Ventolin Nebula

Active material: Salbutamol
When ATH: R03AC02
CCF: Bronchodilators – beta₂-adrenomimetik
ICD-10 codes (testimony): J44, J45, J46
When CSF: 12.01.01.02.01
Manufacturer: GLAXO WELLCOME GmbH & Co (Germany)

Pharmaceutical form, composition and packaging

The solution for inhalations in Nebula as a clear liquid from colorless to pale yellow.

Excipients: sodium chloride, sulfuric acid divorced, Purified water.

2.5 ml – plastic vials, welded together in the form of strip (10) – Packages of laminated aluminum foil (2) – packs cardboard.

Pharmacological action

Of selective beta₂-adrenomimetik. At therapeutic doses, it acts on the β₂-adrenergic receptors of bronchial smooth muscle, exerting little impact on the β₁-adrenergic receptors of myocardium.

Salbutamol inhibits the release of histamine from mast cells, leukotrienes, prostaglandin D₂ and other biologically active substances for a long time. Inhibits early and late bronchial reactivity. It has a pronounced bronchodilator effect, arresting or preventing bronchospasm, reduce airway resistance. It increases lung capacity. Increases mucociliary clearance (chronic bronchitis up 36%), stimulates mucus secretion, activates the function of ciliated epithelium.

It inhibits the release of inflammatory mediators from mast cells and basophils, in particular histamine release, induced antibodies to IgE, removes suppression of antigen mucociliary transport and release of neutrophil chemotactic factor. Prevents the development of allergen-induced bronchospasm. It may lead to a decrease in the number of β₁-adrenoreceptorov, incl. on lymphocytes. It has a number of metabolic effects: reduces the concentration of potassium in the plasma, affects glycogenolysis and insulin release, okazyvayet gipyerglikyemichyeskii (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.

The recommended therapeutic dosage has no negative effect on the cardiovascular system, It does not cause an increase in blood pressure. To a lesser extent, compared with the drugs of this group, It has a positive chrono- and inotropic effect. It causes expansion of the coronary arteries.

Once inhaled forms of action develops quickly, the effect of start – through 5 m, max. – through 30-90 m (75% maximum effect is reached within 5 m), duration – 4-6 no.

Pharmacokinetics

Absorption

After inhalation use systemic absorption fast, but low. If ingestion (incl. with partial ingestion by inhalation) absorption vыsokaya. From 10% to 20% dose enters the lower respiratory tract. The remainder of the delay in an inhaler or deposited in the oropharynx and then swallowed. Part dose, which remains in the airway, absorbed by the lung tissues, without being in them metabolize, and enters the bloodstream.

Distribution and metabolism

Salbutamol binding to plasma proteins is 10%.

Swallowed part inhaled dose is rapidly absorbed from the gastrointestinal tract and subjected to intensive metabolism in the “first pass” through the liver, turning into a phenolic sulphate.

It penetrates through the placental barrier.

Deduction

Unchanged drug and conjugate are derived mainly from urine (69-90%). A small number of (4%) – the bile. Most of the dose is excreted within salbutamol 72 hours.

Testimony

- Relief and prevention of asthma attacks (incl. in the complex treatment of status asthmaticus);

- Treatment of bronchial obstruction, refractory to conventional bronchodilator therapy (incl. in chronic obstructive pulmonary disease).

Dosage regimen

Apply inhalation. The drug Ventolin Nebula is not intended for injection.

The drug Ventolin Nebula should be used under the supervision of professionals with a special inhaler (nebuliser) mask, T-tube or endotracheal tube. In the case of the risk of hypoxia due to hypoventilation, the inhaled air may be oxygen enriched.

Ventolin Nebula is designed for use in undiluted form, However, if necessary prolonged administration of salbutamol solution (more 10 m) the drug may be diluted with sterile 0.9% sodium chloride solution. Solution, remaining unused in the chamber after inhalation nebulizer, must be discarded.

Unnecessarily. Many nebulizers are available when a steady stream of air, it is not excluded, that the drug would be sprayed into the environment. Considering this, Ventolin Nebula should be used in well ventilated areas; this recommendation especially strictly be observed in hospitals, nebulizers which can be simultaneously used by several patients.

Adults and children over 1.5 years

The average starting dose of salbutamol, administered by inhalation via a nebuliser, is 2.5 mg, but it can be increased to 5 mg. Inhalation can be repeated 4 once a day. For the treatment of severe airway obstruction adult patients may apply the drug at higher doses – to 40 mg / day – under strict medical supervision in a hospital.

Side effect

Allergic reactions: rarely – angioedema, hives, kaliopenia.

CNS: often – tremor, headache; rarely – hyperactivity.

Cardio-vascular system: often – tachycardia; rarely – arrhythmia, supraventricular tachycardia, arrythmia, atrial fibrillation, expansion of peripheral vascular.

The respiratory system: rarely – paradoxical bronchospasm.

From the digestive system: rarely – irritation of the mouth and throat.

