Novatron Neo aerosol d / ing. 100mcg / dose, 200 dose

Bronchial asthma:

• relief of symptoms of bronchial asthma when they occur;

• prevention of bouts of bronchospasm 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, pulmonary emphysema.

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

The drug is intended only for inhalation administration by inhalation through the mouth.

An increased need for the use of ?2-adrenoreceptor agonists may be a sign of worsening bronchial asthma. In such a situation, it may be necessary to reevaluate the patient's treatment regimen with consideration of the advisability of prescribing simultaneous therapy with GCS.

Because overdose may 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 4 to 6 hours.

For patients who have difficulty synchronizing inspiration with a pressurized metered dose inhaler, a spacer may be used.

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

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 ?g (1 inhalation), if necessary, the dose can be increased to 200 ?g (2 inhalations).

It is not recommended to use the drug more often than 4 times / 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 section 'Special instructions').

Preventing attacks of bronchospasm associated with exposure to an allergen or exercise-induced

Adults

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

Children

The recommended dose is 100 mcg (1 inhalation) 10-15 minutes before exposure to a 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 / day.

Children

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

Preparing for the first use

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 ensure adequate operation. When not in use for several days, one spray into the air should be done after thoroughly shaking the can.

Application

1. Remove the protective cap from the spray tip. Make sure the inside and outside of the spray tip are clean.

2. Shake the can well in a vertical motion.

3. Turn the canister upside down with the spray nozzle and hold the can upright between your thumb, middle, and forefinger with your thumb under the spray nozzle.

The cylinder must be upside down (according to the arrow on the cylinder label).

4. Breathe out as deeply as possible, then place the spray nozzle in your mouth and wrap your lips around it.

5. Starting inhalation through the mouth, press the top of the balloon to spray the drug, while continuing to inhale slowly.

6. Hold your breath, remove the spray nozzle from your mouth and exhale through your nose.

7. If you need to perform the next inhalation, you should wait about 30 seconds, holding the inhaler vertically, then perform steps 2-6.

8. Close the spray nozzle with the protective cap.

Important!

There is no rush to complete stages 4, 5 and 6. It is important to start inhaling as slowly as possible just before pressing the inhaler. The first few times it is recommended to practice in front of a mirror. If there is 'fog' coming out of the top of the inhaler or from the corners of the mouth, start over from stage 2.

If the doctor has given the patient other instructions for using the inhaler, they must be strictly followed. The patient should contact the doctor if it is difficult to use the inhaler.

Cleaning

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

1. Remove the protective cap from the spray tip and remove the spray tip from the cylinder.

2. Thoroughly rinse the spray nozzle and protective cap under warm running water

4. Thoroughly dry the spray nozzle and protective cap inside and out.

5. Place the spray nozzle on the cylinder and valve stem, close the free hole of the spray nozzle with a protective cap.

Do not immerse the cylinder in water.

Aerosol for inhalation dosed in the form of a suspension of white or almost white color.

1 dose

salbutamol sulfate 120.5 mcg,

which corresponds to the content of salbutamol 100 ?g

Excipients: ethanol (ethyl alcohol) - 3.42 mg, propellant HFA-134a (1,1,1,2-tetrafluoroethane) - 26.46 mg.

• Hypersensitivity to the active substance or any other component that is part of the drug;

• management of premature birth; threatening abortion.

  Carefully

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

pharmachologic effect

Salbutamol is a selective agonist of ?2-adrenergic receptors (beta2-adrenergic agonist). In therapeutic doses, it acts on the ?2-adrenergic receptors of the smooth muscles of the bronchi and has a short (4 to 6 hours) bronchodilatory effect on the ?2-adrenergic receptors with a rapid onset of action (within 5 minutes) with reversible airway obstruction.

It has a pronounced bronchodilatory effect, preventing or stopping bronchospasm, 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.

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.

