Novatron solution for inhalation 1mg / ml, 2.5ml No. 10

• Prevention and relief of bronchospasm in bronchial asthma;

• symptomatic treatment of broncho-obstructive syndrome (including chronic bronchitis and pulmonary emphysema);

• reversible bronchial obstruction (prevention and treatment), including chronic obstructive pulmonary disease.

The drug Novatron is used by inhalation using nebulizer inhalers (see 'How to work with the drug').

Adults, incl. elderly patients, and children over 18 months: the usual single dose is 2.5 mg, when applied 3-4 times / day using inhalation through a nebulizer. If necessary, the dose can be increased to 5 mg 3-4 times / 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.

The procedure for working with the drug

1. Before using the drug, you must read the instructions of the manufacturer of the nebulizer.

2. Prepare the nebulizer according to the manufacturer's instructions.

3. Take the ampoule and shake it while holding the neck.

4. Squeeze the ampoule with your hand, while there should be no release of the drug, and rotate and separate the valve with rotating movements.

5. Squeeze the solution into the nebulizer reservoir.

6. Use the nebulizer according to the manufacturer's instructions.

7. The solution left unused in the nebulizer chamber should be discarded immediately after each use.

8. Thoroughly wash the nebulizer.

When using the drug, avoid contact with the eyes.

Solution for inhalation in the form of a clear, colorless to slightly brownish or yellowish-brownish liquid.

1 ml

salbutamol sulfate 1.2 mg,

which corresponds to the content of salbutamol 1 mg

Excipients: sodium chloride - 9 mg, 0.05M sulfuric acid solution - up to pH 3.0-5.0, water d / i - up to 1 ml.

• Hypersensitivity to the components of the drug;

• children's age up to 18 months.

  The drug is not used in case of premature birth and the threat of abortion.

  Carefully

• Tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, pregnancy, breastfeeding period.

pharmachologic effect

Bronchodilator. In therapeutic doses, it has a pronounced stimulating effect on the ?2-adrenergic receptors of the bronchi, blood vessels and myometrium. Virtually no effect on the? 1-adrenergic receptors of the heart.

It has a pronounced bronchodilator effect, preventing or arresting spasm of the bronchi, reduces resistance in the airways, and increases the vital capacity of the lungs. Increases mucociliary clearance (in chronic bronchitis up to 36%), stimulates mucus secretion, activates the functions of the ciliated epithelium. May lead to a decrease in the number of ?-adrenergic receptors. It has a number of metabolic effects: it reduces the concentration of potassium ions in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.

In the recommended therapeutic doses, it does not adversely affect the cardiovascular system, does not cause an increase in blood pressure. To a lesser extent, in comparison with drugs of this group, it has a positive chrono- and inotropic effect. Causes expansion of the coronary arteries.

After the use of inhalation forms, the action develops quickly, the onset of the effect - after 5 minutes, maximum - after 30-90 minutes (75% of the maximum effect is achieved within 5 minutes), duration - 3-6 hours.

Pharmacokinetics

Absorption and distribution

During inhalation, 10-20% of the inhaled dose reaches the small bronchi, the rest is deposited in the upper respiratory tract. After inhalation, systemic absorption is fast, but low.

Plasma protein binding - 10%. Penetrates the placental barrier.

Metabolism and excretion

Undergoes presystemic metabolism in the liver and in the intestinal wall, inactivated by phenolsulfotransferase.

T1 / 2 - 4-6 hours. It is excreted by the kidneys (69-90%), mainly in the form of an inactive phenol sulfate metabolite (60%) within 72 hours and with bile (4%).

Side effect

From the immune system: very rarely - hypersensitivity reactions, which included angioedema, urticaria, bronchospasm, arterial hypotension and collapse.

From the side of metabolism: rarely - hypokalemia, hyperglycemia.

From the nervous system: often: tremor, headache; very rarely - hyperactivity.

From the side of the cardiovascular system: often - tachycardia; infrequently - increased heart rate, myocardial ischemia; very rarely - heart rhythm disturbance, including atrial fibrillation, supraventricular tachycardia and extrasystole; rarely, peripheral vasodilation.

