Novatron neo, aerosol 100 mcg/dose 200 doses

Pharmacotherapeutic group: Bronchodilator – selective β2-adrenomimetic

ATX code: R03AC02

Pharmacological properties

Indications

1. Bronchial asthma:
   • cure bronchial asthma symptoms when they occur;
   • prevent attacks of bronchospasm associated with allergen exposure or caused by physical activity;
   • use as a component in long-term maintenance therapy of bronchial asthma.
2. Other chronic lung diseases with reversible airway obstruction, including chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema.

Bronchodilators should not be the sole or main component of therapy for unstable or severe bronchial asthma. If there is no response to salbutamol in patients with severe bronchial asthma, glucocorticosteroid (GCS) therapy is recommended to achieve and maintain disease control. Lack of response to salbutamol therapy may indicate the need for urgent medical consultation or treatment.

Active ingredient

Salbutamol

Composition

1 dose of the drug contains:

The active substance:

Salbutamol sulfate – 0.1205 mg, in terms of salbutamol 0.100 mg,

Excipients:

Ethanol anhydrous (ethyl alcohol absolute) – 3.42 mg,

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

How to take, the dosage

The drug is intended to be administered by inhalation by mouth only. An increased need for β2-adrenoreceptor agonists may be a sign of worsening bronchial asthma. In such a situation, the patient’s treatment regimen may need to be reevaluated to consider whether concomitant therapy with glucocorticosteroids is appropriate.

Because overdose may be accompanied by adverse reactions, the dose or frequency of administration of the drug may be increased only on the recommendation of the physician.

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

In patients who have difficulty synchronizing inhalations using a pressurized metered-dose aerosol inhaler, a spacer may be used.

In children and infants receiving salbutamol, a pediatric spacer device with a face mask is appropriate.

Cure 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 section “Special Precautions”).

Prevent bronchospasm attacks associated with allergen exposure or caused by exercise

Adults

The recommended dose is 200 mcg (2 inhalations) 10-15 minutes before exposure to the triggering agent or exercise.

Children

The recommended dose is 100 mcg (1 inhalation) 10-15 minutes before exposure to the triggering factor or exertion; 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 first use

Please remove the protective cap from the spray nozzle before first use. Then shake the can vigorously with a vertical motion, turn the can upside down with the inhaler tip upside down and spray two times in the air to ensure proper operation. If not used for several days, one spray in the air after shaking the can thoroughly.

Application:

1. Remove the protective cap from the spray head as shown in Figure 1. Make sure that the inside and outside surfaces of the sprayhead are clean.
   
2. Shake the can well in a vertical motion.
3. Turn the can upside down with the spray head down, hold the can vertically between your thumb and middle finger and place your thumb under the spray head as shown in Fig. 2. Point the can upwards (arrow on can label)!
   
4. exhale as deeply as possible, then place the spray head in your mouth and cup it around your lips.
5. Inhaling through your mouth, squeeze the top of the spray bottle to atomize the product while continuing to inhale slowly.
6. Hold your breath, remove the spray head from your mouth and breathe out through your nose.
7. If the next inhalation is needed, wait approximately 30 seconds with the inhaler vertical and then continue with points 2-6.
8. Close the nebulizer head with the protective cap.

IMPORTANT

Phase 4, 5 & 6 so do not rush. It is important that you start inhaling as slowly as possible just before you press the inhaler. The first few times, it is advisable to practice in front of a mirror. If you see a “mist” coming out of the top of the inhaler or from the corners of your mouth, you should start again from stage 2.

If your doctor has given you other instructions on how to use your inhaler, then follow them strictly. Contact your doctor if you have difficulty using your inhaler.

Cleaning:

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

1. Remove the protective cap from the spray head and remove the spray head from the can.
2. Rinse the spray head and protective cap thoroughly under warm running water as shown in Figure 3.
   
3. Dry the spray nozzle and protective cap thoroughly inside and outside.
4. Place the spray nozzle on the cylinder and valve stem, close the free opening of the spray nozzle with the protective cap.
   Do not immerse the cylinder in water!

