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INSPIOLTO RESPIMAT is a brand name for Tiotropium, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ............................................................................................... 4 WARNINGS AND PRECAUTIONS .............................................................................. 4…
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, INSPIOLTO RESPIMAT should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing a long-acting beta-adrenergic agonist or a long- acting muscarinic antagonist, as an overdose may result.
g. 4 times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. Patients should be made aware that for optimum benefit, INSPIOLTO RESPIMAT must be used regularly, even when asymptomatic.
Recommended Dose and Dosage Adjustment The recommended dose for adults is 5 mcg tiotropium and 5 mcg olodaterol given as two inhalations from the RESPIMAT inhaler once daily, at the same time of the day. 5 mcg olodaterol per inhalation (2 inhalations comprise one medicinal dose).
Dosing in Special Populations No dosage adjustment is required in patients over 65 years of age, patients with mild and moderate hepatic impairment, or renally impaired patients. However, as with all predominantly renally excreted drugs, INSPIOLTO RESPIMAT use should be monitored closely in patients with moderate to severe renal impairment.
INSPIOLTO RESPIMAT has not been studied in patients with severe hepatic impairment (see ACTION AND CLINICAL PHARMACOLOGY). INSPIOLTO RESPIMAT should not be used in patients under 18 years of age. Inspiolto® Respimat ® Product Monograph Page 16 of 50 Missed Dose Patients should be advised that if they forget to take a dose, they should take one as soon as they remember.
INSPIOLTO RESPIMAT should not be taken more than once per day (two inhalations/dose). Administration INSPIOLTO RESPIMAT should be administered once daily, at the same time of day, every day via inhalation through the RESPIMAT inhalation device only.
To ensure proper administration of INSPIOLTO RESPIMAT, the doctor or other qualified health care professional should teach the patient how to operate the RESPIMAT inhalation device (see Part III CONSUMER INFORMATION).
OVERDOSAGE Symptoms Tiotropium:
INSPIOLTO RESPIMAT (tiotropium bromide monohydrate and olodaterol hydrochloride) is contraindicated in patients with hypersensitivity to tiotropium bromide monohydrate or olodaterol hydrochloride or to any of the excipients (see DOSAGE FORM COMPOSTION AND PACKAGING SECTION).
g. ipratropium. All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication (see WARNINGS AND PRECAUTIONS). INSPIOLTO RESPIMAT is not indicated for the treatment of asthma.
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 long- acting beta2-adrenergic agonist (salmeterol) to 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 olodaterol, one of the active ingredients in INSPIOLTO RESPIMAT. INSPIOLTO RESPIMAT is only indicated for COPD. The safety and efficacy of INSPIOLTO RESPIMAT in patients with asthma have not been established.
INSPIOLTO RESPIMAT is not indicated for the treatment of asthma. General INSPIOLTO RESPIMAT should not be used more frequently than once daily. Not for use in asthma INSPIOLTO RESPIMAT is only indicated for COPD. INSPIOLTO RESPIMAT should not be used in asthma due to the absence of long-term safety and efficacy data in asthma with INSPIOLTO RESPIMAT.
It has been shown that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a 28-week, large placebo-controlled US study comparing the safety of a twice-daily long-acting beta2-adrenergic agonist (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13 out of 13,176 in patients treated with salmeterol vs.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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High doses of tiotropium bromide may lead to signs and symptoms of exaggerated anticholinergic effects, such as constipation, voiding difficulties or increased intraocular pressure causing pain, vision disturbances or reddening of the eye.
No adverse events, beyond dry mouth/throat and dry nasal mucosa in a dose-dependent (10-40 mcg daily) incidence, were observed following 14-day dosing of up to 40 mcg tiotropium inhalation solution in healthy subjects with the exception of pronounced reduction in salivary flow from day 7 onwards.
