Pharmacodynamics
Salbutamol is a selective β2-adrenergic receptor agonist. In therapeutic doses, it acts on β2-adrenergic receptors of bronchial smooth muscle, having little or no effect on β1-adrenergic receptors of the myocardium. It has a pronounced bronchodilator effect, preventing or relieving bronchospasm, and reduces resistance in the respiratory tract. Increases vital capacity of the lungs. Increases mucociliary clearance (in chronic bronchitis up to 36%), stimulates mucus secretion, activates the functions of the ciliated epithelium.
At recommended therapeutic doses it does not have a negative effect on the cardiovascular system and does not cause an increase in blood pressure. To a lesser extent, compared to drugs of this group, it has a positive chrono- and inotropic effect. Causes dilation of the coronary arteries.
It has a number of metabolic effects: it reduces the concentration of potassium in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, and increases the risk of developing acidosis.
After using inhalation forms, the action develops quickly, the onset of the effect is after 5 minutes, the maximum is after 30–90 minutes (75% of the maximum effect is achieved within 5 minutes), the duration is 4–6 hours.
Pharmacokinetics
After inhalation administration, 10–20% of the dose of salbutamol reaches the lower respiratory tract. The rest of the dose remains in the inhaler or is deposited in the oropharynx and is then swallowed. The fraction deposited in the respiratory tract is absorbed into the lung tissue and blood, but is not metabolized in the lungs.
The degree of binding of salbutamol to plasma proteins is about 10%.
Once in the blood, salbutamol is metabolized in the liver and excreted, mainly in the urine, unchanged or in the form of phenolic sulfate.
The ingested portion of the inhalation dose is absorbed from the gastrointestinal tract and undergoes active metabolism during the first passage through the liver, turning into phenolic sulfate. Unchanged salbutamol and the conjugate are excreted primarily in the urine.
Salbutamol administered intravenously has a T1/2 of 4–6 hours. It is excreted partly by the kidneys and partly as a result of metabolism to inactive 4′-O-sulfate (phenolic sulfate), which is also excreted mainly in the urine. Only a small part of the administered dose of salbutamol is excreted in feces. Most of the dose of salbutamol administered intravenously, orally or by inhalation is excreted within 72 hours.
Pharmacological properties of the drug Ventolin™ nebula
Pharmacodynamics. Salbutamol is a selective β2-adrenergic receptor agonist. In therapeutic doses, it acts on β2-adrenergic receptors of the bronchial muscles with minimal or complete absence of effect on β1-adrenergic receptors of the heart. Pharmacokinetics. After inhalation administration, 10–20% of the administered dose reaches the lower respiratory tract. The remaining amount settles in the “delivery” device or in the nasopharynx, from where it is swallowed. Part of the dose that reaches the respiratory tract is absorbed into the lung tissue and enters the general bloodstream, but is not metabolized in the lungs. The onset of action of the drug occurs 4–5 minutes after inhalation, the duration of action is 4–6 hours. Once in the systemic circulation, the drug is metabolized in the liver and excreted mainly by the kidneys unchanged and in the form of a phenol sulfate metabolite. A dose of the drug that enters the digestive system from the nasopharynx is absorbed into the gastrointestinal tract, undergoes the first stage of metabolism in the liver to a phenol sulfate compound, and then is excreted by the kidneys.
Indications for the drug Ventolin®
bronchial asthma:
— relief of attacks of bronchial asthma, incl. with exacerbation of severe bronchial asthma;
- prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity;
- use as one of the components in long-term maintenance therapy of bronchial asthma;
COPD accompanied by reversible airway obstruction;
Chronical bronchitis.
Contraindications
hypersensitivity to any component of the drug;
management of preterm birth;
threatened abortion;
children under 2 years of age.
With caution: tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, seizures, renal or hepatic failure, simultaneous use of non-selective β-blockers, pregnancy, period lactation.
Use during pregnancy and breastfeeding
The drug is prescribed to pregnant women only when the expected benefit to the patient outweighs the potential risk to the fetus.
