Bromhexin 4 Berlin-Chemie solution 60ml

Bromhexin 4 Berlin-Chemie solution instruction

You can buy Bromhexin 4 Berlin-Chemie solution here

Composition

100 ml of solution contain
active substance - bromhexine hydrochloride 0.080 g
Excipients:
propylene glycol, sorbitol, concentrated apricot flavor, 0.1 M hydrochloric acid, purified water.

Pharmacokinetics

After oral administration, bromhexine is absorbed almost completely; its half-life is approximately 0.4 hours. Tmax for oral administration is 1 hour. The effect of the first passage through the liver is about 80%. Biologically active substances are formed in the process of excretion. Binding to plasma proteins - 99%.
A decrease in plasma concentration is multiphase. The half-life after which the action ceases is about 1 hour. In addition, the final half-life is approximately 16 hours. This is caused by the redistribution of small amounts of bromhexine in the tissues. The volume of distribution is approximately 7 L per kg of body weight. Bromhexine does not accumulate in the body.
Bromhexine crosses the placental barrier, and also penetrates into the cerebrospinal fluid and breast milk.
Excretion mainly through the kidneys, since metabolites are formed in the liver. Due to the high degree of binding of bromhexine to proteins and its significant volume of distribution, as well as due to its slow redistribution from tissues to the blood, excretion of any significant part of the drug through dialysis or forced diuresis is unlikely.
In severe liver diseases, a decrease in the clearance of the starting material can be expected. In severe renal failure, the half-life of bromhexine may be prolonged. Under physiological conditions, nitrosation of bromhexine is possible in the stomach.

Pharmacodynamics

Bromhexine is a synthetic derivative of the plant active ingredient vasicin. It has a secretolytic effect and promotes the evacuation of secretions from the bronchi. Animal experiments have shown that this drug increases the proportion of the serous component in bronchial secretions. This facilitates the transport of sputum by reducing its viscosity and enhancing the functioning of the ciliary epithelium.
With the use of bromhexine, an increase in the concentration of antibiotics amoxicillin, erythromycin and oxytetracycline in sputum and bronchial secretion is noted. The clinical significance of this effect has not been determined.

Indications for use

- as a secretolytic agent in acute and chronic diseases of the bronchi and lungs, accompanied by impaired formation and excretion of mucus.

Dosage and administration

Oral solution
Unless otherwise specified, the following dosage of the drug Bromhexin 4 Berlin-Chemie is recommended:
Adults and adolescents over 14 years of age - 2 to 4 scoops of the drug Bromhexin 4 Berlin-Chemie three times a day (which is equivalent to 24 - 48 mg of bromhexine hydrochloride per day).
Children and adolescents from 6 to 14 years old, as well as patients weighing less than 50 kg, take 2 scoops of Bromhexin 4 Berlin-Chemie three times a day (equivalent to 24 mg of bromhexine hydrochloride per day).
Children under 6 years old are recommended 1 scoop of the drug Bromhexin 4 Berlin-Chemie three times a day (which is equivalent to 12 mg of bromhexine hydrochloride per day).
The use of Bromhexin 4 Berlin-Chemie is permitted only in children over 2 years old and under the supervision of a doctor.
Instructions for use in special patient groups:
The use of the drug Bromhexin 4 BERLIN-Chemie in case of impaired liver function or in serious renal diseases requires special care (bromhexine should be used in a lower dose or with longer intervals).
It is recommended to take the drug with a sufficient amount of fluid.
The duration of treatment is determined individually in accordance with the indications and course of the disease. Take BROMHEXIN 4 Berlin-Chemie without the recommendation of a doctor is allowed no more than 4-5 days.

Side effects

By the frequency of occurrence, side effects are classified as follows:
Often ≥ 1/10
Often ≥ 1/100 to <1/10
Sometimes ≥ 1/1000 to <1/100
Seldom ≥ 1/10000 to <1/1000
Very rarely <1/10000
Unknown
According to available data, it is not amenable to
Sometimes:
fever
hypersensitivity reactions (skin rash, Quincke's edema, shortness of breath, itching, urticaria)
- nausea, abdominal pain, vomiting, diarrhea
Very rarely
- anaphylactic reactions, up to the development of shock
- severe skin reactions, for example, Stevens-Johnson syndrome and Lyell syndrome (see section "Special instructions").
At the first manifestations of a hypersensitivity reaction, anaphylactic reactions or the appearance of any unusual changes on the skin and mucous membranes, immediately stop taking Bromhexin 4 Berlin-Chemie and consult a doctor.

Messages about possible adverse reactions

Reporting possible side effects after registration of the drug plays an important role. This allows you to continue monitoring the benefit / risk ratio for this drug. Health workers should report any potential adverse reactions.

