BROMHEXINE-LM [Bromhexine Hydrochloride] 8 mg Tablets
BROMHEXIN- LM
instructions for medical use of the medicinal product
Tradename
Bromhexin- LM , Bromhexin - LM
International non-proprietary name
Bromhexine, Bromhexine
Compound
Each tablet contains:
active ingredient: bromhexine hydrochloride 8 mg
Excipients: starch, calcium sulfate, magnesium stearate
Dosage form
Tablets.
Pharmacotherapeutic group
mucolytic agent.
Pharmacological properties
Pharmacodynamics
Mucolytic (secretolytic) agent, has an expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of bronchial secretion); activates ciliated epithelium, increases volume and improves sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration. The effect appears after 2-5 days from the start of treatment.
Pharmacokinetics
Bromhexine is rapidly absorbed from the gastrointestinal tract and is extensively metabolized during the "first pass" through the liver. Bioavailability is about 20%. In healthy patients, Cmax in plasma is determined after 1 hour.
Widely distributed in body tissues. About 85-90% is excreted in the urine mainly in the form of metabolites. The metabolite of bromhexine is ambroxol.
The binding of bromhexine to plasma proteins is high. T1 / 2 in the terminal phase is about 12 hours.
Bromhexine crosses the BBB. In small quantities it penetrates the placental barrier.
Only small amounts are excreted in the urine with a T1 / 2 of 6.5 hours.
The clearance of bromhexine or its metabolites may be reduced in patients with severely impaired liver and kidney function.
Indications for use
• Acute and chronic bronchopulmonary diseases, accompanied by difficulty in expectorating viscous sputum: tracheobronchitis, bronchitis of various etiologies (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pulmonary emphysema, pneumonia (acute and chronic), pneumoconiosis, cystic fibrosis.
• Sanitation of the bronchial tree in the preoperative period and during therapeutic and diagnostic intrabronchial manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.
Contraindications
• Hypersensitivity to the components of the drug;
• pregnancy and breastfeeding period;
• peptic ulcer of the stomach and 12 duodenal ulcer (in the acute stage);
• children's age up to 3 years.
Dosage and administration
Inside, regardless of the meal, drink plenty of water.
Adults and children over 10 years old - 8 mg 3-4 times / day.
Children aged 6 to 10 years - 6-8 mg 3 times / day; at the age of 3 to 6 years - 4 mg 3 times / day.
If necessary, the dose for adults can be increased to 16 mg 4 times / day.
The therapeutic effect may appear on the 4-6th day of treatment. The course of treatment is from 4 to 28 days. During treatment, it is recommended to consume a sufficient amount of liquid to maintain the secretolytic effect of bromhexine. Without consulting a doctor, it is not recommended to take the drug for more than 4-5 days.
Special instructions and precautions
In cases of bronchial motility disorders (for example, with a rare syndrome of primary
ciliary dyskinesia) or with a significant amount of sputum secreted, the use of
Bromhexine- LM requires caution due to the risk of delayed discharge into
airways.
Take with caution in violation of kidney function and with
severe liver disease (for example, reduce the dose or increase the interval between doses).
In case of gastric ulcer, as well as indications of gastric bleeding in history, Bromhexine- LM should be used under the supervision of a physician.
Use with caution in patients suffering from bronchial asthma.
Do not use simultaneously with drugs containing codeine, because. this makes it difficult to cough up loose sputum.
The attention of patients taking the drug should be paid to the possibility of increased sputum separation.
During treatment, it is recommended to consume a sufficient amount of liquid to maintain the secretolytic effect of bromhexine.
In children, treatment should be combined with postural drainage or chest vibration massage, which facilitates the evacuation of secretions from the bronchi.
Influence on the ability to drive vehicles and mechanisms
Due to the possible development of side effects when using the drug (dizziness, headache), care should be taken when performing
potentially hazardous activities requiring increased concentration
attention and speed of psychomotor reactions.
Use during pregnancy and during breastfeeding
Contraindicated in the first trimester of pregnancy. Use in the II-III trimesters of pregnancy and during breastfeeding is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.
Interaction with other drugs
Bromhexine is not prescribed simultaneously with drugs that suppress
cough center (including those containing codeine), as this makes it difficult to expel liquefied sputum (leads to the accumulation of bronchial secretions in the airways). Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin,
oxytetracycline, ampicillin, amoxicillin), sulfanilamide drugs into bronchial secretions during 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. With simultaneous use with drugs that cause symptoms of irritation of the gastrointestinal tract, it is possible to increase the irritant effect on the mucous membranes of the gastrointestinal tract.
The drug is not compatible with alkaline solutions.
Side effect
From the immune system: rarely - hypersensitivity reactions, bronchospasm; the frequency is unknown - anaphylactic reactions, including anaphylactic shock, angioedema and pruritus, rhinitis.
From the nervous system: infrequently - dizziness, headache.
From the digestive system: infrequently - nausea, diarrhea, vomiting, abdominal pain; frequency unknown - exacerbation of gastric ulcer and 12 duodenal ulcer, dyspepsia.
From the skin and subcutaneous tissues: rarely - skin rash, urticaria; frequency unknown - severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis.
On the part of laboratory parameters: very rarely - an increase in the activity of "liver" transaminases in the blood serum.
If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
Symptoms: nausea, vomiting, diarrhea and other gastrointestinal disorders.
Treatment: symptomatic, there is no specific antidote. In case of an overdose, it is necessary to induce vomiting, and then give the patient water. Gastric lavage is recommended within 1-2 hours after taking the drug.
Storage conditions
Store at temperatures between 15-30°C.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 3 blisters with instructions for use in a cardboard box.