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TRIMBOW is a brand name for Glycopyrronium, supplied as a aerosol, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRIMBOW™ (beclomethasone dipropionate, glycopyrronium (as bromide) and formoterol fumarate dihydrate) pressurized inhalation solution is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), indicated in adult patients who are…
Verbatim from this product's HC label. Tap a section to expand.
, 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, TRIMBOW should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA or LAMA, as an overdose may result.
• When beginning treatment with TRIMBOW, patients who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular basis 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 TRIMBOW.
• TRIMBOW should not be used to treat acute symptoms of COPD. , salbutamol) to relieve acute symptoms such as shortness of breath and advised to have this available for use at all times. • Patients should be made aware that for optimum benefit, TRIMBOW must be used regularly, even when asymptomatic.
2 Recommended Dose and Dosage Adjustment The recommended and maximum dose of TRIMBOW is two inhalations twice daily, as two inhalations in the morning and two inhalations in the evening at the same time every day.
Pediatrics (< 18 years of age):
TRIMBOW should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age):
No dosage adjustment is required in patients 65 years of age and older. 3 Pharmacokinetics, Renal Insufficiency). No dose adjustment is required in patients with mild to moderate renal impairment. Hepatic impairment Due to formoterol being primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment (classified as having Child-Pugh class C), and patients with hepatic disease should be closely monitored.
3 Pharmacokinetics, Hepatic Insufficiency). 4 Administration TRIMBOW is for oral inhalation only. TRIMBOW should be administered as two inhalations twice daily, as in two inhalations in the morning and two inhalations in the evening at the same time every day.
Patients should be advised to rinse their mouth with water (without swallowing) after inhaling the prescribed dose. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique.
and 10 CLINICAL PHARMACOLOGY). If such effects occur, TRIMBOW may need to be discontinued. 4 Drug-Drug Interactions). Caution is also required when treating patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalemia.
Driving and Operating Machinery There have been no studies investigating the effect of TRIMBOW on the ability to perform tasks that require judgment, motor or cognitive skills. Based on the pharmacological profile (see 10 CLINICAL PHARMACOLOGY), TRIMBOW is expected to have no or negligible influence on the ability to drive and use machines.
The occurrence of headache or blurred vision may influence the ability to drive or to use machinery. TRIMBOW™ (beclomethasone diproprionate / glycopyrronium (as bromide) / formoterol fumarate dihydrate) Page 10 of 47 Unclassified / Non classifié Ear/Nose/Throat Localized infections of the mouth and pharynx with Candida albicans, which are associated with the use of inhaled glucocorticosteroids, have occurred in patients treated with TRIMBOW during clinical studies.
Patients should therefore be advised to rinse their mouth with water (without swallowing) after inhalation of TRIMBOW to reduce the risk of oropharyngeal candidiasis. , oral) antifungal therapy while treatment with TRIMBOW continues.
4 Drug-Drug Interactions).
Endocrine and Metabolism Hyperglycemia:
The inhalation of formoterol may cause a rise in blood glucose levels. Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Hypokalemia:
Potentially serious hypokalemia may result from beta2-agonist therapy. This has the potential to produce adverse cardiovascular effects. Particular caution is advised in patients with severe COPD as this effect may be potentiated by hypoxia.
3 Pharmacokinetics, Renal Insufficiency). No dose adjustment is required in patients with mild to moderate renal impairment. Hepatic impairment Due to formoterol being primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment (classified as having Child-Pugh class C), and patients with hepatic disease should be closely monitored.
3 Pharmacokinetics, Hepatic Insufficiency). 4 Administration TRIMBOW is for oral inhalation only. TRIMBOW should be administered as two inhalations twice daily, as in two inhalations in the morning and two inhalations in the evening at the same time every day.
Patients should be advised to rinse their mouth with water (without swallowing) after inhaling the prescribed dose. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique.
The patient should be advised to read and carefully follow the instructions for use (see Patient Medication Information, Instructions for Use). 5 Missed Dose If a dose is missed, the patient should be instructed to take the next dose as soon as they remember, unless it is almost time for the next dose, in which case the next dose should be taken at the correct time.
The patient should be instructed not to double the dose. 5 OVERDOSE An overdose of TRIMBOW may produce signs and symptoms due to the individual components’ pharmacological actions (see 7 WARNINGS AND PRECAUTIONS). An overdose of TRIMBOW may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include, dry mouth, nausea, muscle spasm, tremor, headache, palpitations, systolic hypertension, tachycardia, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), constipation, difficulties in voiding.
TRIMBOW 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Glycopyrronium in Canada.
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The patient should be advised to read and carefully follow the instructions for use (see Patient Medication Information, Instructions for Use). 5 Missed Dose If a dose is missed, the patient should be instructed to take the next dose as soon as they remember, unless it is almost time for the next dose, in which case the next dose should be taken at the correct time.
The patient should be instructed not to double the dose. 5 OVERDOSE An overdose of TRIMBOW may produce signs and symptoms due to the individual components’ pharmacological actions (see 7 WARNINGS AND PRECAUTIONS). An overdose of TRIMBOW may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include, dry mouth, nausea, muscle spasm, tremor, headache, palpitations, systolic hypertension, tachycardia, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), constipation, difficulties in voiding.
