pharmachologic effect
Expectorant, mucolytic agent.
Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough. In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.
Directions for use and doses
The mucolytic effect of the drug occurs when taking large amounts of liquid. Therefore, drinking plenty of fluids is recommended during treatment.
Oral use
The drug is taken orally after meals, adding to water, tea, milk or fruit juice.
- Adults and children over 12 years of age: the first 2-3 days, 4 ml (80 drops) 3 times a day (which corresponds to 90 mg of ambroxol per day), then 4 ml (80 drops) 2 times a day (which corresponds to 60 mg ambroxol per day).
- Children from 6 to 12 years old: 2 ml (40 drops) 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day).
- Children from 2 to 6 years old: 1 ml (20 drops) 3 times a day (which corresponds to 22.5 mg of ambroxol per day).
- Children under 2 years of age: 1 ml (20 drops) 2 times a day (which corresponds to 15 mg of ambroxol per day). For children under 2 years of age, the drug is prescribed only under the supervision of a doctor.
Maximum daily dose when taken orally: for adults – 90 mg, for children 6-12 years old – 45 mg, for children 2-6 years old – 22.5 mg, for children under 2 years old – 15 mg.
Use in the form of inhalations
The drug can be used using any modern equipment for inhalation (except steam inhalers). Before inhalation, the amount of the drug corresponding to the required dosage is mixed with a solvent (0.9% sodium chloride solution - for optimal air humidification - in a 1:1 ratio). Before inhalation, it is recommended to warm the inhalation solution to body temperature. Since during inhalation therapy a deep breath can provoke a cough, inhalations should be carried out in normal breathing mode. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators to avoid nonspecific irritation of the respiratory tract and their spasm.
When using the drug in a bottle, a measuring cup is included to accurately measure the dose of the drug.
Dosage for inhalation
- Adults and children over 6 years of age: 1-2 inhalations per day, 2-3 ml of solution (which corresponds to 15-45 mg of ambroxol per day).
- Children under 6 years of age: 1-2 inhalations per day of 2 ml of solution (which corresponds to 15-30 mg of ambroxol per day).
Taking the drug for more than 4-5 days is possible only on the recommendation of a doctor.
Beraxol-solopharm 7.5 mg/ml 100 ml solution for oral administration and inhalation
pharmachologic effect
Expectorant mucolytic agent.
Composition and release form Beraxol-solopharm 7.5 mg/ml 100 ml solution for oral administration and inhalation
Solution - 1 ml:
- Active ingredients: ambroxol hydrochloride - 7.5 mg;
- Excipients: sodium chloride - 6.22 mg, sodium hydrogen phosphate dihydrate - 4.35 mg, anhydrous citric acid - 1.83 mg, benzalkonium chloride - 0.225 mg, water for injection - up to 1 ml;
- Solvent composition (per 1 ml): sodium chloride - 9 mg, water for liquid - up to 1 ml.
Solution for oral administration and inhalation 7.5 mg/ml.
50 or 100 ml of the drug in glass bottles, sealed with a dropper stopper and a lid with first opening control.
1 bottle complete with a measuring cup along with instructions for use in a cardboard pack.
1, 2 or 4 ml of the drug in dropper tube / ampoules A and 1, 2 or 4 ml of solvent in dropper tube / ampoules B made of low-density polyethylene.
10 dropper tubes/ampoules A in a foil film bag and 10 dropper tubes/ampoules B in a foil film bag.
1 or 2 foil film bags with dropper tubes / ampoules A together with 1 or 2 foil film bags with dropper tubes / ampoules B (set) or without them, along with instructions for use in a cardboard pack.
Description of the dosage form
Solution for oral administration and inhalation (bottle or dropper tube / ampoule A) in the form of a clear, colorless or slightly colored liquid; solvent (dropper tube / ampoule B) - transparent, colorless liquid; the prepared solution (drug + solvent) is a clear, colorless or slightly colored liquid.
