Bromhexine - instructions for use, dose, side effects, contraindications

Excipients: ethanol 95% - 150,000 mg, levomentol 0.340 mg, sorbitol noncrystallizing 70 % - 2142.855 mg, methylparahydroxybenzoate - 8,200 mg, hydrochloric acid - 1,420 mg, water - up to 5 ml.

Description:

Colorless, transparent or slightly opalescent liquid with a characteristic odor.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:

Bromhexine has mucolytic (secretolitic), expectorant and weak antitussive action. The mucolytic effect is associated with the depolymerization of mucoprotein and mucopolysaccharide fibers and an increase in the serous component of the bronchial secretion.

Pharmacokinetics:

Ingestion bromohexine almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability depends on the individual characteristics of the organism, the activity of renal enzymes during the primary passage of the active substance through the liver and is approximately 20%. Bromhexine in plasma binds to proteins, penetrates through blood-brain and placental barriers, as well as into breast milk. In the liver bromohexine is subjected to demethylation and oxidation, part of the metabolites formed retains activity. The limiting half-life is 15 hours due to slow back diffusion from the tissues.

The maximum concentration in the blood is reached about 1 hour after admission.

Excreted by the kidneys. With chronic renal failure is impaired isolation of bromhexine metabolites. With repeated use bromohexine can to accumulate.

Indications:

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

Sanitation of the bronchial tree in the preoperative period and during the medical and diagnostic intrabronchial manipulation, prevention of congestion in bronchus thick viscous sputum after surgery.

Contraindications:

hypersensitivity to the components of the drug;
pregnancy and the period of breastfeeding;
peptic ulcer (at the stage of exacerbation);
children up to 3 years;
hereditary intolerance to fructose (because the drug contains sorbitol).

Carefully:

Use with caution in patients with gastric hemorrhage in history, with bronchial diseases accompanied by excessive accumulation of secretion, with history of episodes of hemoptysis, kidney and / or liver failure. Presence of alcohol in the preparation (ethanol 95%) can have an adverse effect on children, pregnant women, people with brain diseases, epilepsy, with craniocerebral trauma, alcoholism.

The bromhexine solution contains sorbitol. Sorbitol can also have a mild laxative effect.

Pregnancy and lactation:

Bromhexine penetrates the placental barrier, as well as into the breast milk.The drug is contraindicated for use during pregnancy and during breastfeeding. If you need to use the drug during lactation at the time of treatment should stop breastfeeding.

Dosing and Administration:

Inside.

Adults and children over 10 years of age: 10-20 ml 3 times a day (daily dose of 24-48 mg of bromhexine).

Children from 6 to 10 years, as well as patients with a body weight of less than 50 kg - 5-10 ml 3 times a day (daily dose - 12-24 mg of bromhexine).

Children from 3 to 6 years - 2.5-5 ml 3 times a day (daily dose - 12 mg of bromhexine).

For the convenience of dosing, use the attached measuring cup (measuring spoon).

During the treatment it is recommended to use a sufficient amount of liquid that supports the secretolitic action of bromhexine.

Side effects:

From the gastrointestinal tract: abdominal pain, indigestion, incl. nausea, vomiting, exacerbation of gastric ulcer and duodenal ulcer.

Allergic reactions: hypersensitivity reactions (skin rash, itching, angioedema, rhinitis), urticaria, fever, anaphylactic reactions, including anaphylactic shock.

From the skin and subcutaneous tissues: Stevens-Johnson syndrome, Lyell's syndrome, acute generalized exanthematous pustulosis.

Other: dizziness, headache, increased activity of "hepatic" transaminases in the blood serum.

In patients with sorbitol / fructose intolerance under the influence of sorbitol contained in the drug, nausea, vomiting and diarrhea, lowering of blood sugar level (accompanied by tremors, cold sweat, palpitation, a sense of fear), increased activity of "liver" transaminases.

Overdose:

The following symptoms are possible: nausea, vomiting, diarrhea and other gastrointestinal disorders.

Treatment: there is no specific antidote. In case of overdose, it is necessary to induce vomiting, and then give the patient a liquid (milk or water). Gastric lavage is recommended within 1-2 hours after taking the drug.

Interaction:

Bromhexine Do not prescribe concomitantly with antitussive agents (including those containing codeine), as they can make it difficult to cough up bromhexine thinning sputum.

Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillium), sulfonamide drugs in the bronchial secret.

The drug is incompatible with alkaline solutions.

Special instructions:

When treating, you must take a sufficient amount of fluid, which increases the expectorant effect.

In cases of violation of bronchial motility or a significant amount of sputum produced (for example, with rare malignant cilia syndrome), the use of bromhexine requires caution in connection with the risk of delayed discharge in the airways.

Note for patients with diabetes: in 5 ml of solution (1 measuring spoon) contains 1.5 g of sorbitol, which corresponds to 0.12 bread units.

The composition of the drug includes alcohol at a concentration of 30,000 grams, which equals 0.6 g for one dose of adults (20 ml), respectively, for children (2.5 ml) - 0.075 g.

Effect on the ability to drive transp. cf. and fur:

Admission of recommended therapeutic doses (20 ml 3 times a day) does not affect the speed of the patient's psychomotor reactions.

A significant excess of the recommended doses of a drug containing alcohol may affect the speed of psychomotor reactions and be dangerous when driving a machine or working with equipment.

Form release / dosage:

Solution for oral administration 4 mg / 5 ml.

Packaging:

To 50 ml or 100 ml of solution in bottles of glass of orange glass or polymeric bottles, equipped with a plastic incisionwith or without the user ukuporennyh cap polymer.

A label is attached to the vial on the basis of a self-adhesive film.

Each bottle, along with the instructions for use, as well as a measuring cup or measuring spoon, or without a measuring cup, a measuring spoon is placed in a cardboard package (packet)

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003103

Date of registration:21.07.2015

Expiration Date:21.07.2020

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine (Bromhexine)