Salbutamol, 100 mcg/dose 12 ml aerosol (200 doses)

Salbutamol is a selective β2-adrenoreceptor agonist. In therapeutic doses it acts on β2-adrenoceptors of bronchial smooth muscle, with a minor effect on β1-receptors of the myocardium. It has a pronounced bronchodilator effect, preventing or arresting bronchial spasm, reduces airway resistance. Increases the vital capacity of the lungs.

In the recommended therapeutic doses it does not have adverse effects on the cardiovascular system and does not cause increase of blood pressure.

To a lesser extent, in comparison with the drugs of this group, it has positive chrono- and inotropic effects. Causes dilation of coronary arteries.

It has a number of metabolic effects: it decreases the concentration of potassium in the plasma, affects glycogenolysis and insulin secretion, has hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increasing the risk of acidosis.

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

Indications

1. Bronchial asthma:

– management of bronchial asthma attacks, including in exacerbation of severe bronchial asthma;

– Prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical exertion;

– Use as a component of long-term maintenance therapy of bronchial asthma.

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

Active ingredient

Salbutamol

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

The product does not contain chlorofluorocarbon propellants.

1 cylinder of the product contains:

Active ingredient:

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

Auxiliary substances:

oleyl alcohol 0.015 g,

ethanol (rectified ethyl alcohol) 0.485 g,

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

The product does not contain chlorofluorocarbon propellants.

How to take, the dosage

Salbutamol aerosol for inhalation, 100 µg/dose, is for inhalation use only.

The decision about increasing the dose or frequency of use of the drug can only be made by a doctor.

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

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 a sudden increase in the dose is indicative of a worsening course of the disease.

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

Preventing attacks of bronchospasm 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 triggering factor.

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

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

Preventing attacks of bronchospasm 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 provocative factor.

Preparing for first use:

Before using the drug for the first time, remove the protective cap from the inhaler nozzle. Then shake the bottle vigorously with a vertical motion, turning the bottle upside down with the inhaler tip facing down and spraying the air twice to ensure proper valve function.

If the product has not been used for several days, one spray in the air should be conducted after shaking the can thoroughly.

Interaction

The simultaneous use of salbutamol and non-selective β2-adrenoreceptor blockers, such as propranololol, is not recommended.

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

It potentiates the effects of central nervous system stimulants.

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

Concomitant use with m-cholinoblockers (including inhaled) may contribute to increased intraocular pressure.

Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

Special Instructions

Patients should be instructed on the correct use of Salbutamol. Correct use of the drug and clear adherence to the instructions are necessary 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 drug cylinder must be warmed to room temperature (warm the cylinder by hand for a few minutes, no other methods should be used!).

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

If your mouth feels uncomfortable and your throat feels clammy, you should rinse your mouth with water after inhalation.

Bronchodilators should not be the sole or primary component of therapy for unstable or severe bronchial asthma.

If the regular dose of the medication becomes less effective or less prolonged (medication should last at least 3 hours), the patient should see a physician. Increasing the dose or frequency of salbutamol should only be done under medical supervision. Reducing the interval between subsequent doses is possible only in exceptional cases and should be strictly justified. An increased need for the use of inhaled β2-adrenoreceptor agonists with a short duration of action for the treatment of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient’s treatment plan should be reconsidered. Taking high doses of salbutamol during an exacerbation of bronchial asthma may cause “ricochet” syndrome (each subsequent attack becomes more intense). In severe attacks of suffocation, a break between inhalations should be at least 20 minutes.

The risk of complications increases with both significant duration of treatment and abrupt withdrawal of the drug. Prolonged use of salbutamol should be accompanied by the use of anti-inflammatory drugs for basal therapy.

The sudden and progressive worsening of bronchial asthma may be life-threatening for the patient, so in such cases it is necessary to urgently address the issue of prescribing or increasing the dose of glucocorticosteroids. Daily monitoring of peak expiratory velocity is recommended in such patients.

Salbutamol should be used with caution in patients with thyrotoxicosis.

Therapy with β2-adrenoreceptor agonists, especially when administered parenterally or by nebulizer, may lead to hypokalemia. Particular caution is recommended during treatment of severe attacks of bronchial asthma, because in these cases hypokalemia may be increased as a result of simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, as well as due to hypoxia. In such cases it is necessary to control the serum potassium level.

Contraindications

Hypersensitivity to any component of the drug.

Children under 2 years of age.

With caution:

In a history of tachyarrhythmia, myocarditis, heart defects, aortic stenosis, coronary heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes, glaucoma, epilepsy, renal or liver failure.

In simultaneous use of non-selective β2-adrenoblockers, pregnancy, during lactation.

Side effects

In terms of frequency, side effects can be divided into the following categories: very common (1/10), common (1/100 and < 1/10), infrequent (1/1000 and < 1/100), rare (1/10 000 and < 1/100), very rare (< 1/10 000) occur.

Immune system disorders: rare – dermatitis, very rare – hypersensitivity reactions, including angioedema, skin rash.

Mechanisms: rarely – hypokalemia.

Nervous system disorders: often – tremor, headache, anxiety; rarely – dizziness, drowsiness, fatigue; very rarely – hyperactivity.

The cardiovascular system: often – tachycardia, palpitations; rarely – dilation of peripheral vessels with skin hyperemia, discomfort or pain in the chest; very rarely – arrhythmia, including atrial fibrillation, supraventricular tachycardia, extrasystole, decreased blood pressure and collapse.

Respiratory system disorders: rarely – cough, irritation of the airways; very rarely – bronchospasm (paradoxical or caused by hypersensitivity to the drug).

Gastrointestinal tract: rarely – dryness and irritation of the mucous membrane of the mouth and throat, change in taste sensation, nausea, vomiting.

Muscular system disorders: rare – muscle cramps.

Overdose

Symptoms:

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

Treatment:

In salbutamol overdose, the best antidotes are cardioselective β2-adrenoblockers. However, β2-adrenoreceptor blockers should be used with caution (risk of bronchospasm).

The use of high doses of salbutamol may cause hypokalemia; therefore serum potassium concentration should be monitored if overdose is suspected.

Similarities

Salbutamol, Salbutamol-MCFP, Salbutamol-Pharmstandart, Novatron