Novatron neo inhalation aerosol metered dose 100micrograms/dose 200 doses, 1pc

Composition

1 dose of the drug contains:

Active ingredient:

Salbutamol sulfate – 0.1255 mg, in terms of salbutamol 0.100 mg,

Auxiliary substances:

Anhydrous ethanol (absolute ethyl alcohol) – 3.42 mg,

Propellant HFA-134a (1,1,1,2-tetrafluoroethane) – 26.46 mg

Pharmacological action

Pharmacotherapy group: Bronchodilator-beta-2-adrenomimetic selective ATX code: R03AC02 Pharmacological properties

Pharmacodynamics

Mechanism of action

Salbutamol is a selective beta-2-adrenergic agonist (beta-2-adrenomimetic). In therapeutic doses, it acts on the beta-2-adrenergic receptors of the smooth muscles of the bronchi and has a short (from 4 to 6 hours) bronchodilator effect on beta-2-adrenergic receptors with a rapid onset of action (within 5 minutes) with reversible airway obstruction.

It has a pronounced bronchodilating 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.

In the recommended therapeutic doses, it does not have a negative effect on the cardiovascular system, 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.

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

Pharmacokinetics

Suction

After inhalation,10-20% of the salbutamol dose reaches the lower respiratory tract. The remainder of the dose remains in the inhaler or is deposited in the oropharynx and then swallowed. The fraction deposited in the respiratory tract is absorbed into the lung tissue and blood, but is not metabolized in the lungs.

Distribution

The degree of binding of salbutamol to plasma proteins is 10%.

Metabolism

When it enters the systemic circulation, salbutamol undergoes hepatic metabolism and is mainly excreted by the kidneys in unchanged form or in the form of phenolic sulfate. The ingested portion of the inhaled dose is absorbed from the gastrointestinal tract and undergoes significant metabolism during the” first pass ” through the liver, turning into phenolic sulfate. Unchanged salbutamol and conjugate are mainly excreted by the kidneys.

Deduction

Intravenously administered salbutamol has a half-life of 4-6 hours.

Salbutamol is excreted partly by the kidneys and partly as a result of metabolism to the inactive 4′ – O-sulfate (phenolic sulfate), which is also mainly excreted by the kidneys. Only a small part of the administered dose of salbutamol is excreted through the intestine. Most of the dose of salbutamol administered intravenously, orally or by inhalation is excreted within 72 hours.

Indications

Bronchodilators should not be the only or main component of treatment for unstable or severe asthma. In the absence of a response to salbutamol in patients with severe bronchial asthma, it is recommended to conduct therapy with glucocorticosteroids (corticosteroids) in order to achieve and maintain disease control. Failure to respond to salbutamol therapy may indicate an urgent need for medical advice or treatment.

Use during pregnancy and lactation

Fertility

There are no data on the effects of salbutamol on human fertility. No adverse effects on animal fertility were found in preclinical studies.

Pregnancy

In pregnant women, salbutamol should only be prescribed if the expected benefit to the mother exceeds the potential risk to the fetus.

There are reports of rare cases of various malformations in children, including cleft palate formation and limb malformations, when mothers take salbutamol during pregnancy. In some of these cases, mothers took several concomitant medications during pregnancy. Due to the absence of a permanent nature of defects and the background frequency of congenital anomalies, ranging from 2% to 3%, a causal relationship with salbutamol intake has not been established.

Breast-feeding period

Salbutamol probably passes into breast milk, and therefore it is not recommended to prescribe it to nursing women, except in cases where the expected benefit to the mother herself exceeds the potential risk to the child. There is no data on whether salbutamol present in breast milk has a harmful effect on the newborn.

Contraindications

• Hypersensitivity to the Active ingredient or any other component that is part of the drug.
• Management of preterm labor.
• Threatening abortion.

With caution

Salbutamol should be used with caution in patients with thyrotoxicosis, tachyarrhythmia, myocarditis, heart defects, aortic stenosis, coronary heart disease, severe chronic heart failure, arterial hypertension, pheochromocytoma, decompensated diabetes mellitus, glaucoma.

Side effects

The adverse reactions listed below are classified by organ and system, and by frequency of occurrence: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (

Immune system disorders: very rarely – hypersensitivity reactions, including angioedema, urticaria, bronchospasm, decreased blood pressure and collapse.

Metabolic and nutritional disorders: rarely-hypokalemia. Therapy with beta-2-adrenoreptor agonists can lead to clinically significant hypokalemia.

Nervous system disorders: often-tremor, headache; very rarely-hyperactivity.

Cardiac disorders: often-tachycardia; infrequently – palpitation sensation; very rarely – arrhythmias, including atrial fibrillation; supraventricular tachycardia and extrasystole.

Vascular disorders: rarely-peripheral vasodilation.

Respiratory, thoracic and mediastinal disorders: very rare – paradoxical bronchospasm.

Gastrointestinal disorders: infrequently-irritation of the oral and pharyngeal mucosa.

Musculoskeletal and connective tissue disorders: infrequently-muscle cramps.

If any of the adverse reactions listed in the instructions get worse or you notice any other adverse reactions that are not listed in the instructions, tell your doctor.

Interaction

It is not recommended to use salbutamol and non-selective beta-blockers, such as propranolol, at the same time.

