Ambroxol-ALSI - Instructions For The Use Of Tablets, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ambroxol-ALSI

Ambroxol-ALSI: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ambroxol-ALSI

ATX code: R05CB06

Active ingredient: ambroxol (Ambroxol)

Producer: ALSI Pharma, CJSC (Russia)

Description and photo update: 2020-14-05

Ambroxol-ALSI is a mucolytic and expectorant drug.

Release form and composition

The drug is produced in the form of tablets: round, flat-cylindrical, white or almost white, with a chamfer and a line (10 pcs. In blisters, in a cardboard box 1, 2, 3, 4 or 5 cell packs, as well as instructions for use Ambroxol-ALSI).

Composition for 1 tablet:

• active substance: ambroxol hydrochloride - 30 mg;
• additional components: potato starch, magnesium stearate, lactose monohydrate, colloidal silicon dioxide.

Pharmacological properties

Pharmacodynamics

Ambroxol is an active N-demethylated metabolite of bromhexine. It has a secretolytic, secretomotor and expectorant effect.

The drug increases the motor activity of the cilia of the ciliated epithelium (due to the effect on Clara cells in the bronchioles and type 2 pneumocytes in the alveoli), stimulates the function of the bronchial glands, and also enhances the secretion of endogenous surfactant (a substance that ensures the sliding of bronchial secretions in the airway lumen).

In bronchial secretions, the proportion of the serous component increases, which helps to improve the structure of secretions, dilute and reduce the viscosity of sputum. Due to this, mucociliary transport and excretion of sputum from the bronchi are improved.

On average, the effect of Ambroxol-ALSI occurs 30 minutes after taking the pill and lasts from 6 to 12 hours, depending on the dose taken.

Pharmacokinetics

The absorption of ambroxol is fast and almost complete. The maximum plasma concentration is reached after 1–3 hours. The volume of distribution is 552 liters. Ambroxol undergoes the effect of primary passage through the liver, which reduces its absolute bioavailability by about a third.

About 80–90% binds to plasma proteins. Ambroxol passes through the blood-brain barrier, crosses the placenta to the fetus and is secreted in breast milk.

Ambroxol metabolism occurs in the liver. The main pathway is conjugation, which results in the formation of pharmacologically inactive metabolites.

The final half-life of the drug from blood plasma is from 7 to 12 hours. The total half-life, including metabolites, is 22 hours. The rate of total clearance is approximately 660 ml / min.

Ambroxol-ALSI is excreted by the kidneys (more than 90% in the form of metabolites and approximately 10% in the form of unchanged ambroxol).

In patients with severely impaired renal function (creatinine clearance is less than 30 ml / min), it is possible to slow down the excretion of metabolites; in patients with severe hepatic impairment, ambroxol clearance decreases by 20–40%.

Dialysis and forced diuresis are ineffective for the elimination of the drug, since it has a high degree of binding to plasma proteins, has a significant volume of distribution, and slowly flows back from tissues to the blood.

Indications for use

Ambroxol-ALSI is used for disorders of sputum transport and secretion in patients with chronic and acute respiratory diseases, such as:

• chronic and acute bronchitis;
• COPD (chronic obstructive pulmonary disease);
• pneumonia;
• bronchiectasis;
• bronchial asthma with difficult sputum discharge.

Contraindications

Absolute:

• children under 6 years of age;
• first trimester of pregnancy;
• lactation period;
• lactase deficiency, glucose-galactose malabsorption syndrome, hereditary galactose intolerance (since the tablets contain lactose);
• hypersensitivity to the main or auxiliary ingredients of the drug.

Relative (Ambroxol-ALSI is used with caution):

• severe liver failure;
• renal failure of any severity;
• peptic ulcer of the duodenum and stomach (including indications in the anamnesis);
• increased mucus secretion and impaired bronchial motility (for example, in patients with a rare syndrome of primary ciliary dyskinesia);
• second and third trimesters of pregnancy.

Ambroxol-ALSI, instructions for use: method and dosage

Ambroxol-ALSI tablets are taken orally, after meals. They should be taken with a sufficient amount of liquid.

For children aged 6–12 years, it is recommended to give 1/2 tablet (15 mg) 2 or 3 times a day. Teenagers over 12 years old and adults are usually prescribed 1 tablet (30 mg) 3 times a day for the first 2-3 days, and then the dose of the drug is reduced to 1 tablet 2 times a day.

If the symptoms of the disease persist within 4-5 days from the start of treatment, you should consult a doctor to clarify the diagnosis.

