Description
Release form
Solution for inhalation in nebulas, for use with a nebulizer.
Packing
20 pcs.
Pharmacological action of
Salbutamol is selective agonist of b2-adrenergic receptors.
In therapeutic doses, it acts on the b2-adrenergic receptors of the smooth muscles of the bronchi, having little or no effect on the b1-adrenergic receptors of the myocardium.
Indications
Relief and prevention of bronchial asthma attacks, including as part of complex treatment of asthmatic status.
In the complex therapy of other chronic lung diseases accompanied by reversible airway obstruction, including chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema.
Contraindications
Hypersensitivity to the active substance or any other component that is part of the drug.
Children under 18 months of age (data on the clinical efficacy of nebulized salbutamol in children under 18 months of age are not available).
Non-injection salbutamol dosage forms should not be used to manage uncomplicated preterm delivery or if there is a risk of abortion.
With caution
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 symptoms.
Pregnancy and lactation
Pregnancy
Pregnant women should only be prescribed if the expected benefit to the mother outweighs the potential risk to the fetus.
During post-registration monitoring, rare cases of various malformations in children were identified, including the formation of a cleft palate and malformations of the extremities, while mothers are taking Ventolin ® Nebula during pregnancy.
In some of these cases, mothers took several medications during pregnancy. Due to the lack of a permanent nature of the defects and the background incidence of congenital anomalies ranging from 2 to 3%, a causal relationship with the drug has not been established.
Breastfeeding period
Ventolin ® Nebula is likely to pass into breast milk, therefore, the drug is not recommended for nursing women, unless the expected benefit to the mother outweighs the potential risk to the baby.
There is no evidence of whether salbutamol present in breast milk has a negative effect on the newborn.
Fertility
There is no data on the effect of Ventolin ® Nebula on human fertility. In preclinical studies, an undesirable effect on animal fertility has not been identified.
Special instructions
Instruct patients to use Ventolin inhaler correctly.
Bronchodilators should not be the only or main component of therapy for unstable or severe bronchial asthma.
If the effect of the usual dose of Ventolin becomes less effective or less prolonged (the effect of the drug should last at least 3 hours), the patient should consult a doctor.
An increased need for short-acting inhaled b2-adrenoreceptor agonists to control symptoms of asthma indicates an exacerbation of the disease. In such cases, the patient’s treatment plan should be reviewed. A sudden and progressive worsening of bronchial asthma can pose a threat to the patient ² ¢s life, so in such situations it is urgent to decide on the appointment or increase in the dose of glucocorticosteroids. In such patients, it is recommended to monitor peak expiratory flow daily.
Very high doses of salbutamol can lead to the development of adverse reactions, so only a doctor can decide whether to increase the dose or frequency of use of the drug. Patients using Ventolin Nebula at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, you can not independently increase the dose or frequency of administration of the drug, but you should immediately consult a doctor.
Ventolin Nebula should be used with caution in patients who have already taken high doses of other sympathomimetics.
Salbutamol should be used with caution in patients with thyrotoxicosis.
Therapy with b2-adrenoreceptor agonists, especially when administered parenterally or with a nebulizer, can lead to hypokalemia. Particular caution is recommended in the treatment of severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to control the level of potassium in the blood serum.
Composition of
In 1 ml of solution contains:
active substance:
salbutamol sulfate – 1.2 mg, which corresponds to the content of 1 mg of salbutamol
auxiliary components:
sulfuric acid (diluted to pH 3.54.5),
sodium chloride,
purified water.
Dosage and administration
The preparation Ventolin ® Nebula is intended for inhalation 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 agonists can be a sign of aggravation of the course of bronchial asthma. In such a situation, a reappraisal of the patient’s treatment regimen may be necessary with consideration of the advisability of prescribing simultaneous glucocorticosteroid therapy.
Since an overdose can be accompanied by the development of adverse 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 should be used with a nebulizer under medical supervision. Aerosol delivery can be carried out using a face mask, a T-shaped tube or through an endotracheal tube. A ventilation regimen with intermittent positive pressure can be used, however, the need to use this option is rare.
In case of risk of hypoxia due to hypoventilation, the inhaled air may be enriched with oxygen. The drug Ventolin Nebula is intended for undiluted use, however, if you need long-term administration (more than 10 minutes), the drug can be diluted with a sterile 0.9% sodium chloride solution.
Since many nebulizers work only in the presence of a constant flow of air, it is possible that the sprayed product will enter the environment. With this in mind, Ventolin ® Nebula should be used in well-ventilated rooms, especially in hospitals where several patients can use nebulizers in the same room at the same time.
Treatment of chronic bronchospasm resistant to traditional therapy, and treatment of an acute attack of bronchial asthma (asthmatic status)
Adults and children 12 years of age and older
The average initial dose of salbutamol administered by inhalation with a 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.
Children 4 to 11 years old
The average initial dose of salbutamol administered by inhalation with a nebulizer is 2.5 mg, but can be increased to 5 mg. Inhalations can be repeated 4 times a day.
The clinical efficacy of Ventolin ® Nebula in children under the age of 18 months has not been established. In view of the possibility of developing transient hypoxemia, additional oxygen therapy should be considered.
Side effects
Undesirable reactions listed below are described in the following: and organ systems and frequency of occurrence. The frequency of occurrence is determined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1/1 000), very rarely (<1/10 000, including isolated cases). Frequency categories were formed on the basis of clinical trials of the drug and post-registration observation. Frequency of adverse reactions Immune disorders Very rare: hypersensitivity reactions, including angioedema, urticaria, bronchospasm, arterial hypotension and collapse. Metabolic and nutritional disorders Rarely: hypokalemia. Beta 2-agonist group therapy may result in clinically significant hypokalemia. Very rare: lactic acidosis. Very rare cases of lactic acidosis have been reported in patients who received salbutamol intravenously and in the form of nebula for the treatment of exacerbations of bronchial asthma. Disorders of the nervous system Often: tremors, headache. Very rare: hyperactivity. Heart disorders Often: tachycardia. Infrequently: palpitations. Very rare: arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole. Frequency unknown: myocardial ischemia. Vascular disorders Rarely: peripheral vasodilation. Disorders of the respiratory system, chest and mediastinal organs Very rare: paradoxical bronchospasm. Disorders of the gastrointestinal tract Infrequently: irritation of the mucous membrane of the oral cavity and pharynx. Violations of the musculoskeletal and connective tissue Infrequently: muscle cramps. Drug Interactions It is not recommended to use salbutamol and non-selective b-adrenoreceptor blockers, such as propranolol, at the same time. Salbutamol is not contraindicated in patients who receive monoamine oxidase inhibitors (MAOIs). Overdose Cardioselective b-blockers are the best antidotes for an overdose of salbutamol. However, b-adrenoceptor blockers should be used with caution in patients with a history of bronchospasm. Using large doses of salbutamol can cause hypokalemia, therefore, serum potassium should be monitored for suspected overdose. Storage conditions Store only in the original package at temperatures below 30 ° C. After opening the foil packing, store the nebulas for no more than 3 months at a temperature below 30 ° C in a light-proof place. The unused salbutamol solution remaining in the nebulizer chamber cannot be stored and should be poured. conditions vacation from drugstores prescription from prescription ska through pharmacies In retseptu lekarstvennaja form Solution for ynhalyatsyy Appointment children prescribed by a doctor, nursing mothers, children over 2 years, Adults as prescribed by a doctor, Pregnant as prescribed by a doctor Indications Indications Bronchial asthma, bronchospasm, low trainability Glakso SmithKlyan, United Kingdom
