Not butapier solution for ing. 1mg/ml Comte. 2 ml No. 10

Pharmacological properties

Pharmacodynamics. salbutamol is selection agonist β2-адренорецепторов. in therapeutic doses works on β2-адренорецепторы bronchial muscles with the minimum or total absence of action on β1-адренорецепторы hearts.

Pharmacokinetics After inhalation application from 10 to 20% of the entered dose reaches the lower airways. The rest remains in the transport system or in a stomatopharynx from where it is swallowed. A part of a dose which reached airways is absorbed in tissue of lungs and gets to a blood-groove, but is not metabolized in lungs.

on the 4-5th minute after inhalation, duration of action is 4–6 h

After hit in a system blood-groove medicine is metabolized in a liver, emitted mainly with kidneys in not changed look and in the form of a fenolsulfatny metabolite.

in a GIT, there passes the first stage of metabolism in a liver before fenolsulfatny connection, then is allocated with kidneys.

Indication

for knocking over of attacks oh and also for treatment of patients with hobl.

by

for inhalation application by inhalation through a mouth by means of the nebulizer and is applied under control of the doctor.

Solution not to enter

by an injection and not to swallow.

Adult (including patients of advanced age)

Usual initial dose of salbutamol by inhalation makes 2-2.5 mg. It can be raised to 4–5 mg. It is possible to repeat inhalation 4 times a day.

dose can be raised by

For treatment of adult patients with heavy obstruction of airways to 40 mg/days, however such treatment should be carried out in stationary conditions under observation of the doctor.

Children

Usual initial dose of salbutamol by inhalation makes 2-2.5 mg. It can be raised to 4–5 mg. It is possible to repeat inhalation 4 times a day.

Clinical performance of use of salbutamol aged up to 18 months is not established to

by way of a nebulization.

As the tranzitorny anoxemia is possible

, it is necessary to consider need of performing additional oxygen therapy.

Nebutamol is usually applied in not divorced look. However, if inhalation needs to carry out for a long time (10 min.), contents of a container can be diluted with sterile physiological solution.

Inhalation of aerosol can be carried out by

by means of a special front mask or a mouthpiece. It is necessary to carry out periodic ventilation of the room where inhalation is carried out. In case of risk of developing a hypoxia because of hypoventilation, the inhaled air should be enriched with oxygen.

Increase in a dose and frequency of use of medicine only the doctor can carry out

, considering possibility of side effects when exceeding a dose.

Instruction for use of the medicine Nebutamol.

1. To prepare the nebulizer for use.

2. To open a polymeric package and to take a one-dose container. Not to take a container from a package if in it there is no need.

3. To stir up a container. To leave other containers in a polymeric package and to place them in a cardboard box.

4. Holding a container for the upper edge, to turn other edge to open a container.

5. To insert a container into the nebulizer open edge down and to press slightly. Make sure that all medicine flowed in the nebulizer.

6. To assemble the nebulizer and to use for designated purpose.

After use to wash out the nebulizer, to utilize residues of medicine.

Contraindication

Hypersensitivity in the anamnesis to any component of medicine. though salbutamol in the form of solution for in/in injections and sometimes in the form of tablets and suppositories is applied when conducting premature births, salbutamol in the form of aerosol to inhalations at these indications is not applied. do not apply salbutamol at threat of an abortion.

Side effects

Given below, are classified by bodies and systems and according to emergence frequency. frequency of emergence is classified as: very often (≥1/10), it is frequent (≥1/100 and 1/10), infrequently (≥1/1000 and 1/100), is rare (≥1/10,000 and 1/1000), is very rare (1/10,000), including isolated cases. generally very frequent and frequent side effects are determined by data of clinical trials whereas rare and very rare — according to spontaneous messages.

from the immune system: very seldom — reactions of hypersensitivity, including a Quincke's disease, a small tortoiseshell, a bronchospasm, hypotension and collapse.

Metabolic violations: seldom — a hypopotassemia. Potentially heavy hypopotassemia can be the result of treatment with agonists β ₂ - adrenoceptors; very seldom — lactoacidosis. Patients OH in a stage have aggravations which are treated by the salbutamol entered in/in or via the nebulizer, seldom or never there can be lactoacidosis.

from nervous system: often — a tremor, a headache, it is very rare — hyperactivity.

from a cardiovascular system: often — tachycardia; infrequently — the strengthened heartbeat; very seldom — violations of a warm rhythm, including fibrillation of ventricles, supraventricular tachycardia and premature ventricular contraction, a peripheral vazodilatation, frequency is not defined — myocardium ischemia.

from a respiratory system: very seldom — a paradoxical bronchospasm.