Contraindications

- increased sensitivity to the active substance or to other excipients
lactation period

Drug interactions

When using Bromhexin 4 Berlin-Chemie in combination with antitussive drugs, dangerous secretion may occur due to suppression of the cough reflex - therefore, when prescribing such a combination of drugs, a particularly thorough examination is necessary.
With the simultaneous use of drugs that cause symptoms of irritation of the gastrointestinal tract, it is possible to increase the irritating effect on the mucous membranes of the gastrointestinal tract.

special instructions

Skin reactions: as a result of the use of bromhexine in extremely rare cases, severe skin reactions have occurred, for example, Stevens-Johnson syndrome and Lyell's syndrome. If any unusual changes appear on the skin and mucous membranes, stop taking BROMHEXIN 4 Berlin-Chemie immediately and consult a doctor.
Gastric and duodenal ulcer: Bromhexin 4 Berlin-Chemie should not be used if you suffer (or have suffered in the past) an ulcer of the stomach or duodenal ulcer, as bromhexine can affect the barrier function of the gastrointestinal mucosa.
Lungs and airways: in connection with the possible accumulation of secretion, caution should be exercised when using Bromhexin 4 Berlin-Chemie in patients with impaired bronchial motility and enhanced secretion of mucus (eg, with a rare disease such as primary ciliary dyskinesia [ciliary dyskinesia]) .
Disorders from the liver and kidneys: in case of impaired liver function or serious renal diseases, special care must be taken (use bromhexine in a lower dose or with longer intervals).
In severe renal failure, an accumulation of metabolites of bromhexine, which is formed in the liver, is likely.
It is recommended to periodically monitor liver function, especially with prolonged treatment.
Children: The use of Bromhexin 4 BERLIN-Chemie is allowed only in children from 2 years old and under the supervision of a doctor.
Propylene glycol, sorbitol: due to propylene glycol, which is part of the drug, Bromhexin 4 Berlin-Chemie can cause the same symptoms in children that they occur after drinking alcohol.
In this regard, the drug is contraindicated in a rare hereditary disease - congenital fructose intolerance.
Calorie content 2.6 kcal / g sorbitol.
One scoop contains 2 g of sorbitol (a source of 0.5 g of fructose), which is equivalent to approximately 0.17 bread unit.
Perhaps a mild laxative effect of the drug due to the sorbitol contained in it.

Pregnancy and lactation

Pregnancy

To date, there is no experience with the use of bromhexine in pregnancy; therefore, the use of BROMHEXIN 4 Berlin-Chemie for pregnant women is allowed only after a thorough assessment by the doctor of the risk and benefit; use in the first trimester of pregnancy is not recommended.

Lactation

Since the active substance is excreted in breast milk, the use of Bromhexin 4 BERLIN-Chemie during lactation is not allowed.

Overdose

Symptoms: cases of overdose in humans, representing a danger, are still unknown.
A study of overdose cases was published, according to which vomiting was observed in 4 out of 25 cases of an overdose of bromhexine, and three children noted such phenomena as vomiting, as well as loss and confusion, ataxia, double vision, mild metabolic acidosis and rapid breathing. In children taking up to 40 mg of bromhexine, symptoms were absent even without taking measures to remove this substance from the body. There are no data on the chronic toxic effects of the drug in humans.
Therapeutic measures: after a significant overdose, blood circulation control and, if necessary, symptomatic therapeutic measures are indicated. Due to the low toxicity of bromhexine, the need for more invasive measures to reduce absorption or accelerate elimination usually does not arise. In addition, due to pharmacokinetic characteristics (large volume of distribution, slow redistribution processes and significant binding to proteins), dialysis and forced diuresis do not significantly affect the excretion of a substance from the body.
Since children over 2 years of age usually have only mild symptoms, even after taking a significant dose, there is no need to use antidotes when taking up to 80 mg of bromhexine hydrochloride (i.e. 100 ml of BROMHEXIN 4 Berlin-Chemie); for young children, this limit is 60 mg of bromhexine hydrochloride (6 mg / kg body weight).
Note: when taking higher doses, the effect of excipients should also be taken into account (see the sections "composition" and "Special instructions" - propylene glycol and sorbitol).

Release form and packaging

60 ml in brown glass bottles with a plastic or aluminum screw cap.
1 bottle together with a measuring spoon and instructions for medical use in the state and Russian languages ​​are put in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children!
Shelf life - 3 years.
Not more than 3 months after the first opening of the bottle.
Do not use after the expiration date indicated on the package.

Terms of sell

You can buy solution Bromhexin 4 Berlin-Chemie without a prescription.