Expiration date: 03/2026

Release Form: Aerosol for inhalation

Composition

1 dose solution for inhalation contains: salbutamol - 100 mcg.

Packaging

Inhaler with inhalation device contains 200 doses.

pharmachologic effect

Salbutamol is a selective antagonist of the .beta.-2 adrenergic receptors. At therapeutic doses it acts on the .beta.-2-adrenergic receptors of the smooth muscles of the bronchi, providing pronounced bronchodilator effect, prevents and relieves bronchospasm, increases lung capacity. It prevents the release of histamine, slow reacting substances from mast cells and neutrophil chemotactic factors. It is a small positive chrono-and inotropic effect on the myocardium, expansion of coronary artery, practically does not reduce blood pressure. Has tocolytic effect: it lowers the tone and contractile activity of the myometrium. The drug starts 5 minutes after inhalation and lasts for 4-6 hours. It has a number of metabolic effects: reduces the content of K + in the plasma affects glycogenolysis and insulin release, has a hyperglycemic (especially in asthmatic patients) and lipolytic effect, increases the risk of acidosis.

Testimony

Prevention and relief of bronchospasm in:

• Bronchial asthma.
  
• Chronic obstructive pulmonary disease (COPD).
  
• Chronic bronchitis.
  
• Emphysema.
  

Contraindications

• Cardiac arrhythmias (paroxysmal tachycardia, ventricular arrythmia politopnye), tachyarrhythmias.
  
• Myocarditis.
  
• Heart disease, aortic stenosis.
  
• Cardiac ischemia.
  
• Thyrotoxicosis.
  
• Decompensated diabetes.
  
• Glaucoma.
  
• Epilepsy.
  
• Pyloroduodenal narrowing.
  
• Liver failure.
  
• Kidney failure.
  
• Pregnancy.
  
• Simultaneous treatment with nonselective beta-blockers.
  
• Children under 2 years old.
  
• Hypersensitivity to any component of the drug.
  

Be wary prescribers in the following cases:

• Chronic heart failure.
  
• Hyperthyroidism.
  
• Arterial hypertension.
  
• Pheochromocytoma.
  

Pregnancy and breast-feeding

The drug is contraindicated during pregnancy. During the period of lactation (breastfeeding) is prescribed only in cases where the expected benefit to the mother outweighs any potential risk to the child.

Dosing and Administration

Adults and children over 12 years - 100-200 mg Salbutamol (1 to 2 inhalation doses) for the relief of asthma attacks.

To control the flow of mild asthma - 1-2 doses of 1 - 4 times a day and an average disease severity - at the same dosage in combination with other antiasthmatic agents.

To prevent asthma physical effort - for 20-30 minutes before loading dose of 1-2 at the reception.

Children from 2 to 12 years in the development of bronchial asthma attack, and to prevent attacks of asthma associated with exposure to the allergen or exercise-induced, the recommended dose is 100-200 mg (1 or 2 inhalations).

The daily dose of Salbutamol should not exceed 800 mcg (8 inhalations).

Side effects

CNS: tremor of the hands (a typical side-effect for all beta2-agonists), headache, dizziness, irritability, anxiety, sleep disturbance, insomnia. The drug can cause excitement and increase motor activity in children.

Since the cardiovascular system: the expansion of peripheral vascular (flushing of skin), small compensatory increase in heart rate, increased blood pressure. Perhaps the appearance of arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).

Allergic reactions: In rare cases - angioedema, urticaria, erythema, nasal congestion, bronchospasm, hypotension, collapse.

From the digestive system: nausea, vomiting, dyspepsia.

The respiratory system: bronchospasm paradoxical, irritation of the mucous membrane of the oral cavity and pharynx (throat), coughing.

On the part of metabolism: possible hypokalemia (can pose a serious danger to the patient), reversible hyperglycemia.

Other: muscle cramps.

Special instructions

In patients with severe or unstable asthma over the use of bronchodilators should not be the primary or only method of treatment. If the action of the usual dose Salamol Eco becomes less effective or less long (effect of the drug should be kept at least 3 hours), the patient should see a doctor. Frequent use of salbutamol may exacerbate bronchospasm, sudden death, and therefore between taking regular doses of the drug to take breaks in a few hours. Increasing demand for the use of inhaled agonists .beta.-2-adrenergic receptors with a short duration of action for the control of asthma symptoms indicative of an exacerbation of the disease. In such cases, you should review the patient's treatment plan and decide on the appointment or increasing the dose of inhaled or systemic glucocorticosteroids (GCS). ?-agonist therapy 2 adrenoceptor may lead to hypokalemia. Particular caution is advised to exercise in the treatment of severe asthma attacks, as in these cases, hypokalemia may be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids, diuretics, and also due to hypoxia. In such situations it is necessary to control the potassium level in the blood serum. Balloon with salamol Eco can not puncture, disassemble or dispose of in fire, even if it is empty. Like most other means of inhalation of aerosol dispensers, Salamol Eco may be less effective at low temperatures. Upon cooling spray is recommended to get it out of the plastic case and warm hands for a few minutes.

Drug interactions

Theophylline and other xanthine, while the use of salbutamol increases the risk of tachyarrhythmias, means for inhalation anesthesia, levodopa - severe ventricular arrhythmias. Not recommended simultaneous use Salamol Eco and nonselective beta-adrenoceptor blockers, such as propranolol. Monoamine oxidase inhibitors, and tricyclic antidepressants increase the effect of salbutamol and may lead to a sharp decrease in pressure. Salbutamol increases the effects of stimulants of the central nervous system side effects of thyroid hormones, cardiac glycosides. Reduces the effectiveness of antihypertensive drugs and nitrates. Hypokalemia may be enhanced by the simultaneous use of xanthine derivatives, glucocorticoids, diuretics. Co-administration of anticholinergic drugs (including inhalants) can increase intraocular pressure.

Overdose

Symptoms include nausea, vomiting, irritability, hallucinations, tachycardia, ventricular flutter, the expansion of peripheral blood vessels, lowering blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremor, headache.

Treatment: removal of preparation, cardioselective beta-blockers, symptomatic therapy. If you suspect an overdose should monitor the level of potassium in the blood serum.

Storage conditions

Store at temperatures not above 30 ° C, protected from direct sunlight.