Has a number of metabolic effects: reduces the concentration of potassium in the blood plasma, affects glycogenolysis and insulin secretion, 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 tissues and blood, but is not metabolized in the lungs.

Distribution

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

Metabolism

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

Withdrawal

Introduced in / in salbutamol has a T1 / 2 of 4-6 hours. Salbutamol is excreted partly by the kidneys and partly as a result of metabolism to inactive 4'-O-sulfate (phenolic sulfate), which is also excreted mainly by the kidneys. Only a small part of the administered dose of salbutamol is excreted through the intestine. Most of the dose of salbutamol introduced into the body IV, oral or inhalation, is excreted within 72 hours.

Side effect

From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, decreased blood pressure and collapse.

From the side of metabolism: rarely - hypokalemia. Therapy with ? 2 -adrenoreceptor agonists can lead to clinically significant hypokalemia.

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

From the side of the cardiovascular system: often - tachycardia; infrequently - palpitations; rarely, peripheral vasodilation; very rarely - arrhythmias, including atrial fibrillation; supraventricular tachycardia and extrasystole.

From the respiratory system: very rarely - paradoxical bronchospasm.

From the gastrointestinal tract: infrequently - irritation of the oral mucosa and pharynx.

From the musculoskeletal system: infrequently - muscle cramps.

If any of the adverse reactions indicated in the instructions are aggravated or any other adverse reactions not indicated in the instructions are noted, the patient should be informed about this by the doctor.

Application during pregnancy and lactation

Pregnancy

Pregnant women should be prescribed salbutamol 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 the formation of a 'cleft palate' and malformations of the limbs, while mothers take salbutamol during pregnancy. In some of these cases, the mothers took multiple concomitant medications during pregnancy. Due to the absence of a permanent nature of the defects and the background incidence of congenital anomalies, ranging from 2% to 3%, a causal relationship with the intake of salbutamol has not been established.

Breastfeeding period

Salbutamol probably passes into breast milk, and therefore it is not recommended to prescribe it to lactating women, unless the expected benefit to the mother herself outweighs the potential risk to the baby. There is no evidence of whether salbutamol present in breast milk has a harmful effect on the newborn.

Fertility

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

special instructions

Treatment of bronchial asthma is recommended 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 bronchial asthma.

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

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 at-risk patients, daily monitoring of peak expiratory flow is recommended.

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

Particular care is recommended to be exercised in the treatment of severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, GCS, 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 formulation of salbutamol or another short-acting inhaled bronchodilator. The drug should be discontinued immediately, the patient's condition should be assessed and, if necessary, alternative therapy should be prescribed.

If there is no effect from the use of a previously effective dose of inhaled salbutamol for at least 3 hours, the patient should consult a doctor for any additional measures.

Patients should be instructed on 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.

Overdose

Signs and symptoms of an overdose of salbutamol are transient phenomena pharmacologically caused by stimulation of ?-adrenergic receptors (see sections 'Special instructions' and 'Side effects'), such as decreased blood pressure, tachycardia, muscle tremor, nausea, vomiting. The use of high doses of salbutamol can cause metabolic changes, including hypokalemia, therefore it is necessary to monitor the concentration of potassium in the blood serum. With the use of high doses, as well as with an overdose of short-acting beta-agonists, the development of lactic acidosis was observed, therefore, in case of an overdose, control of an increase in serum lactate and the possibility of developing metabolic acidosis (especially if tachypnea persists or worsens, despite the elimination of other signs of bronchospasm, such as wheezing).

Drug interactions

It is not recommended to simultaneously use salbutamol and non-selective ?-adrenoreceptor blockers, such as propranolol.

Salbutamol is not contraindicated in patients receiving MAO inhibitors.

In patients with thyrotoxicosis, salbutamol enhances the effect of CNS stimulants and tachycardia.

Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias.

Simultaneous administration with anticholinergics (including inhalation) can increase intraocular pressure.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.