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

Active substance:	1 mg / ml	2 mg / ml
Salbutamol Sulfate	1.2 mg	2.4 mg
in terms of salbutamol	1.0 mg	2.0 mg
Excipients:
Sodium chloride	9.0 mg
0.05 M sulfuric acid solution	to pH 3.0-5.0
Water for injections	up to 1.0 ml

Description:

Transparent from colorless to slightly brownish or yellowish-brownish liquid.

Pharmacotherapeutic group:Bronchodilator - beta2-adrenomimetic 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 bronchodilator effect, preventing or reducing spasm of the bronchi, reduces resistance in the airways, 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 application of inhaled forms of action develops rapidly, the start effect - after 5 minutes, maximum - after 30-90 minutes (75% of the maximum effect is reached within 5 minutes) duration - 3-6 hours.

Pharmacokinetics:

During inhalation 10-20% of the inhaled dose reaches the small airways and 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 phenol sulfotransferase. Half-life (T1/2) - 4-6 hours. It is excreted by the kidneys (69-90%), mainly in the form of an inactive phenol sulfate metabolite (60%) for 72 hours and with bile (4%).

Indications:

Prophylaxis and relief of bronchospasm in bronchial asthma, symptomatic treatment of bronchial obstructive syndrome (including chronic bronchitis and pulmonary emphysema), reversible bronchial obstruction (prevention and treatment), including chronic obstructive pulmonary disease.

Contraindications:

Hypersensitivity, children under 18 months.

The drug is not used in cases of premature birth and with the threat of abortion.

Carefully:Tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, pregnancy, the period of breastfeeding.

Pregnancy and lactation:

It is not recommended to appoint salbutamol during pregnancy and breastfeeding, unless the expected benefit to the mother exceeds any possible risk to the fetus or child.

Dosing and Administration:

Salbutamol-SOLOfarm is administered by inhalation with nebulizer inhalers (see the "Procedure for the preparation" section of this manual). Adults, including the elderly, and children over 18 months of age: the usual single dose of 2.5 mg, when applied 3-4 times a day with the help of inhalations through a nebulizer. If necessary, the dose may be increased to 5 mg 3-4 times a day.

To treat severe airway obstruction in adult patients, higher doses may be administered - up to 40 mg / day under strict medical control in a hospital setting.

The order of work with the drug:

1. Before using the drug, it is necessary to read the instructions of the manufacturer of the nebulizer.

2. Prepare the nebulizer according to the manufacturer's instructions.

3. Take the ampoule and shake it, holding it by the neck (Figure 1).

4. Press the ampoule with your hand, do not release the preparation, and turn and detach the valve with rotating movements (Fig. 2).

5. Extract the solution into the nebulizer reservoir (Figure 3).

6. Use a nebulizer according to the manufacturer's instructions.

7. The solution left unused in the nebulizer chamber should be poured out immediately after each use.

8. Wash the nebulizer thoroughly.

When using the drug, avoid contact with the solution in the eyes.

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, bronchospasm, hypotension and collapse.

From the side of metabolism:

Rarely: hypokalemia. hyperglycemia.

From the nervous system:

Often: tremor, headache.

Very rarely: hyperactivity.

From the cardiovascular system:

Often: tachycardia.

Infrequent: increased heart rate, myocardial ischemia.

Rarely: disturbance of the heart rhythm, including atrial fibrillation,

supraventricular tachycardia and extrasystole.

Rarely: peripheral vasodilation.

From the respiratory system:

Very rarely: paradoxical bronchospasm.

From the gastrointestinal tract:

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

From the musculoskeletal system:

Infrequently: muscle cramps.

Overdose:

Symptoms acute poisoning with inhalation: more frequent hyperglycemia, hypokalemia, lowering blood pressure (BP), lactic acidosis, 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; when tachycardia is administered cardioselective beta 1-blockers. The appointment of beta1-adrenoblockers (selective) in patients with bronchial asthma requires extreme caution because of the risk of bronchospasm.

Interaction:

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

Due to the hypokalemic effect salbutamol strengthens the action of stimulants of the central nervous system, strengthens the cardiotropic action of thyroid hormones, increases the likelihood of glycosidic intoxication.

Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias.

A possible increase in the number of heartbeats and an increase in blood pressure when taking salbutamol may necessitate correction of the dose of antihypertensive and antianginal drugs.

Monoamine oxidase inhibitors and tricyclic antidepressants can enhance beta-adrenergic effects of salbutamol and lead to a sharp drop in blood pressure.

Diuretics and glucocorticosteroid drugs increase the hypokalemic effect of salbutamol.

Simultaneous use with m-holinoblokatorami (including inhalation) can help increase intraocular pressure.

Special instructions:

Bronchodilators should not be the only or main component of asthma therapy for unstable or severe flow.

Patients taking Salbutamol-SOLOfarm at home should be warned that if the usual dose is less effective or less prolonged, you can not increase the dose or frequency of the drug yourself, but you should immediately consult a doctor.

When using the drug, avoid contact with the solution in the eyes.

As in the case of other inhalation therapies, there may be cases of paradoxical bronchospasm. In this case, you must immediately stop taking the drug with the appointment of an alternative treatment. Solutions that do not meet the neutral pH level in some patients can cause a paradoxical bronchospasm.

Salbutamol can cause reversible metabolic changes, for example, an increase in the concentration of glucose in the blood. Patients with diabetes mellitus may develop decompensation, in some cases, reported the development of ketoacidosis. Simultaneous use of glucocorticosteroids can enhance this effect. There have been reports of rare cases of lactic acidosis,associated with the use of high doses of beta2-adrenomimetics short-acting with a nebulizer. mainly in patients with exacerbation of bronchial asthma. An increase in the concentration of lactate can lead to dyspnea and compensatory hyperventilation of the lungs, which can be misinterpreted as signs of unsuccessful treatment of bronchial asthma and lead to an unreasonable increase in the use of short-acting beta2-adrenergics. Therefore, it is recommended to monitor the concentration of lactate in the blood serum, and also to monitor the possible subsequent development of metabolic acidosis. Salbutamol should be administered with caution to patients with thyrotoxicosis.

Treatment with beta2-adrenomimetics can lead to significant hypokalemia. Particular caution should be exercised in cases of severe bronchial asthma, since the onset of hypokalemia may be facilitated by concomitant treatment with xanthine derivatives, glucocorticosteroids, diuretics, and hypoxia. In such situations it is recommended to monitor the potassium level in the serum.Do not use Salbutamol-SOLOfarm to prevent premature birth and in case of threat of miscarriage.

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

In case of adverse reactions to patients, it is recommended to refrain from driving and other mechanisms, and also to be cautious when engaging in activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for inhalation 1 mg / ml and 2 mg / ml.

Packaging:

By 2.5 ml into ampoules of low density polyethylene.

10 ampoules in a foil-foil bag.

For 1, 2, 3 or 6 packages of foil film together with instructions for medical use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

After opening the package - 3 months.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004431

Date of registration:28.08.2017

Expiration Date:28.08.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp26.09.2017

Illustrated instructions

Instructions

Salbutamol-SOLOfarm (Salbutamol-SOLOpharm)