Bromgeksin-Darnitsa

General characteristics. Structure:

Pharmacological properties:

Drug shows mucolytic (sekretolitichesky) and expectorant action. The mucolytic effect is connected with a depolymerization and depression of mucoprotein and mukopolisakharidny fibers. One of important features of effect of Bromhexine is its ability to stimulate formation of surfactant – surfactant липидо - proteinaceous мукополисахаридной the nature, synthesized in cells of alveoluses: biosynthesis of surfactant is broken at various bronchopulmonary diseases. The last leads to disturbance of stability of alveolar cells, weakening of their reaction to adverse effects.

Bromhexine is quickly soaked up from digestive tract. Bioavailability makes about 20%. At healthy volunteers the maximum concentration (Cmax) in plasma is defined in 1 hour. Linkng of Bromhexine with proteins of plasma high. It is widely distributed in body tissues. Bromhexine gets through a blood-brain barrier. In small amounts gets through a placenta. At prolonged repeated use can kumulirovat. Is exposed to intensive metabolism at the first passing through a liver. In a liver is exposed to demethylation and oxidation. The main metabolite of Bromhexine is Ambroxol. About 85-90% are brought out of an organism with urine, mainly in the form of metabolites. The elimination half-life (T1/2) makes 12-15 hours owing to slow return diffusion of fabrics.

Indications to use:

Sekretolitichesky therapy at the acute and chronic bronkhopulmonalny diseases which are followed by a phlegm otkhozhdeniye complication.

Route of administration and doses:

Drug is used inside, irrespective of meal. Duration of reception depends on indications and disease and is established individually.

To adults and children aged from 14 years: on 1-2 tablets (8-16 mg) 3 times a day. A course of treatment – 4-5 days.

To children aged from 6 up to 14 years, and also the patient with body weight less than 50 kg: on 1 tablet (4-8 mg) 3 times a day. A course of treatment – 4-5 days.

In case of renal failures or a serious illness of a liver the dose of drug needs to be reduced.

Features of use:

At treatment it is necessary to accept enough liquid that strengthens expectorant effect of Bromhexine.

With care to use drug to the patients having bronchial asthma and to patients with a renal or liver failure (that is to increase intervals between receptions or to reduce a dose).

At an acute renal failure it is necessary to consider a possibility of accumulation of metabolites of Bromhexine in a liver.

At prolonged use of drug it is recommended to control function of a liver from time to time.

Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is impossible to use drug.

At the first manifestations of any disturbances from skin or mucous membranes during use of Bromhexine of a hydrochloride it is necessary to stop immediately drug use (perhaps, this beginning of development of such heavy complications as Stephens-Johnson's syndrome or a Lyell's disease).

Use during pregnancy or feeding by a breast.

During pregnancy and feeding a breast drug is appointed taking into account a ratio advantage for mother/risk for a fruit.

During feeding by a breast use of Bromhexine is contraindicated owing to its penetration into breast milk.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

There are no messages that drug can influence ability to drive the car or to work with other mechanisms.

Children.

Drug is used to children aged from 6 years. To children up to 6 years apply in other dosage forms.

Side effects:

From the central nervous system: a headache (as migraine), dizziness.

From respiratory system: strengthening of cough, bronchospasm.

From system of digestion: the dispeptic phenomena, nausea, vomiting, diarrhea, an abdominal pain, an aggravation of a peptic ulcer of a stomach and duodenum, tranzitorny increase in activity of aminotransferases in blood serum.

From immune system: skin rashes, skin itch, small tortoiseshell; very seldom – a Quincke's edema, anaphylactic reactions, including an acute anaphylaxis; it was extremely seldom reported about severe damages of skin: Stephens-Johnson's syndrome and a Lyell's disease connected using mucolytic means, such as Bromhexine. Mostly, they could be explained with weight of a current of a basic disease or a concomitant use of other drug. At emergence of skin reactions or reactions on mucous membranes the patient should stop administration of drug and to see a doctor.

Others: the strengthened sweating.

Interaction with other medicines:

Antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline), sulfanamide medicines – at the combined use with Bromhexine raise concentration of antibiotics and streptocides in a bronchopulmonary secret and in a phlegm.

Antibechics – the combined use with Bromhexine leads to accumulation of slime in respiratory tracts and difficulty of removal of a phlegm from bronchial tubes against the background of reduction of cough. Such combination is not recommended.

The medicines irritating a digestive tract (for example, non-steroidal anti-inflammatory drugs) – at the combined use with Bromhexine perhaps mutual strengthening of effects of irritation of a mucous membrane.

Contraindications:

Hypersensitivity to drug components; peptic ulcer of a stomach and duodenum; the diseases of respiratory system proceeding with formation of a plentiful liquid phlegm.

Overdose:

Symptoms: dispeptic frustration, nausea, vomiting, diarrhea, dizziness, headache, diplopia, ataxy, slight metabolic acidosis, tachypnea.

Treatment: to cause vomiting, to carry out a gastric lavage (in the first 1-2 hours after reception), symptomatic therapy. At considerable overdose it is necessary to carry out monitoring of cardiovascular system. Because of high extent of linkng with proteins of plasma, large volume of distribution and slow return distribution of Bromhexine from fabrics in blood it is not necessary to expect acceleration of removal of drug at a hemodialysis or an artificial diuresis.

Storage conditions:

Period of validity. 3 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in a blister strip packaging; on 5 blister strip packagings in a pack; on 10 or 20 tablets in blister strip packagings.