During post-registration surveillance, rare cases of various malformations in children, including the formation of a cleft palate and malformations of the limbs, were identified when mothers took salbutamol during pregnancy. In some of these cases, mothers took multiple concomitant medications during pregnancy. A cause-and-effect relationship with taking the drug has not been established.
Salbutamol is likely to pass into breast milk and is therefore not recommended for use in nursing women unless the expected benefit to the patient outweighs the potential risk to the baby. There is no evidence whether salbutamol present in breast milk is harmful to the newborn.
Special instructions for the use of Ventolin™ nebula
Ventolin Nebulas should be used by inhalation through the mouth and should not be injected or swallowed. Treatment of asthma should be carried out according to a step-by-step program, the patient's condition must be assessed clinically and using pulmonary function tests. An increase in the frequency of use of inhaled β2-agonists indicates a deterioration in asthma control. In this case, the patient's therapy must be reconsidered, because worsening asthma is a life-threatening condition that requires the initiation or increase in the use of corticosteroids. Patients who belong to the risk group are recommended to monitor the maximum expiratory flow daily. Patients treated with Ventolin Nebula at home should be warned of the following: if a once effective dose of the drug does not provide relief from treatment or the duration of this relief decreases, they should consult a doctor rather than increase the dose of the drug or the frequency of its use on their own. Ventolin Nebula should be used with caution in the treatment of patients receiving high doses of other sympathomimetics. The use of sympathomimetics, including salbutamol, has an effect on the cardiovascular system. Based on post-licensing data and published literature, there is evidence of rare cases of myocardial ischemia associated with the use of salbutamol. Patients with heart disease (eg, coronary artery disease, arrhythmia, or severe heart failure) and who are being treated with salbutamol should seek medical attention if they experience chest pain or other symptoms that indicate worsening heart disease. Attention should be paid to assessing symptoms such as shortness of breath and chest pain, which can be the result of both heart disease and diseases of the respiratory system. Salbutamol is prescribed with caution to patients with thyrotoxicosis. When treating patients with a combination of nebulized salbutamol and ipratropium bromide, cases of acute angle-closure glaucoma were sometimes observed. Therefore, the combination of nebulized salbutamol with anticholinergic drugs, which are also administered by nebulization, should be used with caution. Patients should receive proper instructions regarding the correct use of the drug and be warned to avoid contact of the spray aerosol with the eyes. Severe hypokalemia may result from treatment with β2-adrenergic agonists; This is mainly observed when using parenteral forms or a nebulizer. Particular attention is paid to patients with severe exacerbation of asthma, because hypokalemia can be potentiated by the concomitant use of xanthine derivatives, steroids, diuretics and hypoxia. In this situation, it is recommended to check the level of potassium in the blood plasma. Like other β2-adrenergic agonists, Ventolin Nebula can lead to reversible metabolic changes, such as hyperglycemia. Compensation for such changes in patients with diabetes mellitus is not always possible, therefore there are isolated reports of the development of ketoacidosis in such patients. Concomitant use of corticosteroids may exacerbate this condition. Very rarely, cases of lactic acidosis have been reported in patients with acute asthma who were treated with high doses of salbutamol, which was administered intravenously or via a nebulizer. An increase in the level of lactate in the blood plasma can cause the development of suffocation and compensatory hyperventilation of the lungs, which can be mistakenly regarded as insufficient effectiveness of anti-asthma treatment and, in turn, lead to inappropriate intensification of treatment with short-acting β2-adrenergic receptor agonists. Therefore, it is recommended to monitor the level of lactate in the blood plasma of such patients and, accordingly, the presence of metabolic acidosis. During pregnancy and breastfeeding . Salbutamol during pregnancy is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. Based on the fact that salbutamol can be excreted in breast milk, its use during breastfeeding may not be recommended, except in situations where the expected benefit to the mother will outweigh the potential risk to the child. Children . The clinical effectiveness of using salbutamol by nebulization in children under 18 months of age has not been established, therefore the use of the drug is not recommended. There are no reports of effects on the ability to drive vehicles or operate other machinery , but if side effects from the central nervous system (tremor) occur, these activities should be limited.
Side effects
Adverse reactions are listed depending on the anatomical and physiological classification and frequency of occurrence, which is defined as follows: very often (≥1/10), often (≥1/100 and <1/10), sometimes (≥1/1000 and <1 /100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000), including isolated cases.