From the respiratory system: very rarely - paradoxical bronchospasm.

From the gastrointestinal tract: infrequently - irritation of the mucous membranes of the oral cavity and pharynx.

From the musculoskeletal system: infrequently - muscle cramps.

Application during pregnancy and lactation

It is not recommended to prescribe salbutamol during pregnancy and breastfeeding, unless the expected benefit to the mother outweighs any possible risk to the fetus or child.

Application in children

Contraindication: children up to age 18 months.

Use in elderly patients

Applied in accordance with the recommended dosage regimen.

special instructions

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

Patients using Novatron at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, you cannot independently increase the dose or frequency of use of the drug, but you should immediately consult a doctor.

When using the drug, avoid contact with the eyes.

As with other means of inhalation therapy, cases of paradoxical bronchospasm may occur. In this case, you must immediately stop taking the drug with the appointment of an alternative treatment. Solutions that do not correspond to a neutral pH level can cause paradoxical bronchospasm in some patients.

Salbutamol can cause reversible metabolic changes, for example, an increase in the concentration of glucose in the blood. In patients with diabetes mellitus, decompensation may develop; in some cases, the development of ketoacidosis has been reported. The simultaneous use of corticosteroids can enhance this effect.

Reported rare cases of lactic acidosis associated with the use of high doses of short-acting beta2-adrenomimetics using a nebulizer, mainly in patients with exacerbation of bronchial asthma. An increase in lactate concentration can lead to shortness of breath and compensatory hyperventilation of the lungs, which can be misinterpreted as signs of unsuccessful treatment of bronchial asthma and lead to an unreasonable increase in the appointment of short-acting beta2-adrenergic agonists. Therefore, it is recommended to monitor the concentration of lactate in the blood serum, as well as monitor the possible subsequent development of metabolic acidosis.

Salbutamol should be used with caution in patients with thyrotoxicosis.

Treatment with beta2-adrenergic agonists can lead to significant hypokalemia. Particular care should be taken in cases of severe bronchial asthma, since the occurrence of hypokalemia can be facilitated by concomitant treatment with xanthine derivatives, corticosteroids, diuretics, as well as hypoxia. In such situations, it is recommended to monitor serum potassium levels.

You should not use the drug Novatron to prevent premature birth and if there is a threat of miscarriage.

Influence on the ability to drive vehicles and mechanisms

In the event of adverse reactions, patients are advised to refrain from driving and other mechanisms, as well as to be careful when engaging in activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms of acute poisoning with inhalation use: more frequent - hyperglycemia, hypokalemia, decreased blood pressure, lactic acidosis, tachycardia, muscle tremor, nausea, vomiting; less frequent - agitation, respiratory alkalosis; rare - hallucinations, paranoia, convulsions, tachyarrhythmia.

Symptoms of chronic intoxication with inhalation use: more frequent - lowering blood pressure, tachycardia, tremor, vomiting; less frequent - agitation; rare - convulsions, tachyarrhythmia.

Treatment: symptomatic; with tachycardia, cardioselective beta1-blockers are administered. The appointment of beta1-blockers (selective) in patients with bronchial asthma requires extreme caution due to the risk of bronchospasm.

Drug interactions

Incompatible (pharmacological antagonism) with non-selective beta-blockers (which must also be taken into account when using ophthalmic forms of beta-blockers).

Due to the hypokalemic effect, salbutamol enhances the effect of CNS stimulants, enhances the cardiotropic effect of thyroid hormones, and increases the likelihood of glycosidic intoxication.

Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa - severe ventricular arrhythmias.

A possible increase in heart rate and an increase in blood pressure while taking salbutamol may necessitate a dose adjustment of antihypertensive and antianginal drugs.

MAO inhibitors and tricyclic antidepressants can enhance the beta-adrenergic effect of salbutamol and lead to a sharp decrease in blood pressure.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Simultaneous use with m-anticholinergics (including inhalation) can increase intraocular pressure.