. In this case it is necessary to appoint immediately alternative forms of medicine or other high-speed inhalation bronchodilators. Not butapier it is necessary to cancel, estimate immediately a condition of the patient and, if necessary, to begin alternative therapy.

from a digestive tract: infrequently — irritation of a mucous membrane of a mouth and throat.

from a musculoskeletal system: infrequently — muscular spasms.

Nebutamol is required to use

by inhalation through a mouth and it is not necessary to enter by an injection or to swallow.

Treatment at OH needs to be carried out by

according to the step-by-step program, the condition of the patient is required to be estimated clinically and by functional pulmonary tests.

Increase in frequency of use of inhalation agonists β ₂ - adrenoceptors demonstrates deterioration in control over OH. In that case therapy of the patient needs to be reconsidered because deterioration in a current OH is a life-threatening state which demands the beginning or increase in application of GKS. Patients of risk group are recommended to carry out control of the maximum expiratory rate daily.

Patients, receiving the medicine Nebutamol in house conditions, it is required to warn about the following: if the effective dose of medicine does not give relief from treatment or duration of this simplification decreases, it is necessary to see a doctor, but not to raise a dose or frequency of its application independently.

Nebutamol with care apply

to treatment at the patients applying other sympathomimetics in high doses.

Use of sympathomimetics, including salbutamol, influences a cardiovascular system. According to post-license application and to the published data of literature, there are certificates on exceptional cases of developing of the ischemia of a myocardium associated with use of salbutamol. The patients with heart diseases (for example an ischemic heart disease, arrhythmia or heavy heart failure) receiving salbutamol in case of the developing of a stethalgia or other symptoms demonstrating exacerbation of a heart trouble should ask for medical care. The attention should be paid to assessment of such symptoms as short wind and a stethalgia which can be a consequence of both a heart disease, and a disease of a respiratory system.

With care salbutamol is appointed a sick thyrotoxicosis.

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At treatment of patients with a salbutamol combination in nebula and an ipratropiuma of bromide sometimes observed cases of development of sharp closed-angle glaucoma. Therefore the salbutamol combination in nebula with anticholinergic medicaments which are administered by a nebulization should be applied with care. Patients need to give appropriate instructions of rather correct use of medicine and to warn that it is necessary to avoid hit of the sprayed aerosol in eyes. - adrenoceptors the heavy hypopotassemia which is mainly observed at application of parenteral forms or the nebulizer can be p>

Result of treatment with agonists β _{2. Special attention is paid to patients sharp heavy OH because the hypopotassemia can be exponentiated by the accompanying application of derivatives of xanthines, steroids, diuretics and a hypoxia. In this situation it is recommended to check potassium level in blood plasma.}

As well as other agonists β ₂ - adrenoceptors, Nebutamol can lead to reversible metabolic changes, for example to increase in level of glucose in blood.

Compensation of such changes at patients with diabetes is not always possible

therefore there are separate messages about development of ketoacidosis in these patients. Simultaneous application of GKS can aggravate this state.

It is very rare at patients OH in aggravation stages which were treated by the salbutamol in high doses applied in/in or via the nebulizer it was reported about cases of development of lactoacidosis. Increase in level of a lactate in blood can cause development of suffocation and compensatory hyperventilation of lungs, can be mistakenly regarded as insufficient efficiency of antiasthmatic treatment and, in turn, to lead to an inappropriate intensification of treatment by short-range agonists β ₂ - adrenoceptors. Therefore it is recommended to control lactate level in blood plasma of such patients and, respectively, presence at them of a metabolic acidosis.

Use during pregnancy and feeding by a breast. Salbutamol during pregnancy is appointed only when the expected advantage for mother is higher than possible risk for a fruit.

As salbutamol can be emitted to

with breast milk, it is not recommended to appoint it during feeding a breast, except for a situation when the expected advantage for mother exceeds possible risk for the child.

Children. Clinical performance of use of salbutamol aged up to 18 months is not established by way of a nebulization therefore use of medicine is not recommended.

Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no data on influence, in case of side effects from nervous system (tremor) control of vehicles or work with mechanisms needs to be limited.

Interaction

Salbutamol is not appointed along with such non-selective blocker of β-adrenoceptors as propranolol.

for application by the patient applying MAO inhibitors.

Overdose

Most widespread signs and symptoms of overdose of not butapier are the tranzitorny changes pharmacological induced by beta-agonists (for example tachycardia, a tremor, a headache).

as a result of overdose of salbutamol the hypopotassemia therefore it is necessary to control potassium level in blood plasma can arise.

Treatment consists in the termination of intake of salbutamol and purpose of the corresponding symptomatic therapy, such as cardioselective blockers of β-adrenoceptors for treatment of patients with warm symptomatology (for example tachycardia). It is necessary to appoint medicaments of group of blockers of β-adrenoceptors with care the patient with a bronchospasm in the anamnesis.

Storage conditions

At a temperature not above 25 °C. not to allow freezing and impact of direct sunlight.