Salamol Steri-Neb - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Salbutamol is a stimulator of beta2-adrenergic receptors, which exerts an effect on the smooth muscles of the respiratory tract, causing its relaxation and preventing bronchoconstriction. Reduces resistance in the airways, increases the vital capacity of the lungs. Prevents the release of histamine, leukotrienes, prostaglandin D2 and other biologically active substances from mast cells. At recommended therapeutic doses, it does not adversely affect the cardiovascular system (CCC), does not cause an increase in blood pressure.To a lesser extent compared with the drugs of this group, it has a positive chrono- and inotropic effect. Causes the enlargement of the coronary arteries. 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.

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. The maximum concentration of salbutamol in the blood plasma is observed after 3 hours. The connection with plasma proteins is 10%. It is subjected to presystemic metabolism in the liver and intestinal wall. The half-life (T1 / 2) is 3-7 hours. It is excreted by the kidneys, mostly unchanged (about 90%) and in the form of an inactive phenol sulfate metabolite (about 60%) for 72 hours and with bile. Salbutamol penetrates the blood-brain barrier, creating concentrations equal to about 5% of the concentration in the blood plasma.

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

Contraindications:Hypersensitivity, children under 18 months.

Carefully:In patients with tachyarrhythmia, IHD, myocarditis, heart defects, aortic stenosis, severe chronic heart failure, hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, and during pregnancy and lactation.

Pregnancy and lactation:It is not recommended to appoint salbutamol during pregnancy and breastfeeding, except when the expected benefit to the mother exceeds any possible risk to the fetus.

Dosing and Administration:

The preparation of CALAMOL STERI-HEB is inhaled using nebulizer inhalers (see the "Technique of use" section of this manual).

Adults, including the elderly, and children over 18 months of age: the usual single dose - 2.5 mg, with the reception 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.

TECHNIQUE OF USE OF THE PREPARATION:

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

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

* Separate the ampoule with sterile solution from the block, to do this, turn and pull it (as in Fig. 1).

* While holding the ampoule vertically upwards with the cap, break off the cap (Fig.2).

* Extract the solution into the reservoir of your nebulizer (Fig. 3).

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

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

* Wash the nebulizer thoroughly.

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

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%.

Often - a feeling of palpitation, headache, tremor, anxiety.

Infrequently - coughing, irritation of the respiratory tract, mucous membrane of the mouth and pharynx, dizziness. Dryness in the mouth and throat, change in taste.

Rarely - bronchospasm (paradoxical or caused by hypersensitivity to the drug), dermatitis, allergic reactions (including angioedema, skin rash, urticaria), arterial hypotension and collapse (hypersensitivity reactions), facial hyperemia, discomfort or chest pain, arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole, an increase in the number of cardiac contractions, accompanied by an increase in blood pressure. Drowsiness, sleep disturbance, fatigue, hypokalemia, hyperglycemia, lactic acidosis, muscle cramps, nausea, vomiting.

Overdose:

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

Treatment: symptomatic; when tachycardia is administered cardioselective beta 1-blockers. The administration of beta1-blockers (selective) in patients with bronchial asthma requiresextreme caution because of the danger of bronchospasm.

Interaction:

Incompatible (pharmacological antagonism) with non-selective beta-blockers (which should also be taken into account when using eye forms of beta-adrenergic blockers).

In consequence of hypokalemic effect salbutamol enhances the effect of stimulants * central nervous system, strengthens 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 the beta-adrenergic effect 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:

Patients using Salamol Steri-Neb at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, you can not independently increase the dose or frequency of the drug, and 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 correspond to a neutral pH level in some patients can cause a paradoxical bronchospasm.

Salbutamol should be given 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 occurrence of hypokalemia can 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 the drug Salamol Steri-Neb to prevent premature delivery and the threat of miscarriage.

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

Form release / dosage:

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

Packaging:

For 2.5 ml of the drug in a vial of low density polyethylene. 5 ampoules are welded to each other in the form of a block. 4 blocks together with the instruction for use are placed in a cardboard box. 6 blocks together with the instruction for use are placed in a cardboard box and 2 cardboard bundles are placed in a cardboard box.

Storage conditions:Store at a temperature of no higher than 25 ° C, in a place protected from light, do not freeze. Keep out of the reach of children.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-000272

Date of registration:17.02.2011

The owner of the registration certificate:AIVEX Pharmaceuticals Yukey LimitedAIVEX Pharmaceuticals Yukey Limited United Kingdom

Manufacturer: & nbsp

IVAX Pharmaceuticals UK, Ltd. United Kingdom

Information update date: & nbsp22.08.2015

Illustrated instructions

Instructions

Salamol Steri-Neb (Salamol Steri-Neb)