Bromhexin 4 Berlin-Chemie, 4 mg/5 ml 60 ml

Pharmacotherapeutic group: expectorant mucolytic agent

ATC code: R05CB02

Pharmacological properties

Pharmacodynamics<

Bromhexin has mucolytic (secretolytic) and expectorant (secretomotor) effects. It reduces the viscosity of sputum; it activates the permeable epithelium, increases the volume of sputum and improves its discharge. Stimulates production of endogenous surfactant, which provides stability of alveolar cells during breathing. The effect is seen 2-5 days after the start of treatment.

Pharmacokinetics

absorption. After oral administration, bromhexine is rapidly and almost completely absorbed from the gastrointestinal tract. Half-absorption period is about 0.4 h. Maximum concentration in blood plasma after oral administration is reached after 1 hour.

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

Metabolism.80% of bromhexine undergoes a “first pass” effect through the liver to form biologically active metabolites. In severe liver disease there is a decrease in clearance of bromhexine.

Elimation Bromhexine is excreted from the body mainly as metabolites. The half-life of reaching minimum effective concentration after reaching equilibrium between absorption and excretion is approximately 1 h. The final half-life is about 16 h due to reverse distribution of small amounts of bromhexine from tissues.

Extracted mainly by the kidneys as metabolites formed in the liver. Due to the high degree of binding to plasma proteins and high volume of distribution, as well as slow redistribution from tissues into blood, significant excretion of bromhexine by 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 bromhexin under physiological conditions in the stomach is possible.

Indications

Cough, Bronchial asthma, Lung inflammation (pneumonia), Chronic obstructive pulmonary disease, BronchitisSecretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired sputum secretion and transport (eg, acute and chronic bronchitis, bronchiectasis, tracheobronchitis, pneumonia, emphysema, mucoviscidosis, tuberculosis, pneumoconiosis).

Active ingredient

Bromhexin

Composition

Content per 100 ml of solution:
Active ingredient: bromhexine hydrochloride – 0,08 g;
Excipients: propylene glycol, sorbitol, apricot-scented fragrance concentrate, 0,1 M (3,5%) hydrochloric acid solution, purified water.

How to take, the dosage

A solution for oral administration. 1 scoop contains 5 ml of solution.

Unless otherwise prescribed, the following doses are recommended:

Adults and adolescents over 14 years of age: 3 times daily, 2-4 scoops (24-48 mg bromhexine per day).

Children 6 to 14 years of age and patients with a body weight less than 50 kg: 3 times daily, 2 scoops (24 mg bromhexine per day).

Children from 2 to 6 years: 3 times a day, 1 scoop (12 mg bromhexine per day) – to be used as prescribed.

In case of impaired renal function and/or severe liver disease, the intervals between doses should be increased, or the dose should be reduced. Consult your physician on this issue.

A sufficient fluid intake is recommended during therapy with Bromhexin 4 by Berlin-Chemie.

Bromhexin 4 Berlin-Chemie should not be taken for more than 4-5 days without consulting the physician. The duration of use is determined by the doctor on an individual basis and depends on the indications and the course of the disease.

Interaction

Bromhexin 4 Berlin-Chemie can be prescribed concomitantly with other drugs used in the treatment of bronchopulmonary diseases.

Bromhexin is not prescribed concomitantly with cough suppressants (including those containing codeine) because the suppression of the reflex makes it difficult to evacuate the liquefied sputum, which may lead to accumulation of secretions in the airways.

Bromhexin 4 Berlin-Chemie promotes penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin) into the bronchial secretion in the first 4-5 days of antimicrobial therapy. The clinical significance of this possible interaction has not been proven.

In concomitant use with drugs with irritant effect on gastro-intestinal tract (e.g., some non-steroidal anti-inflammatory drugs), it is possible increased irritation of the latter on the gastric mucosa.

Special Instructions

In cases of impaired bronchial motility or with a significant volume of sputum secreted (e.g., rare primary ciliary dyskinesia syndrome) the use of Bromhexin 4 Berlin-Chemie requires caution due to the increased risk of airway obstruction.

