BERODUAL Fenoterol Hydrobromide / Ipratropium Bromide 50mcg / 20mcg / act. Metered-Dose Inhaler 100act.
RXDRUG-DRP-7892
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Features
Brand
Berodual
Full Details
Dosage Strength
50 mcg / 20 mcg per actuation
Drug Ingredients
- Fenoterol
- Ipratropium
Drug Packaging
Metered-Dose Inhaler 100 doses
Generic Name
Fenoterol Hydrobromide / Ipratropium Bromide
Dosage Form
Metered-Dose Inhaler
Registration Number
DRP-7892
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Fenoterol hydrobromide/ipratropium bromide (Berodual) is a bronchodilator for the prevention and treatment of symptoms in chronic obstructive airway disorders with reversible bronchospasm such as bronchial asthma and especially chronic bronchitis with or without emphysema. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid-responsive chronic obstructive pulmonary disease (COPD).
Dosage/Direction for Use
The dosage should be adapted to the individual requirements. The following dosages are recommended:
Berodual MDI: Adults and Children >6 years: Acute Asthma Episodes: 2 actuations are sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, two further actuations may be taken.
If an attack has not been relieved by 4 actuations, further actuations may be required. In these cases, patients should consult the doctor or the nearest hospital immediately.
Intermittent and Long-Term Treatment (in asthma fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution should be used only on an as needed basis).
1-2 actuations for each administration, up to a maximum of 8 actuations per day (average 1-2 actuations 3 times daily).
In children fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation should only be used on medical advice and under the supervision of an adult.
Berodual F UDV: Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator such as fenoterol hydrobromide + ipratropium bromide (Berodual) pressurised inhalation solution has been insufficient in providing relief after consultation with an experienced physician.
The treatment with the nebuliser solution in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases two unit dose vials may be required for symptom relief. Administration should be stopped when sufficient symptom relief is achieved.
Adults (including the elderly) and adolescents >12 years: Acute episodes of bronchospasm: 1 unit-dose vial is sufficient for prompt symptom relief in most cases. In very severe cases two unit dose vials may be required for symptom relief.
Children ≤ 12 years: Because of insufficient information the general use in children ≤ 12 years of age is not recommended.
Administration: Berodual MDI: Before first time use of the pressurised inhalation, solution the following rules should be observed: Remove protective cap and depress the valve twice.
Before each use, the following rules should be observed: 1. Remove protective cap. (If the inhaler has not been used for more than three days the valve has to be actuated once).
2. Breathe out deeply.
3. Hold the inhaler, and close lips around the mouthpiece. The arrow and the base of the container should be pointing upwards.
4. Breathe in as deeply as possible, pressing the base of the canister firmly at the same time, this releases one pressurised inhalation. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and breathe out. The same action should be repeated for a second inhalation.
5. Replace the protective cap after use.
Berodual F UDV: This solution is ready for use and requires no dilution.
The unit dose vials are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally.
Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) solution for inhalation can be administered using a range of commercially available nebulising devices. The lung and systemic drug exposure is dependent on the nebuliser used and may be higher than with Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) pressurised inhalation solution depending on the efficiency of the device.
Where wall oxygen is available the solution is best administered at a flow rate of 6 - 8 litres per minute.
The instructions provided by the manufacturer of the nebulising device for proper care, maintenance and cleaning of the equipment should be followed.
1. Prepare the nebuliser for filling, according to the instructions provided by the manufacturer or physician.
2. Tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebuliser reservoir.
5. Assemble the nebuliser and use as directed.
6. After use throw away any solution left in the reservoir and clean the nebuliser, following the manufacturer's instructions.
Berodual MDI: Adults and Children >6 years: Acute Asthma Episodes: 2 actuations are sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, two further actuations may be taken.
If an attack has not been relieved by 4 actuations, further actuations may be required. In these cases, patients should consult the doctor or the nearest hospital immediately.
Intermittent and Long-Term Treatment (in asthma fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution should be used only on an as needed basis).
1-2 actuations for each administration, up to a maximum of 8 actuations per day (average 1-2 actuations 3 times daily).
In children fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation should only be used on medical advice and under the supervision of an adult.
Berodual F UDV: Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator such as fenoterol hydrobromide + ipratropium bromide (Berodual) pressurised inhalation solution has been insufficient in providing relief after consultation with an experienced physician.
The treatment with the nebuliser solution in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases two unit dose vials may be required for symptom relief. Administration should be stopped when sufficient symptom relief is achieved.
Adults (including the elderly) and adolescents >12 years: Acute episodes of bronchospasm: 1 unit-dose vial is sufficient for prompt symptom relief in most cases. In very severe cases two unit dose vials may be required for symptom relief.
Children ≤ 12 years: Because of insufficient information the general use in children ≤ 12 years of age is not recommended.
