Salbutamol, inhalation aerosol, 12ml

Composition

1 dose of the drug contains:

Active ingredient:

salbutamol sulfate (in terms of 100% substance) 0.1208 mg (equivalent to 0.1 mg of salbutamol).

Auxiliary substances:

oleyl alcohol 0.0625 mg,

ethanol (rectified ethyl alcohol) 2.02 mg,

propellant R 134a (1,1,1,2-tetrafluoroethane, HFA 134a) 56.91 mg.

The product does not contain chlorofluorocarbon propellants.

1 bottle of the drug contains:

Active ingredient:

salbutamol sulfate (in terms of 100% substance) 0.029 g (equivalent to 0.024 g of salbutamol).

Auxiliary substances:

oleyl alcohol 0.015 g,

ethanol (rectified ethyl alcohol) 0.485 g,

propellant R 134a (1,1,1,2-tetrafluoroethane, HFA 134a) 13.659 g (up to 12.00 ml).

The product does not contain chlorofluorocarbon propellants.

Pharmacological action

Salbutamol is a selective beta-2-adrenergic agonist. In therapeutic doses, it acts on the β2-adrenoreceptors of the smooth muscles of the bronchi, having a slight effect on the β1-receptors of the myocardium. It has a pronounced bronchodilating effect, preventing or stopping bronchospasm, reduces resistance in the airways. Increases the vital capacity of the lungs.

In the recommended therapeutic doses, it does not have a negative effect on the cardiovascular system, does not cause an increase in blood pressure.

To a lesser extent, compared with 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: reduces the concentration of potassium in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increasing the risk of acidosis.

After the use of inhaled forms, the effect develops quickly, the beginning of the effect – in 5 minutes, maximum-in 30-90 minutes (75% of the maximum effect is achieved within 5 minutes), duration – 4-6 hours.

Indications

1. Bronchial asthma:

– relief of asthma attacks, including severe asthma exacerbation;

– prevention of bronchospasm attacks associated with allergen exposure or caused by physical exertion;

– use as one of the components in long-term maintenance therapy of bronchial asthma.

2. Chronic obstructive pulmonary disease (COPD) accompanied by reversible airway obstruction, chronic bronchitis.

Contraindications

Hypersensitivity to any component of the drug.

Children under 2 years of age.

With caution:  

If there is a history of tachyarrhythmia, myocarditis, heart defects, aortic stenosis, coronary heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, epipripadies, renal or hepatic insufficiency.

When taking non-selective beta-2 blockers at the same time, pregnancy, lactation.

Side effects

By frequency, side effects can be divided into the following categories: very common (1/10), common (1/100 and < 1/10), uncommon (1/1000 and < 1/100), rare (1/10,000 and < 1/100), very rare (

From the immune system: rarely-dermatitis, very rarely-hypersensitivity reactions, including angioedema, skin rash.

From the side of metabolic processes: rarely-hypokalemia.

From the nervous system: often-tremor, headache, anxiety; rarely-dizziness, drowsiness, fatigue; very rarely-hyperactivity.

From the cardiovascular system: often-tachycardia, palpitation sensation; rarely-dilated peripheral vessels with hyperemia of the skin, discomfort or pain in the chest; very rarely-arrhythmia, including atrial fibrillation, supraventricular tachycardia, extrasystole, low blood pressure and collapse.

From the respiratory system: rarely-cough, irritation of the respiratory tract; very rarely-bronchospasm (paradoxical or caused by hypersensitivity to the drug).

From the gastrointestinal tract: rarely-dryness and irritation of the oral and pharyngeal mucosa, changes in taste sensations, nausea, vomiting.

Musculoskeletal disorders: rarely-muscle cramps.

Interaction

Concomitant use of salbutamol and non-selective beta-2 blockers, such as propranolol, is not recommended.

Salbutamol is not contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).

Enhances the action of central nervous system stimulants.

Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias; drugs for inhalation anesthesia, levodopa – severe ventricular arrhythmias.

Concomitant use with m-holinoblokatorami (including inhalation) may increase intraocular pressure.

Diuretics and glucocorticosteroids enhance the hypokalemic effect of salbutamol.

How to take, course of use and dosage

The drug Salbutamol aerosol for inhalation dosed with 100 mcg / dose is intended only for inhalation use.

Only a doctor can decide whether to increase the dose or frequency of use of the drug.

