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

Mucolytic (secretolitic), has an expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mukoproteinovye and mucopolysaccharide fibers, increases the serous component of the bronchial secretion); activates ciliated epithelium, increases volume and improves sputum discharge.Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells in the process of breathing. The effect is manifested after 2-5 days from the beginning of treatment.

Pharmacokinetics:

Ingestion bromohexine almost completely (99%) is absorbed into the gastrointestinal tract for 30 minutes. Bioavailability is low (the effect of primary "passage" through the liver). Bromhexine in the plasma binds to proteins, penetrates through hematoencephalic and placental barriers, as well as in breast milk. In the liver bromohexine is demethylated and oxidized, metabolized to pharmacologically active ambroxol. Half-life (T1 / 2) -15 h (due to slow reverse diffusion from tissues). It is excreted by the kidneys. In chronic renal failure, excretion of metabolites of bromhexine is impaired. With repeated use bromohexine can cumulate.

Indications:

Acute and chronic bronchopulmonary diseases, accompanied by difficulty in withdrawing viscous sputum: tracheobronchitis, bronchitis of different etiology (incl. complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, emphysema, pneumonia (acute and chronic), pneumoconiosis, cystic fibrosis.

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

Contraindications:

Hypersensitivity to the components of the drug, peptic ulcer and duodenal ulcer, pregnancy, the period of breastfeeding, children under 3 years of age, hereditary lactose intolerance, glucose-galactose malabsorption, deficiency of lactase.

Carefully:

Carefully use in patients with gastric bleeding in history, with bronchial diseases accompanied by excessive accumulation of secret, with history of episodes of hemoptysis, renal and / or liver failure.

Pregnancy and lactation:

Bromhexine penetrates the placental barrier, as well as into 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, regardless of food intake.

Children over 10 years of age: 24-48 mg (6-12 tablets) divided into 3 doses per 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 - 12-24 mg (3-6 tablets) divided into 3 doses per day (daily dose - 12-24 mg of bromhexine).

Children from 3 to 6 years - 6-12 mg (1 1/2 -3 tab.), divided into 3 doses per day (daily dose - 6-12 mg of bromhexine).

Therapeutic effect may occur on the 4 - 6th day of treatment.

The course of treatment is from 4 to 28 days.

Patients with renal insufficiency are prescribed smaller doses or increase the interval between doses.

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.

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 for 1 -2 hours after taking the drug.

Interaction:

Bromhexine is not prescribed concomitantly with drugs that suppress the cough center (including those containing codeine), as this makes it difficult to escape the diluted sputum (accumulation of bronchial secretions in the airways).

Bromhexine promotes the penetration of antibiotics (amoxicillin, ampicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs in the bronchial secret in the first 4-5 days of antimicrobial therapy. The combined use of bromhexine with some non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone or butadione) can cause irritation of the gastric mucosa.

Special instructions:

Very rarely reported on the occurrence of Stevens-Johnson and Lyell syndromes, in a temporary connection with the drug Bromhexine. If any changes occur on the skin or mucous membrane, stop taking the medication and consult a doctor.

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

In children, treatment should be combined with postural drainage or vibration massage of the chest, facilitating the evacuation of secretions from the bronchi.

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

Admission of recommended therapeutic doses (16 mg 3 times a day) does not affect the speed of the patient's psychomotor reactions. In case of side effects when using the drug, care should be taken when driving vehicles and mechanisms.

Form release / dosage:

Tablets for children 4 mg.

Packaging:

For 10, 20, 25, 30, 40 or 50 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate or polypropylene for drugs, sealed with polyethylene caps high pressure with the control of the first opening or lids with polypropylene a "push-turn" system or low-pressure polyethylene caps with control of the first opening.

One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

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-004535

Date of registration:13.11.2017

Expiration Date:13.11.2022

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

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp05.12.2017

Illustrated instructions

Instructions

Bromhexine (Bromhexine)