Bromhexine 8

Overdose

Life-threatening overdoses when using the drug Bromhexin 8 in humans are unknown.

Symptoms: as a rule, there are no signs of the disease that go beyond the usual side effects.

Treatment for acute overdose: artificial vomiting, gastric lavage, symptomatic therapy.

Contraindications

hypersensitivity to the components of the drug,

peptic ulcer disease (in the acute stage),

pregnancy,

lactation,

children under 12 years of age (due to the presence of alcohol).

With caution: violation of the motor function of the bronchi and increased volume of secreted secretions (for example, with ciliary dyskinesia syndrome or immobility of the cilia-the risk of stagnation of sputum), bronchial asthma (accidental inhalation of levomentol, eucalyptus and mint oils in the composition of the drug can lead to laryngospasm or can cause an attack of bronchial asthma), reduced kidney function or severe liver disease (should be used with extreme caution. t.e. increasing the intervals between doses of the drug or reducing the dose taken), severe renal failure (possible accumulation of bromhexine metabolites formed in the liver should be taken into account)

Incompatibilities

Bromhexin 8 can be prescribed simultaneously with other drugs used in the treatment of bronchopulmonary diseases.

Bromhexin 8 is not prescribed simultaneously with antitussive agents (including those containing codeine), because they can make it difficult to cough up liquefied sputum.

Bromhexin 8 promotes the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs into the bronchial secretions in the first 4-5 days of antimicrobial therapy.

Pharmaceutical form

A clear, slightly yellowish solution with a fragrant smell.

Undesirable effects

The frequency of adverse reactions listed below was determined according to the following criteria: very common (≥10%), common (≥1% to <10%), infrequent (≥0.1% to <1%), rare (≥0.01% to <0.1%), very rare (<0.01%), frequency unknown (cannot be estimated based on available data).

On the part of the immune system: rarely-hypersensitivity reactions, the frequency is unknown-anaphylactic reactions, including anaphylactic shock, angioedema, itching.

From the gastrointestinal tract: infrequently-nausea, abdominal pain, vomiting, diarrhea, rarely-exacerbation of gastric ulcer and duodenal ulcer.

From the skin and subcutaneous tissue: rarely-rash, urticaria, frequency unknown-severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis).

From the nervous system: rarely-dizziness, headache.

From the liver and biliary tract: very rarely — an increase in the activity of hepatic transaminases in blood plasma.

General well-being: infrequently-fever, allergic reaction (suffocation).

Pharmacy sales terms

Without a prescription.

Special instructions

Severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported in patients taking bromhexine.

It is necessary to immediately stop taking drugs and seek medical advice if symptoms of a progressive skin reaction (sometimes associated with the development of blisters and damage to the mucous membranes) appear.

Bromhexine 8 mg / ml, drops for oral administration, contains 41 vol.% ethyl alcohol. If the dosage is observed, up to 0.36 g of alcohol enters the body with each intake of one dose of the drug. The risk to health is possible, in particular, in patients with liver diseases, alcoholism, epilepsy, patients with diseases or brain damage, pregnant women, nursing women and children. The effect of other drugs can be weakened or strengthened.

Do not use the drug Bromhexin 8 in patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.

With prolonged use of bromhexine, it is recommended to monitor liver function from time to time.

The effect of the drug on the ability to drive vehicles, mechanisms. Taking the recommended therapeutic doses does not affect the rate of psychomotor reactions of the patient. A significant excess of the recommended doses of the drug containing alcohol can affect the speed of psychomotor reactions and is dangerous when driving a car or working with mechanisms.

Therapeutic indications

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

Pharmacotherapeutic group

  • Expectorant mucolytic agent [Secretolytics and stimulants of motor function of the respiratory tract]

Pharmacodynamic properties

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

Pharmacokinetic properties

When taken orally, bromhexine is almost completely (99%) absorbed into the gastrointestinal tract within 30 minutes. Bioavailability is 80% due to the effect of the first pass through the liver. Bromhexine in plasma binds to proteins, penetrates through the BBB and the placental barrier. In the liver, bromhexine undergoes demethylation and oxidation, and some of the resulting metabolites (ambroxol) remain active. T1/2 is 15 h due to slow reverse diffusion from the tissues. Cmax the blood level is reached approximately 1 hour after administration. It is excreted by the kidneys. In CRF, the release of bromhexine metabolites is disrupted. With repeated use, bromhexine can accumulate.

Special precautions for storage

At room temperature 15-25 °C.

Keep out of reach of children.

Shelf life of the drug Bromhexin 85 лет.

Do not use after the expiration date indicated on the package.

Nature and contents of container

Drops for oral administration 100 g
active substance:  
bromhexine hydrochloride 0.8 g
excipients: star anise fruit oil — 0.025 g, bitter fennel fruit oil — 0.075 g, levomentol — 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, concentrated hydrochloric acid 36% — 0.039 g, potassium phosphate dihydrate — 0.6 g, sodium hydrophosphate dodecahydrate — 0.031 g, purified water — 51,805 g  
Release form

Drops for oral administration of 8 mg / ml. 20, 50 or 100 ml of the drug is placed in a brown glass bottle with a vertical built-in dropper. Each bottle is labeled and placed in a cardboard pack.

Nosological classification (ICD-10)

  • A16 Respiratory tuberculosis, not confirmed bacteriologically or histologically
  • E84. 0 Cystic fibrosis with pulmonary manifestations
  • J04. 1 Acute tracheitis
  • J18 Pneumonia without specifying the causative agent
  • J37. 1 Chronic laryngotracheitis
  • J42 Chronic bronchitis, unspecified
  • J43 Emphysema
  • J44 Other chronic obstructive pulmonary disease
  • J47 Bronchiectatic disease [bronchiectasis]
  • J64 Pneumoconiosis, unspecified
  • R09. 3 Sputum

Dosage (Posology) and method of administration

Inside, 3 times a day (if the doctor does not prescribe a different dosage).

Patients Single dose Maximum daily dose
Adults and adolescents over 14 years of age 23-46 drops (corresponds to 8-16 mg of bromhexine hydrochloride) 138 drops = 48 mg of bromhexine hydrochloride
Adolescents from 12 to 14 years of age and patients with a body weight of 50 kg 23 drops (corresponds to 8 mg of bromhexine hydrochloride) 69 drops = 24 mg of bromhexine hydrochloride

In case of renal insufficiency, the required dose of the drug is reduced or the intervals between its administration are increased.

During treatment, it is recommended to consume a sufficient amount of fluid, which supports the secretolytic effect of bromhexine.

If the picture of the disease worsens or after 4-5 days there is no improvement, you should consult your doctor.

ATC - Anatomical and therapeutic chemical classification

R05CB02 Bromhexine