Administration: Berodual MDI: Before first time use of the pressurised inhalation, solution the following rules should be observed: Remove protective cap and depress the valve twice.
Before each use, the following rules should be observed: 1. Remove protective cap. (If the inhaler has not been used for more than three days the valve has to be actuated once).
2. Breathe out deeply.
3. Hold the inhaler, and close lips around the mouthpiece. The arrow and the base of the container should be pointing upwards.
4. Breathe in as deeply as possible, pressing the base of the canister firmly at the same time, this releases one pressurised inhalation. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and breathe out. The same action should be repeated for a second inhalation.
5. Replace the protective cap after use.
Berodual F UDV: This solution is ready for use and requires no dilution.
The unit dose vials are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally.
Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) solution for inhalation can be administered using a range of commercially available nebulising devices. The lung and systemic drug exposure is dependent on the nebuliser used and may be higher than with Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) pressurised inhalation solution depending on the efficiency of the device.
Where wall oxygen is available the solution is best administered at a flow rate of 6 - 8 litres per minute.
The instructions provided by the manufacturer of the nebulising device for proper care, maintenance and cleaning of the equipment should be followed.
1. Prepare the nebuliser for filling, according to the instructions provided by the manufacturer or physician.
2. Tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebuliser reservoir.
5. Assemble the nebuliser and use as directed.
6. After use throw away any solution left in the reservoir and clean the nebuliser, following the manufacturer's instructions.
Overdosage
Symptoms: The effects of overdosage are expected to be primarily related to fenoterol.
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, anginal pain, arrhythmias and flushing.
Metabolic acidosis and hypokalaemia have also been observed with fenoterol when applied in doses higher than recommended for the approved indications of fenoterol hydrobromide/ipratropium bromide (Berodual/Berodual F UDV).
Expected symptoms of overdosage with ipratropium bromide (such as dry mouth, visual accommodation disturbances) are mild and transient in nature, in view of the wide therapeutic range and topical administration.
Therapy: Treatment with fenoterol hydrobromide/ipratropium bromide (Berodual) should be discontinued. Acid base and electrolyte monitoring should be considered. Administration of sedatives, and in severe cases intensive care treatment may be needed.
Beta-receptor blockers, preferably beta1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma or COPD because of the risk of precipitating severe bronchospasm, which may be fatal.
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, anginal pain, arrhythmias and flushing.
Metabolic acidosis and hypokalaemia have also been observed with fenoterol when applied in doses higher than recommended for the approved indications of fenoterol hydrobromide/ipratropium bromide (Berodual/Berodual F UDV).
Expected symptoms of overdosage with ipratropium bromide (such as dry mouth, visual accommodation disturbances) are mild and transient in nature, in view of the wide therapeutic range and topical administration.
Therapy: Treatment with fenoterol hydrobromide/ipratropium bromide (Berodual) should be discontinued. Acid base and electrolyte monitoring should be considered. Administration of sedatives, and in severe cases intensive care treatment may be needed.
Beta-receptor blockers, preferably beta1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma or COPD because of the risk of precipitating severe bronchospasm, which may be fatal.
Contraindications
Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) is contraindicated in patients with known hypersensitivity to fenoterol hydrobromide or atropine-like substances or to any of the excipients of the product. Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) is also contraindicated in patients with hypertrophic obstructive cardiomyopathy and tachyarrhythmia.
Warnings
Berodual MDI: The plastic mouthpiece has been specially designed for use with fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution to ensure that you always get the right amount of the medicine.
The mouthpiece must never be used with any other pressurised inhalation, solution nor must the fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution be used with any mouthpiece other than the one supplied with the product.
The container is under pressure and should by no account be opened by force or exposed to temperatures above 50°C.
The mouthpiece must never be used with any other pressurised inhalation, solution nor must the fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution be used with any mouthpiece other than the one supplied with the product.
The container is under pressure and should by no account be opened by force or exposed to temperatures above 50°C.
Special Precautions
Hypersensitivity. Discontinue paradoxical bronchospasm immediately & substitute w/ an alternative therapy. Predisposed narrow-angle glaucoma; DM, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, or w/ pre-existing urinary outflow tract obstruction (eg, prostatic hyperplasia or bladder-neck obstruction); cystic fibrosis. Patients w/ underlying severe heart disease (eg, ischaemic heart disease, arrhythmia, or severe heart failure). Hypokalemia, dyspnoea. Review patient's therapy plan in particular w/ the adequacy of anti-inflammatory therapy w/ inhaled corticosteroid to prevent potentially life threatening deterioration of disease control. Concomitant use w/ other sympathomimetic bronchodilators. Monitor serum K levels in patients susceptible to arrhythmia receiving digoxin. +ve results w/ regard to fenoterol tests for non-clinical substance abuse eg, doping. May impair ability to drive or operate machinery. Pregnancy & lactation.
