Universal reference book for medicines
Product name: SALBUTAMOL-TEVA (SALBUTAMOL-TEVA)

Active substance: salbutamol

Type: Bronchodilator-beta- 2- adrenomimetic

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by NORTON WATERFORD (Ireland) under the trade name IVAX Pharmaceutical Ireland (Ireland)
Composition, form of production and packaging
Aerosol for inhalation dosage
, when sprayed on the glass forms a spot of white.

1 dose

salbutamol sulfate 124 mcg,

which corresponds to the content of salbutamol 100 μg

[PRING] hydrofluoroalkane (HFA-134a) - 26.46 mg, ethanol - 3.42 mg.

200 doses - aluminum cylinders (1) with a dosing device - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Salbutamol is a selective antagonist?
2- adrenoreceptors. In therapeutic doses, does it act on? 2- adrenoreceptors of smooth muscles of the bronchi, having a pronounced bronchodilator effect, prevents and stops bronchospasm, increases the vital capacity of the lungs. Prevents the release of histamine, a slowly reacting substance from mast cells and neutrophil chemotaxis factors. Causes a slight positive chrono-inotropic effect, dilates coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect: it lowers the tone and contractile activity of the myometrium.
It has a number of metabolic effects: it reduces the K + content in the plasma, affects glycogenolysis and insulin secretion, has hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.

The effect of the drug begins 5 minutes after inhalation and lasts for 4-6 hours.

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 the unchanged form or in the form of phenolic sulfate. The degree of binding of salbutamol with plasma proteins is 10%. C max blood plasma - 30 ng / ml. Part of the dose received in the digestive tract is absorbed and subjected to intensive metabolism during the "first passage" through the liver, turning into phenolic sulfate. The unchanged drug and conjugate are excreted mainly in the urine. Most of the dose of salbutamol administered intravenously, orally or by inhalation, is deduced within 72 hours. T 1/2 - 3.7-5 h.
INDICATIONS

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

DOSING MODE

Adults and children over 12 years of age : 100-200 micrograms (1-2 inhalation doses) for arresting asthma attacks.
To monitor the course of asthma of mild severity- 1-2 doses 1-4 times / day and moderate severity of the disease - in the same dosage in combination with other anti-asthmatic drugs. 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 or 2 inhalations).

The daily dose should not exceed 800 mcg (8 inhalations).

Instructions for use of the inhaler

Check the operation of the inhaler before using it for the first time, or if you have not used it for a while.

1. Remove the cap from the inhaler.
Ensure that there is no dust and dirt in the outlet tube.
2. Hold the cylinder upright, placing your thumb on the bottom, and the index finger on the top of the cylinder.

3. Shake the can vigorously up and down.

4. Take as much as possible deep exhalation (without tension).
Tighten the lips of the exit tube of the can.
5. Take a slow deep breath.
At the moment of inspiration, press the index finger on the valve of the can, releasing the dose of the medicine. Continue to inhale slowly.
6. Take the inhaler tube out of your mouth and hold your breath for 10 seconds or as long as you can without stress.
Slowly exhale.
If more than one dose is required, wait for about a minute and then repeat the procedure from step 2. Put the cap back on the inhaler.

In steps 3 and 4, do not rush.
At the time of release, it is important to inhale as slowly as possible. In the beginning, practice around the mirror. If you notice steam coming from the top of the can or from the corners of the mouth, start again from step 2.
Cleaning the inhaler

The inhaler should be cleaned at least once a week.
Remove the metal can from the plastic case and rinse the case and cap with warm water. Do not use hot water.Thoroughly dry, but do not use heating devices for this. Put the cylinder back in the case and put on the cap. Do not immerse the metal cylinder in water.
SIDE EFFECT

Salamol Eco can cause finger tremors, which is a typical side effect for all agonists?
2- adrenoreceptors. There may be headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia, peripheral vascular hyperemia, a slight compensatory increase in heart rate, increased AD, chest pain, arthralgia.
Hypersensitivity reactions (including angioedema, hives, erythema, nasal congestion, bronchospasm, arterial hypotension and collapse) may develop;
muscle cramps, nausea, vomiting, indigestion.
Inhalation drugs can cause a paradoxical bronchospasm.
Inhalation preparations can cause irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough.
Salbutamol therapy can cause hypokalemia, which can be a serious danger to the patient, as well as reversible metabolic disorders, for example, an increase in the concentration of glucose in the blood.

The drug can cause excitation and increased motor activity in children.
There may be arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole).
CONTRAINDICATIONS

- rhythm disturbances (paroxysmal tachycardia, polytopic ventricular extrasystole);

- myocarditis;

- heart diseases;

- aortic stenosis;

- cardiac ischemia;

- Tachyarrhythmia;

- thyrotoxicosis;

Decompensated diabetes mellitus;

- glaucoma;

- epileptic seizures;

- pyloroduodenal constriction;

renal or hepatic insufficiency;

- simultaneous reception of non-selective beta-blockers;

- Pregnancy;

- Children's age up to 2 years;

- Hypersensitivity to any component of the drug.

With caution - chronic heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.

PREGNANCY AND LACTATION

Contraindicated in pregnancy.

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in liver failure.

APPLICATION FOR CHILDREN

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 or 2 inhalations).

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 the usual dose of Salamol Eco 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.

Increased need for inhaled agonists?
2- adrenoreceptors with a 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 SCS should be decided.
Therapy is agonist?
2- adrenoreceptors can lead to hypokalemia. It is recommended to exercise extreme caution in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia may increase as a result of simultaneous use of xanthine derivatives, GCS, diuretics, and also due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.
Cylinder with Salamol Eco can not be pierced, disassembled or thrown into the fire, even if it is empty.
Like most other inhalation agents in aerosol packages, Salamol Eco can be less effective at low temperatures. When cooling the bottle, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
OVERDOSE

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

Treatment: withdrawal of the drug, cardioselective beta-blockers;
symptomatic therapy. If you suspect an overdose, you should monitor the potassium level in the blood serum.
DRUG INTERACTION

Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias;
means for inhalation anesthesia, levodopa - severe ventricular arrhythmias.
It is not recommended to simultaneously use Salamol Eco and nonselective beta-adrenoreceptor blockers, such as propranolol.

MAO inhibitors and tricyclic antidepressants increase the effect of salbutamol and can lead to a sharp decrease in blood pressure.

Salbutamol enhances the effect of CNS stimulants, side effects of thyroid hormones, cardiac glycosides.

Reduces the effectiveness of antihypertensive drugs, nitrates.

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

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children, at a temperature of no higher than 30 ° C, protecting from direct sunlight.
Do not freeze. Shelf life - 3 years.
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