Bromhexine-Akrikhin 8 mg 30 tablets

Indications

- acute and chronic bronchopulmonary diseases accompanied by difficulty in expectorating viscous sputum: tracheobronchitis, bronchitis of various etiologies (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pulmonary emphysema, pneumonia (acute and chronic), pneumoconiosis, cystic fibrosis.
- sanitation of the bronchial tree in the preoperative period and during therapeutic and diagnostic intrabronchial procedures, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Method of administration and doses

Orally, regardless of food intake.
Adults and children over 14 years - 8-16 mg (1-2 tablets of 8 mg) 3-4 times a day.
Children 6-14 years - 8 mg (1 tablet of 8 mg) 3 times a day.
Children 3-6 years - 4 mg (1 tablet of 4 mg) 3 times a day.
Therapeutic effect may manifest on the 4th-6th day of treatment.
Treatment course - from 4 to 28 days.
In case of impaired kidney function and/or severe liver disease, the intervals between doses should be increased, or the dose should be reduced.
Consultation with the attending physician is necessary on this matter.
During treatment, it is recommended to consume an adequate amount of fluid to maintain the secretolytic action of bromhexine.
Without consulting a doctor, it is not recommended to take bromhexine for more than 4-5 days.
If there is no improvement during the treatment or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.
Use the medication only according to the indications, method of administration, and in the doses specified in the instructions.

Composition per tablet
active ingredient: bromhexine hydrochloride calculated as 100% substance - 4 mg / 8 mg;
excipients: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, calcium stearate.

Description of the dosage form

Round flat-cylindrical tablets from white to white with a yellowish or grayish tint, with a facet. The presence of "marbling" is allowed.

• hypersensitivity to bromhexine and/or other components of the drug;

• peptic ulcer disease of the stomach and/or duodenum (including in the history);

• pregnancy (first trimester);

• breastfeeding period;

• children under 6 years of age - for 8 mg tablets;

• children under 3 years of age - for 4 mg tablets;

• lactose intolerance, lactase deficiency and/or glucose-galactose malabsorption. With caution

• renal and/or hepatic insufficiency;

• bronchial diseases accompanied by excessive secretion accumulation;

• history of hemoptysis episodes;

• history of gastric bleeding;

• pregnancy (second and third trimester).
Use during pregnancy and breastfeeding
The use of the drug in the first trimester of pregnancy is contraindicated.
Use in the second and third trimester of pregnancy is only possible in cases where the expected benefit to the mother outweighs the potential risk to the development of the fetus.
If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Section: Special Instructions

In cases of bronchial motility disorders (for example, in the rare syndrome of primary ciliary dyskinesia) or with a significant volume of sputum produced, the use of bromhexine requires caution due to the risk of retention of secretions in the respiratory tract. Patients taking bromhexine should be made aware of the possibility of increased sputum production. In cases of kidney dysfunction and severe liver disease, the drug Bromhexine-Akrikhin should be used with special caution (for example, reduce the dose or increase the interval between doses). In severe renal failure, the possibility of accumulation of metabolites formed in the liver should be considered. Periodic monitoring of liver function is recommended, especially during prolonged treatment. Rare cases of severe skin diseases, such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), and acute generalized exanthematous pustulosis have been observed during the use of bromhexine. If allergic reactions and/or signs of progressive skin rash occur (sometimes in combination with the appearance of blisters and mucous membrane lesions), the use of the drug should be immediately discontinued and a doctor should be consulted. During treatment, it is recommended to consume an adequate amount of fluids to maintain the secretolytic action of bromhexine. In children, treatment should be combined with postural drainage or chest vibration massage to facilitate the evacuation of secretions from the bronchi.

Effect on the ability to drive vehicles and operate machinery
Due to the possible development of side effects when using the drug (dizziness, headache), caution should be exercised when performing potentially dangerous activities that require increased attention and quick psychomotor reactions (driving vehicles, working with moving machinery, dispatcher work, operator work).