From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolic disorders: rarely - hypokalemia (therapy with β2-agonists can lead to significant hypokalemia); very rarely - lactic acidosis. Very rare cases of lactic acidosis have been reported in patients receiving IV salbutamol and Ventolin Nebula to treat exacerbations of asthma.
From the nervous system: often - tremor, headache; very rarely - hyperactivity.
From the cardiovascular system: often - tachycardia; sometimes - strong heartbeat (pulsation, palpitation); rarely - dilatation of peripheral vessels; very rarely - arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole.
From the respiratory system, chest and mediastinal organs: very rarely - paradoxical bronchospasm.
From the gastrointestinal tract: sometimes - irritation of the mucous membrane of the mouth and pharynx.
From the musculoskeletal system: sometimes - muscle cramps.
Interaction
The simultaneous use of salbutamol and non-selective beta-adrenergic blockers such as propranolol is not recommended.
Salbutamol is not contraindicated in patients receiving MAO inhibitors.
In patients with thyrotoxicosis, it enhances the effect of central nervous system stimulants and tachycardia.
Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmia; agents for inhalation anesthesia, levodopa - severe ventricular arrhythmia.
Simultaneous administration with anticholinergic drugs (including inhaled ones) may increase intraocular pressure.
Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.
Directions for use and doses
Inhalation. Only a doctor can decide whether to increase the dose or frequency of use of the drug. It is not recommended to use the Ventolin® inhaler more than 4 times a day. The need for frequent use of maximum doses of Ventolin® or a sudden increase in dose indicates a worsening of the disease.
Adults (including elderly patients)
Relieving an attack of bronchospasm: the recommended dose is 100–200 mcg (1–2 inhalations).
Prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity: the recommended dose is 200 mcg (2 inhalations) 10–15 minutes before exposure to the provoking factor.
Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.
Children
Relieving an attack of bronchospasm: the recommended dose is 100–200 mcg (1–2 inhalations).
Prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity: the recommended dose is 100–200 mcg (1–2 inhalations) 10–15 minutes before exposure to the provoking factor.
Long-term maintenance therapy: the recommended dose is 200 mcg (2 inhalations) 4 times a day. Ventolin® can be administered through the Babyhaler spacer.
Instructions for use of the inhaler
Checking the inhaler: before using the inhaler for the first time or if the inhaler has not been used for a week or longer, remove the cap from the mouthpiece by lightly squeezing the cap on the sides, shake the inhaler well and press the aerosol valve to release 1 inhalation dose into the air to make sure the inhaler is working properly.
Using an inhaler
1. Remove the cap from the mouthpiece by lightly squeezing the sides of the cap.
2. Inspect the mouthpiece inside and out to make sure it is clean.
3. Shake the inhaler well.
4. Hold the inhaler between your index finger and thumb in a vertical position, bottom up, with your thumb resting on the base under the mouthpiece.
5. Exhale slowly, deeply, wrapping your lips around the mouthpiece without squeezing it with your teeth.
6. Inhaling as deeply as possible through your mouth, simultaneously press the top of the inhaler to release 1 inhalation dose of salbutamol.
7. Hold your breath for a few seconds, remove the mouthpiece from your mouth, then exhale slowly.
8. To receive the second dose, hold the inhaler in an upright position, wait about 30 seconds and then repeat steps 3–7.
9. Close the mouthpiece tightly with the protective cap.
Attention! When following steps 5, 6 and 7, you should not rush. You should begin inhaling as slowly as possible, just before pressing the inhaler valve. It is recommended to practice in front of a mirror the first few times. If “fog” is visible coming from the top of the inhaler or from the corners of the mouth, then you should start over from step 3.
If your doctor has given other instructions for using your inhaler, you should strictly follow them. You should contact your doctor if you have difficulty using your inhaler.
Cleaning the inhaler: the inhaler must be cleaned at least once a week.
1. Remove the metal can from the plastic case and remove the mouthpiece cover.
2. Rinse the plastic case and mouthpiece cover thoroughly under running warm water.
3. Dry the plastic case and mouthpiece cover completely, both outside and inside. Avoid overheating.
4. Place the metal can into the plastic case and put on the mouthpiece cap.
Do not immerse the metal can in water.