Should signs of serious anticholinergic toxicity appear, vital signs should be carefully monitored and appropriate therapy should be initiated. e. myocardial ischaemia, hypertension or hypotension, tachycardia, QTc prolongation, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia and metabolic acidosis.
Treatment of Overdose Treatment with INSPIOLTO RESPIMAT should be discontinued. Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Electrocardiogram monitoring is recommended in the event of overdosage.
Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Inspiolto® Respimat ® Product Monograph Page 17 of 50 For management of a suspected drug overdose, contact your regional Poison Control Centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Tiotropium:
Tiotropium is a long acting muscarinic receptor antagonist (LAMA), also known as an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the lungs, inhibition of M3-receptors at the smooth muscle results in relaxation of the airways.
The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. Tiotropium bromide is a quaternary ammonium molecule with duration of action sufficient to provide 24 hours of bronchoprotection with once-a-day inhalational administration.
The long duration of action of tiotropium is thought to be due to its slow dissociation kinetics from the muscarinic M3-receptor subtype. Dissociation from M2-receptors is faster than from M3, which in functional in vitro studies, elicited (kinetically controlled) receptor subtype selectivity of M3 over M2.
As an N-quaternary anticholinergic, tiotropium is topically selective when administered by inhalation to the lung. Pharmacological in vitro and in vivo studies profiled tiotropium as a potent, long acting bronchodilator suitable for a once-daily dose regimen.
Olodaterol:
Olodaterol has a high affinity and high selectivity to the human beta2-adrenoceptor. In vitro studies have shown that olodaterol has more than 241-fold greater agonist activity at beta2- adrenoceptors compared to beta1-adrenoceptors and 2299-fold greater agonist activity compared to beta3-adrenoceptors.
The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in […]
34). The increased risk of asthma related death may represent a class effect of the long- Inspiolto® Respimat ® Product Monograph Page 5 of 50 acting beta2-adrenergic agonists, including olodaterol, one of the active ingredients of INSPIOLTO RESPIMAT.
No study adequate to determine whether the rate of asthma-related death is increased in patients treated with INSPIOLTO RESPIMAT has been conducted. e. as rescue therapy. INSPIOLTO RESPIMAT has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose.
Acute symptoms should be treated with an inhaled short-acting beta2-agonist. INSPIOLTO RESPIMAT should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. The use of INSPIOLTO RESPIMAT in this setting is inappropriate.
When prescribing INSPIOLTO RESPIMAT, the healthcare professional should also provide the patient with an inhaled, short-acting bronchodilator for treatment of COPD symptoms that occur acutely, despite regular once-daily use of INSPIOLTO RESPIMAT.
g. four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. COPD may deteriorate acutely over a period of hours or chronically over several days or longer.
If INSPIOLTO RESPIMAT no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of INSPIOLTO RESPIMAT beyond the recommended dose is not appropriate in this situation. Excessive Use and Use with other LABA and LAMA products As with other inhaled bronchodilators, INSPIOLTO RESPIMAT should not be used more often or at higher doses than recommended.
g. ipratropium, tiotropium, glycopyrronium, aclidinium, umeclidinium), as an overdose may result (see DRUG INTERACTIONS). Effects on Ability to Drive or Use Machines There have been no studies investigating the effect of INSPIOLTO RESPIMAT on the ability to perform tasks that require judgement, motor or cognitive skills.
The occurrence of dizziness or blurred vision may influence the ability to drive or to use machinery. Anticholinergic Effects Like other anticholinergic drugs, INSPIOLTO RESPIMAT should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Inspiolto® Respimat ® Product Monograph Page 6 of 50 Worsening of Narrow-Angle Glaucoma INSPIOLTO RESPIMAT should be used with caution in patients with narrow-angle glaucoma. Patients should be cautioned to avoid getting the mist into their eyes.
They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma. g. eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).
Instruct patients to consult a physician immediately should any of these signs or symptoms develop. Miotic drops alone are not considered to be effective treatment. Worsening of Urinary […]