Bromhexine 8 mg 20 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, 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: 1-2 tablets (8-16 mg) 3-4 times a day. Special patient groups
In case of impaired kidney function and/or severe liver disease, the intervals between doses should be increased, or the dose should be reduced. It is necessary to consult the attending physician on this matter.
Children
Children aged 6 to 14 years: 1 tablet of 8 mg 3 times a day.
Children over 14 years: the dosing regimen is similar to that of adults. The therapeutic effect may manifest on the 4th to 6th day of treatment.
Course of treatment - from 4 to 28 days. It is not recommended to take bromhexine for more than 4-5 days without consulting a doctor.

Composition per tablet
Active ingredient: bromhexine hydrochloride - 8.0 mg.
Excipients: potato starch, lactose (milk sugar), sucrose (white sugar), calcium stearate.

Round flat-cylindrical tablets of white color, with a bevel.

• hypersensitivity to bromhexine or to any of the excipients;

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

• pregnancy (first trimester);

• breastfeeding period;

• children under 6 years of age;

• rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;

• rare hereditary fructose intolerance, sucrose/isomaltase deficiency.

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 trimesters).

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, bromhexine should be used with special caution (for example, by reducing the dose or increasing 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 have been observed during the use of bromhexine, such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), as well as acute generalized exanthematous pustulosis. If allergic reactions and/or signs of progressive skin rash (sometimes in combination with the appearance of blisters and mucous membrane lesions) occur, 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. Each tablet contains 200 mg of carbohydrates (potato starch, lactose, sucrose), which corresponds to 0.02 bread units (BE). This should be taken into account by patients with diabetes mellitus. In children, treatment should be combined with postural drainage or chest vibration massage to facilitate the evacuation of secretions from the bronchi.

Side effects

Adverse reactions are distributed by frequency of occurrence according to the following scheme: very often (≥ 1/10), often (from ≥1/100 to < 1/10), infrequently (from ≥1/1,000 to < 1/100), rarely (from ≥ 1/10,000 to < 1/1,000), very rarely (< 1/10,000), frequency unknown (impossible to assess based on available data).Disorders of the immune systemRarely: hypersensitivity reactions, bronchospasm;Frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, rhinitis.Disorders of the nervous systemInfrequently: dizziness, headache.Gastrointestinal disordersInfrequently: nausea, vomiting, diarrhea, abdominal pain;Frequency unknown: exacerbation of peptic ulcer disease of the stomach and duodenum, dyspepsia.Disorders of the skin and subcutaneous tissueRarely: skin rash, urticaria;Frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis.General disorders and reactions at the injection siteInfrequently: fever.Laboratory and instrumental dataVery rarely: increased activity of "liver" transaminases in the blood serum.If you have any adverse reactions listed in the instructions or they worsen, or you notice any other adverse reactions not listed in the instructions, inform your doctor.Section: OverdoseSymptoms: nausea, vomiting, diarrhea, and other gastrointestinal disorders. Treatment: symptomatic, no specific antidote available. 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.InteractionBromhexine is not 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, an enhancement of the irritating effect on the mucous membranes of the gastrointestinal tract may occur. The drug is incompatible with alkaline solutions.

Pharmacodynamics

Mucolytic (secretolytic) agent, it has expectorant and mild antitussive effects. 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. It 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

When taken orally, 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 and placental barriers. 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 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 failure, an increase in the half-life of bromhexine metabolites cannot be excluded. Nitrosation of bromhexine may occur under physiological conditions in the stomach. With repeated use, bromhexine may accumulate.

Description

Bromhexine 8 mg, 20 tablets is a medication that helps to cope with diseases of the upper respiratory tract. It acts as a mucolytic, meaning it softens and thins mucus, facilitating its expulsion.

The medication is recommended for bronchitis of various etiologies, tracheobronchitis, and other diseases accompanied by a cough with difficult-to-expectorate mucus. This remedy acts quickly and effectively, and thanks to its convenient form (tablets), it is easy to dose and take the medication.

Before starting to take this medication, it is necessary to consult with a healthcare provider to determine the optimal dosage and treatment regimen. It should be remembered that Bromhexine is not a standalone treatment and should be prescribed in combination with other medications.