Pressurized inhalation "Salbutamol-Neo" is used for the following indications:
short-term (from 4 to 6 hours) bronchodilation with rapid onset (approximately within 5 minutes) in cases of airway obstruction; relief of attacks of shortness of breath in diseases accompanied by airway obstruction, such as bronchial asthma; prevention of attacks of bronchospasm associated with the action of an allergen or caused by physical exertion; in the complex therapy of patients with bronchial asthma.
Composition
The active substance is salbutamol sulfate (one dose of aerosol contains 100 μg of salbutamol sulfate, expressed as salbutamol).
Excipients: oleyl alcohol, ethanol 96%, tetrafluoroethane.
Contraindication
history of hypersensitivity to the components of the drug; although salbutamol in the form of a solution for injection and sometimes in the form of tablets is used in premature labor, salbutamol in the form of an aerosol for inhalation is not used for these indications; salbutamol is not used in case of threatened abortion.
Method of application
The drug is intended for inhalation use through the mouth only. Patients who have difficulty synchronizing breathing with the use of an inhaler are recommended to additionally use a spacer - a device to facilitate inhalation of inhaled drugs.
Adults (including elderly patients)
For the relief of acute asthma symptoms, including acute bronchospasm, one inhalation (100 mcg) can be used as a minimum starting dose. If necessary, the dose can be increased to 200 mcg (two inhalations).
Prophylactically, 200 mcg (two inhalations) is used 10-15 minutes before physical exertion or expected contact with allergens.
For long-term maintenance therapy, it is recommended to use 200 mcg (two inhalations) 4 times a day.
Children aged 4 to 12 years
For the relief of acute bronchospasm, one inhalation (100 mcg) is used. If necessary, the dose can be increased to 200 mcg (two inhalations).
Children over 12 years of age are given doses as for adults.
Prophylactically, 200 mcg (two inhalations) is used 10-15 minutes before physical exertion or expected contact with allergens.
For long-term maintenance therapy, it is recommended to use 200 mcg (two inhalations) 4 times a day.
The total daily dose of salbutamol should not exceed 800 mcg (8 inhalations). An increased need for beta-2 agonists may indicate worsening of bronchial asthma. In these conditions, the patient's treatment regimen should be reviewed and the need for GCS therapy should be considered.
Preparing for first use
Before using the container for the first time, remove the protective cap from the inhaler nozzle. Then shake the container well with vertical movements, turn the container with the inhaler nozzle down and spray two times into the air to ensure adequate operation. In case of a break in use for several days, spray once into the air after shaking the container thoroughly.
Using
Remove the protective cap from the inhaler nozzle. Make sure that the inner and outer surfaces of the inhaler nozzle are clean. Shake the container well with vertical movements. Turn the container upside down with the inhaler nozzle, hold the container vertically between your thumb and middle and index fingers so that the thumb is under the inhaler nozzle. Exhale as deeply as possible, then place the inhaler nozzle in your mouth between your teeth and cover it with your lips, without biting it. Starting to inhale through your mouth, press the top of the container to spray the drug, while continuing to inhale slowly and deeply. Hold your breath, remove the inhaler nozzle from your mouth and remove your finger from the top of the container. Continue to hold your breath as long as possible. If you need to take another inhalation, wait approximately 30 seconds, holding the inhaler vertically, then follow steps 2-6.
Close the inhaler nozzle with the protective cap.
Important! Do steps 4, 5 and 6 slowly. It is important to start breathing in as slowly as possible before spraying. The first few times you should practice in front of a mirror. If a "cloud" appears on the sides of your mouth, you need to start again from step 2.
Fraction
The inhaler nozzle should be cleaned at least once a week.
Remove the protective cap from the inhaler nozzle and remove the inhaler nozzle from the container. Wash the inhaler nozzle and protective cap thoroughly under warm running water. Dry the inhaler nozzle and protective cap thoroughly inside and out. Put the inhaler nozzle on the container and the valve stem, close the free hole of the inhaler nozzle with the protective cap.
Do not immerse the container in water.
Application features
Pregnant women
Salbutamol is likely to pass into breast milk, so caution should be exercised when administering it to breastfeeding women. It is unknown whether the presence of salbutamol in breast milk causes harmful effects on the newborn/infant, so its use during breastfeeding should be limited to cases where the benefit of its use for the woman outweighs the possible risk to the child.
Drivers
There is no data on the effect of the drug on the reaction rate when driving or using other mechanisms. In case of adverse reactions from the nervous system (tremor), driving or working with mechanisms should be limited.
Overdose
The most common signs and symptoms of salbutamol overdose are transient changes pharmacologically induced by beta-agonists, such as tachycardia, tremor, hyperactivity and metabolic disturbances, including hypokalemia.
Hypokalemia may occur as a result of an overdose of salbutamol, therefore it is necessary to check the level of potassium in the blood serum. Cases of lactic acidosis have been reported with the use of high therapeutic doses or overdose with short-acting beta-agonists. Therefore, serum lactate levels should be checked and metabolic acidosis should be monitored accordingly, especially in the case of persistent or increasing rapid breathing despite improvement in symptoms of bronchospasm, such as stridor.
Side effects
The adverse reactions listed below are classified by organ system and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥ 1/10000 and <1/1000), very rare (<1/10000), including isolated cases, frequency unknown.
Immune system disorders: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, hypotension and collapse.
From the side of metabolism: rarely - hypokalemia (potentially the use of beta-2-agonists can cause severe hypokalemia).
Neurological disorders: often - tremor, headache; very rarely - hyperactivity.
Cardiac disorders: often - tachycardia; infrequently - palpitations; very rarely - cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole; frequency unknown - myocardial ischemia.
Vascular disorders: rarely - peripheral vasodilation.
Respiratory, thoracic and mediastinal disorders: very rarely - paradoxical bronchospasm.
Gastrointestinal disorders: infrequently - irritation of the mucous membranes of the mouth and pharynx.
Musculoskeletal and connective tissue disorders: infrequently - muscle cramps.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze. Protect from falls, impacts, and direct sunlight.
Shelf life - 2 years.
