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

Aerosol for inhalation in a container (aerosolized aluminum bottle) with a dosing valve and a plastic applicator with a protective cap. There should be no external damage: dents, corrosion and leaks. The contents of the container, the pressurized suspension, leave a white or almost white spot on the slide when sprayed.

Pharmacotherapeutic group:Bronchodilator - beta2-adrenomimetic is selective.

ATX: & nbsp

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

R.03.A.C.02 Salbutamol

Pharmacodynamics:Broncholytic agent, in therapeutic doses, has a pronounced stimulating effect on beta2-adrenoreceptors of bronchi, blood vessels and myometrium. Virtually no effect on beta 1-adrenoreceptors of the heart.

Has a pronounced broshholitic effect, preventing or reducing spasm of the bronchi, reduces resistance in the respiratory tract, increases the vital capacity of the lungs. Increases mucociliary clearance (with chronic bronchitis to 36%), stimulates the secretion of mucus, activates the functions of ciliated epithelium. Can lead to a decrease in the number of beta-adrenergic receptors. It has a number of metabolic effects: it reduces the concentration of potassium ions in the plasma, affects glycogenolysis and insulin secretion, has hyperglycemic (especially in patients with bronchial asthma) and a lipolytic effect, increases the risk of 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 onset of the effect is 5 minutes, the maximum after 30-90 minutes (75% of the maximum effect, achieved within 5 minutes), duration - 3-6 hours.

Pharmacokinetics:During inhalation, 10-20% of the inhaled dose reaches the small bronchi, the rest is deposited in the upper respiratory tract. After inhalation, systemic absorption is fast, but low. Connection with plasma proteins - 10%. Penetrates through the placenta. It is subjected to presystemic metabolism in the liver and in the intestinal wall, it is inactivated by means of phenolsulfotransferase. Half-life ('T1 / 2) -4-6 hours. It is excreted by the kidneys (69-90%), mainly in the form of inactive falsole sulfate metabolite (60%) for 72 hours and with bile (4%).

Indications:Bronchial asthma - prevention and relief of bronchospasm attacks, prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical exertion. Other chronic lung diseases, accompanied by reversible airway obstruction: chronic obstructive pulmonary disease (XOBL), chronic bronchitis, emphysema.

Contraindications:Hypersensitivity to any of the components of the drug, children's age (up to 2 years). Management of preterm labor. Threatening abortion.

Carefully:

Tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, pregnancy, lactation.

Pregnancy and lactation:During pregnancy, prescription of the drug can be recommended only when the expected benefit for the mother exceeds the possible risk to the fetus. Proceeding from the fact that salbutamol can be excreted in breast milk, its appointment during the period of breastfeeding can be recommended only when the expected benefit to the mother exceeds the possible risk to the child. There is no evidence as to whether the person present in breast milk salbutamol harmful effect on the newborn.

Dosing and Administration:

Inhalation: for the prevention of bronchospasm attacks: adults - 100-200 micrograms (1-2 inhalations) 4 times during the day; children - up to 100-200 mcg 4 times a day. Curbing an attack of bronchospasm - 100-200 mcg for children and adults. Prevention of bronchospasm attacks caused by physical activity or associated with exposure to an allergen: adults -200 mcg (2 inhalations) for 10 to 15 minutes before the effect of the provoking factor; children - 100 mcg (1 inhalation) for 10-15 minutes before exposure to a provoking factor, if necessary, the dose may be increased to 200 mcg. Do not ingest more than 12 inhalations per day. The need for frequent use of additional doses of the drug Salbutamol or a sharp increase in the dose indicates a worsening of the course of bronchial asthma.

In case of unpleasant sensations in the mouth and perspiration in the throat after inhalation, rinse the mouth with water.

Preparation for the first use.

Before using the container for the first time, remove the protective cap from the inhaler. Then shake the container well with vertical movements, turn the container upside down and make two sprays into the air to make sure that it works properly. In case of a break in use for several days, one spray should be made into the air after a thorough shaking of the container.

Application:

1. Remove the protective cap from the nozzle-inhaler. Make sure the inner and outer surfaces of the nozzle-inhaler are clean.

2. Shake the container well with vertical movements.

3. Turn the container with the inhaler downward, hold the container vertically between the thumb, middle and index fingers so that the thumb is under the inhaler nozzle.

4. Make the deepest exhalation, then place the inhaler-nozzle in the mouth between your teeth and grasp it with your lips, without biting at the same time.

5. Starting the inspiration through the mouth, press the top of the container to spray the drug, while continuing to slowly and deeply inhale.

6. Hold your breath, remove the inhaler from your mouth and lift your finger from the top of the container. Continue to hold your breath as much as possible.

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

Close the nozzle-inhaler with a protective cap. IMPORTANT:

Fulfill points 4, 5 and 6, slowly. It is important to start inhaling as slowly as possible before spraying. The first few times should be practiced in front of the mirror. If a "cloud" appears on the sides of the mouth, you must start again from step 2.

Cleaning:

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

1. Remove the protective cap from the nozzle-inhaler, and remove the inhaler-nozzle from the container.

2. Carefully wash the nozzle-inhaler and protective cap under warm running water.

3. Carefully dry the nozzle-inhaler and the protective cap inside and out.

4. Put on the inhaler-nozzle on the container and the valve stem, close the free aperture of the nozzle-inhaler protective cap.

