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

Excipients: cetyl oleate 24.4 mg / 0.2 mg, fluorotrichloromethane (chlad-11) 6,000 mg / 49.2 mg, difluorodichloromethane (chladone-12) 10800 mg / 88.5 mg.

Description:The contents of a metal cylinder with a dosing valve are a suspension under pressure and form a white spot when sprayed onto a slide.

Pharmacotherapeutic group:Bronchodilator - beta-2-adrenomimetic is selective.

ATX: & nbsp

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

R.03.A.C.02 Salbutamol

Pharmacodynamics:

Salbutamol is a selective beta2-adrenergic receptor agonist. At therapeutic doses it acts on beta2-adrenergic receptors bronchial smooth muscle, exerting a pronounced bronchodilator effect, prevents and relieves bronchoconstriction, increases lung capacity. Prevents the release of histamine, a slowly reacting substance from mast cells and neutrophil chemotaxis factors. Causes a slight positive chrono and inotropic effect on the myocardium, the expansion of the coronary arteries, practically does not reduce blood pressure.It has a tocolytic effect: it lowers the tone and contractile activity of the myometrium. The action of the drug begins 5 minutes after inhalation and lasts for 4-6 hours.

It has a number of metabolic effects: it reduces the level of K + in the plasma, has hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.

Pharmacokinetics:After inhalation, 10 to 20% of the dose falls into the respiratory tract. The rest is retained in the device or settles in the oropharynx and then swallowed. Part of the dose that remains in the airway is absorbed by the lung tissue, without being metabolized in the lungs, and enters the bloodstream. If it enters the systemic circulation, it can be metabolized in the liver and excreted mainly with urine in an unchanged form.

Part of the dose that enters the gastrointestinal tract is absorbed and subjected to intensive metabolism during the first passage through the liver. The invariable preparation and conjugate are excreted mainly with urine. Most of the dose of salbutamol is excreted within 72 hours.The degree of binding of salbutamol with plasma proteins is 10%.

The maximum concentration in blood plasma is 30 ng / ml.

The half-life is 3.7-5 h.

Indications:

Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis and emphysema.

Contraindications:Hypersensitivity to any component of the drug, rhythm disturbances (paroxysmal tachycardia, polytropic ventricular extrasystole), myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe heart failure, decompensated diabetes mellitus, glaucoma, epipriplets, pylorodouden narrowing, renal or. hepatic insufficiency, pregnancy, simultaneous reception of non-selective beta-blockers, children under 2 years old.

Carefully:

Heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.

Pregnancy and lactation:

Contraindicated during pregnancy.

During lactation, it is prescribed only in cases where the expected benefit to the mother exceeds any possible risk to the child.

Dosing and Administration:Inhalation.

Adults and children over 12 years of age: 100-200 micrograms of salbutamol (1-2 inhalations) for arresting attacks of suffocation.

In the absence of effect after 5 minutes, repeated inhalation is possible. The subsequent inhalation can be carried out not earlier, than in 2 hours.

To monitor the course of mild asthma - 1-2 dose 1-4 times a day and an average disease severity - at the same dosage in combination with other antiasthmatic agents.

For the prevention of asthma physical effort - for 20-30 minutes before the load 1-2 doses per reception.

Children from 2 to 12 years: with the development of an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion, the recommended dose is 100-200 μg (1-2 inhalations).

The daily dose of salbutamol should not exceed 1200 mcg (12 inhalations).

When using a metered aerosol, the following instructions must be strictly followed:

1. Shake the balloon thoroughly before use.

2. Put the nebulizer on the cylinder, remove the cover from the sprayer.

3. Make a deep exhalation.

4. Turn the balloon upside down, grasp the mouthpiece with your lips, draw a strong breath and simultaneously press the bottom of the cylinder. In this case, a strong aerosol release occurs.Hold your breath for a few seconds and, taking the mouthpiece from your mouth, make a slow exhalation.

5. After use, cover the mouthpiece with a lid to protect it from contamination.

Patients (including young children) who find it difficult to perform the right breathing exercise are advised to use a special device (spacer) for inhaling the drug that increases the respiratory volume and smooths the inaccuracies of the asynchronous inspiration.

Side effects:

By frequency, side effects can be divided into the following categories: very frequent (> 1/10), frequent (> 1/100 and <1/10), infrequent (> 1/1000 and <1/100), rare, (> 1/10 000 and <1/100), very rare (<1/10 000).

From the immune system: very rarely - hypersensitivity reactions, including angioedema, hives, erythema, nasal congestion, bronchospasm.

On the part of metabolic processes: rarely - hypokalemia, as well as reversible metabolic disorders, for example, an increase in the concentration of glucose in the blood.

From the central nervous system: often - a tremor, a headache; not often - dizziness; very rarely - increased excitability, anxiety, sleep disturbance, insomnia, fatigue.

From the cardiovascular system: rarely - a slight compensatory increase in heart rate, an increase in blood pressure; very rarely - arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole, arterial hypotension and collapse; rarely - the expansion of peripheral vessels (congestion of the facial skin).

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

From the digestive system: not often - a change in taste; rarely - dryness or irritation of the mucous membrane of the mouth and pharynx (pharyngitis), nausea, vomiting.

From the musculoskeletal system: rarely - muscle cramps.

Overdose:

Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vascular dilatation, lowering of arterial pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremor, headache.

Treatment: drug withdrawal, cardioselective beta-blockers; symptomatic therapy.

If you suspect an overdose, you should monitor the potassium level in the blood serum.

Interaction:Theophylline and other xanthines with simultaneous application with salbutamol increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias.

Not recommended salbutamol and nonselective beta-adrenergic receptor blockers, such as propranolol.

Monoamine oxidase inhibitors and tricyclic antidepressants increase the effect of salbutamol and can lead to a sharp drop in blood pressure.

Salbutamol enhances the action of stimulants of the central nervous system, a side effect on the heart of thyroid hormones.

Increases the likelihood of developing glycosidic intoxication. Reduces the effectiveness of antihypertensive drugs, nitrates.

Hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics.

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

Special instructions:

In patients with a severe or unstable course of bronchial asthma, the use of bronchodilators should not be the primary or only method of therapy.If the effect of a normal dose of salbutamol becomes less effective or less prolonged (the drug should last at least 3 hours), the patient should consult a doctor.

Frequent use of salbutamol can lead to increased bronchospasm, sudden death, and therefore between the doses of regular doses of the drug should take breaks in a few hours.

The increased need for the use of inhaled beta2-adrenoceptor agonists with short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the treatment plan of the patient should be reviewed and the question of prescribing or increasing the dose of inhaled or systemic glucocorticosteroids should be considered.

Therapy with beta2-adrenoreceptor agonists can lead to hypokalemia. Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, since in these cases, hypokalemia may increase as a result of simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, and also due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.

Effect on the ability to drive transp. cf. and fur:Data on the impact on the ability to manage motor vehicles and / or other mechanisms are not available.

Form release / dosage:

Aerosol for inhalation dosed with 100 μg / dose.

Packaging:For 90 doses (12 ml) of the drug in aluminum aerosol canisters with a valve pressurizing, spray for antiasthmatics and a cap. Each cylinder with a nebulizer, cap and instructions for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep away from children. Keep away from heating system and direct sunlight.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001925

Date of registration:14.10.2011

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp22.08.2015

Illustrated instructions

Instructions

Salbutamol (Salbutamol)