostatic hyperplasia, narrow-angle glaucoma, urinary retention or narrow-angle glaucoma
• Cardiovascular effects, such as cardiac arrhythmias (e.g., atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists. Should be used with caution in patients with recent myocardial infarction <6 months, any unstable or life threatening cardiac arrhythmia, cardiac arrhythmia requiring intervention or a change in drug therapy in the past year or hospitalization due to heart failure within the past year
• Caution is recommended when driving a car or operating machinery. Patients should be advised that they may experience undesirable effects such as dizziness or blurred vision during treatment
• Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, severe milk protein allergy or itchiness may occur
• Should only be used after careful risk/benefit assessment: in patients with moderate to severe renal impairment
• Clinical data on fertility is not available
• May cause inhalation-induced bronchospasm, and if this occurs treatment should be discontinued immediately
• The patient should be instructed to consult a doctor immediately in the event of signs and symptoms of acute narrow-angle glaucoma, prostatic hyperplasia and bladder-neck obstruction
• Should only be administered to pregnant women if the expected benefits outweigh any possible risk to the unborn child
• The safety and effectiveness have not been established in women undergoing labour and delivery
• Should only be administered to nursing women if the expected benefits outweigh any possible risk to the infant
• The efficacy and safety in children and adolescents under 18 years has not been established

For more information: 
Please consult the Product Monograph at https://SpirivaPM.ca for important information relating to adverse reactions, interactions, and dosing information not discussed in this piece. The Product Monograph is also available by calling us at 1-800-263-5103 ext. 84633.