Do not immerse the container in water!

Side effects:

Side effect, listed below, is classified by organs and systems, as well as by the frequency of its 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).

From the immune system.

Very rarely: hypersensitivity reactions, which included angioedema, hives, bronchoconstriction, hypotension and collapse.

From the side of metabolism and metabolism.

Rarely: hypokalemia.

From the nervous system.

Often: tremor, headache.

Very rarely: hyperactivity.

From the cardiovascular system.

Often: tachycardia.

Infrequent: increased heart rate.

Very rarely: disturbance of the heart rhythm, including atrial fibrillation, supraventricular tachycardia and extrasystole.

Rarely: peripheral vasodilation.

From the respiratory system.

Very rarely: paradoxical bronchosnasm.

From the gastrointestinal tract.

Infrequent: irritation of the mucous membranes of the mouth and pharynx.

From the musculoskeletal system.

Infrequently: muscle cramps.

Overdose:

Symptoms of acute poisoning with inhalation: more frequent - hyperglycemia, hypokalemia, lowering blood pressure (BP), lactatacidosis, tachycardia, muscle tremor, nausea, vomiting; less frequent - excitation, respiratory alkalosis; rare - hallucinations, paranoia, convulsions, tachyarrhythmia. Symptoms of chronic intoxication with inhalation: more frequent - lowering blood pressure, tachycardia, tremor, vomiting; less frequent - agitation; rare - cramps, tachyarrhythmia.

Treatment: symptomatic, 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, the likelihood of developing extrasystole against the background of cardiac glycosides.

'Theophylline and other xanthines, when used at the same time, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias. Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, increasing the effect of salbutamol, can lead to a sharp decrease in blood pressure.

Incompatible (pharmacological antagonism) with nonselective beta-adrenoblockers (which should also be considered when using eye forms of beta-blockers).

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

Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

Special instructions:Frequent use of salbutamol can lead to an increase in bronchospasm, sudden death, in connection with which between taking the next dose of the drug should take breaks in a few hours (6 hours). Reduction of these intervals can occur only in exceptional cases.The increased demand for short-acting bronchodilators, in particular salbutamol, to relieve symptoms of bronchial asthma indicates a worsening of the course of the disease. In this case, the treatment plan should be reviewed and the expediency of prescribing or increasing the dose of glucocorticosteroids should be considered. Bronchodilators should not be the only or the main component of therapy of bronchial asthma.

When using a metered aerosol, the following instructions must be strictly followed: shaking the container with aerosol before each use, clearly synchronizing the inhalation and receipt of the drug, maximizing the deep, intense and long enough breath, holding the breath for 10 seconds after inhalation. Patients (including children of young age) who find it difficult to perform a correct breathing maneuver are advised to use a special device (spacer) for inhaling the drug, increasing the respiratory volume and smoothing the inaccuracy of the asynchronous inspiration.

Adrenergic bronchodilators can be used in pregnancy,because the potential risk of placental hypoxia for the fetus against uncontrolled bronchial asthma significantly exceeds the risk associated with their use. However, when used during pregnancy, care should be taken because they can cause tachycardia and hyperglycemia in the mother (especially in the presence of diabetes) and fetus, as well as cause the mother to delay labor, reduce blood pressure, acute circulatory insufficiency and pulmonary edema. Inhaling high doses of salbutamol can cause a rise in blood glucose levels.

There is information about single cases of myocardial ischemia associated with the use of salbutamol. Patients with heart disease (eg, ischemic heart disease, arrhythmia or severe heart failure) who use salbutamol, if they have chest pain or other symptoms that indicate an exacerbation of the heart disease, you should seek medical help. Attention should be paid to the assessment of such symptoms as dyspnoea and chest pain, which can be a consequence of both heart disease and respiratory system diseases.

As with other inhalants, the therapeutic effect may decrease when the container is cooled. Therefore, before use, the container should be warmed to room temperature (warm the container by hand for several minutes, it is inadmissible to use other methods).

The contents of containers are under pressure, so containers can not be heated, broken, punctured or burned, even when they are empty. Taking high doses of salbutamol with exacerbation of asthma can lead to a syndrome of "ricochet" (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 long-term treatment and with a sudden withdrawal of the drug. Increase the dose or frequency of salbutamol intake should only be performed under the supervision of a physician.

Effect on the ability to drive transp. cf. and fur:

In case of adverse reactions, patients are advised to refrain from driving and other mechanisms, as well as to use caution when engaging in activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Aerosol for inhalation dosed with 100 mcg / dose - 90 doses and 200 doses.

Packaging:

For 90 doses (7.02 g) or 200 doses (15.2 g) in a container (aerosolized aluminum bottle) with a dosing valve. A label is attached to the container or fastened with a paint.

One container, complete with a plastic applicator with a protective cap, along with instructions for use, is placed in a pack of cardboard.

Storage conditions:Store 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.

Terms of leave from pharmacies:On prescription

Registration number:LP-002874

Date of registration:24.02.2015

The owner of the registration certificate:ALVILS, LTD. ALVILS, LTD. Russia

Manufacturer: & nbsp

ALVILS, LTD. Russia

Information update date: & nbsp18.08.2015

Illustrated instructions

Instructions

Salbutamol (Salbutamol)