In impaired renal function and in severe liver disease, Bromhexin 4 Berlin-Chemie should be used with extreme caution (e.g., it is recommended to reduce doses or increase intervals between doses). In severe renal impairment, the possibility of cumulation of metabolites formed in the liver must be taken into account.

Liver function monitoring is recommended, especially with long-term treatment.

There is evidence of very rare cases of severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) when taking bromhexin.

In case of allergic reactions and/or signs of progressive skin rash (sometimes combined with blisters and mucous membrane lesions) the drug should be stopped immediately and a doctor should be consulted.

The use of Bromhexin 4 Berlin-Chemie in children over 2 years of age is possible only under the supervision of a physician.

Propylene glycol, the component of Bromhexin 4 Berlin-Chemie may cause symptoms in children similar to those which occur after alcohol consumption.

Please note for diabetics: 5 ml of the solution (1 scoop) contains 2 g sorbitol (equivalent to 0.5 g fructose), which corresponds to 0.17 bread units.

Sorbitol may have a slight laxative effect.

Influence of the drug on driving and operating ability

Bromhexin 4 Berlin-Chemie has no effect on the speed of psychomotor reactions when taken in recommended doses.

Synopsis

transparent colorless slightly viscous liquid with a characteristic apricot odor.

Contraindications

• high sensitivity to bromhexin and other drug components;
• peptic ulcer disease and/or duodenal ulcer (including anamnesis);
• pregnancy (1st trimester);
• breastfeeding period;
• children under 2 years of age;
• congenital fructose intolerance.

With caution

• renal and/or hepatic failure;
• children from 2 to 6 years of age (doctor’s prescription).

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Side effects

Possible side effects are listed below in descending frequency of occurrence: very common (>1/10), common (>1/100, >1/10), infrequent (>1/1000, >1/100), rare (>1/10000, <1/1000), very rare, including isolated reports (<1/10000), frequency not established (cannot be estimated from available data).

Gastrointestinal tract

Infrequent: nausea, vomiting, diarrhea, abdominal pain;

An immune system side

Rarely: hypersensitivity reactions;

Frequency not established:anaphylactic reactions, including anaphylactic shock, angioedema, skin itching.

Skin and subcutaneous tissue

Rarely: skin rash, urticaria;

Frequency not established: severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis (see section “Special Precautions”).

General disorders

Infrequent:fever.

In all forms of allergic reactions (hypersensitivity, anaphylaxis) or in case of any skin and/or mucous membrane lesions, the drug should be stopped and the attending physician should be informed immediately.

Overdose

Life-threatening overdose symptoms with Bromhexin 4 Berlin-Chemie are unknown.

Symptoms:A published study of overdoses reported vomiting in 4 of 25 overdoses. Vomiting was noted in three children, as well as stunned consciousness, ataxia, diplopia, mild metabolic acidosis, and tachypnea. In children, the symptoms did not occur with bromhexin doses up to 40 mg, even when untreated.

There is no evidence of chronic toxicity of bromhexine in humans.

Treatment:In severe overdose, circulatory monitoring and, if necessary, symptomatic treatment are indicated. Due to the low toxicity of bromhexin, usually there is no need for invasive measures aimed at reducing its absorption (forced vomiting, gastric lavage) or to accelerate excretion. In addition, due to the peculiarities of pharmacokinetics (high volume of distribution, slow redistribution processes and high degree of binding to proteins), effective removal of bromhexine from the body by dialysis or forced diuresis should not be expected.

Since only mild symptoms are expected in children from 2 years of age, even after large doses of bromhexine, detoxification may not be performed at doses of bromhexine hydrochloride up to 80 mg (e.g., 100 ml of Bromhexin 4 Berlin-Chemie). In younger children, the appropriate dose limit is 60 mg of bromhexine hydrochloride (6 mg/kg body weight).

In case of overdose, side effects caused by excipients are also possible.

Pregnancy use

Use of the drug in the first trimester of pregnancy is contraindicated. In II and III trimesters of pregnancy, the drug may be used only if the estimated benefit to the mother exceeds the possible risk to the fetus. Administration of the drug during breast-feeding is contraindicated.

Similarities

Bromhexin 8 Berlin-Chemie, Bromhexin Nicomed, Bromhexin, Bromhexin-Acri.