Bromhexine 8 mg 50 tablets

Indications

The drug Bromhexine is used in adults and children over 3 years of age for the following 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 bronchial manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Method of administration and doses

Orally, regardless of food intake.
Adults
8-16 mg (1-2 tablets) 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 over 14 years
The same dosage as for adults.
Children from 6 to 14 years
8 mg (1 tablet) 3 times a day.
Children from 3 to 6 years
4 mg (1/2 tablet) 3 times a day.
Therapeutic action may manifest on the 4th-6th day of treatment.
Treatment course - from 4 to 28 days.
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 with the drug, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the indications, method of administration, and in the doses specified in the instructions.

Composition per tablet:
Active ingredient: bromhexine hydrochloride – 8.0 mg.
Excipients: lactose monohydrate (milk sugar) - 101.5 mg; corn starch - 15.0 mg; povidone-K25 - 4.5 mg; magnesium stearate - 1.0 mg.

Round flat-cylindrical tablets of white or almost white color with a bevel and a score line.

Contraindications

• hypersensitivity to bromhexine and/or to any of the excipients;

• pregnancy (first trimester);

• breastfeeding period;

• peptic ulcer disease of the stomach and duodenum (in the acute stage);

• children under 3 years of age;

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption (since the drug contains lactose).

With caution

Renal and/or hepatic insufficiency; bronchial diseases accompanied by excessive secretion accumulation; history of hemoptysis; 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 production, 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 diseases, the drug 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. Monitoring of liver function is recommended, especially during prolonged treatment. There are reports of very rare cases of severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis) occurring in the context of bromhexine use. 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 fluid to maintain the secretolytic action of bromhexine.
Children
In children, treatment should be combined with postural drainage or chest vibration massage to facilitate the evacuation of secretions from the bronchi. The use of the drug Bromhexine in children over 2 years of age is possible only under medical supervision.
Excipients
The drug Bromhexine contains lactose. Patients with rare hereditary diseases, such as galactose intolerance, lactose intolerance due to lactase deficiency, or glucose-galactose malabsorption syndrome, should not take this medication.

Side effects

Adverse reactions are listed below according to anatomical-physiological classification and frequency of occurrence. Frequency is defined as follows: very common (>1/10); common (>1/100 - 1/1000 - 1/10000 -

Symptoms
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 can be prescribed simultaneously with other medications used in the treatment of bronchopulmonary diseases. Bromhexine is not prescribed simultaneously with antitussive agents (including those containing codeine), as the suppression of the cough reflex hinders the evacuation of liquefied mucus, which may lead to the accumulation of secretions in the respiratory tract.
Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin) and sulfanilamide medications into bronchial secretions during the first 4-5 days of antimicrobial therapy. The clinical significance of this possible interaction has not been proven. 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 tract 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.

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 of starting treatment.

Pharmacokinetics

Absorption
When taken orally, bromhexine is almost completely (99%) absorbed in the gastrointestinal tract within 30 minutes. Bioavailability is low (due to the first-pass effect through the liver).
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.
Biotransformation
In the liver, bromhexine undergoes demethylation and oxidation, being metabolized to the pharmacologically active ambroxol. The half-life (T1/2) is 15 hours (due to slow reverse diffusion from tissues).
Elimination
Excreted by the kidneys. 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 elimination of bromhexine through dialysis or forced diuresis is not expected. In chronic renal failure, the elimination of bromhexine metabolites is impaired. With repeated use, bromhexine may accumulate.

Description

Bromhexine 8 mg 50 pcs. tablets are 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 the formation of sputum with increased viscosity (bronchial asthma, cystic fibrosis, tuberculosis, pneumonia, tracheobronchitis, obstructive bronchitis). 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.