Ventolin® Nebules
Ventolin® Nebula is intended for inhalation administration only by inhalation through the mouth.
Ventolin® Nebula is not intended for injection or oral administration. An increased need for the use of beta2-adrenergic receptor agonists may be a sign of worsening bronchial asthma. In such a situation, it may be necessary to re-evaluate the patient's treatment regimen and consider the advisability of prescribing concomitant therapy with a glucocorticosteroid.
Since an overdose may be accompanied by the development of undesirable reactions, the dose or frequency of use of the drug can be increased only on the recommendation of a doctor.
The duration of action of salbutamol in most patients is from 4 to 6 hours.
Ventolin® Nebula must be used under medical supervision using a nebulizer. Aerosol delivery can be done using a face mask, T-tube, or through an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. If there is a risk of developing hypoxia due to hypoventilation, the inhaled air can be enriched with oxygen.
The drug Ventolin® Nebula is intended for use undiluted, however, if long-term administration (more than 10 minutes) is necessary, the drug can be diluted with a sterile 0.9% sodium chloride solution.
Since many nebulizers operate only with a constant flow of air, it is possible that the nebulized drug will be released into the environment. Taking this into account, Ventolin® Nebulas should be used in well-ventilated areas, especially in hospitals where several patients can simultaneously use nebulizers in the same room.
Treatment of chronic bronchospasm resistant to traditional therapy and treatment of acute severe bronchial asthma (status asthmaticus)
Adults and children over 18 months
The average starting dose of salbutamol administered by inhalation via nebulizer is 2.5 mg, but can be increased to 5 mg. Inhalations can be repeated 4 times a day. For the treatment of severe airway obstruction in adult patients, higher doses can be used - up to 40 mg / day under strict medical supervision in a hospital setting.
The clinical effectiveness of Ventolin® Nebula in children under 18 months of age has not been established. Due to the possibility of transient hypoxemia, supplemental oxygen therapy should be considered.
INSTRUCTIONS FOR USE OF NEBUL
Ventolin® Nebula can be diluted with a sterile 0.9% sodium chloride solution. Any solution remaining unused in the nebulizer chamber should be discarded.
Step-by-step instruction
I. Use of nebula.
II. Nebula breeding
III. After using nebul.
I. Use of nebulas
1. The strip, consisting of nebulae, is contained in a laminated aluminum foil bag. Do not open the package before using the nebula.
2. To open the bag, use scissors to cut the edge of the bag along the marked dotted line.
3. Hold the strip of nebulas in one hand and grab the last nebula in the row with your other hand.
4. Turn the nebula down and away from you.
5. Place the remaining nebulas back into the bag and place the bag back into the carton.
6. Hold the separated nebula by the top and twist the nebula body to open it.
7. Place the open end of the nebula into the nebulizer chamber and slowly squeeze the nebula. Make sure that the contents of the nebula are completely poured into the nebulizer chamber.
8. Assemble the nebulizer and use it according to the instructions for use.
Make sure that the “fog” formed during inhalation does not get into your eyes!
II. Nebula Breeding
1. Do not dilute the contents of the nebulas unless directed by a doctor.
2. If the doctor recommended diluting the solution, pour the contents of the nebula into the nebulizer chamber.
3. Add the amount of sterile 0.9% sodium chloride solution recommended by your doctor. To dilute liquid from nebulas, use only sterile 0.9% sodium chloride solution.
4. Place the lid on the nebulizer chamber and shake thoroughly to mix the contents.
III. After using nebul
1. Use a new nebula for each procedure. The nebula should only be opened before use. If some liquid remains in the nebula, it should not be used for subsequent inhalations.
2. Pour out the solution remaining in the nebulizer chamber after inhalation.
3. Clean the nebulizer as recommended in the instructions for use.
Overdose
Symptoms: more frequent - hypokalemia, decreased blood pressure, tachycardia, muscle tremors, nausea, vomiting; less frequent - agitation, hyperglycemia, respiratory alkalosis, hypoxemia, headache; rare - hallucinations, convulsions, tachyarrhythmia, ventricular flutter, dilatation of peripheral vessels.
