Novatron neo, aerosol 100 mcg/dose 200 doses

Pharmacotherapeutic group: Bronchodilator – selective β2-adrenomimetic

ATX code: R03AC02

Pharmacological properties

Indications

Bronchial asthma:
relief of symptoms of bronchial asthma when they occur;
prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity;
use as one of the components in long-term maintenance therapy of bronchial asthma.
Other chronic lung diseases accompanied by reversible airway obstruction, including chronic obstructive disease (COPD), chronic bronchitis, emphysema.

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

Pharmacological effect

Pharmacotherapeutic group: Bronchodilator – selective β2-adrenergic agonist

ATX code: R03AC02

Pharmacological properties

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 the treatment of unstable or severe bronchial asthma.

An increased need for the use of short-acting bronchodilators, in particular β2-adrenergic receptor agonists, to relieve the symptoms of bronchial asthma indicates a worsening of the disease. In such cases, the patient’s treatment plan should be reconsidered.

A sudden and progressive worsening of bronchial asthma can pose a potential threat to the patient’s life, therefore, in such situations, the advisability of prescribing or increasing the dose of GCS should be considered. In patients at risk, daily monitoring of peak expiratory flow is recommended.

Therapy with β2-adrenergic agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia.

Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the 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 inhalation therapy agents, paradoxical bronchospasm may develop when taking salbutamol with increased wheezing immediately after using the drug. This condition requires immediate treatment using an alternative formulation of salbutamol or another short-acting inhaled bronchodilator. The drug should be discontinued immediately, the patient’s condition assessed and, if necessary, alternative therapy prescribed.

If a previously effective dose of inhaled salbutamol fails to respond for at least three hours, the patient should consult a doctor for any additional measures.

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

Impact on the ability to drive vehicles and machinery

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

Active ingredient

Salbutamol

Composition

1 dose of the drug contains:

Active ingredient:

Salbutamol sulfate – 0.1205 mg, equivalent to salbutamol 0.100 mg,

Excipients:

Anhydrous ethanol (absolute ethyl alcohol) – 3.42 mg,

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

Pregnancy

Fertility

There are no data on the effects of salbutamol on human fertility. In preclinical studies, no undesirable effects on animal fertility were identified.

Pregnancy

Salbutamol should be prescribed to pregnant women only if the expected benefit to the mother outweighs the potential risk to the fetus.

There is evidence of rare cases of various malformations in children, including cleft palate and limb malformations, when mothers take salbutamol during pregnancy. In some of these cases, mothers took multiple concomitant medications during pregnancy. Due to the lack of permanent nature of the defects and the background incidence of congenital anomalies of 2% to 3%, a cause-and-effect relationship with salbutamol has not been established.

Breastfeeding period

Salbutamol is likely to pass into breast milk and is therefore not recommended for use in nursing women unless the expected benefit to the mother outweighs the potential risk to the baby. There is no evidence whether salbutamol present in breast milk is harmful to the newborn.

Contraindications

Hypersensitivity to the active substance or any other component of the drug.
Management of premature birth.
Threatened 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

Adverse reactions listed below are classified by organs and systems, as well as by the frequency of their occurrence: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000, including isolated cases).

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

Metabolic and nutritional disorders: rarely – hypokalemia.
Therapy with β2-adrenergic agonists may lead to clinically significant hypokalemia.

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

Cardiac disorders: often – tachycardia; infrequently – feeling of heartbeat; very rarely – arrhythmias, including atrial fibrillation; supraventricular tachycardia and extrasystole.

Vascular disorders: rarely – peripheral vasodilation.

Disorders of the respiratory system, chest and mediastinum: very rarely – paradoxical bronchospasm.

Gastrointestinal disorders: uncommon – irritation of the mucous membrane of the mouth and pharynx.

Musculoskeletal and connective tissue disorders: uncommon – muscle cramps.

If any of the adverse reactions indicated in the instructions worsen or you notice any other adverse reactions not listed in the instructions, notify your doctor.

Interaction

It is not recommended to use salbutamol and non-selective beta-adrenergic receptor blockers simultaneously, such as propranolol.

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

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

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

Overdose

Signs and symptoms of salbutamol overdose are transient phenomena, pharmacologically caused by stimulation of β-adrenergic receptors (see sections “Special instructions” and “Side effects”), such as decreased blood pressure, tachycardia, muscle tremors, 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. With the use of high doses, as well as with overdose of short-acting beta-agonists, the development of lactic acidosis has been observed, so 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).

Storage conditions

At a temperature not exceeding 25 °C.

Do not freeze.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date.

Manufacturer

Grotex LLC, Russia