Amkesol (ambroxol hydrochloride) tablets №20

Description

Ingredients

active substances: 1 tablet contains:

• ambroxol hydrochloride (in terms of 100% substance) 15 mg (mg);
• ketotifen hydrofumarate (in terms of 100% substance) 1 mg (mg);
• licorice root dry extract (Extrastum Glycyrrhizae aqua siccum) (4.8-5.5:1) (extractant – aqueous ammonia solution) 10 mg (mg), (in terms of glycyrrhizic acid) 0.8 mg (mg);
• theobromine (in terms of 100% substance) 50 mg (mg);

excipients: microcrystalline cellulose, croscarmellose sodium, potato starch, calcium stearate.

Medicinal form

Tablets.

The main physical and chemical properties:

flat-cylindrical tablets from light yellow to gray-yellow with a brownish tint; impregnations of different sizes and colors are found.

Pharmacotherapeutic group

Antitussives and mucolytics. ATX code R05F B01.

Pharmacological properties

Amkesol is a mucolytic and expectorant broncholytic agent with pronounced anti-inflammatory and anti-allergic activity. Each component of the drug has certain pharmacological properties.

Ambroxol hydrochloride.

Pharmacodynamics.

Ambroxol hydrochloride is a secretolytic and secretomotor agent from the group of benzylamines, stimulates the serous cells of the glands of the mucous membrane of the bronchi, which leads to an increase in mucus secretion and a change in the ratio of serous and mucous components of sputum; activates hydrolytic enzymes and increases the motor activity of the ciliated epithelium of the bronchi; promotes the separation of pathological secretions from the walls of the bronchi and its removal from the respiratory tract; increases the content of surfactant in the lungs and prevents its destruction in pneumocytes, which helps to improve the drainage function of the lungs.

Pharmacokinetics.

Ambroxol hydrochloride is quickly and completely absorbed when administered orally, and penetrates well into lung tissue. The maximum concentration of ambroxol hydrochloride in blood plasma is determined 2 hours after oral administration. Metabolized in the liver. The half-life is 10-12 hours; excreted in the urine.

Ketotifen hydrofumarate.

Pharmacodynamics.

Ketotifen hydrofumarate exhibits anti-allergic activity by suppressing the action of endogenous mediators of inflammation and the release of mediators of allergy (histamine, leukotrienes), prevents the sensitization of eosinophils by cytokines, which leads to inhibition of the migration of eosinophil granulocytes to the center of inflammation, and prevents the development of bronchial hyperactivity, which is caused by the platelet activation factor or stimulation allergens Ketotifen hydrofumarate prevents the development of bronchospasm and has antiasthmatic properties.

Pharmacokinetics.

Ketotifen hydrofumarate is absorbed internally almost completely; bioavailability is 50%. The maximum concentration of ketotifen hydrofumarate occurs after 2-4 hours, the half-life is biphasic and is 3-5 hours and 21 hours, respectively. Metabolism of ketotifen hydrofumarate occurs in the liver.

Licorice root extract.

Pharmacodynamics.

Licorice root extract has an expectorant, anti-inflammatory and antispasmodic effect. Glycyrrhizic acid has anti-inflammatory properties. Liquiritoside (flavonoid glucoside) and 2,2,4-trioxychalcone act as antispasmodics.

Pharmacokinetics.

The pharmacokinetics of the extract have not been studied in detail.

Theobromine.

Pharmacodynamics.

Theobromine is 3,7-dimethylxanthine, an alkaloid of the group of purine bases. Causes weak stimulation of the central nervous system (CNS), cardiac activity; increases the concentration of CAMF in tissues, which leads to the expansion of the bronchi, increased mucociliary clearance, improvement of bronchopulmonary blood circulation and suppression of the release of mediators of anaphylactic reactions.

Pharmacokinetics.

Theobromine is absorbed quickly and completely. Plasma concentration is reached after 15-45 minutes. Easily penetrates into all tissues of the body, including the central nervous system. It is metabolized in the liver.