Treatment: the best antidotes are cardioselective β-blockers. However, beta-adrenergic blockers should be used with caution in patients with a history of bronchospasm attacks. The use of large doses of salbutamol can cause hypokalemia, therefore, if overdose is suspected, serum potassium levels should be monitored.
Overdose of Ventolin™ nebula, symptoms and treatment
The most common signs and symptoms of Ventolin Nebula overdose are transient changes pharmacologically induced by β-adrenergic agonists (eg, tachycardia, tremor, headache). As a result of an overdose of salbutamol, severe hypokalemia may occur, so the level of potassium in the blood plasma should be checked. Treatment consists of discontinuing salbutamol and administering appropriate symptomatic therapy, such as cardioselective beta-blockers to treat patients with cardiac abnormalities (eg, tachycardia, palpitations). Drugs of the β-adrenergic blocker group should be prescribed with caution to patients with a history of bronchospasm.
special instructions
Patients should be instructed on the correct use of the Ventolin® inhaler.
Bronchodilators should not be the only or main component of the treatment of unstable or severe bronchial asthma.
If the effect of the usual dose of Ventolin® becomes less effective or shorter lasting (the effect of the drug should last at least 3 hours), the patient should consult a doctor.
An increased need for the use of inhaled β2-adrenergic agonists with a short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient's treatment plan should be reconsidered. A sudden and progressive deterioration of bronchial asthma can pose a threat to the patient's life, therefore, in such situations, it is necessary to urgently decide on prescribing or increasing the dose of GCS. In such patients, daily monitoring of peak expiratory flow is recommended.
Salbutamol should be used with caution in patients with thyrotoxicosis.
Therapy with β2-adrenergic agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia. Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the level of potassium in the blood serum.
Impact on the ability to drive a car and/or other mechanisms. No data.
Ventolin Nebula solution for inhalation 2.5 mg/2.5 ml No. 20
A country
Germany
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Salbutamol
Compound
sodium chloride - 9 mg, diluted sulfuric acid - qs to pH 3.5-4.5, purified water - up to 1 ml.
pharmachologic effect
Selective agonist of β2-adrenergic receptors. In therapeutic doses, it acts on β2-adrenergic receptors of bronchial smooth muscle and has a short-term effect (from 4 to 6 hours), a bronchodilator effect on β2-adrenergic receptors with a rapid onset of action (within 5 minutes) with reversible airway obstruction.
Indications for use
— relief and prevention of attacks of bronchial asthma (including as part of complex therapy for status asthmaticus); — as part of complex therapy of other chronic lung diseases accompanied by reversible airway obstruction, including
Interaction
The simultaneous use of salbutamol and non-selective beta-adrenergic blockers such as propranolol is not recommended. Salbutamol is not contraindicated in patients receiving MAO inhibitors (monoamine oxidase). In patients with thyrotoxicosis, it enhances the effect of central nervous system stimulants and tachycardia. Salbutamol increases the likelihood of developing extrasystole while taking cardiac glycosides. Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias. Concomitant use with inhalation anesthesia agents and levodopa increases the likelihood of developing severe ventricular arrhythmias. Concomitant use with anticholinergic drugs (including inhaled ones) may increase intraocular pressure. Diuretics and corticosteroids increase hypokalemia, which can be caused by salbutamol.
Side effect
The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10), often (≥1/100 and From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, arterial hypotension and collapse. From the metabolic side and nutrition: rarely - hypokalemia. Therapy with drugs of the beta2-agonist group can lead to clinically significant hypokalemia. Very rarely - lactic acidosis. Very rare cases of lactic acidosis have been reported in patients who received salbutamol intravenously and in the form of nebulas for the treatment of exacerbations of bronchial asthma. With side of the nervous system: often - tremor, headache; very rarely - hyperactivity. From the heart: often - tachycardia; infrequently - palpitations; very rarely - arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole. From the blood vessels: rarely - peripheral vasodilation Disorders of the respiratory system, chest and mediastinal organs: very rarely - paradoxical bronchospasm. From the digestive system: infrequently - irritation of the mucous membrane of the mouth and pharynx. From the musculoskeletal system: infrequently - muscle cramps.
