Ventolin: instruction for use
Dosage form
Aerosol for inhalation, metered, 100 mcg / dose, 200 doses
Composition
One dose contains
active substance – salbutamol sulfate 120.5 mcg (equivalent to 100 mcg salbutamol),
excipient – 1,1,1,2-tetrafluoroethane (propellant HFA-134a), ozone-safe.
Description
A homogeneous suspension of white or almost white.
Pharmacotherapeutic group
Drugs for the treatment of obstructive airways diseases. Adrenergic drugs for inhalation use. Selective beta2-adrenomentics. Salbutamol.
ATX Code R03AC02
Pharmacological properties
Pharmacokinetics
Absorption
When using an https://ventolin-albuterol.com/, from 10 to 20% of the dose taken reaches the lower respiratory tract, where it is adsorbed by the lung tissue and enters the lung vessels, but is not metabolized here.
The remainder remains in the delivery device or settles in the oropharynx with further ingestion of the drug.
Distribution
Plasma protein binding is 10%.
Metabolism
When the circulation system reaches the thresholds, salbutamol is metabolized by the hepatic mechanism and excreted mainly in the urine as an unchanged product and phenol sulfate.
Salbutamol is metabolized during the first passage through the liver and, in connection with the ingestion of small amounts during inhalation, in the intestinal wall; the main metabolite is an inactive sulfate conjugate, which is excreted in the urine.
Breeding
T½ salbutamol when administered intravenously is 4-6 hours. Salbutamol is rapidly excreted in the urine as an inactive metabolite of 4’-O-sulfate and unchanged substance; in small quantities excreted in feces. Most of the salbutamol taken is excreted within 72 hours.
Pharmacodynamics
Ventolin® is a selective β2-adrenergic receptor agonist. In therapeutic doses, it affects the β2-adrenergic receptors of the muscles of the bronchi.
Ventolin® has a short duration of action (from 4 to 6 hours) and a quick onset of action (about 5 minutes from the time of use).
Children
Clinical studies in children under 4 years of age have shown a similar safety profile compared to older children, adolescents, and adults.
Indications for use
As part of complex therapy:
- to stop and prevent the development of bronchospasm in patients with reversible airway obstruction (asthma, chronic bronchitis, emphysema)
- to alleviate the symptoms of an attack of bronchial asthma or to prevent them before contact with a known trigger (allergen).
Bronchodilators should not be the only or main component of bronchial asthma therapy. If a patient with asthmadoes not respond to salbutamol therapy, it is recommended to use inhaled corticosteroids to achieve and maintain symptom control. An insufficient response to salbutamol therapy may be a signal for urgent medical intervention / therapy.
Dosage and administration
Ventolin® as an aerosol is used only for inhalation by inhalation of an aerosol through the mouth.
Adults and Seniors
The increased need for β2 agonists may indicate a worsening of asthma. In such cases, it is recommended to re-evaluate the ongoing therapy and consider the possibility of additional administration of GCS.
Due to the risk of adverse reactions if the recommended doses are exceeded, the frequency of administration and the doses used should be increased only as directed by the doctor.
The duration of the action of Ventolin® in most patients is 4-6 hours.
Persons who have difficulty coordinating inspiration and releasing medication from an inhaler can use Ventolin® preprat with a spacer device.
Young children are also better off using Ventolin® through a spacer.
The need for taking the drug should not exceed 4 times a day (800 mg). A sudden increase in the need for the drug indicates poorly correlated asthma or worsening of its course.
Relief of an acute attack of bronchospasm
Adults: From 100 mcg as a single, initial dose. If necessary, the dose can be increased to 200 mcg (2 inhalations)
Children: 100 mcg once. If necessary, the dose can be increased to 200 mcg.
Prevention of bronchospasm caused by physical exertion, or allergic etiology
Adults: 200 mcg before exercise or expected exposure to an allergen
Children: 100 mcg during exercise or expected contact with an allergen, 10-15 minutes before exposure to these factors. If necessary, the dose can be increased to 200 mcg.
Long-term maintenance therapy
Adults and children 100-200 mcg of the drug 4 times a day.
The duration of treatment is determined by the attending physician.
Instructions for use with the inhaler
The effect of the drug may be weakened if the inhaler is cold. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes. The spray can not be disassembled, punctured and thrown into the fire, even if it is empty.
