Salbutamol AB - instructions for use, dose, side effects, contraindications

Description:White or white with a yellowish tinge suspension, located in a cylinder with a metering valve and a nebulizer. When spraying 5 doses of the drug on the glass leaves a spot of white.

Pharmacotherapeutic group:Bronchodilator - beta2-adrenomimetic is selective.

ATX: & nbsp

R.03.A.C Selective beta-2-adrenomimetics

R.03.A.C.02 Salbutamol

Pharmacodynamics:

Bronchodilator. In therapeutic doses has a pronounced stimulating effect on beta2-adrenoreceptors of bronchi, blood vessels and myometrium. Virtually no effect on beta 1 -adrenoceptors of the myocardium. Prevents the development of an allergen-induced bronchospasm. Can lead to a decrease in the number of beta-adrenergic receptors. including on lymphocytes. Has a number of metabolic effects: reduces the concentration of potassium in the plasma, affects glycogenolysis and insulin secretion,has hyperglycemic (especially in patients with bronchial asthma) and a lipolytic effect, increases the risk of developing acidosis.

In recommended therapeutic doses does not have a negative effect on the cardiovascular system, does not cause an increase in blood pressure. To a lesser degree, in comparison with the drugs of this group, it has a positive chrono- and inotropic effect. Causes the enlargement of the coronary arteries.

After the application of inhalation forms, the effect develops rapidly, the beginning of the effect - after 5 minutes, a maximum - in 30-90 minutes (75% of the maximum effect is achieved within 5 minutes), the duration of action is 3-6 hours.

Pharmacokinetics:

After inhalation, 10-20% of the inhaled dose reaches the small bronchi and, without being metabolized, is gradually absorbed into the systemic circulation, the rest is deposited in the upper respiratory tract or in the oropharynx and then swallowed.

Once in the blood, salbutamol metabolized in the liver and excreted mainly with urine in the unchanged form and in the form of phenolic sulfate.The swallowed portion of the inhalation dose is absorbed from the gastrointestinal tract and is subjected to active metabolism during "first passage through the liver", turning into phenolic sulfate. Unchanged salbutamol and the conjugate is excreted mainly in the urine.

Most of the dose of salbutamol administered intravenously, orally or by inhalation is excreted within 72 hours. The degree of binding of salbutamol with plasma proteins is about 10%. The maximum concentration in blood plasma is 30 ng / ml. The half-life is 3-7-5 hours.

Indications:

1. Bronchial asthma:

- relief of attacks of bronchial asthma, including with exacerbation of severe bronchial asthma;

- prevention of attacks of bronchospasm associated with exposure to an allergen or caused by physical exertion;

- application as one of the components with prolonged maintenance therapy of bronchial asthma.

2. Chronic obstructive pulmonary disease (COPD), accompanied by reversible airway obstruction, chronic bronchitis.

Contraindications:

- Hyper-sensitivity to any component of the drug;

- children's age up to 2 years;

- pregnancy.

Carefully:Use the drug with caution if patients with a history of tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, arterial hypertension. thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, epiprip, renal or hepatic insufficiency, simultaneous reception of non-selective β-adrenoblockers, lactation period.

Pregnancy and lactation:

Contraindicated during pregnancy.

During the period of breastfeeding, the drug is administered with caution (it is not known whether it penetrates salbutamol in breast milk) and only in those cases where the expected benefit to the mother exceeds any possible risk to the child.

Dosing and Administration:

Only for inhalation.

Solve the issue of increasing the dose or frequency of the drug can only be a doctor.

It is not recommended to use the drug more than 4 times a day. The need for frequent use of maximum doses of the drug or in a sudden increase in dose indicates a worsening of the course of the disease.

Adults and children over 12 years.

Causing an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Prevention of attacks of bronchospasm associated with exposure to an allergen or caused by physical exertion: the recommended dose is 200 mcg (2 inhalations) 10-15 minutes before the impact of the provoking factor. Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day. The maximum daily dose: 1200 mcg (12 inhalations).

Children from 2 to 12 years.

Causing an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Preventing attacks of bronchospasm associated with exposure to an allergen or caused by physical exertion: the recommended dose is 100-200 μg (1-2 inhalations) 10-15 minutes before the impact of the provoking factor. Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day. The maximum daily dose: 800 mcg (8 inhalations).

Use of the inhaler

1. Remove the cap from the inhaler (make sure there is no dust and dirt in the outlet tube).

2. Before inhalation, it is recommended to take a standing or sitting position.

3. Before use, the balloon is shaken thoroughly.

4. Make a deep exhalation.

5. A balloon with an aerosol is turned with a valve-spray head downward, it covers the mouthpiece with the lips, takes a deep breath and simultaneously presses on the bottom of the cylinder. This results in an aerosol release.

6. Hold your breath for a few seconds and, taking the mouthpiece from your mouth, make a slow exhalation.

Warnings. When using a metered aerosol, the following instructions must be strictly followed: shaking the can with aerosol before each use, clear synchronization of inspiration and drug intake, maximum deep, intense and long enough inhalation, holding the breath after inhalation for 10 seconds. It is recommended to rinse the mouth with water before applying the drug.

Cleaning the inhaler

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

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

2. Rinse thoroughly and dry the spray nozzle and protective cap under warm running water. Do not use heaters when drying.

3. Put the spray nozzle on the cylinder and valve stem, close the nozzle opening with a protective cap.

Do not put the cylinder in water!

