Bromhexine 8 drops 8mg / ml 20ml

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Bromhexine 8 drops 8mg / ml 20ml

Pharmacological group

Secretolytics and respiratory motor function stimulants

Composition and release form

Drops for oral administration 100 g
Bromhexine hydrochloride 0.8 g
excipients: star anise fruit oil - 0.025 g bitter fruit fennel oil - 0.075 g levomenthol - 0.15 g thyme herb oil - 0.025 g mint oil - 0.025 g eucalyptus oil - 0.025 g sucrose - 10 g polysorbate 80 - 0.4 g ethanol 96% - 36 g hydrochloric acid concentrated 36% - 0.039 g potassium phosphate dihydrate - 0.6 g sodium hydrophosphate dodecahydrate - 0.031 g purified water - 51.805 g
in dark glass dropper bottles of 20 ml in a cardboard box 1 dropper bottle.

Description of the dosage form
Transparent, slightly yellowish solution with a fragrant odor.

pharmachologic effect

Pharmacological action - mucolytic, expectorant.

Pharmacokinetics
When ingested, Bromhexine is almost completely (99%) absorbed in the gastrointestinal tract within 30 minutes. Bioavailability - 80% due to the effect of "first pass" through the liver. Plasma bromhexin binds to proteins, penetrates the BBB and placental barrier. In the liver, Bromhexine undergoes demethylation and oxidation, part of the resulting metabolites (Ambroxol) remains active. The final T1 / 2 is 15 hours due to slow reverse diffusion from the tissues. Cmax in the blood is reached approximately 1 hour after administration. Excreted by the kidneys. In chronic renal failure, the release of Bromhexine metabolites is impaired. With repeated use, Bromhexine may accumulate.

Pharmacodynamics
Bromhexin 8 has a mucolytic (secretolytic), expectorant and weak antitussive effect. It reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of the bronchial secretion) activates the ciliated epithelium, increases the volume and improves the sputum discharge.

Indications
Acute and chronic bronchopulmonary diseases accompanied by the formation of sputum of increased viscosity (pneumonia, tracheobronchitis, obstructive bronchitis, bronchiectasis, pulmonary emphysema, cystic fibrosis, tuberculosis, pneumoconiosis).

Contraindications
hypersensitivity to the drug components
peptic ulcer disease (acute)
pregnancy
breast-feeding
children's age up to 12 years (due to the presence of alcohol).
Precautions - respiratory diseases, accompanied by an excessive accumulation of secretion in the stomach bleeding history of renal and / or liver failure, hereditary fructose intolerance to glucose-galactose malabsorption, or lack of sucrose-isomaltose bronchial asthma (since accidental inhalation levomenthol, eucalyptus and peppermint oils in the composition drug may cause laryngism or may cause an attack of bronchial asthma).

Use during pregnancy and lactation
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects
Nausea, abdominal pain, vomiting, diarrhea sometimes - fever, hypersensitivity (skin rashes, angioedema, choking, itching, urticaria) very rarely - an anaphylactic reaction, up to shock is extremely rare - exacerbation of gastric ulcer and duodenal ulcer, dizziness, headache, increased activity of hepatic transaminases.
Inside Adults and adolescents over 14 years old - 23–46 drops (corresponding to 8–16 mg of bromhexine hydrochloride) 3 times a day for adolescents from 12 to 14 years old and patients whose body weight is below 50 kg - 23 drops (corresponds to 8 mg of bromhexine hydrochloride ) 3 times a day.
In renal insufficiency, the required dose of the drug is reduced or increased the intervals between its intakes.
In the course of treatment, it is recommended to consume a sufficient amount of liquid, which supports the secretolytic action of Bromhexine.
If the picture of the disease worsens or there is no improvement after 4–5 days, you should consult a doctor.

special instructions
It should be borne in mind that the preparation includes ethyl alcohol (41%). When the dosage is observed, the patient takes up to 0.36 g of alcohol per 1 ml (23 drops). It is dangerous for people with liver diseases, alcoholism, epilepsy, brain diseases, as well as for pregnant women and children.
Very rarely was reported the occurrence of Stevens-Johnson and Lyell syndromes, which are in temporary connection with taking Bromhexin 8. If there is a change in the skin or mucous membrane, it is necessary to stop taking the drug and consult a doctor.

Shelf life

5 years

Storage conditions

At room temperature 15–25 ° C.


It is a pharmaceutical drug. Use only as directed by your doctor.