Side effects

When taking Ambroxol-ALSI, the following adverse events may develop [classification of disorders: very often (≥ 1/10); often (from ≥ 1/100 to <1/10); infrequently (from ≥ 1/1000 to <1/100); rarely (from ≥ 1/10 000 to <1/1000); very rare (<1/10 000, including isolated cases); with an unknown frequency (it is impossible to establish the incidence of adverse reactions based on the available information)]:

• digestive system: often - decreased sensitivity in the mouth and pharynx, nausea; infrequently - vomiting, dyspeptic disorders, abdominal pain, diarrhea; rarely - dryness of the mucous membranes of the mouth and pharynx, heartburn, constipation;
• respiratory system: rarely - rhinorrhea, dry mucous membranes of the upper respiratory tract;
• immune system: rarely - hypersensitivity reactions; with an unknown frequency - anaphylactic reactions (including anaphylactic shock), itching, Quincke's edema, etc.;
• skin and subcutaneous fat: rarely - urticaria, skin rash; with an unknown frequency - toxic epidermal necrolysis, malignant exudative erythema, erythema multiforme, acute generalized eczematous pustulosis;
• other reactions: infrequently - a violation of taste; rarely - headache, fever, weakness, urinary disorders.

Overdose

In case of an overdose of Ambroxol-ALSI, the patient develops nausea, vomiting and heartburn, indigestion occurs, and pain is felt in the upper abdomen. Short-term anxiety is sometimes observed. In the case of severe intoxication, blood pressure can significantly decrease.

It is recommended to induce vomiting and in the first few hours after an overdose to flush a sick stomach. The patient is given fatty foods. Other necessary symptomatic treatment is given. Hemodialysis and forced diuresis are ineffective.

special instructions

To enhance the mucolytic effect of Ambroxol-ALSI during treatment, it is necessary to drink plenty of fluids (water, tea, juices, etc.).

The drug is prescribed with caution to patients who have impaired mucociliary transport or a weakened cough reflex (due to the risk of sputum accumulation in the bronchi).

During treatment with Ambroxol-ALSI, it is not recommended to do breathing exercises. In the case of a severe course of the disease, it is necessary to perform aspiration of the liquefied secretion.

With bronchial asthma, taking Ambroxol can cause increased coughing.

Severe skin lesions (malignant exudative erythema and toxic epidermal necrolysis) in the early phase may be accompanied by fever, rhinitis, body pain, sore throat and cough. In symptomatic therapy, mucolytics are sometimes misused. In isolated reports, such severe skin lesions coincided in time with ambroxol, but the exact causal relationship has not been established. In case of severe allergic reactions, you should immediately stop treatment and urgently consult a doctor.

Ambroxol-ALSI can be used in patients with impaired renal function only as directed by a doctor.

Information for patients with diabetes mellitus: 1 tablet contains less than 0.01 XE (bread unit).

Influence on the ability to drive vehicles and complex mechanisms

Special studies on the effect of ambroxol on the ability to drive vehicles and work with other potentially dangerous and complex mechanisms have not been conducted. No cases of such influence have been identified.

Application during pregnancy and lactation

Ambroxol-ALSI is contraindicated for pregnant women in the first trimester, as well as for mothers who are breastfeeding. In the second and third trimesters of pregnancy, the drug is used after assessing the benefit to the mother / risk to the fetus ratio.

Pediatric use

Ambroxol-ALSI tablets are contraindicated in children under 6 years of age.

With impaired renal function

Patients with renal impairment should be careful during drug therapy.

For violations of liver function

Patients with severe hepatic impairment should be careful when using Ambroxol-ALSI.

Drug interactions

Ambroxol-ALSI should not be taken simultaneously with antitussives, which make it difficult for sputum to pass.

Ambroxol increases the concentration of erythromycin, amoxicillin, doxycycline and cefuroxime in bronchial secretions.

Analogs

Ambrohexol-ALSI analogs are Ambrohexal, Ambrobene, Ambroxol, Ambrosan, Bronhorus, Bronchoxol, Lazongin, Lazolvan, Neo-Bronchol, Medox, Suprima-kof, Flavamed, Halixol, Toraxol Solution Tablets, etc.

Terms and conditions of storage

Store out of the reach of children, at a temperature not exceeding 25 ° C.

The shelf life of the tablets is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Ambroxol-ALSI

According to reviews, Ambroxol-ALSI is a fairly effective cough remedy. The drug is cheaper than many similar drugs. The tablets are safe and easy to take.

However, it is noted that the drug does not always help with a strong cough. Another disadvantage is the bitter taste of the tablets. In addition, as disadvantages, patients often mention the impossibility of using the drug in the first trimester of pregnancy, during breastfeeding and in children under 6 years of age.

Price for Ambroxol-ALSI in pharmacies

The price for Ambroxol-ALSI in the form of 30 mg tablets (30 pcs. In a package) is 35–40 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!