Bromhexin 8 Berlin-Chemie, 8 mg 25 pcs

Pharmacotherapeutic group: expectorant mucolytic agent

ATX: R05CB02

Pharmacological properties

Pharmacodynamics

Bromhexin has mucolytic (secretolytic) and expectorant (secretomotor) effects.

It reduces the viscosity of sputum, activates the atrial epithelium, increases the volume of sputum and improves its discharge. Stimulates the production of endogenous surfactant, which provides stability to 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

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

Active ingredient

Bromhexin

Composition

Composition per 1 tablet:

Kernel:

The active ingredient: bromhexine hydrochloride – 8,000 mg.

Harmful ingredients:lactose monohydrate, corn starch, gelatin, colloidal anhydrous silica, magnesium stearate;

Shell: sucrose, calcium carbonate, magnesium carbonate, talc, macrogol 6000, povidone K 25, glucose syrup, carnauba wax, titanium dioxide (E 171), quinoline yellow dye (E 104).

How to take, the dosage

The drug is taken orally after a meal, without chewing, with plenty of liquid.

Adults and adolescents over 14 years of age: 1 to 2 pills 3 times daily (24-48 mg/day).

Children 6 to 14 years of age and patients with a body weight less than 50 kg: 1 tablet 3 times daily (24 mg/day).

In case of impaired renal and/or hepatic function, the intervals between doses should be increased, or the dose should be reduced. Your physician should be consulted about this issue.

Bromhexin should not be taken for more than 4-5 days without consulting a physician.

The duration of use is determined on an individual basis and depends on the indication and the course of the disease.

Interaction

Bromhexin is not prescribed simultaneously with cough suppressants (including those containing codeine), because by suppressing the reflex the evacuation of liquefied sputum becomes difficult, which may lead to accumulation of secretion in the respiratory tract.

Bromhexin 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 irritant effect of the latter on the gastric mucosa.

Special Instructions

In cases of impaired bronchial motility (e.g., rare primary ciliary dyskinesia syndrome) or when the volume of sputum secreted is significant, the use of Bromhexin 8 Berlin-Chemie requires caution due to the increased risk of airway obstruction.

In impaired renal function and in severe liver disease, Bromhexin 8 Berlin-Chemie should be used with extreme caution (e.g., reduce the dose or increase the interval between doses). In severe renal impairment, the possibility of cumulation of metabolites formed in the liver must be considered.

Periodic monitoring of liver function 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 bromhexine. If allergic reactions and / or signs of progressive skin rash (sometimes combined with the appearance of blisters and mucous membrane lesions) should immediately stop using the drug and consult a physician.

Synopsis

Yellow to greenish-yellow coated tablets slightly biconvex with an almost white core.

Contraindications

• high sensitivity to bromhexine and other drug components;
• lactase deficiency, rare hereditary intolerance to galactose or fructose, glucose-galactose malabsorption syndrome, sugar-isomaltase deficiency;
• gastric and duodenal ulcer (including anamnesis);
• pregnancy (first trimester);
• children under 6 years of age.

With caution

• in impaired renal function and/or liver disease;
• in impaired bronchial motility accompanied by excessive secretion;

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Side effects

Bromhexin 8 by Berlin-Chemie is usually well tolerated.

Possible side effects are listed below in descending order of 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 individual reports (< 1/10000), frequency not determined (cannot be estimated based on available data).

Injury to the immune system

Rarely: hypersensitivity reactions;

Frequency not established:anaphylactic reactions, up to and including anaphylactic shock; angioedema, skin itching.

Skin and subcutaneous tissue disorders

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 indications”).

Gastrointestinal tract

Infrequent:nausea, vomiting, abdominal pain, diarrhea.

General disorders

Infrequent: fever.

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

Overdose

Life-threatening symptoms of overdose with Bromhexin 8 Berlin-Chemie are unknown.

Symptoms:Dangerous cases of overdose in humans are not known to date.

A study of overdoses has been published that found vomiting in 4 of 25 overdoses. Vomiting was reported 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, no detoxification can be performed at doses of bromhexine hydrochloride up to 80 mg (for example, 10 tablets of 8 mg). 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

Administration of the drug during pregnancy is possible in the 2nd and 3rd trimesters only if the expected benefits to the mother exceed the possible risk to the fetus. The use of bromhexin during breastfeeding is contraindicated.

Similarities

Bromhexin 4 Berlin-Chemie, Bromhexin Nicomed, Bromhexin, Bromhexin-Acri