VENTOLIN

VENTOLIN


BUY VENTOLIN

INSTRUCTIONS

on medical use of VENTOLIN

Trade name of the drug: Ventolin

International Nonproprietary Name: Salbutamol

Chemical name: (RS) -1- (4-hydroxy-3-hydroxymethylphenyl) -2-tetrabutylamino) ethanol sulfate.


Dosage form: aerosol for inhalation dosed with 100 μg / dose


Composition of the preparation:

Active substance: salbutamol sulfate 120.5 μg in a single dose (equivalent to 100 μg of salbutamol).

Excipients: propellant GR106642X (1,1,1,2-tetrafluoroethane, also known as HFA 134a or norflurane). Does not contain chlorofluorocarbons.


Description: Aluminum inhaler, equipped with a plastic dispenser with a protective cap, containing a suspension of white or almost white color.


Pharmacotherapeutic group: Bronchodilator - beta-2-adrenomimetic selective.
ATX code: R03AC02.

Pharmacological properties

Pharmacodynamics.

Salbutamol is a selective β 2 -adrenoreceptor agonist. In therapeutic doses, it acts on β2-adrenergic receptors of the smooth muscles of the bronchi, with little or no effect on the β 1 -adrenoceptors of the myocardium. 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.

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.

It has a number of metabolic effects: it reduces the concentration of potassium 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.

After the application of inhalation forms, the effect develops rapidly, the onset of the effect is 5 minutes, the maximum after 30-90 minutes (75% of the maximum effect, achieved within 5 minutes), duration - 4-6 hours.

Pharmacokinetics. After inhalation, 10-20% of the dose of salbutamol reaches the lower respiratory tract. The rest of the dose remains in the inhaler or is deposited in the oropharynx and then swallowed. The fraction deposited in the respiratory tract is absorbed into the lung tissue and blood, but not metabolized in the lungs.

The degree of binding of salbutamol with plasma proteins is about 10%.

Once in the blood, salbutamol is hepatic metabolism and excreted, mostly with urine, unchanged or in the form of phenolic sulfate.

The swallowed portion of the inhalation dose is absorbed from the gastrointestinal tract and is subjected to active metabolism during "first passage through the liver", turning into phenolic sulfate. Unchanged salbutamol and conjugate are excreted mainly in the urine.

Introduced intravenously, salbutamol has a half-life of 4 to 6 hours. It is excreted partially by the kidneys and partly by metabolism to inactive 4'-O-sulfate (phenolic sulfate), which is also excreted mainly in the urine. Only a small part of the administered dose of salbutamol is excreted with feces. Most of the dose of salbutamol administered intravenously, orally or by inhalation, is excreted within 72 hours.


Indications for use

1. Bronchial asthma

- relief of attacks of bronchial asthma, including with exacerbation of severe bronchial asthma;

- prevention of bouts of bronchospasm associated with exposure to an allergen or caused by physical exertion.

- use as one of the components with prolonged maintenance therapy of bronchial asthma.

2. Chronic obstructive pulmonary disease (COPD), accompanied by reversible airway obstruction, chronic bronchitis.

Contraindications

- Hypersensitivity to any component of the drug.

- Management of premature birth.

- Threatening abortion.

- Children under 2 years old.

Use caution if the patient has a history of tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, glaucoma, epicentricks, renal or hepatic insufficiency, simultaneous reception of non-selective β-adrenoblockers, pregnancy, lactation.

Application in pregnancy and lactation

Pregnant women are prescribed a drug only if the expected benefit for the patient exceeds the potential risk to the fetus. During post-registration observation, rare cases of various developmental malformations in children, including the formation of "wolf mouth" and developmental limbs, were detected against the background of the intake of salbutamol by mothers during pregnancy. In some of these cases, mothers took several concomitant medications during pregnancy. Causal relationship with the drug is not established.

Salbutamol probably penetrates into breast milk, and therefore it is not recommended to administer it to nursing women, except for those. cases, when.Expected benefit for the patient outweighs the potential risk for the child. There is no evidence of whether the salbutamol present in breast milk has a deleterious effect on the newborn.

Dosing and Administration

Aerosol Ventolin is intended only for inhalation.

The doctor can decide whether to increase the dose or the frequency of the drug.

It is not recommended to use Ventolin inhaler more often 4 times a day. The need for frequent use of maximum doses of Ventolin or in a sudden increase in dose indicates a worsening of the course of the disease.

Adults (including elderly patients). Causing an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Prevention of attacks of bronchospasm associated with exposure to allergens or caused by physical exertion: the recommended dose is 200 mcg (2 inhalations) for 10-15 minutes before the effect of the provoking factor.

Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.

Children. Causing an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).

Prevention of attacks of bronchospasm associated with exposure to an allergen or caused by physical exertion: the recommended dose is 100-200 μg (1-2 inhalations) for 10-15 minutes before the impact of the provoking factor.

Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.

Ventolin can be administered via the spacer "Babyhaler".

Instructions for use of the inhaler

Checking the inhaler

Before using the inhaler for the first time, or if the inhaler has not been used for a week or longer, remove the cap from the mouthpiece by squeezing the cap slightly on the sides, shake the inhaler lightly and press the aerosol valve to release one inhalation dose into the air to ensure the inhalation is working.

Use of an inhaler

1. Remove the cap from the mouthpiece by gently squeezing the cap from the sides.

2. Inspect the mouthpiece from the inside and outside to make sure it is clean.

3. Shake the inhaler well.

4. Hold the inhaler between the index and thumb in an upright position with the bottom facing up, with the thumb on the base under the mouthpiece.