Side effects:By frequency, side effects can be divided into the following categories: very frequent (> 1/10), frequent (> 1/100 and <1/10), infrequent (> 1/1 000 and <1/100). rare (> 1/10 000 and <1/1 000), very rare (<1/10 000).

From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, rash, bronchospasm, lowering of blood pressure, collapse.

On the part of metabolic processes: rarely - hypokalemia, an increase in the concentration of glucose and free fatty acids in the blood. Severe hypokalemia can potentially result from β2-agonist therapy.

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

From the side of the cardiovascular system: often - tachycardia; rarely - heart palpitations; very rarely - arrhythmia, including atrial fibrillation, supranventicular tachycardia, extrasystole, increased blood pressure; rarely - the expansion of peripheral vessels.

From the respiratory system: very rarely - a paradoxical bronchospasm, a cough.

From the gastrointestinal tract: rarely - irritation of the mucous membrane of the oral cavity and pharynx.

From the musculoskeletal system: rarely - convulsions.

Overdose:

Symptoms of an overdose of sbbutamol: more frequent - hypokalemia, lowering of arterial pressure, tachycardia, muscle tremor, vomiting; less frequent -excitation, hyperglycemia, hypoxemia, lactic acidosis, leukocytosis, respiratory alkalosis, headache; rare - hallucinations, convulsions, tachyarrhythmias, fluttering of the ventricles.

Treatment: symptomatic (it is necessary to cancel the drug), with tachyarrhythmias introduce cardioselective beta-blockers (with caution because of the risk of bronchospasm).

Interaction:Enhances the effect of stimulants of the central nervous system, tachycardia in patients with thyrotoxicosis, increases the likelihood of developing extrasystole against the background of cardiac glycosides. Theophylline and other xanthines with simultaneous application increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, hvdopa - severe ventricular arrhythmias.

Monoamine oxidase inhibitors and tricyclic antidepressants, increasing the effect of salbutamol, can lead to a sharp drop in blood pressure.Incompatible (pharmacological antagonism) with non-selective beta-adrenoblockers (which should also be taken into account when using eye forms of beta-adorenoblokatorov).

Simultaneous administration with M-holinoblokatorami (including inhalation) can promote increased intraocular pressure.

Diuretics, xanthines and glucocorticosteroids increase the hypokalemic effect of salbutamol.

Special instructions:Frequent use of salbutamol may lead to an increase in bronchospasm, sudden death, and therefore, between the doses of regular doses of the drug should take breaks in a few hours (6 hours). Reduction of these intervals can occur only in exceptional cases. When using a metered aerosol, the following instructions must be strictly followed: shaking the can with aerosol before each use, clear synchronization of inspiration and drug intake, maximum deep, intense and long enough inhalation, holding the breath after inhalation for 10 seconds. Patients (including young children) who find it difficult to perform a correct breathing maneuver,it is recommended to use for the inhalation of the drug a special device (spacer), increasing the respiratory volume and smoothing the inaccuracies of the asynchronous inspiration. As with the use of other inhalants, the therapeutic effect may decrease with cooling of the balloon. Therefore, before using the balloon with the drug should be warmed to room temperature (warm the balloon with your hands for several minutes, you can not use other methods!).

The contents of the cylinders are under pressure, so cylinders can not be heated, disassembled, pierced or burned, even when they are empty. In case of unpleasant sensations in the mouth and perspiration in the throat after inhalation, the mouth should be rinsed with water.

Bronchodilators should not be the only or main component of asthma therapy for unstable or severe flow. If the effect of the usual dose of the drug becomes less effective or less prolonged (the drug should last at least 3 hours), the patient should consult a doctor. Increased need for the use of inhaled beta2-adrenoreceptor agonists with shortduration of action for the treatment of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient's treatment plan should be reviewed. Taking high doses of salbutamol with exacerbation of asthma can cause the syndrome "rebound" (each subsequent attack becomes more intense). In case of a severe attack of suffocation, the interval between inhalations should be at least 20 minutes. The risk of complications increases both with a considerable duration of treatment, and with a sharp withdrawal of the drug. Long-term use of salbutamol should be accompanied by the use of anti-inflammatory drugs for basic therapy.

Sudden and progressive deterioration of bronchial asthma can pose a threat to the life of the patient, so in such cases, it is urgent to decide whether to prescribe or increase the dose of glucocorticosteroids. In such patients it is recommended to monitor the peak exhalation rate daily. Use the drug with caution in patients with thyrotoxicosis. Therapy with B2-adrenoreceptor agonists can lead to hypokalemia.Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, and also due to hypoxia. In such cases, it is necessary to monitor the potassium level in the blood serum.

Effect on the ability to drive transp. cf. and fur:There is no information in the reference literature on the effect of salbutamol inhalation on a patient's ability to drive and / or other mechanisms. The content in a single dose of 2363 μg of ethyl alcohol is so small that it can not affect the ability to drive and / or other mechanisms.

Form release / dosage:

Aerosol for inhalation dosed, 100 mcg / dose.

Packaging:For 11 g (300 doses) in aluminum aerosol cans, equipped with valves with pressure dosing and spray nozzles with protective caps. Each cylinder with a spray nozzle and instruction for use is placed in a pack of cardboard.

Storage conditions:Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003013

Date of registration:01.06.2015

The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia

Manufacturer: & nbsp

ALTAYVITAMINS, CJSC Russia

Information update date: & nbsp18.08.2015

Illustrated instructions

Instructions

Salbutamol AB (Salbutamol AB)