Indication

Acute and chronic diseases of the respiratory tract, accompanied by difficult separation of viscous sputum.

Contraindications of Amkesol

• Amkesol (ambroxol hydrochloride) should not be used in patients with known hypersensitivity to ambroxol hydrochloride or to other components of the drug.
• Ulcer disease of the stomach and duodenum.

Features of the use of the drug

It is necessary to consult a doctor before use.

Treatment of patients with arterial hypertension should be carried out under the supervision of a doctor.

Ketotifen can lower the seizure threshold, so the drug should be used with caution in patients with epilepsy.

Serious skin reactions: erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis (Lyell’s syndrome), and acute generalized exanthematous pustulosis have been reported in association with ambroxol hydrochloride. If there are signs of progression of the rash on the skin (sometimes associated with the appearance of blisters or damage to the mucous membrane), you should immediately stop treatment with ambroxol hydrochloride and seek medical help.

Also, in the early stages of Stevens-Johnson syndrome or Lyell syndrome, patients may have nonspecific, flu-like symptoms such as runny nose, aches, rhinitis, cough, and sore throat. Symptomatic treatment with drugs against coughs and colds can be mistakenly used for such non-specific, flu-like symptoms. Therefore, if new lesions of the skin or mucous membranes appear, you should immediately seek medical help and stop treatment with the drug.

Since ambroxol can increase mucus secretion, the drug Amkesol®, tablets, should be used with caution in the case of impaired bronchial motility and increased mucus secretion (for example, in such a rare disease as primary ciliary dyskinesia), due to the possibility of secretion accumulation.

Patients with impaired kidney function or severe liver failure should take Amkesol®, tablets, only after consulting a doctor. When using Amkesol (ambroxol hydrochloride), as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites that are formed in the liver in patients with severe renal failure.

Use during pregnancy or breastfeeding.

Amkesol (ambroxol hydrochloride) is contraindicated during pregnancy or breastfeeding.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

During the use of the drug, one should refrain from driving vehicles, performing work with potentially dangerous mechanisms that require increased attention and speed of reaction.

Method of application and doses of Amkesol

Recommended for adults and children over 12 years old.

For oral use after meals.

Daily dose. The usual recommended therapeutic dose for treatment is 1 tablet 3 times a day (morning, afternoon, evening).

The course of treatment is from 4 to 14 days. The duration of treatment depends on the indication for use, the course of the disease and is determined by the doctor.

Children.

Assign to children over 12 years old.

Overdose

Pain in the epigastric region, nausea, vomiting; drowsiness, disorientation, confusion; tachycardia, arterial hypotension; convulsions, especially in children.

Treatment: wash the stomach, see a doctor. Symptomatic therapy.

Side effects of Amkesol (ambroxol hydrochloride)

General disorders: reactions from the mucous membranes, dyspnoea.

From the immune system, skin and subcutaneous tissue: skin rash, urticaria, angioedema, pruritus, anaphylactic reactions, including anaphylactic shock, other allergic reactions, erythema, severe skin lesions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome ), acute generalized exanthematous pustulosis, angioedema, erythema multiforme.

From the gastrointestinal tract: nausea, vomiting, dyspepsia, abdominal pain, dry mouth, diarrhea, constipation, salivation, possible increase in the activity of liver enzymes, weight gain, dry throat.

From the respiratory system: rhinorrhea, dyspnea (as a hypersensitivity reaction).

From the urinary system: dysuria.

Infections: cystitis.

From the side of the cardiovascular system: slight arterial hypertension is possible.

On the part of the central nervous system: drowsiness, dry mouth and light dizziness, which disappear on their own with continued treatment, sometimes, very rarely, especially in children, increased irritability, insomnia, increased excitability, dysgeusia are possible.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions in the post-marketing period of a medicinal product is important as it allows for continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.