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

Excipients: sucrose (granulated sugar) - 2.0 mg, potato starch - 6.4 mg, lactose monohydrate - 125.3 mg, microcrystalline cellulose - 6.8 mg, calcium stearate -1.5 mg

Description:Tablets are white, flat-cylindrical, with a bevel.

Pharmacotherapeutic group:mucolytic and expectorant

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics: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:When ingested almost completely (99%) is absorbed into the gastrointestinal tract for 30 minutes. Bioavailability is low (the effect of primary "passage" through the liver). It penetrates the placental barrier and the blood-brain barrier. In the liver it is demethylated and oxidized, metabolized to pharmacologically active ambroxol. The half-life (T1 / 2) is 15 hours (due to slow back diffusion from the tissues). It is excreted by the kidneys. With chronic renal failure, excretion of metabolites is impaired. With multiple applications can cumulate.

Indications:

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

stomach and duodenum, hereditary lactose intolerance,

deficiency of lactase, glucose-galactose malabsorption, pregnancy (I trimester), the period of breastfeeding, children under 6 years.

Carefully:

Renal and / or liver failure; diseases of the bronchi accompanied by excessive accumulation of secretion, in the anamnesis - gastrointestinal bleeding; pregnancy

(II and III trimester).

Pregnancy and lactation:

The use of bromhexine in the first trimester of pregnancy is contraindicated.

Use in the II and III trimester of pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk of development for the fetus.

If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:

Inside, regardless of food intake.

Adults and children over 14 years of age: 8 - 16 mg (1 -2 tab.) 3-4 times a day.

Children aged 6-14 years: 4-8 mg (1/2-1 tab.) 3 times a day. Therapeutic effect may occur on the 4 - 6th day of treatment.

The course of treatment is from 4 to 28 days.

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

Side effects:

Allergic reactions, dyspepsia, incl. nausea, vomiting; exacerbation of peptic ulcer of stomach and duodenum, dizziness, headache, increased activity of "liver" transaminases.

Overdose:

Symptoms: dyspeptic disorders, incl. nausea, vomiting, diarrhea.

Treatment: artificial vomiting, gastric lavage (in the first 1 - 2 hours after administration).

Interaction:

Do not prescribe concomitantly with drugs that suppress the cough center (incl. codeine), as this makes it difficult to escape the diluted sputum (accumulation of bronchial secretions in the airways).

Bromhexine contributes to the penetration of antibiotics (amoxicillin, 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:

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

In children, treatment should be combined with postural drainage or vibratory chest massage, which facilitates the secretion of bronchial secretions

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

In connection with the possible development of side effects when using the drug (dizziness, headache), care should be taken when driving vehicles and mechanisms.

Form release / dosage:

Tablets 8 mg.

Packaging:

For 10 or 25 tablets in a contour mesh package.

5 contour cell packs of 10 tablets or 2 contourcell packs of 25 tablets together with instructions for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, 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 expiry date printed on the package

Terms of leave from pharmacies:Without recipe

Registration number:LP-002198

Date of registration:23.08.2013

Expiration Date:23.08.2018

The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Manufacturer: & nbsp

BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine (Bromhexine)