Novatron, 1 mg/ml 2.5 ml 10 pcs.

The bronchodilator in therapeutic doses has a pronounced stimulatory effect on the beta2-adrenoreceptors of the bronchial blood vessels and myometrium. It has practically no effect on the beta1-adrenoreceptors of the heart.

It has a marked bronchodilator effect, preventing or stopping spasm of the bronchi; it 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 atrial fibrillation epithelium. It may lead to a decrease in the number of beta-adrenoreceptors.

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

In the recommended therapeutic doses does not adversely affect the cardiovascular system does not cause an increase in blood pressure. To a lesser extent compared to the drugs of this group, it has positive chrono- and inotropic effects.

It causes dilation of the coronary arteries. After the use of inhaled forms the action develops quickly The beginning of the effect – after 5 minutes, the maximum effect – after 30-90 minutes (75% of the maximum effect is reached within 5 minutes) duration – 3-6 hours.

Pharmacokinetics:

When inhaled 10-20% of the inhaled dose reaches the small bronchi the rest is deposited in the upper airways. After inhalation the systemic absorption is fast but low. Binding with plasma proteins is 10%. It penetrates through the placenta.

It is subject to presystemic metabolism in the liver and is inactivated in the intestinal wall by phenolsulfotransferase. Period of half-life (T1/2) – 4-6 hours. It is excreted by kidneys (69-90%) mainly as inactive phenolsulfate metabolite (60%) within 72 hours and with bile (4%).

Indications

Active ingredient

Composition

1 ml of the drug contains:

Active substance:

1 mg/mL

2 mg/mL

Salbutamol sulfate

1.2 mg

2.4 mg

calculated to salbutamol

1.0 mg

2.0 mg

Excipients:

Sodium chloride

9.0 mg

0.05 M sulfuric acid solution

to pH 3.0-5.0

water for injection

up to 1.0 ml

How to take, the dosage

Novatron is used by inhalation with nebulizer inhalers (see “How to use the drug” in this leaflet).

Adults including the elderly and children over 18 months: the usual single dose is 25 mg when used 3-4 times a day via nebulizer inhalation. If necessary, the dose may be increased to 5 mg 3-4 times a day.

To treat severe airway obstruction in adult patients, higher doses of up to 40 mg/day may be used under close medical supervision in a hospital setting.

The order of administration of the drug:

1. Read the nebulizer manufacturer’s instructions before using the medication.

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

3. take the vial and shake it by holding the neck (Fig. 1).

4: Press the ampoule down with the hand, making sure that the product does not seep out, and twist the valve and remove it (Fig. 2).

5. Press the solution into the nebulizer reservoir (Fig. 3).

6. Operate the nebulizer according to the manufacturer’s instructions.

7. Any residual solution in the nebulizer chamber must be discarded immediately after each use.

8. Wash the nebulizer thoroughly.

You should avoid getting the solution in your eyes when using the product.

Interaction

Incompatible (pharmacological antagonism) with non-selective beta-adrenoblockers (which should also be considered when using ocular forms of beta-adrenoblockers).

Due to the hypokalemic effect, salbutamol increases the effect of central nervous system stimulants increases the cardiotropic effect of thyroid hormones increases the likelihood of glycoside intoxication.

Theophylline and other xanthines, when used concomitantly with salbutamol, increase the likelihood of tachyarrhythmias; levodopa inhalant anesthetics, severe ventricular arrhythmias.

Possible increase in heart rate and blood pressure during administration of salbutamol may necessitate dosage adjustment of hypotensive and antianginal drugs.

Monoamine oxidase inhibitors and tricyclic antidepressants may increase the beta-adrenergic effects of salbutamol and cause a sharp decrease in blood pressure.

Diuretics and glucocorticosteroid drugs increase the hypokalemic effect of salbutamol.

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

Special Instructions

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

Patients using Novatron at home should be cautioned that if the effects of the usual dose become less effective or prolonged, the dose or frequency of use should not be increased on its own but should immediately consult a physician.

When using the drug, avoid getting the solution into the eyes.

As with other inhalation therapy agents, paradoxical bronchospasm may occur. In this case the drug should be discontinued immediately and an alternative treatment should be prescribed. Solutions not corresponding to neutral pH in some patients may cause paradoxical bronchospasm.

Salbutamol may cause reversible metabolic changes such as increased blood glucose concentrations. In patients with diabetes mellitus development of decompensation is possible in some cases the development of ketoacidosis has been reported. Concomitant use of glucocorticosteroids may increase this effect.

Rare cases of lactoacidosis have been reported associated with the use of high doses of short-acting beta2-adrenomimetics using a nebulizer primarily in patients with exacerbation of bronchial asthma.

Elevated lactate concentrations may lead to dyspnea and compensatory pulmonary hyperventilation that may be misinterpreted as signs of failed bronchial asthma treatment and lead to unwarranted increased prescribing of short-acting beta2-adrenomimetics.

Therefore, it is recommended that serum lactate concentrations be monitored and the possible subsequent development of metabolic acidosis be monitored.

Salbutamol should be used with caution in patients with thyrotoxicosis.

The treatment with beta2-adrenomimetics may lead to significant hypokalemia.

Particular caution should be exercised in cases of severe bronchial asthma because concomitant treatment with xanthine derivatives, glucocorticosteroid diuretics, and hypoxia may contribute to hypokalemia. Monitoring of serum potassium levels is recommended in these situations.

Novatron should not be used to prevent preterm labor and at risk of miscarriage.

Contraindications

Hypersensitivity in children under 18 months of age.

The drug is not used in preterm labor and at risk of abortion.

With caution:

Tachyarrhythmia myocarditis cardiac malformations aortic stenosis coronary heart disease severe chronic heart failure arterial hypertension thyrotoxicosis pheochromocytoma decompensated diabetes mellitus glaucoma pregnancy period of breastfeeding.

Side effects

The following side effects are classified by organs and systems and by frequency of occurrence: very common (≥ 1/10) common (≥ 1/100 < 1/10) infrequent (≥ 1/1000 < 1/100) rare (≥ 1/10000 < 1/1000) very rare (< 1/10000. including isolated cases).

Immune system disorders:

Very rare: Hypersensitivity reactions which included angioedema urticaria bronchospasm hypotension and collapse.

Metabolic disorders:

Rarely: hypokalemia. hyperglycemia.

Nervous system disorders:

Often: tremor headache.

Very rare: hyperactivity.

Cardiovascular system side:

Often: tachycardia.

Infrequent: palpitations myocardial ischemia.

very rarely: abnormal heart rhythm including atrial fibrillation supraventricular tachycardia and extrasystole.

Rarely: peripheral vasodilation.

Respiratory system disorders:

Very rarely: paradoxical bronchospasm.

Gastrointestinal tract disorders:

Infrequent: irritation of the mucous membranes of the oral cavity and pharynx.

Skeletal and muscular system disorders:

Infrequent: muscle cramps.

Overdose

Symptoms of acute intoxication by inhalation use: more frequent – hyperglycemia hypokalemia decreased blood pressure (BP) lactoacidosis tachycardia muscle tremor nausea vomiting; less frequent – agitation respiratory alkalosis; rare – hallucinations paranoia convulsions tachyarrhythmia.

Symptoms of chronic intoxication when inhaled: more frequent – decrease in BP tachycardia tremor vomiting; less frequent – agitation; rare – convulsions tachyarrhythmia.

Treatment: symptomatic; in tachycardia administer cardioselective beta1-

adrenoblockers. Administration of beta1-adrenoblockers (selective) in patients with bronchial asthma requires extreme caution because of the risk of bronchospasm.

Pregnancy use

Similarities