Solution for inhalation from colorless to light yellow color, transparent.
1 ml
salbutamol (in the form of sulfate) 1 mg
[PRING] sodium chloride - 9 mg, sulfuric acid diluted to pH 3.8-4.2, water q / u - up to 1 ml.
2.5 ml - polyethylene ampoules, welded together in the form of a block (5) - blocks (4) - packs cardboard.
Solution for inhalation from colorless to light yellow color, transparent.
1 ml
salbutamol (in the form of sulfate) 2 mg
[PRING] sodium chloride - 9 mg, sulfuric acid diluted to pH 3.8-4.2, water q / u - up to 1 ml.
2.5 ml - polyethylene ampoules, welded together in the form of a block (5) - blocks (4) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
A bronchodilator, a stimulant? 2- adrenoreceptors. It acts on the smooth muscles of the respiratory tract, causing it to relax and prevent bronchospasm. 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.
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 extent, in comparison 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. C max salbutamol in 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. T 1/2 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
- prevention and relief of bronchospasm in bronchial asthma;
- symptomatic treatment of bronchial obstructive syndrome (including chronic bronchitis and pulmonary emphysema);
chronic obstructive pulmonary disease.
DOSING MODE
The drug Salamol Steri-Neb is used inhalation with the help of inhalers - nebulizers.
Adults (including elderly patients) and children older than 18 months: usual single dose - 2.5 mg, frequency of admission - 3-4 times / day with the help of inhalations through the nebulizer. If necessary, the dose may be increased to 5 mg 3-4 times / day.
Technique of drug use
Before using the drug, it is necessary to read the instructions of the manufacturer of the nebulizer.
1. Prepare the nebulizer according to the instructions of its manufacturer.
2. Separate the ampoule with a sterile solution from the block, to do this, turn and pull it.
3. Holding the ampoule vertically upside down with a cap, break off the cap.
4. Extract the solution into the nebulizer reservoir.
5. 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. Thoroughly wash the nebulizer.
When using the drug, avoid contact with the solution in the eyes.
SIDE EFFECT
Determination of the frequency of adverse effects (according to WHO recommendations): very often (? 10%); often (? 1%, but <10%); infrequently (? 0.1%, but <1%);rarely (? 0.01%, but <0.1%); very rarely (<0.01%).
From the cardiovascular system: often - a feeling of heartbeat; rarely - arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole, an increase in heart rate, accompanied by an increase in blood pressure.
From the nervous system: often - headache, tremor, anxiety; infrequently - dizziness; rarely - drowsiness, sleep disturbance, fatigue.
On the part of the respiratory system: rarely - bronchospasm (paradoxical or caused by hypersensitivity to the drug).
From the digestive system: rarely - nausea, vomiting.
Allergic reactions: rarely - angioedema, skin rash, urticaria, arterial hypotension and collapse (hypersensitivity reactions).
From the skin: rarely - dermatitis, hyperemia of the skin of the face.
From the side of metabolism: rarely - hypokalemia, hyperglycemia, lactic acidosis.
Local reactions: infrequent - cough, irritation of the respiratory tract, mucous membrane of the mouth and pharynx, dry mouth and pharynx, change in taste sensations.
Other: rarely - discomfort or pain in the chest, muscle cramps.
CONTRAINDICATIONS
- Children's age up to 18 months;
- Hypersensitivity to the components of the drug.
With caution: in patients with tachyarrhythmia, ischemic heart disease, myocarditis, heart defects, aortic stenosis, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, during pregnancy and lactation.
PREGNANCY AND LACTATION
It is not recommended to prescribe salbutamol during pregnancy and during breastfeeding, except when the expected benefit for the mother exceeds any possible risk to the fetus.
APPLICATION FOR CHILDREN
Contraindicated for children under 18 months.
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, but should immediately consult a doctor.
When using the drug, avoid contact with the solution in the eyes.
As with the use of other means of inhalation therapy, it is possible to develop a 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 beta 2 -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, GCS, 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.
OVERDOSE
Symptoms: nausea, vomiting, increased excitability, tachycardia, fluttering of the ventricles, lowering of arterial pressure, hypoxemia, lactic acidosis, hypokalemia, hyperglycemia, muscle tremor, headache, hallucinations.
Treatment: symptomatic therapy; when tachycardia is administered cardioselective beta 1- adrenoblockers. The appointment of cardioselective beta- 1- adrenoblockers in patients with bronchial asthma requires extreme caution because of the risk of bronchospasm.
DRUG 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 enhances the effect of CNS stimulants, 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.
Possible increase in heart rate and increased blood pressure on the background of salbutamol intake may necessitate correction of the dose of antihypertensive and antianginal drugs.
MAO inhibitors and tricyclic antidepressants can increase the beta-adrenergic effect of salbutamol and lead to a sharp decrease in blood pressure.
Diuretics and GCS increase the hypokalemic effect of salbutamol.
Simultaneous use with m-holinoblokatorami (including inhalation) can promote increased intraocular pressure.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C; Do not freeze. Shelf life - 2 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
