VENTACORT
(Salbutamol)




COMPOSITION

Each dose of the medicine contains

Active ingredient: salbutamol (as salbutamol sulfate) 100 mcg.

Excipients: oleic acid, ethanol, hydrofluoroalkane 134а.

THERAPEUTIC INDICATIONS

Bronchial asthma:

- arresting bronchial asthma attacks, including cases of exacerbation of severe bronchial asthma;

- prevention of bronchospasm attacks related to an allergen or caused by physical activity;

- administration as one of the components of long-term supportive therapy of bronchial asthma.

Chronic obstructive pulmonary disease (COPD) accompanied with reversible obstruction of the respiratory tract, including chronic bronchitis and pulmonary emphysema.

CONTRAINDICATIONS

- hypersensitivity to any component of the drug;

- management of preterm delivery;

- threatened abortion.

Use the drug with caution in case of history of tachyarrhythmia, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, as well as in pregnancy and lactation.

ADVERSE EFFECTS

The used side effects frequency parameters presented below are classified in the following way: very frequently (>1/10), frequently (from >1/100 to <1/10), infrequently (from >1/1000 to <1/100), rarely (from >1/10000 to <1/1000), very rarely (<1/10000).

Respiratory tract disorders: very rarely – bronchospasm.

Cardiovascular disorders: frequently – tachycardia; very rarely – arrhythmia, supraventricular tachycardia, extrasystole, dilation of peripheral vessels.

Central nervous system disorders: frequently - tremor, headache; very rarely - hyperactivity.

Digestive system disorders: rarely – irritation of oral and pharyngeal mucosa.

Musculoskeletal system disorders: rarely – muscle cramps.

Metabolism disorders: rarely - hypokalemia.

Allergic reactions: very rarely – angioneurotic edema, urticaria.

DOSAGE AND ADMINISTRATION

Metered-dose aerosol Ventacort is designed only for inhalation administration by mouth using the inhalation device. Shake the spray can before each administration.

Adults (including elderly patients) and children over 12 years old:

- arresting a bronchospasm attack: the recommended dose is 100-200 mcg (1-2 inhalations);

- prevention of bronchospasm attacks related to an allergen or caused by physical activity: the recommended dose is 200 mcg (2 inhalations) 10-15 minutes before the exposure to the provoking factor;

- long-term supportive therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times daily.

Children:

- arresting a bronchospasm attack: the recommended dose is 100-200 mcg (1-2 inhalations);

- prevention of bronchospasm attacks related to an allergen or caused by physical activity: the recommended dose is 100-200 mcg (1-2 inhalations) 10-15 minutes before the exposure to the provoking factor;

- long-term supportive therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times daily.

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

Directions for use of the inhalation device (for patients)

Inhalation device check

Before the first administration remove the cap from the mouthpiece, slightly pressing the sides of the cap, and hold the device between the thumb and the fingers of one hand in such a way that the thumb is on the base under the mouthpiece. Shake the device well and release one spray into the air in order to ensure that the device functions properly.

Use of the device

1. Remove the cap from the mouthpiece, slightly pressing the sides of the cap.

2. Examine the device from outside and inside, including the mouthpiece, in order to find foreign objects.

3. Shake the device well so as to make sure that any foreign objects are removed and that the contents of the device are homogeneously mixed.

4. Hold the device between the thumb and the fingers of one hand vertically, bottom up, with the thumb resting on the base under the mouthpiece.

5. Breathe out as fully as possible, then put the mouthpiece into the mouth between the teeth, pressing lips together around the mouthpiece, but not biting it.

6. Right after the beginning of breathing in through the mouth press the tip of the inhalation device in order to start spraying of Ventacort, continuing breathing in deeply and slowly.

7. Holding your breath, remove the device from the mouth and take the thumb off the tip of the device. Continue holding your breath as long as possible.

8. To make the second inhalation, hold the device vertically and approximately in 30 seconds repeat paragraphs 3-7.

9. After the use of the device rinse your mouth with water and spit it out.

10. Immediately close the cap of the mouthpiece by way of pressing and snapping it in the right position. If the cap does not snap, turn the cap of the mouthpiece and try to close it once more. Do not press the cap with force.

The drug may be used via spacer as well.

Attention! Do not hurry, performing paragraphs 5, 6 and 7. Begin breathing in as slowly as possible, just prior to pressing the cap of the device.

It is recommended to practise in front of the mirror for the first several times.

If the patient sees ‘mist’ coming out of the front part of the device of from the corners of the mouth, he should start from paragraph 2 again.

If the doctor gives other instructions on the use of the device, observe these strictly. In case of difficulties in using the device contact the doctor.

Little children cannot use the inhalation device themselves; adults must help them. Wait for the child to breathe out and bring the device into action at the beginning of breathing in. Practise using the device together with the child. Older children and adults with weak hands should hold the device in both hands. Both index fingers should be placed on the upper part of the device, and both thumbs on the base under the mouthpiece.

Cleaning of the inhalation device

Clean the device at least once weekly.

1. Remove the protective cap from the mouthpiece.

2. Do not withdraw the metal can from the plastic jacket.

3. Wipe the mouthpiece inside and outside and the plastic jacket outside with dry cloth or a cotton swab.

4. Cover the mouthpiece with the protective cap.

Do not immerse the metal can in water.

SPECIAL INDICATIONS

Patients should be instructed about the proper use of the inhalation device Ventacort.

Bronchodilators should not be the only or the main component of treatment of unstable or severe bronchial asthma.

If the effect of the usual dose of Ventacort becomes less efficient or shorter (it should persist for at least 3 hours), the patient should contact the doctor.

The increase in the demand for inhalation short-acting β2-adrenergic receptor agonists for control of bronchial asthma indicates exacerbation of the disease. In such cases the treatment plan for the patient should be reviewed. Sudden and progressive deterioration of bronchial asthma may constitute life-threatening situation for the patient, thus in such cases the issue of prescription or increasing of the dose of glucocorticosteroids should be urgently considered. Daily monitoring of the peak expiratory flow rate of such patients should be established.

Exercise caution using Ventacort in patients with thyrotoxicosis.

Therapy with β2-adrenergic receptor agonists, especially in parenteral administration or with the use of a nebulizer, may result in hypokalemia. Exercise extreme caution during treatment of severe bronchial asthma attacks, as in such cases hypokalemia may aggravate as a result of simultaneous administration of xanthine derivatives, glucocorticosteroids and diuretics, and as a result of hypoxia. In such cases serum potassium level control must be established.

PREGNANCY AND LACTATION

Administration of the drug in this category of patients is possible only when the expected benefit for the mother outweighs the potential risk for the fetus or the infant.

MANUFACTURED FORM AND PACKAGE

Metered-dose aerosol inhaler of 200 doses in a metal inhaler with a dosage device with or without a dose indicator.

An inhaler together with a spray device, a protective cap and a leaflet in a carton box.

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