Instructions for medical use medicine
Salbutamol
Tradename
Salbutamol
International nonproprietary name
Salbutamol
Dosage form
Aerosol for inhalation, dosed, 100 mcg/dose, 200 doses
Compound
One dose contains
active substance - salbutamol sulfate 120.5 mcg (equivalent to salbutamol 100 mcg),
excipient- 1,1,1,2-tetrafluoroethane (HFA-134a propellant), ozone-safe.
Description
Homogeneous suspension of white or almost white color.
Pharmacotherapeutic group
Drugs for the treatment of obstructive diseases respiratory tract. Inhalation sympathomimetics. Beta 2-adrenergic agonists are selective. Salbutamol.
ATX code R03AC02
Pharmacological properties
Pharmacokinetics
When using an aerosol, 10 to 20% of the dose taken reaches the lower respiratory tract, where it is adsorbed by the lung tissue and penetrates the blood vessels of the lungs, but is not metabolized here. The remaining part remains in the delivery device or settles in the oropharynx with further ingestion of the drug.
Maximum plasma concentrations are reached after 2-4 hours.
Plasma protein binding is 10%.
When thresholds are reached by the circulatory system, salbutamol is metabolized through the hepatic mechanism and is excreted primarily in the urine as unchanged product and phenol sulfate.
Salbutamol is metabolized during the first passage through the liver and, due to the ingestion of small quantities during inhalation, in the intestinal wall; the main metabolite is an inactive sulfate conjugate, which is excreted in the urine.
T ½ salbutamol at intravenous administration is 4-6 hours. Salbutamol is rapidly excreted in the urine as an inactive metabolite 4'-O-sulfate and unchanged substance; excreted in small quantities in feces. Most of Salbutamol taken is excreted from the body within 72 hours. Salbutamol does not cross the blood-brain barrier.
Pharmacodynamics
Salbutamol is a selective β 2 -adrenergic receptor agonist. IN therapeutic doses stimulates β 2 -adrenergic receptors of the bronchial muscles, providing a bronchodilator effect.
Salbutamol has a short duration of action (4 to 6 hours) and a rapid onset of action (about 5 minutes from the moment of application).
Children
Clinical studies conducted in children under 4 years of age have demonstrated a similar safety profile compared to older children, adolescents and adults.
Indications for use
- relief and prevention of the development of bronchospasm in patients with reversible airway obstruction (asthma, chronic bronchitis, emphysema)
To relieve symptoms of an attack bronchial asthma or warning them before contact with a known trigger (allergen). Bronchodilators should not be the only or main component of asthma therapy. If a patient with asthma does not respond to salbutamol therapy, inhaled corticosteroids are recommended to achieve and maintain symptom control. Insufficient response to salbutamol therapy may be a signal for urgent medical intervention/therapy.
Directions for use and doses
Salbutamol in aerosol form is used only for inhalation by inhaling the aerosol through the mouth.
An increased need for β 2 -agonists may indicate a worsening of asthma. In such cases, it is recommended to re-evaluate the therapy and consider the possibility of additional administration of GCS.
Due to the risk of adverse reactions if recommended doses are exceeded, the frequency of administration and doses used should be increased only as directed by a doctor.
Pduration of actiondrug Calbutamol in most patientsamounts to4-6 hours
Individuals who have difficulty coordinating inhalation and release of medication from an inhaler may use the drug Salbutamol using a spacer-like device.
The need to take the drug should not exceed 4 times a day (800 mg). A sudden increase in the need for the drug indicates a worsening of asthma.
Relief of an acute attack of bronchospasm
Adults: from 100 mcg to 200 mcg of the drug Salbutamol once.
Children: 100 mcg once. If necessary, the dose can be increased to 200 mcg.
Warning exercise-induced bronchospasm or allergic etiology
Adults: 200 mcg up to physical activity or expected contact with an allergen
Children: 100 mcg before physical activity or expected contact with an allergen. If necessary, the dose can be increased to 200 mcg.
Long-term maintenance therapy I
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 using the inhaler
The effect of the drug may be weakened if the inhaler is cold. When the canister cools, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes. The can cannot be disassembled, pierced or thrown into fire, even if it is empty.
Checking the functionality of the inhaler
Before using the inhaler for the first time, you must carefully remove the cap from the mouthpiece, shake the inhaler vigorously and spray two doses of the drug into the air to ensure that the device is working properly. If the inhaler has not been used for 5 days or more, it should be shaken well and two doses of the drug sprayed into the air to ensure that it is working properly.
Using an inhaler
1. Remove the protective cap from the inhaler mouthpiece. Check the inside and outside of the inhaler, including the mouthpiece, for cleanliness and dryness, and for any loose parts of the device.
2. Shake the inhaler vigorously to evenly mix the contents of the inhaler and to remove any loose parts from the surface of the device.
3. Place the inhaler vertically between the thumb and forefinger, placing thumb on the base, below the mouthpiece.
4. Exhale deeply (as far as possible). Then place the mouthpiece between your teeth (without biting it) and wrap your lips tightly around it.
5. Take a deep breath through your mouth. While continuing to take a deep breath, press the top of the inhaler.
6. Hold your breath, remove the inhaler from your mouth and put it away forefinger from the top of the inhaler. Continue to hold your breath as much as possible.
7. If you need to continue inhalation, you should wait approximately half a minute, holding the inhaler vertically, and then repeat steps 2 to 6.
8. After inhalation, carefully place the dust cap on the mouthpiece.
Attention
Take your time when performing the steps indicated in points 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 performed correctly, you must first control the method of taking the medicine in front of a mirror. A “haze” appearing from the inhaler, lips or nose during inhalation indicates an incorrect inhalation technique and it is necessary to practice using the inhaler again, starting from point 2.
If your doctor has given you any other recommendations for using the drug, follow your doctor's recommendations. Tell your doctor about any difficulties you have with taking the drug.
Cleaning the inhaler
The inhaler should be cleaned at least once a week.
1. Remove the metal container from the plastic body of the inhaler and remove the mouthpiece cover.
2. Rinse the sprayer with warm running water.
3. Dry the sprayer thoroughly inside and out.
4. Place the container and mouthpiece cover back into place.
DO NOT IMMERSE THE METAL CONTAINER INTO WATER.
Side effects
Very often (>1/10), often (>1/100,<1/10), нечасто (>1/1,000, <1/100), редко (>1/10,000, <1/1,000), очень редко (<1/10,000).
Often
Tremor, headache
Tachycardia
Infrequently
Irritation of the mucous membrane of the mouth and pharynx
Feeling of heartbeat
Muscle cramps
Rarely
Hypokalemia (beta 2 agonist therapy may lead to severe hypokalemia)
Peripheral vasodilation
Very rarely
Hypersensitivity reactions including urticaria, angioedema, bronchospasm, hypotension, collapse
Paradoxical bronchospasm
Lactic acidosis (in patients receiving salbutamol by intravenous injection and nebulizer to treat exacerbations of asthma)
Hyperactivity
Arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole
Providing data on suspected adverse drug reactions is very important to enable continuous monitoring of the risk/benefit ratio of the drug. Health care professionals should provide information about any suspected adverse reactions to the contacts listed at the end of the prescribing information and through the national reporting system.
Contraindications
Hypersensitivity to any component of the drug
Premature birth
Threatened abortion
Forms of salbutamol not intended for intravenous administration should not be used to terminate premature labor and threatened miscarriage.
Drug interactions
Salbutamol is not contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).
special instructions
For children under 4 years of age, Salbutamol is administered through a spacer.
Treatment of asthma is usually done in stages, with the patient's response monitored clinically and with pulmonary function tests.
An increased need for β2-agonists may indicate worsening asthma control. In such cases, the patient's treatment plan should be reconsidered.
A sudden and progressive deterioration of bronchial asthma can pose a threat to the patient's life, so in such situations it is necessary to urgently decide on the issue of prescribing or increasing the dose of glucocorticosteroids. In such patients, daily monitoring of peak expiratory flow is recommended.
The drug should be used with caution in patients with thyrotoxicosis, heart failure, myocardial ischemia, tachyarrhythmia, hypertrophic cardiomyopathy.
Patients with cardiovascular diseases, including a history of, for example, coronary heart disease, arrhythmia or severe heart failure, when prescribed salbutamol, should be warned that they must consult a doctor in the event of chest pain or other symptoms of exacerbation of cardiovascular disease. vascular disease. Symptoms such as shortness of breath and chest pain should be carefully assessed as they may be due to both cardiovascular and bronchopulmonary dysfunction.
Therapy with b 2 -adrenergic agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia. Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the level of potassium in the blood serum.
As is the case with the use of other inhaled drugs, the development of paradoxical bronchospasm is possible as a result of the occurrence of a spasm immediately after dosing. If paradoxical bronchospasm occurs, immediate relief is required using an alternative drug or a fast-acting inhaled bronchodilator from a different pharmacological group. You should immediately stop treatment with this form of Salbutamol, and, if necessary, prescribe other fast-acting bronchodilators for further use.
If the effect of the usual dose of Salbutamol becomes less effective or shorter lasting (the effect of the drug should last at least 3 hours), the patient should consult a doctor.
The physician must ensure that the patient is using the inhaler correctly and that there is timing between actuation and inhalation for optimal delivery of the drug to the lungs.
Salbutamol should be used with caution in patients who have already taken high doses of other sympathomimetics.
Like other beta-adrenergic agonists, salbutamol can cause reversible metabolic changes, such as an increase in blood glucose concentrations. Patients with diabetes may develop decompensation, and in some cases, the development of ketoacidosis. Concomitant use of glucocorticosteroids may enhance this effect.
When used intravenously, as well as when using a nebulizer solution of short-acting beta-agonists, very rare cases of lactic acidosis associated with high therapeutic doses in patients with exacerbation of bronchial asthma have been described. Increased lactate levels lead to shortness of breath and compensatory hyperventilation, which can be misinterpreted as symptoms of improperly treated asthma. This may lead to erroneous increases in doses of short-acting beta-agonists, so monitoring for increased serum lactate and therefore metabolic acidosis is recommended.
Fertility
There is no data on the effect of the drug on fertility in humans. The drug does not have a negative effect on 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/infant. Salbutamol is likely excreted in breast milk.
In some studies, polydactyly and cleft palate were identified in children when mothers took drugs during pregnancy, including salbutamol (a clear causal relationship between their occurrence and drug use has not been established), and therefore the risk is estimated at 2-3%. Experimental studies revealed the presence of a teratogenic effect of salbutamol: in mice with subcutaneous 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 administration) - non-fusion of the skull bones.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
Considering the possible side effects, you must be careful when driving a vehicle and driving potentially dangerous machinery.
Overdose
Symptoms: Most symptoms of salbutamol overdose are transient adverse reactions of beta-agonists.
In case of overdose, hypokalemia may develop, and therefore monitoring of potassium levels in the blood serum is necessary.
When using high therapeutic doses and overdose with short-acting beta-agonists, the development of lactic acidosis was detected.
Treatment: the use of large doses of salbutamol can cause hypokalemia, therefore, if overdose is suspected, serum potassium levels should be monitored. Monitoring of lactate levels and the subsequent development of metabolic acidosis is necessary (especially in the presence or worsening of tachypnea despite the elimination of bronchospasm).
Release form and packaging
Aerosol for inhalation, dosed, 100 mcg/dose, 200 doses.
200 doses are placed in an aluminum container equipped with a dosing valve, a spray nozzle and a protective cap. 1 cylinder, along with instructions for medical use in the state and Russian languages, is placed in a cardboard pack.
Storage conditions
Store at a temperature not exceeding 30 ºС.
Protect from light and hypothermia.
Keep out of the reach of children!
Shelf life
Do not use after the expiration date.
Conditions for dispensing from pharmacies
On prescription
Manufacturer
Packer
Glaxo Wellcome Production, France
Zone Idustrelle n`2, 23 rue Lavoisier, 27000 EVREUX
Registration Certificate Holder
GlaxoSmithKline Laboratories, France
Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan
Representative office of GlaxoSmithKline Export Ltd in Kazakhstan
050059, Almaty, Furmanov st., 273
Phone number: +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
E-mail address: [email protected]
Have you taken out sick leave due to back pain?
How often do you face the problem of back pain?
Can you tolerate pain without taking painkillers?
Find out more how to deal with back pain as quickly as possible
Beta-adrenergic agonist with a predominant effect on 2-adrenergic receptors.
Drug: SALBUTAMOL
Active substance of the drug:
salbutamol
ATX coding: R03CC02
CFG: Bronchodilator - beta2-adrenergic agonist
Registration number: P No. 015633/01
Registration date: 04/28/04
Owner reg. credential: WARSAW PHARMACEUTICAL WORK POLFA S.A. (Poland)
Salbutamol release form, drug packaging and composition.
Pills
1 tab.
salbutamol
2 mg
15 pcs. — cellular contour packaging (2) — packs.
Pills
1 tab.
salbutamol
4 mg
30 pcs. - bottles (1) - packs.
DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.
Pharmacological action Salbutamol
Beta-adrenergic agonist with a predominant effect on 2-adrenergic receptors (localized, in particular, in the bronchi, myometrium, blood vessels). Prevents and relieves bronchospasm; reduces resistance in the respiratory tract, increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. Compared to other drugs in this group, it has a less pronounced positive chrono- and inotropic effect on the myocardium. Causes expansion of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect, reducing the tone and contractile activity of the myometrium.
Pharmacokinetics of the drug.
When using an aerosol, rapid absorption of salbutamol into the blood is observed; however, its plasma concentrations when used at recommended doses are very low or do not reach the detection limit.
After oral administration, salbutamol is well absorbed from the gastrointestinal tract. Plasma protein binding is 10%. Metabolized on first pass through the liver and possibly in the intestinal wall; the main metabolite is an inactive sulfate conjugate. Salbutamol is not metabolized in the lungs, so its ultimate metabolism and elimination after inhalation depends on the route of administration, which determines the ratio between inhaled and inadvertently ingested salbutamol.
T1/2 from blood plasma is 2-7 hours. Salbutamol is quickly excreted in the urine in the form of metabolites and unchanged substance; excreted in small quantities in feces.
Indications for use:
Prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible airway obstruction in chronic bronchitis and emphysema, broncho-obstructive syndrome in children.
Threatened premature birth with contractile activity of the uterus; childbirth before 37-38 weeks of pregnancy; isthmic-cervical insufficiency, a decrease in fetal heart rate depending on uterine contractions during periods of cervical dilatation and expulsion. For preventive purposes during operations on the pregnant uterus (application of a circular suture in case of insufficiency of the internal os of the uterus).
Dosage and method of administration of the drug.
Orally as a bronchodilator for adults and children over 12 years of age - 2-4 mg 3-4 times a day, if necessary, the dose can be increased to 8 mg 4 times a day. Children aged 6-12 years - 2 mg 3-4 times a day; children 2-6 years old - 1-2 mg 3 times a day.
When administered by inhalation, the dose depends on the dosage form used, the frequency of use depends on the indications and the clinical situation.
As a tocolytic agent, it is administered intravenously in a dose of 1-2 mg.
Side effects of Salbutamol:
From the cardiovascular system: transient dilatation of peripheral vessels, moderate tachycardia.
From the central nervous system: headache, dizziness, nausea, vomiting.
Metabolism: hypokalemia.
Allergic reactions: in isolated cases - angioedema, allergic reactions in the form of skin rash, urticaria, arterial hypotension, collapse.
Other: tremor of the hands, internal trembling, tension; rarely - paradoxical bronchospasm, muscle cramps.
Contraindications to the drug:
Threat of miscarriage in the first and second trimesters of pregnancy, premature placental abruption, bleeding or toxicosis in the third trimester of pregnancy; children under 2 years of age; hypersensitivity to salbutamol.
Use during pregnancy and lactation.
Salbutamol is contraindicated in cases of threatened miscarriage in the first and second trimesters of pregnancy, premature placental abruption, bleeding or toxicosis in the third trimester of pregnancy.
If it is necessary to use salbutamol during pregnancy, the expected benefits of treatment for the mother should be weighed against the potential risk to the fetus. Currently, there is insufficient data on the safety of the use of salbutamol in early pregnancy. Salbutamol is excreted in breast milk, so if it is necessary to use it during lactation, the expected benefits of treatment for the mother and the possible risk for the child should also be assessed.
Special instructions for the use of Salbutamol.
Use with caution for tachyarrhythmias and other heart rhythm disorders, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes mellitus, thyrotoxicosis, glaucoma, acute heart failure (subject to careful medical supervision).
Increasing the dose or frequency of taking salbutamol should be done under the supervision of a physician. Reducing the interval is possible only in exceptional cases and must be strictly justified.
When using salbutamol, there is a risk of developing hypokalemia, therefore, during treatment in patients with severe bronchial asthma, the level of potassium in the blood should be monitored. The risk of hypokalemia increases with hypoxia.
Interaction of Salbutamol with other drugs.
With simultaneous use of salbutamol with non-cardioselective beta-blockers, mutual suppression of therapeutic effects is possible; with theophylline - the risk of developing tachycardia and arrhythmia, in particular supraventricular extrasystole, increases.
With the simultaneous use of salbutamol and xanthine derivatives, corticosteroids or diuretics, the risk of developing hypokalemia increases.
Salbutamol is a drug from the group of 2-adrenergic agonists. Has a bronchodilator effect. It is characterized by a quick effect that begins after 1–3 minutes. The maximum therapeutic effect is observed at 20 minutes and lasts for 5 hours. It is advisable to use inhalations with Salbutamol only on the recommendation of a doctor.
Composition and release form
The components of the drug are:
- Salbutamol phosphate is the active ingredient.
- Hydrofluoroalkane and ethanol are the active ingredients.
The drug is available in several forms:
- film-coated tablets;
- powder for inhalation;
- aerosol for inhalation.
The aerosol is in special cans; each Salbutamol inhaler contains 200 doses.
Sulbatamol preparations can also be produced in the form of:
- capsules for inhalation containing powder;
- concentrate intended for infusion solution;
- syrup;
- retard tablets;
- solution for injection.
Indications for use
Salbutamol preparations have a pronounced bronchodilator effect.
After using the drug, a number of positive factors are noted:
- suppression of bronchial reactivity;
- improving the functioning of the bronchi;
- decreased resistance in the respiratory tract;
- mucus production;
- dilatation of the coronary arteries of the heart muscle;
- sputum discharge.
Unlike other drugs with a similar mechanism of action, Salbutamol does not have a significant effect on the heart and does not reduce blood pressure.
Indications for use of the drug are:
- and bronchitis;
- bronchospasm in all types of bronchial asthma;
- emphysema;
- premature birth, which is not accompanied by complications.
In some cases, pediatricians prescribe Salbutamol solution to treat broncho-obstructive syndrome.
The instructions for use indicate that the drug is indicated for long-term maintenance treatment of bronchitis, as well as nocturnal asthma attacks.
Instructions for use
The dosage of the drug depends on the patient’s age and diagnosis.
If Salbutamol aerosol is involved in the complex treatment of bronchial asthma in a child over 12 years of age, the recommended dose is 100 mcg. Inhalations must be carried out every 6 hours. For young patients from 2 to 12 years old, no more than three inhalations per day are recommended.
The drug is also prescribed to relieve severe attacks in children. The recommended dosage is 1–2 inhalations of the aerosol. Salbutamol is often prescribed to prevent asthma attacks, the likelihood of which increases with intense physical activity or as a result of a collision with an allergen. In this case, it is recommended to carry out inhalation 10–15 minutes before the intended action or contact. In this case, the dosage of the drug remains the same (1-2 breaths).
To eliminate attacks of bronchial asthma, inhalations with Salbutamol through a nebulizer are also prescribed.
Before the inhalation procedure, it is necessary to check the device for serviceability. This is done as follows:
- the cap is removed from the device, then the outlet tube is checked for dust and dirt;
- the can is installed in a vertical position and shakes well;
- the medicine is placed in a nebulizer.
Then the inhalation procedure begins:
- the patient takes a deep breath, throws his head up and firmly clamps the outlet tube with his lips;
- Inhaling slowly and deeply, you need to press the valve of the canister, thus releasing a dose of medicine;
- slowly remove the tube from your mouth, hold your breath for 10 seconds and exhale through your nose.
If you need to take more than 1 dose of Salbutamol during one inhalation procedure, you should repeat all the steps described above, but only after a minute pause. The can is then closed with a cap.
When using an inhaler with Salbutamol, to achieve maximum effectiveness, it is important to follow these recommendations:
- do not rush when releasing the medicine;
- inhale air slowly;
- Before the procedure, it is advisable to practice in front of a mirror.
The duration of inhalation does not exceed 5 minutes. After the procedure, it is necessary to rinse the device thoroughly, carefully removing any remaining solution.
It is important to remember that the initial dosage of Salbutamol should not exceed 2 mg. In severe cases, inhalation of Salbutamol can be carried out every 6 hours. In especially severe cases, the use of Salbutamol solution is possible every 60 minutes. The effect is observed 10 minutes after the procedure.
Possible side effects
Taking the drug Salbutamol can cause disturbances in the functioning of the cardiovascular system, as well as in the functioning of other organs and systems.
Based on the frequency of occurrence, side effects of Salbutamol can be divided into 3 groups. The first includes:
- tremor of the limbs (usually fingers);
- internal trembling throughout the body;
- cardiopalmus;
- sleep disturbance.
The second group of side effects is expressed by the following symptoms:
- migraine that does not respond to painkillers;
- change in taste perceptions;
- decreased performance;
- increased irritability;
- skin rash;
- hyperemia;
- inhibition of thought processes;
- gagging.
The third group includes symptoms that occur extremely rarely. This is often associated with chronic diseases that are not related to the respiratory system. These symptoms are:
- cough;
- panic attacks and causeless anxiety;
- aggressiveness;
- hallucinations;
- angioedema;
- convulsions;
- allergic reaction in the form of skin rashes;
- urinary retention;
- heart collapse;
- hyperactivity;
- supraventricular tachycardia;
- irritation of mucous membranes.
The severity of possible manifestations depends on what form of the drug the patients use. Aerosol Salbutamol reduces the risks of negative effects on the body to a minimum. The main thing is to follow the instructions and follow the doctor's recommendations.
The effect of the drug on the body also depends on the age of the patient and his individual characteristics. In case of hypersensitivity to the components of Salbutamol, you must immediately stop using it.
Contraindications
The drug is prescribed with extreme caution for:
- hyperthyroidism;
- tachycardia;
- dysfunction of the endocrine gland;
- hypertension.
If you have hypertension, the drug should be taken with caution.
It is prohibited for persons with individual intolerance and children under two years to take Salbutamol.
- liver failure;
- heart disease;
- diabetes;
- thyrotoxicosis;
- glaucoma;
- renal failure;
- myocarditis;
- tachyarrhythmia;
- blockage of the lumen of the cardiac artery;
- aortic stenosis;
- epilepsy.
During pregnancy with aggravated medical history, Salbutamol is also not prescribed. The drug can cause maximum harm to the child in the later stages.
During breastfeeding, the decision on the advisability of taking Salbutamol inhalations is made by the attending physician, who compares the risks to the child’s health and the consequences of refusing the drug. It is important to remember that the components of Salbutamol tend to penetrate into breast milk and accumulate in it.
Children from 2 to 12 years old must be supervised by medical personnel throughout treatment.
special instructions
The negative effect of Salbutamol on driving a car has not been proven. But it is better to avoid driving before determining tolerability of the drug.
If the patient feels a decrease in the effectiveness of the drug, but the dosage and frequency of doses remain the same, it is necessary to consult with your doctor. In the event of a paradoxical spasm, treatment with Salbutamol is immediately canceled, and the resulting spasm is relieved with the help of another bronchodilator. Further treatment tactics are being reviewed.
An overdose of Salbutamol can cause uncontrolled bronchospasm, which in rare cases can be fatal. The greatest caution should be exercised in patients with asthma, especially in childhood. The interval between administration of Salbutamol should not be less than 6 hours. Reducing the time between procedures is possible only in severe cases on the recommendation of a doctor.
The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!
Salbutamol belongs to the group of drugs of synthetic origin. According to its clinical and pharmacological action, it belongs to the anti-inflammatory group, beta2-adrenergic agonists and mucolytics with a bronchodilator effect. The drug is used to eliminate and prevent suffocating attacks in bronchial asthma. Refers to medicines for emergency medical care.Compound
The main active ingredient of the drug is salbutamol(per 100 mg - 0.0725 mg). Excipient – cetyl oleate (per 100 mg - 0.1449 mg). The aerosol form contains the following components: fluorotrichloromethane (per 100 mg - 35.64 mg), difluorochloromethane (per 100 mg - 64.15 mg), as well as oleic acid and ethanol. Release form
Salbutamol and other medicines in which it is present as an active ingredient are produced in aerosol form. The drug is contained in an aluminum cylinder equipped with a valve with a dispenser. When pressed, the product is sprayed at the rate of 0.1 mg of the drug (1 dose) in the form of tiny particles. Pharmaceutical companies also produce Salbutamol in tablets with different dosages of Salbutamol (2 and 4 mg). In some cases, it is advisable to use Salbutamol in the form of a solution for intravenous drip injection.pharmachologic effect
The therapeutic dose of the drug has a pronounced stimulating effect on the beta2-adrenergic receptors of the surface of the bronchi, on the muscles of the uterus and blood vessels. Prevents the release of biologically active substances from mast cells for a long time. Helps increase the vital capacity of the lungs, prevents the development of bronchial spasms, and if they occur, stops them, being fast-acting. Eliminates resistance in the lumen of the respiratory tract and suppresses bronchial reactivity. Taking the drug improves the process of sputum discharge, activates the work of ciliated epithelial cells, and prevents the formation of bronchospasm of allergic origin. In some cases, it affects the production of insulin and the breakdown of glycogen, and reduces the level of potassium concentration in plasma. In patients with bronchial asthma, it often provokes an increase in blood glucose and accelerates the breakdown of lipids (this aspect is important in diabetes mellitus).
When using recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and does not increase blood pressure. Causes a slight dilation of the coronary vessels of the heart.
The therapeutic effect occurs in the first minutes of use. The maximum time to achieve the effect is 30-60 minutes, the duration of action is up to three hours. Taking the drug in tablets promotes a more prolonged action (up to 6-8 hours), but the therapeutic effect occurs no earlier than after 30 minutes.
Indications for use
- Prevention of possible complications in the form of bronchospasm and its relief in any form of bronchial asthma.
- Obstructive processes (blockage or narrowing of the lumen of the bronchi) of a reversible nature in the respiratory tract with emphysema and chronic bronchitis.
- Broncho-obstructive syndrome in childhood.
Salbutamol - instructions for use
When prescribing the drug Salbutamol in aerosol form, one or two presses on the valve are recommended (i.e. 1-2 doses per dose). As a rule, this is enough to stop an attack. If the effect does not occur within 5-10 minutes, repeated administration of the drug in the same dose is allowed. The next inhalation is possible after 4-6 hours, but no more than six times a day. The drug in tablet form is prescribed to adults three times a day (1 tablet per dose). Test with Salbutamol
Chronic diseases of the respiratory tract (obstruction, bronchitis, asthma, etc.) lead to a decrease in the vital capacity of the lungs. One of the most important methods for diagnosing such diseases is to assess the dynamics of the indicator responsible for forced expiratory volume per second (FEV 1). With a tendency to fall, several studies over the course of a year confirm the presence of obstructive processes in the lungs. To study the reversibility of obstruction, tests are carried out with the drug Salbutamol. With positive dynamics, reflecting an increase in FEV 1 by more than 15%, the test confirms the presence of reversible obstruction. Most often, with the above diseases, such a result is quite expected.Contraindications
Salbutamol is not recommended for use in children. Age restrictions have a direct connection with the form of release of the drug. For example, the use of aerosols is prohibited for children under 2 years of age, and inhalation powder for children under 4 years of age. Individual intolerance to the main components of the drug and increased sensitivity of the body are also contraindications. During pregnancy, the use of Salbutamol is carried out only under the supervision of a physician.Side effects
- Frequently encountered: trembling inside, trembling of hands, emotional stress, tachycardia.
- Less common: headache, dizziness, peripheral cerebral vasodilatation, nausea, vomiting or urge to do so.
- In some cases: allergic reactions, angioedema, decreased blood pressure, bronchospasm, cardiovascular failure.
- Rarely: panic states, hallucinations, bronchospasm as a result of excessive use.
Salbutamol during pregnancy
For pregnant women suffering from bronchial asthma, taking the drug Salbutamol is recommended strictly in therapeutic doses. Previously, pregnancy was prohibited for women with this pathology. Nowadays, thanks to the existence of drugs that support and stop seizures, there is every chance of giving birth to a healthy child.Salbutamol is successfully used during pregnancy and in other cases (premature birth, placental insufficiency). It should be remembered that the drug should be taken under the supervision of specialists, because There are some restrictions associated with taking Salbutamol. The threat of miscarriage in the 2nd and 3rd trimester of pregnancy and the relaxing effect of the drug on the muscular layers of the uterus are among these limitations. Salbutamol belongs to a group of drugs that are used only if the benefits of taking it outweigh the possible risk to the health of the fetus.
Berodual or Salbutamol?
Both drugs are classified as emergency medicines. The bronchodilator effect is characteristic of both Salbutamol and Berodual. The pharmacological effects of the drugs are identical to each other. However, Berodual contains not only a beta2-adrenergic agonist, but also an m-anticholinergic blocker. This complex enhances the antispasmodic effect on the smooth muscles of the bronchi. The therapeutic effect of Berodual is achieved within 15 minutes, which significantly distinguishes it from the fast-acting Salbutamol. The contraindications and side effects of the drugs are the same; the decision on the need to take it in both cases is decided by the attending physician. Interaction with other drugs
Concomitant use of Salbutamol with drugs whose action is aimed at treating angina pectoris (non-cardioselective beta-blockers) leads to possible mutual suppression, i.e. the therapeutic effect does not occur. Salbutamol in combination with theophylline increases the risk of arrhythmia and tachycardia. When taken simultaneously with diuretics and glucocorticosteroids, the risk of reducing potassium levels in the blood increases.Synonymous drugs
Pharmaceutical manufacturers have created a number of medicines that are synonymous with Salbutamol in terms of therapeutic effect. Replacing one product with another is carried out only after consultation with your doctor. Here are several analogues of the drug Salbutamol:- Ventolin is used to relieve asthma attacks in diseases of the bronchopulmonary system, which are accompanied by obstructive phenomena (bronchial asthma, chronic obstructive pulmonary disease, bronchitis, etc.). For prophylactic purposes: prevention of spasms in the bronchi associated with physical activity or the action of allergens. Used as part of complex therapy aimed at maintaining normal functioning in bronchial asthma.
- Astalin – prevention and treatment of bronchospasms, chronic obstructive bronchitis, pulmonary emphysema.
- Ventilor is an emergency aid for exacerbation of bronchial asthma (bronchospasm).
- Salbuhexal – prevention of bronchospasm, relief of attacks, treatment of emphysema and chronic obstructive bronchitis.
- Salamol – prevention and relief of attacks during exacerbation of bronchial asthma.
Aerosol for inhalation dosed.
Pharmacological group
Selective agonists of β 2 -adrenergic receptors. ATC code R03A C02.
Indications
Treatment and prevention of bronchospasm in bronchial asthma, chronic obstructive bronchitis and emphysema. Long-term treatment of patients with bronchial asthma (as part of complex therapy).
Contraindications
Hypersensitivity to the components of the drug.
Age up to 4 years.
Directions for use and doses
The drug is used only by inhalation to inhale the drug through the mouth.
To relieve bronchospasm attacks in adults, the dose is 100 - 200 mcg (1-2 doses), which, if necessary, is repeated up to 3-4 times a day. The maximum dose is 800 mcg (8 doses) per day.
To relieve bronchospasm attacks in children over 4 years of age, the dose of the drug is 100 mcg; if necessary, it is increased to 200 mcg (2 doses). The maximum dose is 400 mcg (4 doses) per day.
To prevent bronchospasm attacks associated with the influence of an allergen or caused by physical activity, 200 mcg of the drug is prescribed 15 minutes before exposure to the provoking factor. For children, the dose is 100 mcg once.
For long-term maintenance therapy, adults and children over 4 years of age are prescribed 100 - 200 mcg (1-2 doses) of the drug up to 4 times a day.
Before using the aerosol, shake the container and press the dosing valve once or twice.
To use the drug, you should perform the following steps:
If you are prescribed a repeat dose, wait 1 minute and follow the steps described above, starting from point 2.
A spacer can be used for inhalation.
Note. Rinse the spray nozzle with running water once a week. Before doing this, carefully remove the aluminum container. Avoid getting water on the container.
Adverse reactions
From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, arterial hypotension and collapse.
Metabolic disorders: rarely - hypokalemia.
From the nervous system: often - tremor (especially hand tremor), headache.
From the cardiovascular system: tachycardia, very rarely - cardiac arrhythmia, including ventricular fibrillation, supraventricular tachycardia and extrasystole; rarely - peripheral vasodilation.
From the respiratory system: very rarely - paradoxical bronchospasm. In this case, inhaled salbutamol should be stopped immediately and alternative forms of the drug or other fast-acting inhaled bronchodilators should be immediately prescribed.
From the digestive system: irritation of the mucous membranes of the mouth and pharynx.
From the musculoskeletal system: rarely - muscle cramps.
Overdose
Symptoms of overdose may include excessive stimulation of β-adrenergic receptors and/or side effects of varying severity. An overdose can be manifested by tachycardia, arrhythmia, arterial hypotension or hypertension, sleep disturbance, pain in the chest, tremors of the hands and whole body, agitation, and increased fatigue.
Treatment. Salbutamol should be discontinued and appropriate symptomatic therapy should be initiated. The antidote of choice for salbutamol overdose is a cardioselective β-blocker. Drugs in this group should be prescribed with caution to patients with a history of bronchospasm. Due to an overdose of salbutamol, hypokalemia may occur, so it is necessary to control the level of potassium in the blood serum.
Use during pregnancy or breastfeeding
The drug can be used during pregnancy only in cases where the expected benefit to the mother outweighs the possible risk to the fetus.
Salbutamol is excreted in breast milk, so it is not recommended for use in women who are breastfeeding, unless the expected benefit to the mother outweighs the possible risk to the baby.
Children
The drug is used for children under 4 years of age.
Features of application
Treatment of asthma should be carried out with a step-by-step program, the patient's condition should be assessed clinically and using pulmonary function tests. An increase in the frequency of use of inhaled β 2 agonists indicates a deterioration in asthma control. In this case, the patient’s therapy must be reconsidered, since the worsening of asthma is a life-threatening condition and requires the prescription or increase in the dose of corticosteroids that are already being used. For patients at risk, daily peak flow measurements are recommended. If relief is not observed for at least 3 hours after using a previously effective dose of salbutamol, the patient should consult a doctor for additional measures. The inhaler should be used correctly to ensure that the drug reaches the bronchi. For young children, it is advisable to use Babymask for inhalation.
Salbutamol is prescribed with caution to patients with hyperthyroidism.
Therapy with β2-adrenergic agonists may cause hypokalemia. Particular caution is recommended in case of bronchial asthma, since hypokalemia may increase with the simultaneous use of xanthine derivatives, steroids, diuretics and under the influence of hypoxia. It is recommended to regularly monitor serum potassium levels.
The ability to influence the reaction rate when driving vehicles or other mechanisms
There is no data on the effect of salbutamol on the ability to drive a car or use other machinery.
Interaction with other drugs and other types of interactions
The combined use of salbutamol with other sympathomimetics is not recommended, as the risk of side effects from the cardiovascular system increases. The simultaneous use of salbutamol and MAO inhibitors and tricyclic antidepressants is not allowed.