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Interaction

Salbutamol and non-selective β-adrenoceptor blockers, such as propranolol, are not recommended for concomitant use.

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

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

Theophylline and other xanthines increase the likelihood of tachyarrhythmias when used concomitantly. Concomitant administration with anticholinergic agents (including inhaled agents) may contribute to increased intraocular pressure. Diuretics and GCS increase hypokalemic effect of salbutamol.

Special Instructions

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

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

The increased need for short-acting bronchodilators, particularly β2-adrenoreceptor agonists, to relieve bronchial asthma symptoms indicates a worsening course of the disease. In such cases, the patient’s treatment plan should be reconsidered.

The sudden and progressive worsening of bronchial asthma may be potentially life-threatening for the patient, so in such situations, the advisability of prescribing or increasing the dose of GCS should be considered. Daily monitoring of peak expiratory velocity is recommended in at-risk patients.

The therapy with β2-adrenoreceptor agonists, especially when administered parenterally or with a nebulizer, may lead to hypokalemia.

Particular caution is recommended when treating severe attacks of bronchial asthma because in these cases hypokalemia may be increased by concomitant use of xanthine derivatives, GCS, diuretics, as well as due to hypoxia. It is recommended to monitor the plasma potassium concentration in such situations.

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

If the previously effective dose of inhaled salbutamol has had no effect for at least 3 hours, the patient should see a physician for any additional measures.

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

Influence on driving and operating ability

There are no data on the effect of the drug on driving and operating ability.

Contraindications

• Hypersensitivity to the active ingredient or any other ingredient in the drug.
• Preterm birth.
• Threatened abortion.

Cautions

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

Side effects

The adverse reactions listed below 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, including angioedema, urticaria, bronchospasm, decreased blood pressure and collapse.

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

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

Chronic disorders: frequently – tachycardia; infrequently – palpitations; very rarely – arrhythmias, including atrial fibrillation; supraventricular tachycardia and extrasystoles.

Vascular disorders: rarely – peripheral vasodilation.

Respiratory system, chest and mediastinum disorders: very rare – paradoxical bronchospasm.

Gastrointestinal tract disorders: infrequent – irritation of the mucosa of the mouth and throat.

Muscular and connective tissue disorders: infrequent – muscle cramps.

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

Overdose

Signs and symptoms of salbutamol overdose are transient phenomena pharmacologically determined by stimulation of β-adrenergic receptors (see sections “Special indications” and “Adverse effects”), such as decreased blood pressure, tachycardia, muscle tremor, nausea, vomiting.

The use of high doses of salbutamol may cause metabolic changes, including hypokalemia), so it is necessary to monitor the serum potassium concentration. The development of lactacidosis has been observed with high doses as well as with overdose of short-acting β-agonists, so monitoring for elevated serum lactate and the possibility of metabolic acidosis may be indicated in overdose (especially when tachypnoea persists or worsens despite elimination of other signs of bronchospasm, such as wheezing).

Pregnancy use

Fertility

There are no data on the effect of salbutamol on human fertility. No adverse effects on animal fertility have been identified in preclinical studies.

Pregnancy

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

There has been evidence of rare cases of various malformations in children, including the formation of a wolf’s mouth and limb malformations, from mothers taking salbutamol during pregnancy. In some of these cases, the mothers had taken several concomitant medications during pregnancy. Because of the noncontinuous nature of the defects and the background incidence of congenital anomalies, ranging from 2% to 3%, a causal relationship with salbutamol intake has not been established.

Breastfeeding period

Salbutamol is likely to penetrate into breast milk and is therefore not recommended for administration to breastfeeding women unless the expected benefit to the mother herself exceeds the potential risk to the baby. There are no data on whether salbutamol present in breast milk has harmful effects on the newborn.

Similarities

Salbutamol, Salbutamol-MCFP, Salbutamol-Pharmstandart