On the part of the musculoskeletal system: rarely – muscle cramps.

Contraindications

- Children up to age 1.5 years;

- Hypersensitivity to any component of the drug.

Carefully use in patients with a history of tachyarrhythmias, severe chronic heart failure, hypertension, thyrotoxicosis, pheochromocytoma, as well as during pregnancy and lactation.

Pregnancy and lactation

In pregnancy, the drug is prescribed only in cases, when the expected benefit of therapy to the mother outweighs any potential risk to the fetus.

Strictly controlled clinical studies on the teratogenicity of salbutamol was conducted. In separate studies revealed polydactyly in children, whose mothers took during pregnancy, salbutamol (unambiguous causal connection occurrence of this disease with taking the drug is not installed).

Adrenergic bronchodilators may be used during pregnancy, since the potential risk to the fetus placental hypoxia on the background of uncontrolled asthma is much greater than the risk, associated with their use. However, caution should be applied, because the drug can cause tachycardia and hyperglycemia in the mother (especially in the presence of diabetes) and fetus, but also cause a delay in the mother in labor, decrease in blood pressure and pulmonary edema.

Salbutamol, probably, It passes into breast milk, therefore, breast-feeding women are not recommended to use the drug, except, when the expected benefit of therapy to the mother outweighs any potential risk to the child. Unknown, Does any negative impact on the newborn baby salbutamol, present in breast milk.

Cautions

Bronchodilators should not be the sole or main component of treatment of bronchial asthma.

Increasing demand for the use of inhaled β-agonists₂-adrenoceptor short duration of action for the control of asthma symptoms indicating exacerbation. In such cases it is advisable to review the patient's treatment plan. Sudden and progressive deterioration of bronchial asthma can be a threat to the patient's life, Therefore, in such situations, an urgent need to address the issue of the appointment or increasing the dose of GCS. In these patients, it is recommended to carry out daily monitoring of peak expiratory flow rate.

The use of salbutamol in excessive doses can lead to adverse reactions, therefore decide whether to increase the dose or frequency of use of the drug should only be a doctor. Patients, applying Ventolin Nebula home, must be warn, what, if the action of the usual dose becomes less effective or less long, can not independently increase the dose or frequency of administration, but should seek medical advice immediately.

Ventolin Nebula should be used with caution in patients, who have already taken high doses of other sympathomimetic.

Salbutamol should be used with caution in patients with thyrotoxicosis.

It was reported isolated cases of acute angle-closure glaucoma patients, receiving a combination of salbutamol and ipratropium bromide via nebulizer. Given this fact, Caution should be exercised with simultaneous use of salbutamol and anticholinergics with a nebuliser.

Patients should be taught how to use the nebulizer and warn about the inadmissibility of eye solution or aerosol.

Β therapy agonistami₂-adrenoreceptorov, particularly when administered parenterally or via nebulizer, can result in hypokalemia.

Particular caution is advised to exercise in the treatment of severe asthma attacks, since in these cases, hypokalemia may be exacerbated by the simultaneous use of xanthine derivatives, SCS and diuretics, and also due to hypoxia. In such situations it is necessary to control the concentration of potassium in blood serum.

As with other β-adrenergic agonists, salbutamol can induce reversible metabolic changes, such an increase in blood glucose concentration. Patients with diabetes can develop decompensation, and in some cases – ketoacidosis. Concomitant use of corticosteroids may enhance the effect.

Nebulizer not require synchronization with the patient's inspiratory inhalation, allowing wide use in young children and the elderly, which is difficult to perform the respiratory maneuvers.

Use in Pediatrics

Data on the clinical efficacy of salbutamol at Nebula children under 1.5 years no.

Overdose

Symptoms: more frequent – kaliopenia, decrease in blood pressure, Lactic acidosis, tachycardia, muscle tremors, vomiting; observed less frequently – excitation, gipofosfatemiя, leukocytosis, respiratory alkalosis; rarely – hallucinations, paranoia, convulsions, integuments.

Treatment: symptomatic, when tachyarrhythmia enter cardioselective β-blockers.

Drug Interactions

It is not recommended to use both salbutamol and non-selective blockers, β-adrenergic, such as propranolol.

Salbutamol is not contraindicated in patients, receiving MAO inhibitors. Patients with hyperthyroidism increases the effects of CNS stimulants, taxikardiju. It increases the likelihood of developing arrhythmias in patients receiving cardiac glycosides.

Theophylline and other xanthine, while the application increases the risk of tachyarrhythmias; means for inhalation anesthesia, levodopa – severe ventricular arrhythmias. The simultaneous use of anticholinergics (incl. inhalants) can enhance the intraocular pressure. Diuretics and corticosteroids enhance hypokalemia, which can cause salbutamol.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug is in the unopened package should be stored at temperatures below 30 ° C. Shelf life – 3 year.

After opening the package the drug should be stored at temperatures below 30 ° C in a dark place. Shelf life – 3 of the month.

The drug should be stored out of reach of children.