It is not recommended to use the drug more than 4 times a day. The need for frequent use of maximum doses of the drug or for a sudden increase in the dose indicates a worsening of the course of the disease.

It is not recommended to use the drug more than 4 times a day. The need for frequent use of maximum doses of the drug or for a sudden increase in the dose indicates a worsening of the course of the disease.

Relief of an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Prevention of bronchospasm attacks associated with allergen exposure or caused by physical exertion: the recommended dose is 200 mcg (2 inhalations) 10-15 minutes before exposure to the provoking factor.

Children. Long-term maintenance therapy for bronchial asthma and COPD as part of complex therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.

Relief of an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Prevention of bronchospasm attacks associated with allergen exposure or caused by physical exertion: the recommended dose is 100-200 mcg (1-2 inhalations) 10-15 minutes before exposure to the provoking factor.

Preparing for the first application:

Before the first use of the drug, remove the protective cap from the inhaler nozzle. Then shake the balloon vigorously with vertical movements, turn the balloon upside down with the inhaler nozzle and make two sprays into the air to make sure that the valve is working properly.

If there is a break in the use of the drug for several days, one spray should be made into the air after thoroughly shaking the balloon.

Overdose

Symptoms:

More frequent-hypokalemia, decreased blood pressure, tachycardia, muscle tremor, nausea, vomiting; less frequent-agitation, hyperglycemia, respiratory alkalosis, hypoxemia, headache; rare-hallucinations, convulsions, tachyarrhythmia, ventricular flutter, peripheral vascular dilation.

Treatment:

In case of salbutamol overdose, the best antidotes are cardioselective beta-2 blockers. However, beta-2 blockers should be used with caution (risk of bronchospasm).

The use of high doses of salbutamol can cause hypokalemia, so if an overdose is suspected, the concentration of potassium in the blood serum should be monitored.

Special instructions

Patients should be instructed about the correct use of Salbutamol. Proper use of the drug and strict implementation of the instructions is necessary in order to ensure that salbutamol enters the bronchi. At the beginning of treatment, the drug should be used under the supervision of medical personnel and after training in front of a mirror.

As with other inhaled medications, the therapeutic effect may decrease when the balloon is cooled. Therefore, before use, the balloon with the drug should be warmed up to room temperature (warm the balloon with your hands for several minutes, you can not use other methods!).

The contents of the cylinders are pressurized, so the cylinders must not be heated, broken, punctured, or burned, even when they are empty.

In case of unpleasant sensations in the mouth and sore throat after inhalation, the mouth should be rinsed with water.

Bronchodilators should not be the only or main component of treatment for unstable or severe asthma.

If the usual dose of the drug becomes less effective or less prolonged (the effect of the drug should last at least 3 hours), the patient should consult a doctor. Increasing the dose or frequency of salbutamol should only be done under the supervision of a doctor. Reducing the interval between subsequent doses is possible only in exceptional cases and should be strictly justified. An increase in the need for short-acting inhaled beta-2-adrenergic agonists for the treatment of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient’s treatment plan should be reviewed.Taking high doses of salbutamol with an exacerbation of bronchial asthma can cause a “rebound” syndrome (each subsequent attack becomes more intense). In case of a severe attack of suffocation, the interval between inhalations should be at least 20 minutes.

The risk of complications increases both with a significant duration of treatment and with abrupt discontinuation of the drug. Long-term use of salbutamol should be accompanied by the use of anti-inflammatory drugs for basic therapy.

Sudden and progressive deterioration of bronchial asthma can pose a threat to the patient’s life, so in such cases, it is necessary to urgently decide whether to prescribe or increase the dose of glucocorticosteroids. In such patients, it is recommended to monitor the peak expiratory rate daily.

Salbutamol should be used with caution in patients with thyrotoxicosis.

Therapy with beta-2-adrenergic agonists, especially when administered parenterally or with a nebulizer, can lead to hypokalemia. Special care should be taken in the treatment of severe asthma attacks, since in these cases hypokalemia may increase as a result of simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, as well as due to hypoxia. In such cases, it is necessary to monitor the level of potassium in the blood serum.

Storage conditions

Store at a temperature not exceeding 25 °C. Do not freeze it.

Keep out of reach of children.

Keep away from the heating system and direct sunlight.

Protect from falls and bumps.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Salbutamol

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation