What is ambroxol hydrochloride
Ambroxol hydrochloride is a substance that directly affects the secretory function of the respiratory tract, causing the glands to work more actively, which leads to increased production of sputum. In addition, Ambroxol directly affects the motor function of the trachea and bronchi, which explains the expectorant effect. The tissues of the upper and lower respiratory tract are instantly irritated at the slightest fluctuations in the ciliated epithelium, causing a cough that easily expels liquid sputum along with the pathogen.
Can children take Ambroxol?
Infants during the neonatal period (the first 28 days of life) and before reaching the age of two do not have the full ability to cough. Their reflex function of mucus rejection is reduced, and the shocks of exhaled air when coughing are not powerful enough to remove phlegm. Therefore, children under two years of age should not be given mucolytics.
Increased mucus production while taking Ambroxol will cause its accumulation in the lower parts of the lungs and bronchi, which will lead to the addition of a secondary bacterial infection, which will develop pneumonia.
In this connection, taking the drug in syrup form is indicated only for those patients who have already learned to cough - over 2 years of age.
Contraindications
Ambroxol should not be taken by people who have hypersensitivity to at least one component of the drug. Women in the first trimester of pregnancy should avoid taking it.
The drug in tablet form should not be used by people with stomach and duodenal ulcers, as well as in cases of epileptic syndrome.
Other contraindications include hereditary fructose intolerance. The medicine should not be taken for a dry cough that occurs with colds and viral diseases.
How long to take Ambroxol
If an infection occurs in the respiratory tract, the source of infection must be removed from the body as soon as possible, which is actively facilitated by Ambroxol. However, often the cause of cough is bacterial infection of the lower respiratory tract, which the body cannot always cope with on its own. Therefore, over-the-counter use of the drug is possible for no longer than 5 days. If after this period the symptoms of malaise persist, the patient must consult a doctor to prescribe antibacterial therapy.
pharmachologic effect
Expectorant, mucolytic agent.
Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough. In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.
Azt Long and Ambroxol: which is better
ACC is based on the substance acetylcysteine, which, like Ambroxol, improves the rheological properties of sputum: it accelerates its production, reducing viscosity. The ciliated epithelium of the respiratory tract instantly reacts to the irritant, provoking a cough. A drug with the prefix “Long” indicates that the effect of a single dose is prolonged up to 12 hours. This means you need to take it in the morning, once a day. Taking Azz Long at night will cause the patient to have a cough that will suffocate him all night, preventing him from falling asleep.
When choosing between ACC and Ambroxol, you need to rely on the convenience of the release form for the patient and individual intolerance to the components.
Ambroxol and its analogues
The active ingredient Ambroxol is disguised under different brands:
- Ambrobene;
- Lazolvan;
- Orvis Broncho;
- Thoraxol;
- Asterisk Broncho;
- Halixol.
Knowing the name of the active substance, it is easier to find a cheap analogue in the pharmacy, so as not to spend unreasonably large sums on the same thing, but under a different name.
Ambroxol, like drugs under other trade names, is sold in different forms: from tablets to solutions that are taken orally or used as an additive to an inhaler.
How often can you take Ambroxol?
I use the drug in three dosage forms:
- pills;
- nebulizer solution;
- syrup.
Tablets are indicated for children over 12 years of age and adults. The frequency of administration should not exceed 2 times. In rare cases, the doctor may increase the dosage, but it is important to note that taking the pill at night to increase the frequency of doses is contraindicated.
Children are more often prescribed syrup for oral administration or inhalation with ambroxol. The single dose depends on the age and weight of the patient. To prepare the solution, use 4 ml of saline solution and 2 ml of the drug. The duration of the procedure for children under 7 years of age should not exceed 4 minutes. For patients from 7 to 13 years old, increase the duration of inhalation to 6 minutes. Adults are recommended to breathe the solution for at least 10 minutes.
Syrup for oral administration is given to the child three times a day, a teaspoon. The last dose should not be later than two hours before bedtime.
Ambroxol
Dosage form
Solution for oral administration and inhalation
Composition per 1 ml:
Active substance
: ambroxol hydrochloride – 7,500 mg.
Excipients
: benzalkonium chloride – 0.225 mg, sodium chloride – 6.220 mg, citric acid (anhydrous citric acid) – 2.000 mg, sodium hydrogen phosphate dihydrate – 4.350 mg, water – 989.705 mg.
Description
A transparent, colorless or brownish-tinged solution with a weak characteristic odor.
Pharmacotherapeutic group
Expectorant, mucolytic agent.
ATX code
: R05CB06
Pharmacological properties
Pharmacodynamics
Ambroxol has a secretomotor, secretolytic and expectorant effect: it stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surfactant in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, and facilitates the removal of mucus from the respiratory tract.
Pharmacokinetics
Ambroxol is characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose dependence in the therapeutic concentration range. Bioavailability is 70-80%. The maximum concentration (Cmax) in blood plasma after oral administration is achieved after 0.5-3 hours. In the therapeutic concentration range, binding to plasma proteins is approximately 90%. The transition of ambroxol from the blood to tissues when administered orally occurs quickly. The highest concentrations of the active component of the drug are observed in the lungs. Penetrates the blood-brain barrier, placental barrier, and is excreted in breast milk.
Approximately 30% of the administered oral dose undergoes first pass through the liver. Studies on human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol. The remainder of ambroxol is metabolized in the liver to inactive metabolites. The half-life (T1/2) is 10 hours. Excreted by the kidneys: 90% in the form of metabolites, 10% unchanged.
No clinically significant effect of age and gender on the pharmacokinetics of ambroxol was found, so there is no basis for dose adjustment based on these characteristics.
Indications for use
Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.
Contraindications
Hypersensitivity to ambroxol or other components of the drug, pregnancy (first trimester), breastfeeding.
Carefully
Impaired motor function of the bronchi and increased production of sputum (with fixed cilia syndrome), peptic ulcer of the stomach and duodenum during an exacerbation, pregnancy (II-III trimester), children under 2 years of age (used as prescribed by a doctor).
Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug in a lower dose.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during the 1st trimester of pregnancy. If it is necessary to use ambroxol in the II-III trimesters of pregnancy, the potential benefit for the mother should be assessed with the possible risk to the fetus.
During breastfeeding, the use of the drug is contraindicated, since it is excreted in breast milk.
Directions for use and doses
The mucolytic effect of the drug occurs when taking large amounts of liquid. Therefore, drinking plenty of fluids is recommended during treatment.
Oral use:
Use internally after meals, adding to water, tea, milk or fruit juice.
Adults and children over 12 years old
: the first 2-3 days, 4 ml 3 times a day (90 mg ambroxol per day), then 4 ml 2 times a day (which corresponds to 60 mg ambroxol per day);
Children from 6 to 12 years old
: 2 ml 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day);
Children from 2 to 6 years old
: 1 ml 3 times a day (which corresponds to 22.5 mg of ambroxol per day);
Children under 2 years old
: 1 ml 2 times a day (which corresponds to 15 mg of ambroxol per day).
For children under 2 years of age, the drug is prescribed only under the supervision of a doctor.
Maximum daily dose when taken orally: for adults - 90 mg, for children 6-12 years old - 45 mg, for children 2-6 years old - 22.5 mg, for children under 2 years old - 15 mg.
Application in the form of inhalations:
The drug can be used using any modern equipment for inhalation (except for steam inhalers). Before inhalation, the drug is mixed with 0.9% sodium chloride solution (for optimal air humidification - in a ratio of 1: 1). Before inhalation, it is recommended to warm the inhalation solution to body temperature.
Since during inhalation therapy a deep breath can provoke a cough, inhalations should be carried out in normal breathing mode. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators to avoid nonspecific irritation of the respiratory tract and their spasm.
Dosages for inhalations
:
Adults and children over 6 years old
: 1-2 inhalations per day, 2-3 ml of solution (which corresponds to 15-45 mg of ambroxol per day).
Children up to 6 years old
: 1-2 inhalations per day, 2 ml of solution (which corresponds to 15-30 mg of ambroxol per day).
Taking the drug for more than 4-5 days is possible only on the recommendation of a doctor.
Side effect
The frequency of side effects is presented in the following gradation: very often (> 1/10); often (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), unknown (cannot be estimated based on available data).
Gastrointestinal disorders
: often – nausea, decreased sensitivity in the oral cavity and pharynx; uncommon – dyspepsia, pain in the upper abdomen, vomiting, diarrhea; rarely - heartburn, dryness of the mucous membrane of the mouth and pharynx, constipation.
From the respiratory system
: rarely – dryness of the mucous membrane of the respiratory tract, rhinorrhea.
Nervous system disorders
: often – dysgeusia (impaired sense of taste).
Allergic reactions
: rarely - hypersensitivity reactions, skin rash, urticaria, itching, angioedema; very rarely - anaphylactic reactions, including anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome; frequency unknown - acute generalized exanthematous pustulosis.
Others
: rarely – adynamia, fever.
Overdose
Symptoms
: heartburn, dyspepsia, diarrhea, nausea, vomiting, pain in the upper abdomen. There are reports of short-term anxiety. In case of severe overdose, a significant decrease in blood pressure is possible.
Treatment
: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods, symptomatic therapy.
Interaction with other drugs
When used with antitussive drugs, it may be difficult to discharge sputum as a result of suppression of the cough reflex. When used simultaneously with amoxicillin, doxycycline, cefuroxime, erythromycin, ambroxol increases their concentration in bronchial secretions. No clinically significant adverse interactions with other drugs have been reported.
special instructions
Ambroxol should not be taken simultaneously with antitussive drugs, which may inhibit the cough reflex.
Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
Patients taking ambroxol should not be advised to perform breathing exercises; in patients with severe disease, aspiration of liquefied sputum should be performed.
In patients with bronchial asthma, ambroxol may increase cough.
You should not take ambroxol immediately before bed.
In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, it is possible to erroneously prescribe mucolytic agents such as ambroxol hydrochloride. There are isolated reports of the identification of Stevens-Johnson syndrome and Lyell's syndrome, which coincided with the prescription of the drug; however, there is no causal relationship with the drug.
If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help.
If kidney function is impaired, ambroxol should be used only on the recommendation of a doctor.
Ambroxol solution should not be mixed with cromoglicic acid and alkaline solutions.
Patients on a hyposodium diet should keep in mind that 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years of age contains 120 mg of sodium.
Ambroxol solution contains benzalkonium chloride (preservative). In patients with airway hyperactivity, this preservative may cause bronchospasm during inhalation.
The effect of the drug on the ability to drive vehicles and machinery
The effect on the ability to drive vehicles and operate machinery is still unknown.
Release form
Solution for oral administration and inhalation 7.5 mg/ml.
10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 ml of the drug in a dark glass bottle or in a polymer bottle or in a polyethylene terephthalate bottle with or without a polyethylene dropper and a polypropylene screw cap with or without control first opening or sealed with a dropper stopper and a plastic screw cap or with/without a dropper stopper (dropper in the form of a plastic divider), with/without a plastic screw cap and a first opening ring or equipped with a plastic divider, sealed with a plastic cap with/without a first opening ring .
A label made of writing or label paper or a self-adhesive label is attached to each bottle.
Each bottle, along with instructions for use, is placed in a pack of boxed cardboard for consumer packaging or chrome-ersatz cardboard. A measuring cup or measuring spoon can be placed in a cardboard package.
Storage conditions
In a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Best before date
5 years.
Do not use after the expiration date stated on the packaging.
Vacation conditions
Over the counter.
Is it possible to use Ambroxol for laryngitis?
Laryngitis is an inflammation of the upper respiratory tract, localized in the trachea - around the vocal cords. Laryngitis is characterized by a barking cough that gives no rest. With severe inflammation, swelling of the laryngeal tissue is possible, leading to blockage of the airways and asphyxia. Therefore, if you have laryngitis, you need to be careful when taking mucolytics. First of all, you need to see a doctor who will give recommendations. It is possible that, along with ambroxol inhalations, vasoconstrictor therapy will be required to provide protection against swelling in the trachea.
In what cases is it used?
The degree of elasticity and viscosity of sputum can only be determined by how easily it is expectorated.
Ambroxol is especially effective for respiratory diseases and conditions in which phlegm appears and accumulates in the lungs.
The drug can be used for the following conditions:
- pneumonia;
- acute or chronic bronchitis;
- laryngitis;
- asthma;
- rhinitis;
- pharyngitis;
- respiratory tract disorder syndrome in newborns, including premature babies.
Dry cough: why Ambroxol does not help
The cause of a dry cough can be not only low rheology of sputum, but also the localization of inflammation. If the cough occurs due to damage to the tonsils, the removal of sputum from the bronchi will not affect the course of treatment in any way. This is why pharyngitis is not an indication for the use of ambroxol.
An irritating cough caused by inflammation of the nasopharynx, pharynx and larynx cannot be cured with ambroxol. To get rid of infection of the upper sections, it is better to use antiseptic rinsing solutions or in the form of lozenges for resorption.
special instructions
Ambroxol-SOLOpharm should not be taken simultaneously with antitussive drugs that may inhibit the cough reflex.
Ambroxol-SOLOpharm should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
Patients taking ambroxol should not be advised to perform breathing exercises; in patients with severe disease, aspiration of liquefied sputum should be performed.
In patients with bronchial asthma, ambroxol may increase cough.
You should not take ambroxol immediately before bed.
In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, it is possible to erroneously prescribe mucolytic drugs such as ambroxol. There are isolated reports of the identification of Stevens-Johnson syndrome and Lyell's syndrome, which coincided with the prescription of the drug, but there is no cause-and-effect relationship with the drug.
If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help.
If kidney function is impaired, ambroxol should be used only on the recommendation of a doctor.
Ambroxol solution is not recommended to be mixed with cromoglicic acid and alkaline solutions.
Patients on a hyposodium diet should keep in mind that 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years of age contains 120 mg of sodium.
To date, no cases of the drug affecting the ability to drive vehicles and machinery have been identified.
Ambroxol for children: Komarovsky
Popular pediatrician Evgeny Komarovsky reminds parents that during periods of illness it is especially important for a child to drink plenty of fluids, which will ensure natural maintenance of high-quality sputum production.
Adding Ambroxol to the inhaler requires special attention: taking it at night is strictly contraindicated. Otherwise, the child will cough all night, depriving himself and the whole family of sleep.
It is important to remember that Ambroxol is not a cough suppressant. This is a cough stimulant. In other words, taking the drug in any dosage form will lead to increased and more frequent coughing, which ensures timely removal of mucus from the lower respiratory tract.
Ambroxol for pregnant women
Pregnant women should not take the drug only in the first 13 weeks of pregnancy. In the 2nd and 3rd trimester, you can use the medicine if the benefit to the expectant mother outweighs the threat to the fetus.
If we are talking about taking it while breastfeeding, then it is better not to use Ambroxol, since the active component can penetrate into the milk, and, consequently, into the baby’s body.
An interesting study was conducted in which results were obtained regarding the use of medication to treat problems with the respiratory system in an unborn baby. The constituent components are able to penetrate the placenta, which makes it possible to take the drug when the child begins to collect sputum in the lungs. Also, if you take Ambroxol during pregnancy, the baby activates the synthesis of pulmonary surfactant.