5. Do a slow, deep exhalation, grasp the mouthpiece with your lips, without squeezing it with your teeth.

6. While making the deepest inhalation through the mouth, simultaneously press the upper part of the inhaler to release one inhalation dose of Salbutamol.

7. Hold your breath for a few seconds, take the mouthpiece out of your mouth, then exhale slowly.

8. For the second dose, while holding the inhaler in an upright position, wait about 30 seconds and then repeat steps 3-7.

9. Close the mouthpiece firmly with a protective cap.

Attention! Performing stages 5, 6 and 7, you can not hurry. Start inhaling as slowly as possible, just before pressing the inhaler valve. In the first few times it is recommended to practice before the mirror. If you see a "fog" coming from the top of the inhaler or from the corners of the mouth, then you should start all over again from stage 3.

If the doctor gave you other instructions for using the inhaler, then strictly observe them. Contact your doctor if you have difficulty using the inhaler.

Cleaning the inhaler

The inhaler should be cleaned at least once a week.

1. Remove the metal can from the plastic casing and remove the lid of the mouthpiece.

2. Thoroughly rinse the plastic casing and lid of the mouthpiece under a stream of warm water.

3. Dry the plastic housing and the mouthpiece cover completely both outside and inside. Do not overheat.

4. Place the metal can in the plastic casing and put the lid on the mouthpiece.

Do not immerse the metal can into the water.

Side effects

From the immune system: very rarely: hypersensitivity reactions, including angioedema, hives, bronchospasm, hypotension and collapse.

From the side of metabolism: rarely: hypokalemia. The therapy with β2-agonists can lead to significant hypokalemia. Very rarely: lactic acidosis. Very rare cases of lactic acidosis have been reported in patients who received salbutamol intravenously and Ventolin nebula for the treatment of exacerbations of bronchial asthma.

From the nervous system: often: tremor, headache; very rarely: hyperactivity.

From the cardiovascular system: often: tachycardia; sometimes: a strong palpitation (pulsation, palpitation); rarely: widening of peripheral vessels; very rarely: arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole.

From the respiratory system, chest and mediastinum: very rarely: a paradoxical bronchospasm.

From the gastrointestinal tract: sometimes: irritation of the mucous membrane of the mouth and pharynx.

From the musculoskeletal system: sometimes: muscle cramps.

Overdose

Symptoms of overdose: more frequent - hypokalemia, lowering blood pressure, tachycardia, muscle tremor, nausea, vomiting; less frequent - agitation, hyperglycemia, respiratory alkalosis, hypoxemia, headache; rare-hallucinations, convulsions, tachyarrhythmia, flutter of the ventricles, widening of the peripheral vessels.

In case of an overdose of salbutamol, the best antidotes are cardioselective β-adrenoblockers. However, β-adrenoreceptor blockers should be used with caution in patients with a history of bronchospasm. The use of large doses of salbutamol can cause hypokalemia, so if you suspect an overdose, you should monitor the potassium level in the serum.

Interaction with other drugs

It is not recommended to simultaneously use salbutamol and non-selective β-adrenoreceptor blockers, such as propranolol.

Salbutamol is not contraindicated in patients who receive monoamine oxidase inhibitors (MAOI).

In patients with thyrotoxicosis increases the effect of stimulants of the central nervous system, tachycardia.
Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa - severe ventricular arrhythmias. Simultaneous administration with anticholinergics (including inhalation) may help increase intraocular pressure. Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

special instructions
Patients should be instructed about the proper use of the Ventolin inhaler.
Bronchodilators should not be the only or main component of asthma therapy for unstable or severe flow.
If the effect of the usual dose of Ventolin becomes less effective or less prolonged (the drug should last at least 3 hours), the patient should consult a doctor.
The increased demand for the use of inhaled β2-adrenoreceptor agonists with short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient's treatment plan should be reviewed. Sudden and progressive deterioration of bronchial asthma can pose a threat to the life of the patient, so in such situations, it is urgent to decide whether to prescribe or increase the dose of glucocorticosteroids. In such patients it is recommended to monitor the peak exhalation rate daily.
Salbutamol should be used with caution in patients with thyrotoxicosis.
The therapy with β 2 -adrenoreceptor agonists, especially when administered by parenteral or with a nebulizer, can lead to hypokalemia. Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, and also due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.

Impact on the ability to drive and / or other mechanisms. No data.

Form of issue

For 200 doses in an aluminum inhaler equipped with a plastic dosing device with a protective cap. The inhaler and the metering device are assembled together with the instructions for use in a cardboard box.

Shelf life

2 years. Do not use after the expiration date stated on the package.

Storage conditions

At temperatures not exceeding 30 ° C, do not freeze, do not allow exposure to direct sunlight. Keep out of the reach of children.

Conditions of leave from pharmacies

On prescription.

Manufacturer

1. GlaxoSmithKline Pharmaceuticals SA, Poland / GlaxoSmithKline Pharmaceuticals S.A., Poland
Poland, Poznan, 60-322, ul. Grunwaldsk, 189 / ul. Grunwaldzka, 189, 60-322, Poznan, Poland
2. Glaxo Wellcome Production, France / Glaxo Wellcome Production, France
Zone Industriel № 2, 23, ryu Lavoisier, 27091, Evro Sexed 9, France / Z.I. No. 2, 23, rue Lavoisier, 27091, Evreux Cedex 9, France
3. Glaxo Wellcome SA, Spain / Glaxo Wellcome SA, Spain
Avda de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain / Avda de Extremadura 3, 09400 Aranda de Duero Burgos Spain