Contraindications
- hypersensitivity to any component of the drug; - children under 18 months of age (there are no data on the clinical effectiveness of nebulized salbutamol in children under 18 months of age). Non-injectable dosage forms of salbutamol should not be used for the management of uncomplicated preterm labor or threatened abortion. Ventolin® Nebula should be used with caution in patients with thyrotoxicosis, tachyarrhythmia, severe chronic heart failure, arterial hypertension, pheochromocytoma, during pregnancy, during breastfeeding, as well as in patients who have already taken high doses of other sympathomimetics.
Overdose
Symptoms: the most common signs and symptoms of salbutamol overdose are transient phenomena, pharmacologically caused by stimulation of β-adrenergic receptors (see sections “Special instructions” and “Side effects”). The use of large doses of salbutamol can cause hypokalemia; it is necessary to monitor the concentration of potassium in the blood serum. The development of lactic acidosis has been reported when used in high doses, as well as with overdose of short-acting beta-agonists, therefore, in case of overdose, it is recommended to monitor the increase in serum lactate concentration and the associated development of metabolic acidosis (especially if tachypnea persists or worsens despite eliminating other signs of bronchospasm, such as wheezing). Treatment: symptomatic therapy.
special instructions
Treatment of bronchial asthma is recommended to be carried out in stages, monitoring lung function and the patient's clinical response to treatment. Bronchodilators should not be the only or main component of the treatment of unstable or severe bronchial asthma. An increased need for the use of short-acting inhaled β2-adrenergic receptor agonists to relieve symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, it is recommended to reconsider the patient's treatment plan. A sudden and progressive deterioration in the course of bronchial asthma can pose a threat to the patient’s life, therefore, in such situations, it is necessary to urgently decide on the issue of prescribing or increasing the dose of GCS. In such patients, daily monitoring of maximum expiratory flow is recommended. Therapy with β2-adrenergic agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia. Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, corticosteroids and diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the concentration of potassium in the blood serum. As with the use of other inhalation therapy agents, paradoxical bronchoslasm may develop when taking salbutamol with increased wheezing immediately after using the drug. This condition requires immediate treatment using an alternative formulation of salbutamol or another short-acting inhaled bronchodilator. Ventolin® Nebula should be immediately discontinued, the patient's condition assessed, and, if necessary, another fast-acting bronchodilator prescribed to continue treatment. Ventolin® Nebula should be used only by inhalation by inhalation through the mouth. The drug is not intended for injection or oral administration. Patients using Ventolin® Nebula at home should be warned that if the effect of the usual dose becomes less effective or less durable, they should not independently increase the dose or frequency of administration of the drug and should immediately consult a doctor. A small number of cases of acute angle-closure glaucoma have been reported in patients receiving a combination of salbutamol and ipratropium bromide via nebulizer. Given this fact, caution should be exercised when using salbutamol and anticholinergics via nebulizer simultaneously. Patients should receive appropriate instructions for the correct use of Ventolin® Nebula and should also be warned not to get the solution or “mist” into the eyes. Like other beta-adrenergic agonists, salbutamol can cause reversible metabolic changes, such as an increase in blood glucose concentrations. In patients with diabetes mellitus, decompensation may develop; in some cases, the development of ketoacidosis has been reported. Concomitant use of corticosteroids may enhance this effect. Very rare cases of lactic acidosis have been reported associated with the use of high doses of short-acting β2-adrenergic agonists intravenously or via nebulizer, mainly in patients with exacerbation of bronchial asthma). Increased lactate concentrations can lead to shortness of breath and compensatory hyperventilation, which may be misinterpreted as signs of unsuccessful asthma treatment and lead to an unnecessary increase in the use of short-acting β2-adrenergic agonists. Therefore, it is recommended to monitor the concentration of lactate in the blood serum, as well as monitor the possible subsequent development of metabolic acidosis. Effect on the ability to drive vehicles and machines There is no data on the effect of Ventolin® Nebula on the ability to drive vehicles or machines.
Dispensing conditions in pharmacies
On prescription