Use In Pregnancy & Lactation
Pregnancy: Non-clinical data, combined with available experience in humans, have shown no evidence of adverse effects in pregnancy of fenoterol or ipratropium. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the first trimester, should be exercised.
The inhibitory effect of fenoterol on uterine contraction should be taken into account.
Lactation: Non-clinical studies have shown that fenoterol hydrobromide is excreted into breast milk. It is unknown whether ipratropium is excreted into breast milk. But it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by aerosol. However, caution should be exercised when fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) is administered to a nursing woman.
The inhibitory effect of fenoterol on uterine contraction should be taken into account.
Lactation: Non-clinical studies have shown that fenoterol hydrobromide is excreted into breast milk. It is unknown whether ipratropium is excreted into breast milk. But it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by aerosol. However, caution should be exercised when fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) is administered to a nursing woman.
Adverse Reactions
Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic and beta-adrenergic properties of fenoterol hydrobromide/ipratropium bromide (Berodual F UDV). As with all inhalation therapy fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) may show symptoms of local irritation.
The most frequent side effects reported in clinical trials were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, blood pressure systolic increased and nervousness.
The most frequent side effects reported in clinical trials were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, blood pressure systolic increased and nervousness.
Drug Interactions
The chronic co-administration of Fenoterol hydrobromide/ipratropium bromide (Berodual) with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration Fenoterol hydrobromide/ipratropium bromide (Berodual) with other anticholinergic drugs is not recommended.
Other beta-adrenergics and anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilatory effect. The concurrent administration of other beta-mimetics, systemically available anticholinergics and xanthine derivatives (eg, theophylline) may increase the adverse reactions.
A potentially serious reduction in bronchodilation may occur during concurrent administration of beta-blockers.
Hypokalaemia induced by beta2-agonists may be increased by concomitant treatment with xanthine derivatives, corticosteroids, and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.
Beta2-agonist containing medicinal products should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility on the cardiovascular effects of beta-agonists.
Other beta-adrenergics and anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilatory effect. The concurrent administration of other beta-mimetics, systemically available anticholinergics and xanthine derivatives (eg, theophylline) may increase the adverse reactions.
A potentially serious reduction in bronchodilation may occur during concurrent administration of beta-blockers.
Hypokalaemia induced by beta2-agonists may be increased by concomitant treatment with xanthine derivatives, corticosteroids, and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.
Beta2-agonist containing medicinal products should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility on the cardiovascular effects of beta-agonists.
Caution For Usage
Berodual MDI: The container is not transparent. It is therefore not possible to see when it is empty. The inhaler will deliver 200* puffs. When the labelled number of doses have been used the canister may still appear to contain a small amount of fluid. The inhaler should, however, be replaced so that you can be certain that you are getting the right amount of your medicine in each actuation.
Clean your mouthpiece at least once a week.
It is important to keep the mouthpiece of your inhaler clean to ensure that medicine does not build up and block the spray.
For cleaning, first take off the dust cap and remove the canister from the mouthpiece. Rinse warm water through the mouthpiece until no medication build-up and/or dirt is visible.
After cleaning shake out the mouthpiece and let it air-dry without using any heating system. Once the mouthpiece is dry, replace the canister and the dust cap.
Berodual F UDV: Since the unit dose vials contain no preservative, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged unit-dose vials should be discarded.
Unused vials should be discarded three months after opening of the pouch.
Clean your mouthpiece at least once a week.
It is important to keep the mouthpiece of your inhaler clean to ensure that medicine does not build up and block the spray.
For cleaning, first take off the dust cap and remove the canister from the mouthpiece. Rinse warm water through the mouthpiece until no medication build-up and/or dirt is visible.
After cleaning shake out the mouthpiece and let it air-dry without using any heating system. Once the mouthpiece is dry, replace the canister and the dust cap.
Berodual F UDV: Since the unit dose vials contain no preservative, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged unit-dose vials should be discarded.
Unused vials should be discarded three months after opening of the pouch.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic group: Adrenergics in combination with anticholinergics for obstructive airway diseases. ATC code: R03AL01.
Pharmacology: Mode of Action: Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV/Berodual MDI) contains two active bronchodilating ingredients: Ipratropium bromide, exhibiting an anticholinergic effect and fenoterol hydrobromide, a beta-adrenergic agent.
Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In non-clinical studies, it inhibits vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of Ca++ which caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Ca++ release is mediated by the second messenger system consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).
The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.
Non-clinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucociliary clearance or gas exchange.
Fenoterol hydrobromide is a direct-acting sympathomimetic agent, selectively stimulating beta2-receptors in the therapeutic dose range. The stimulation of beta1-receptors comes into effect at a higher dose range. Occupation of beta2-receptors activates adenyl cyclase via a stimulatory GS-protein.
