Novatron solution for inhalation 1mg/ml 2.5ml ampoules, 10pcs

Composition

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1 ml of the drug contains:

Pharmacological action

A bronchodilator in therapeutic doses has a pronounced stimulating effect on the beta-2-adrenergic receptors of the bronchi, blood vessels and myometrium. Practically has no effect on beta-1-adrenergic receptors of the heart.

It has a pronounced bronchodilator effect preventing or stopping bronchospasm reduces resistance in the airways increases the vital capacity of the lungs. Increases mucociliary clearance (up to 36% in chronic bronchitis) stimulates mucus secretion activates the functions of the ciliated epithelium. It can lead to a decrease in the number of beta-adrenergic receptors.

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

At the recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and 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. After the use of inhaled forms, the effect develops quickly the beginning 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:

During inhalation,10-20% of the inhaled dose reaches the small bronchi, the rest settles in the upper respiratory tract. After inhalation, systemic absorption is fast but low. Binding to plasma proteins is 10%. Penetrates through the placenta.

It undergoes presystemic metabolism in the liver and in the intestinal wall by means of phenolsulfotransferase and is inactivated. The half-life (T 1/2) is 4-6 hours. It is excreted by the kidneys (69-90%) mainly as an inactive phenol sulfate metabolite (60%) within 72 hours and with bile (4%).

Indications

Prevention and management of bronchospasm in bronchial asthma symptomatic treatment of bronchial obstructive syndrome (including chronic bronchitis and emphysema) reversible bronchial obstruction (prevention and treatment) including chronic obstructive pulmonary disease.

Use during pregnancy and lactation

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

Contraindications

Hypersensitivity children under 18 months of age.

The drug is not used for preterm birth and at the risk of abortion.

With caution:

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

Side effects

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

From the immune system:

Very rare: hypersensitivity reactions that included angioedema urticaria bronchospasm hypotension and collapse.

From the side of metabolism:

Rare: hypokalemia. hyperglycemia.

Nervous system disorders:

Common: tremor headache.

Very rare: hyperactivity.

From the cardiovascular system:

Common: tachycardia.

Infrequently: increased heart rate, myocardial ischemia.

Very rare: cardiac arrhythmias including atrial fibrillation supraventricular tachycardia and extrasystole.

Rare: peripheral vasodilation.

Respiratory system disorders:

Very rare: paradoxical bronchospasm.

From the gastrointestinal tract:

Infrequently: irritation of the mucous membranes of the mouth and pharynx.

Musculoskeletal disorders:

Infrequently: muscle cramps.

Interaction

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

Due to the hypokalemic effect salbutamol enhances the action of central nervous system stimulants enhances 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; drugs for inhaled anesthesia with levodopa – severe ventricular arrhythmias.

A possible increase in the number of heartbeats and an increase in blood pressure while taking salbutamol may make it necessary to adjust the dose of antihypertensive and antianginal drugs.

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

Diuretics and corticosteroid medications enhance the hypokalemic effect of salbutamol.

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

How to take, course of use and dosage

Novatron is used by inhalation using nebulizer inhalers (see the section “Procedure for working with the drug” in these instructions).

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

Procedure for working with the drug:

1. Before using the drug, read the nebulizer manufacturer’s instructions.

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

3. Take the ampoule and shake it while holding the neck (Fig. 1).

4. Squeeze the ampoule with your hand without releasing the drug and rotate the valve with rotating movements (Fig. 2).

5. Squeeze the solution into the nebulizer tank (Fig. 3).

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

7. The solution remaining unused in the nebulizer chamber should be emptied immediately after each use.

8. Wash the nebulizer thoroughly.

When using the drug, avoid contact with the solution in the eyes.

Overdose

Symptoms of acute poisoning with inhalation use: more frequent hyperglycemia hypokalemia decreased blood pressure (BP) 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-decreased blood pressure tachycardia tremor vomiting; less frequent-agitation; rare-convulsions tachyarrhythmia.

Treatment:  symptomatic; with tachycardia, cardioselective beta-1-

blockers are administered. The use of beta-1-blockers (selective) in patients with bronchial asthma requires extreme caution due to the risk of bronchospasm.

Special instructions

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

Patients using Novatron at home should be warned that if the usual dose becomes less effective or less prolonged they should not increase the dose or frequency of the drug themselves but should immediately consult a doctor.

When using the drug, avoid contact with the solution in the eyes.

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

Salbutamol can cause reversible metabolic changes such as an increase in blood glucose concentration. Decompensation may occur in patients with diabetes mellitus and ketoacidosis has been reported in some cases.Concomitant use of glucocorticosteroids may increase this effect.

Rare cases of lactic acidosis have been reported associated with the use of high doses of short-acting beta-2-adrenomimetics using a nebulizer, mainly in patients with acute bronchial asthma.

An increase in the 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 unjustified increase in the appointment of short-acting beta-2-adrenomimetics.

Therefore, it is recommended to monitor the concentration of lactate in the blood serum and monitor the possible subsequent development of metabolic acidosis.

Salbutamol should be used with caution in patients with thyrotoxicosis.

Treatment with beta-2-adrenomimetics may result in significant hypokalemia.

Special care should be taken in cases of severe bronchial asthma since the occurrence of hypokalemia may be promoted by concomitant treatment with xanthine derivatives glucocorticosteroids diuretics as well as hypoxia. In such situations, it is recommended to monitor the level of potassium in the serum.

Do not use Novatron to prevent preterm labor or risk of miscarriage.

Influence on the ability to drive vehicles and mechanisms:

In case of adverse reactions, patients are advised to refrain from driving a car and other mechanisms, as well as to exercise caution when engaging in activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Salbutamol

Conditions of release from pharmacies

By prescription

Dosage form

inhalation solution