Checking the health of the inhaler
Before the first use of the inhaler, it is necessary to carefully remove the cap from the mouthpiece, shake the inhaler vigorously and spray two doses of the drug into the air to make sure that the device is working. If the inhaler has not been used for 5 days or more, it is necessary to shake it well and spray two doses of the drug into the air to make sure it is working.
Inhaler application
- Remove the protective cap from the mouthpiece of the inhaler. Check the inside and outside of the inhaler, including the mouthpiece, for cleanliness and dryness, as well as for loose parts of the device.
- Vigorously shake the inhaler to evenly mix the contents of the inhaler, as well as to remove all loose parts from the surface of the device.
- Place the inhaler vertically between the thumb and forefinger, placing the thumb on the base, below the mouthpiece.
- Take a deep (as far as possible) exhale. Then place the mouthpiece between your teeth (without biting it) and grip your lips tightly.
- Take a deep breath through your mouth. Continuing to take a deep breath, press the top of the inhaler.
- Hold your breath, remove the inhaler from your mouth and remove your index finger from the top of the inhaler. Continue to hold your breath as far as possible.
- If you need to continue inhalation, you should wait about half a minute, holding the inhaler upright, and then repeat steps 2 through 6.
- After inhalation, carefully put a dust cap on the mouthpiece.
Attention
Take your time when performing the steps specified in paragraphs 4, 5 and 6. It is important that the inhaler is pressed at the beginning of a calm, deep breath. To be sure that the inhalation is done correctly, you must first control the method of taking the medicine in front of the mirror. A “haze” that appears during inhalation from an inhaler, lips or nose indicates an incorrect inhalation technique and it is necessary again, starting from step 2, to practice using the inhaler.
If your doctor has given you any other recommendations for using the drug, follow your doctor’s recommendations. Inform your doctor about any difficulties associated with taking the drug.
Inhaler cleaning
The inhaler should be cleaned at least once a week.
- Remove the metal container from the plastic housing of the inhaler and remove the cap of the mouthpiece.
- Rinse the spray gun with warm running water.
- Thoroughly dry the spray gun inside and out.
- Replace the container and mouthpiece cover.
DO NOT DROP THE METAL CONTAINER IN WATER.
Side effects
Very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1 / 1,000, <1/100), rarely (> 1 / 10,000, <1 / 1,000), very rarely (<1 / 10,000).
Often
- tremor, headache
- tachycardia
Infrequently
- irritation of the oral mucosa and pharynx
- cardiopalmus
- muscle cramps
Seldom
- hypokalemia (therapy with β2-agonists can lead to severe hypokalemia)
- expansion of peripheral vessels
Very rarely
- hypersensitivity reactions, including urticaria, angioedema, bronchospasm, hypotension, collapse
- paradoxical bronchospasm
- lactic acidosis (in patients receiving salbutamol in the form of intravenous injections and through a nebulizer for the treatment of exacerbations of bronchial asthma)
hyperactivity
- arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole
Unknown
Coronary heart disease
Contraindications
- hypersensitivity to any component that is part of the drug
- premature birth
- threatening abortion
- children under 4 years old
Salbumamol release forms not intended for intravenous administration should not be used to terminate preterm birth and a threatened miscarriage.
Drug interactions
It is not recommended to simultaneously use the drug Ventolin® and non-selective β-adrenonoreceptor blockers, such as propranolol.
Ventolin® is not contraindicated in patients who receive monoamine oxidase inhibitors (MAOIs).
Special instructions
Patients should use the inhaler correctly by pressing the inhaler valve at the time of inspiration to ensure optimal delivery of the drug to the lungs. Patients should be warned that upon inhalation, they may experience a different taste compared to the previous inhaler.
Bronchodilators should not be the only or main component of therapy for unstable or severe bronchial asthma. Severe asthma requires regular medical evaluation, including lung function tests, as patients are at risk for severe attacks and even death. For such patients, physicians should consider using the maximum recommended dose of inhaled corticosteroids and / or oral corticosteroid therapy.
Severe exacerbations of asthma should be treated in the usual manner.