The increase in cyclic AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in turn leads to the phosphorylation of myosin-light chain kinase, inhibition of phosphoinositide hydrolysis and the opening of large-conductance calcium-activated potassium channels.
Fenoterol hydrobromide relaxes bronchial and vascular smooth muscles and protects against bronchoconstricting stimuli such as histamine, methacholine, cold air and allergen (early response). After acute administration, the release of bronchoconstricting and pro-inflammatory mediators from mast cells is inhibited. Further, an increase in mucociliary clearance has been demonstrated after administration of higher doses of fenoterol (0.6 mg).
Higher plasma concentrations, which are more frequently achieved with oral or even more so with intravenous administration, inhibit uterine motility. Also at higher doses, metabolic effects are observed: Lipolysis, glycogenolysis, hyperglycemia and hypokalemia, the latter caused by increased K+-uptake primarily into skeletal muscle. Beta-adrenergic effects on the heart such as increase in heart rate and contractility, are caused by the vascular effects of fenoterol, cardiac beta2-receptor stimulation and, at supratherapeutic doses, by beta1-receptor stimulation. As with other beta-adrenergic agents, QTc prolongations have been reported. For fenoterol pressurised inhalation, solutions these were discrete and observed at doses higher than recommended. However, systemic exposure after administration with nebulisers (nebuliser solution, nebuliser solution in unit dose vials) might be higher than with recommended pressurised inhalation, solution doses. The clinical significance has not been established. Tremor is a more frequently observed effect of beta-agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects of β-agonists are subject to the development of tolerance.
Concurrent use of these two active ingredients dilates the bronchi by affecting different pharmacological sites of action. The two active substances thus complement each other in their spasmolytic action on the bronchial muscles and allow a broad therapeutic use in the field of bronchopulmonary disorders associated with constriction of the respiratory tract. The complementary action is such that only a very low proportion of the β-adrenergic component is needed to obtain the desired effect, facilitating individual dosage suited to each patient with a minimum of adverse reactions.
Pharmacology: Mode of Action: Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV/Berodual MDI) contains two active bronchodilating ingredients: Ipratropium bromide, exhibiting an anticholinergic effect and fenoterol hydrobromide, a beta-adrenergic agent.
Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In non-clinical studies, it inhibits vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of Ca++ which caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Ca++ release is mediated by the second messenger system consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).
The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.
Non-clinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucociliary clearance or gas exchange.
Fenoterol hydrobromide is a direct-acting sympathomimetic agent, selectively stimulating beta2-receptors in the therapeutic dose range. The stimulation of beta1-receptors comes into effect at a higher dose range. Occupation of beta2-receptors activates adenyl cyclase via a stimulatory GS-protein.
The increase in cyclic AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in turn leads to the phosphorylation of myosin-light chain kinase, inhibition of phosphoinositide hydrolysis and the opening of large-conductance calcium-activated potassium channels.
Fenoterol hydrobromide relaxes bronchial and vascular smooth muscles and protects against bronchoconstricting stimuli such as histamine, methacholine, cold air and allergen (early response). After acute administration, the release of bronchoconstricting and pro-inflammatory mediators from mast cells is inhibited. Further, an increase in mucociliary clearance has been demonstrated after administration of higher doses of fenoterol (0.6 mg).
Higher plasma concentrations, which are more frequently achieved with oral or even more so with intravenous administration, inhibit uterine motility. Also at higher doses, metabolic effects are observed: Lipolysis, glycogenolysis, hyperglycemia and hypokalemia, the latter caused by increased K+-uptake primarily into skeletal muscle. Beta-adrenergic effects on the heart such as increase in heart rate and contractility, are caused by the vascular effects of fenoterol, cardiac beta2-receptor stimulation and, at supratherapeutic doses, by beta1-receptor stimulation. As with other beta-adrenergic agents, QTc prolongations have been reported. For fenoterol pressurised inhalation, solutions these were discrete and observed at doses higher than recommended. However, systemic exposure after administration with nebulisers (nebuliser solution, nebuliser solution in unit dose vials) might be higher than with recommended pressurised inhalation, solution doses. The clinical significance has not been established. Tremor is a more frequently observed effect of beta-agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects of β-agonists are subject to the development of tolerance.
Concurrent use of these two active ingredients dilates the bronchi by affecting different pharmacological sites of action. The two active substances thus complement each other in their spasmolytic action on the bronchial muscles and allow a broad therapeutic use in the field of bronchopulmonary disorders associated with constriction of the respiratory tract. The complementary action is such that only a very low proportion of the β-adrenergic component is needed to obtain the desired effect, facilitating individual dosage suited to each patient with a minimum of adverse reactions.
MedsGo Class
Antiasthmatic & COPD Preparations
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