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

In patients with thyrotoxicosis, salbutamol increases the effect of central nervous system stimulants and tachycardia.

Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias. Concomitant use with anticholinergic agents (including inhaled ones) may increase intraocular pressure. Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

How to take, course of use and dosage

The drug is intended only for inhalation by inhalation through the mouth. An increased need for the use of beta-2-adrenoreptor agonists may be a sign of exacerbation of bronchial asthma. In such a situation, it may be necessary to re-evaluate the patient’s treatment regimen with consideration of the feasibility of prescribing concomitant therapy with glucocorticosteroids.

Since overdose can be accompanied by the development of undesirable reactions, the dose or frequency of use of the drug can be increased only on the recommendation of a doctor.

The duration of action of salbutamol in most patients is from 4 to 6 hours.

A spacer may be used in patients who have difficulty synchronizing their inhalation with the use of a pressurized metered-dose aerosol inhaler.

In children and infants receiving salbutamol, it is advisable to use a pediatric spacer device with a face mask.

Relief of an attack of bronchospasm

Adults

The recommended dose is 100 or 200 mcg (1 or 2 inhalations).

Children

The recommended dose is 100 mcg (1 inhalation), if necessary, the dose can be increased to 200 mcg (2 inhalations).

It is not recommended to use the drug more than 4 times a day. The need for such frequent use of additional doses of the drug or a sharp increase in the dose indicates a worsening of the course of bronchial asthma (see the section “Special instructions”).

Prevention of bronchospasm attacks related to allergen exposure or caused by physical exertion

Adults

The recommended dose is 200 mcg (2 inhalations) 10-15 minutes before exposure to the provoking factor or load.

Children

The recommended dose is 100 mcg (1 inhalation) 10-15 minutes before exposure to the provoking factor or load, if necessary, the dose can be increased to 200 mcg (2 inhalations).

Long-term maintenance therapy

Adults

The recommended dose is up to 200 mcg (2 inhalations) 4 times a day.

Children

The recommended dose is up to 200 mcg (2 inhalations) 4 times a day.

Preparing for the first application

Before first use, remove the protective cap from the spray nozzle. Then shake the balloon well with vertical movements, turn the balloon upside down with the inhaler nozzle and make two sprays into the air to make sure that it works properly. If there is a break in use for several days, make one spray into the air after thoroughly shaking the cylinder.

Application:

IMPORTANT

When completing stages 4,5, and 6, you should not be in a hurry. It is important that you start inhaling as slowly as possible just before you press the inhaler. For the first few times, it is recommended to practice in front of the mirror. If you see “fog” coming out of the top of the inhaler or from the corners of your mouth, then you should start all over again from stage 2.

If your doctor has given you other instructions for using the inhaler, then follow them strictly. Contact your doctor if you have any difficulties using the inhaler.

Clearing:

The spray nozzle should be cleaned at least once a week.

Overdose

Signs and symptoms of salbutamol overdose are transient events that are pharmacologically caused by stimulation of beta-adrenergic receptors (see sections “Special instructions” and “Side effects”), such as a decrease in blood pressure, tachycardia, muscle tremor, nausea, vomiting. The use of high doses of salbutamol can cause metabolic changes, including hypokalemia), so it is necessary to monitor the concentration of potassium in the blood serum. Lactic acidosis has been observed at high doses, as well as with an overdose of short-acting beta-agonists, therefore, in case of overdose, monitoring for an increase in serum lactate and the possibility of developing metabolic acidosis may be indicated (especially if tachypnea persists or worsens, despite the elimination of other signs of bronchospasm, such as wheezing).

Special instructions

Treatment of bronchial asthma is recommended to be carried out in stages, monitoring the patient’s clinical response to treatment and lung function.

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

An increased need for the use of short-acting bronchodilators, in particular beta-2-adrenergic agonists, to relieve the symptoms of bronchial asthma indicates a worsening of the course of the disease. In such cases, the patient’s treatment plan should be reviewed.

Sudden and progressive worsening of bronchial asthma can pose a potential threat to the patient’s life, so in such situations, the feasibility of prescribing or increasing the dose of corticosteroids should be considered. In patients at risk, it is recommended to monitor the peak expiratory velocity daily.

Therapy with beta-2-adrenergic agonists, especially when administered parenterally or with a nebulizer, can lead to hypokalemia.

Special care should be taken in the treatment of severe asthma attacks, since in these cases hypokalemia may increase as a result of simultaneous use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is recommended to monitor the concentration of potassium in the blood plasma.

As with the use of other means for inhalation therapy, when taking salbutamol, paradoxical bronchospasm may develop with increased wheezing immediately after using the drug. This condition requires immediate treatment with an alternative Form of production of salbutamol or another short-acting inhaled bronchodilator. The drug should be discontinued immediately, the patient’s condition should be evaluated, and alternative therapy should be prescribed if necessary.

If a previously effective dose of inhaled salbutamol does not work for at least three hours, the patient should consult a doctor to take any additional measures.

Patients should be instructed about the correct use of the drug inhaler.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of the drug on the ability to drive vehicles and mechanisms.

Form of production

Aerosol for inhalation dosed 100 mcg / dose. 200 doses per aluminum cylinder, equipped with a metering valve and a spray nozzle. 1 bottle together with the instructions for use in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Salbutamol

Conditions of release from pharmacies

By prescription

Dosage form

inhalation solution