When using sympathomimetics, including salbutamol, symptoms of the cardiovascular system may be observed. In post-marketing studies and published literature, rare cases of coronary heart disease associated with salbutamol have been reported. Patients with underlying severe heart disease (e.g., coronary heart disease, arrhythmia, or severe heart failure) who receive salbutamol should be warned of the need to see a doctor if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to evaluating symptoms such as shortness of breath and chest pain, as they may be related to respiratory or cardiovascular diseases.
Asthma treatment is usually carried out in stages, while the patient’s response should be monitored clinically and by functional pulmonary tests.
Dosage or frequency of use can be increased only on the recommendation of a doctor. An increased need for taking β2-agonists with a short duration of action may indicate a worsening of asthma control. In such cases, you should consult a doctor and review the patient’s treatment plan if treatment with a short-acting bronchodilator becomes less effective or there is a need for more inhalations than usual. In this situation, the patient’s condition should be assessed and the need for enhanced anti-inflammatory therapy (for example, higher doses of inhaled corticosteroids or a course of oral corticosteroids) should be considered.
Use the drug with caution in patients with thyrotoxicosis.
Agonist therapy with b2-adrenergic receptors, especially when administered parenterally or with a nebulizer, can lead to hypokalemia. Special caution is advised in the treatment of severe asthma attacks, since in these cases hypokalemia may be aggravated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics as well as due to hypoxia. In such situations, it is necessary to control the level of potassium in the blood serum.
As in the case of the use of other inhaled drugs, it is possible to develop paradoxical bronchospasm with a direct increase in shortness of breath after a dose. If a paradoxical bronchospasm occurs, its immediate relief is required using an alternative drug or a fast-acting inhaled bronchodilator from another pharmacological group. You should immediately stop treatment with this form of Ventolin®, assess the condition of the patient and, if necessary, prescribe other fast-acting bronchodilators for further use.
If the action of the usual dose of Ventolin® becomes less effective or shorter (the effect of the drug should last at least 3 hours), the patient should consult a doctor.
Fertility
There is no data on the effect of the drug on human fertility. The drug does not adversely affect the fertility of animals.
Pregnancy and lactation
The use of the drug during pregnancy and lactation is justified only if the expected benefit to the mother outweighs the risk to the fetus / baby. Salbutamol is probably excreted in breast milk, should be carefully considered the issue of its appointment to lactating women.
In separate studies, polydactyly and cleavage of the palate in children and disorders of the cardiovascular system were observed against the background of maternal use during pregnancy of drugs, among which was salbutamol (there is no clear causal relationship between their occurrence and the use of the drug), and therefore the degree of risk estimated as 2-3%. In experimental studies, the presence of the teratogenic effect of salbutamol was found: in mice with sc administration (doses 11.5-115 times higher than the maximum recommended in humans for inhalation administration), the development of a “cleft palate” was noted; in rabbits, when administered orally (doses 2315 times higher than the maximum for inhalation) – non-closure of the bones of the skull.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
No data.
Overdose
Symptoms: Most symptoms of an overdose of salbutamol are transient adverse reactions of beta-agonists. The most common signs and symptoms of an overdose of salbutamol are short-term effects pharmacologically mediated by beta-agonists, such as tachycardia, tremor, hyperactivity and metabolic effects, including hypokalemia. In case of an overdose, hypokalemia may develop, and therefore monitoring of the level of potassium in the blood serum is necessary.
With the use of high therapeutic doses and an overdose of short-acting beta-agonists, the development of lactic acidosis was revealed.
Treatment: the use of large doses of salbutamol can cause hypokalemia, so if you suspect an overdose, you should monitor the level of potassium in the blood serum. It is necessary to control the level of lactate and the subsequent development of metabolic acidosis (especially in the presence or worsening of tachypnea despite the elimination of bronchospasm, such as wheezing).
Release form and packaging
Aerosol for inhalation, metered, 100 mcg / dose, 200 doses.
200 doses are placed in an aluminum cylinder equipped with a metering valve, spray nozzle and protective cap. For 1 cylinder, together with instructions for medical use in the state and Russian languages, they are placed in a pack of cardboard.
Storage conditions
Store at a temperature not exceeding 30 ºС.
Protect from light and hypothermia.
Keep out of the reach of children!
Shelf life
2 years
Do not use after the expiration date.
Pharmacy Vacation Terms
On prescription
Manufacturer
Glaxo Wellcome Production, France
23, rue Lavoisier, 27091 EVREUX Cedex 9