Acute overdosage with TRIMBOW™ (beclomethasone diproprionate / glycopyrronium (as bromide) / formoterol fumarate dihydrate) Page 6 of 47 Unclassified / Non classifié beclomethasone, even in excessive doses, is not expected to be a clinical problem.
When used chronically in excessive doses, systemic glucocorticosteroid effects may appear, such as suppression of the hypothalamic pituitary adrenal axis function. In the event of drug overdose, discontinue TRIMBOW and initiate appropriate symptomatic and/or supportive therapy.
The judicious use of a cardioselective beta receptor blocker may be considered, for treating beta2-adrenergic effects, but only under the supervision of a physician and with extreme caution bearing in mind that such medicine can produce bronchospasm.
Cardiac monitoring including electrocardiogram monitoring is recommended in cases of overdosage. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
4 Drug-Drug Interactions, Pharmacodynamic interactions - Related to formoterol). Caution is also recommended when a number of reliever bronchodilators are used. It is recommended that serum potassium levels are monitored in such situations.
Systemic corticosteroid effects:
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include:
Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density, cataracts, glaucoma, central serous chorioretinopathy and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Therefore, it is important that the patient is reviewed regularly. TRIMBOW should be administered with caution in patients with active or quiescent pulmonary tuberculosis and in patients with fungal and viral infections in the airways.
2 Pharmacodynamics). 4 Drug-Drug Interactions). It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects.
In light of the possibility of systemic absorption of inhaled corticosteroids, patients treated with TRIMBOW should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
If such effects occur, appropriate therapy should be considered. TRIMBOW™ (beclomethasone diproprionate / glycopyrronium (as bromide) / formoterol fumarate dihydrate) Page 11 of 47 Unclassified / Non classifié Systemic Steroid Replacement by Inhaled Steroid: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
After withdrawal from systemic corticosteroids, a number of months are required for recovery of HPA function. Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.
During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.
Although TRIMBOW may control COPD symptoms during these episodes, in recommended doses it supplies less than normal physiological amount of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.
During periods of stress or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids immediately and to contact their physicians for further […]
Acute overdosage with TRIMBOW™ (beclomethasone diproprionate / glycopyrronium (as bromide) / formoterol fumarate dihydrate) Page 6 of 47 Unclassified / Non classifié beclomethasone, even in excessive doses, is not expected to be a clinical problem.
When used chronically in excessive doses, systemic glucocorticosteroid effects may appear, such as suppression of the hypothalamic pituitary adrenal axis function. In the event of drug overdose, discontinue TRIMBOW and initiate appropriate symptomatic and/or supportive therapy.
The judicious use of a cardioselective beta receptor blocker may be considered, for treating beta2-adrenergic effects, but only under the supervision of a physician and with extreme caution bearing in mind that such medicine can produce bronchospasm.
Cardiac monitoring including electrocardiogram monitoring is recommended in cases of overdosage. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage Forms, Strengths, Composition and Packaging TRIMBOW is colourless to yellowish liquid solution. TRIMBOW is an inhalation solution, resulting in an aerosol of extrafine particles, which is contained in a sealed pressurized aluminium container with a metering valve.
The pressurized container is inserted in a polypropylene inhaler, which incorporates a mouthpiece and a dose counter (60 actuations or 120 actuations per pressurized container) or a dose indicator (180 actuations per pressurized container) and is provided with a polypropylene mouthpiece cap.
Each TRIMBOW metered dose (the dose leaving the valve) contains 100 mcg of beclomethasone dipropionate, 10 mcg of glycopyrronium (as bromide) and 6 mcg of formoterol fumarate dihydrate. The delivered dose per actuation (the dose leaving the mouthpiece) contains 87 mcg of beclomethasone dipropionate, 9 mcg of glycopyrronium (as bromide) and 5 mcg of formoterol fumarate dihydrate.
Pack sizes:
Single pack of 1 container with either 60, 120 or 180 actuations. Multipack of 2 containers with 120 actuations each (total of 240 actuations). Multipack of 3 containers with 120 actuations each (total of 360 actuations). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Inhalation use Pressurized inhalation solution 100 mcg beclomethasone dipropionate / 10 mcg glycopyrronium (as bromide)/ 6 mcg formoterol fumarate dihydrate per metered actuation Ethanol anhydrous, hydrochloric acid (as aqueous solution), and norflurane TRIMBOW™ (beclomethasone diproprionate / glycopyrronium (as bromide) / formoterol fumarate dihydrate) Page 7 of 47 Unclassified / Non classifié 7 WARNINGS AND PRECAUTIONS General TRIMBOW is not indicated for the treatment of asthma.
Serious Asthma-Related Events – Hospitalizations, Intubations, Death:
Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death (see Salmeterol Multicenter Asthma Research Trial (SMART)). Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients.
These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone (see Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta2- adrenergic Agonist Combination Products).
Available data do not suggest an […]