Section: Side Effects

Adverse reactions are distributed by frequency of occurrence according to the following scheme: very common (≥1/10), common (≥1/100 to

Section: Overdose

Possible symptoms include: nausea, vomiting, diarrhea, and other gastrointestinal disorders.
Treatment: symptomatic, there is no specific antidote.
In case of overdose, it is necessary to induce vomiting, and then give the patient water. Gastric lavage is recommended within 1-2 hours after taking the medication.

Interaction

Bromhexine should not be prescribed simultaneously with medications that suppress the cough center (including those containing codeine), as this complicates the expulsion of liquefied mucus (leading to the accumulation of bronchial secretions in the respiratory tract).
Bromhexine promotes the penetration of antibiotics (amoxicillin, ampicillin, erythromycin, cephalexin, oxytetracycline) and sulfanilamide medications into bronchial secretions during the first 4-5 days of antimicrobial therapy.
The combined use of bromhexine with certain non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone, or butadione) may cause irritation of the gastric mucosa.
When used simultaneously with medications that cause symptoms of gastrointestinal irritation, there may be an enhancement of the irritating effect on the mucous membranes of the gastrointestinal tract.
The drug is incompatible with alkaline solutions.
If you are using the above-mentioned or other medications (including over-the-counter), consult your doctor before using Bromhexine-Akrikhin.

Pharmacodynamics

Mucolytic (secretolytic) agent, it has an expectorant and mild antitussive effect. It reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of bronchial secretions); activates ciliated epithelium, increases the volume and improves the expectoration of sputum. Stimulates the production of endogenous surfactant, ensuring the stability of alveolar cells during respiration. The effect manifests within 2-5 days from the start of treatment.

Pharmacokinetics

Absorption

After oral administration, bromhexine is rapidly and almost completely absorbed from the gastrointestinal tract. The half-absorption period is about 0.4 hours. The maximum concentration in plasma after oral administration is reached within 1 hour.

Distribution

The volume of distribution is approximately 7 l/kg of body weight. The degree of binding to plasma proteins is 99%. Bromhexine crosses the blood-brain barrier and the placental barrier. It penetrates into breast milk and cerebrospinal fluid. Bromhexine does not undergo accumulation.

Metabolism

80% of bromhexine undergoes the "first-pass" effect through the liver, resulting in the formation of biologically active metabolites. In severe liver diseases, a decrease in the clearance of bromhexine is noted.

Excretion

Bromhexine is excreted from the body mainly in the form of metabolites. The half-life to reach the minimum effective concentration after achieving equilibrium between absorption and excretion processes is approximately 1 hour. The terminal half-life is about 16 hours due to the redistribution of small amounts of bromhexine from tissues.

It is primarily excreted by the kidneys in the form of metabolites formed in the liver. Due to the high degree of binding to plasma proteins and a high volume of distribution, as well as slow redistribution from tissues to blood, significant excretion of bromhexine through dialysis or forced diuresis is not expected.

In severe renal insufficiency, an increase in the half-life of bromhexine metabolites cannot be excluded. Nitrosation of bromhexine may occur under physiological conditions in the stomach.

Bromhexine-Akrikhin 8 mg 30 pcs. tablets – is a medication with mucolytic and expectorant effects. The mucolytic effect is associated with the depolymerization and liquefaction of mucoprotein and mucopolysaccharide fibers. Bromhexine has a mild antitussive effect. It is used in the treatment of bronchopulmonary diseases accompanied by difficulty in expectorating viscous sputum: tracheobronchitis, bronchitis of various etiologies (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pulmonary emphysema, pneumonia (acute and chronic), pneumoconiosis, cystic fibrosis. Bromhexine is taken orally regardless of food intake by adults and children from 3 years old in appropriate doses. There are contraindications; it is recommended to consult a doctor before use.