Directions for use and doses
The mucolytic effect of the drug occurs when taking large amounts of liquid. Therefore, drinking plenty of fluids is recommended during treatment.
Oral use
The drug is taken internally from a dropper tube / ampoule A or a bottle (1 ml = 20 drops from the bottle dropper) after meals, adding to water, tea, milk or fruit juice.
Adults and children over 12 years of age: the first 2-3 days, 4 ml (80 drops) 3 times a day (which corresponds to 90 mg of ambroxol per day), then 4 ml (80 drops) 2 times a day (which corresponds to 60 mg ambroxol per day).
Children from 6 to 12 years old: 2 ml (40 drops) 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day).
Children from 2 to 6 years old: 1 ml (20 drops) 3 times a day (which corresponds to 22.5 mg of ambroxol per day).
Children under 2 years of age: 1 ml (20 drops) 2 times a day (which corresponds to 15 mg of ambroxol per day).
For children under 2 years of age, the drug is prescribed only under the supervision of a doctor.
Maximum daily dose when taken orally: for adults – 90 mg, for children 6-12 years old – 45 mg, for children 2-6 years old – 22.5 mg, for children under 2 years old – 15 mg.
Dosage for inhalation
Adults and children over 6 years of age: 1-2 inhalations per day, 2-3 ml of solution (which corresponds to 15-45 mg of ambroxol per day).
Children under 6 years of age: 1-2 inhalations per day of 2 ml of solution (which corresponds to 15-30 mg of ambroxol per day).
Taking the drug for more than 4-5 days is possible only on the recommendation of a doctor.
Pharmacodynamics
Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough.
In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.
Pharmacokinetics
All dosage forms of immediate release ambroxol are characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose dependence in the therapeutic concentration range. The maximum concentration (Cmax) in blood plasma after oral administration is achieved after 1-2.5 hours. The distribution volume is 552 l. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.
The transition of ambroxol from the blood to tissues when administered orally occurs quickly. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of an oral dose is subject to first pass effects through the liver. Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromoantranilic acid.
The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial breakdown to dibromoantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml/min, renal clearance accounts for approximately 8% of the total clearance. Using the radioactive tracer method, it was calculated that after taking a single dose of the drug over the next 5 days, about 83% of the dose taken is excreted in the urine.
Indications for use Beraxol-solopharm 7.5 mg/ml 100 ml solution for oral administration and inhalation
Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.
Contraindications
Hypersensitivity to ambroxol or other components of the drug, pregnancy (first trimester), breastfeeding.
Carefully
Impaired bronchial motor function and increased sputum production (with fixed cilia syndrome), peptic ulcer of the stomach and duodenum during an exacerbation, pregnancy (II-III trimester).
Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug in a lower dose.
Application of Beraxol-solofarm 7.5 mg/ml 100 ml solution for oral administration and inhalation during pregnancy and breastfeeding
The drug is contraindicated for use during the first trimester of pregnancy. If it is necessary to use ambroxol in the 2nd-3rd trimesters of pregnancy, the potential benefit to the mother and the possible risk to the fetus should be assessed.
During breastfeeding, the use of the drug is contraindicated, since it is excreted in breast milk.
special instructions
Beraxol-SOLOpharm should not be taken simultaneously with antitussive drugs that may inhibit the cough reflex.
Beraxol-SOLOpharm should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
Patients taking ambroxol should not be advised to perform breathing exercises; in patients with severe disease, aspiration of liquefied sputum should be performed.
In patients with bronchial asthma, ambroxol may increase cough.
You should not take ambroxol immediately before bed.
In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, it is possible to erroneously prescribe mucolytic drugs such as ambroxol. There are isolated reports of the identification of Stevens-Johnson syndrome and Lyell's syndrome, which coincided with the prescription of the drug, but there is no cause-and-effect relationship with the drug.
If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help.
If kidney function is impaired, ambroxol should be used only on the recommendation of a doctor.
Ambroxol solution is not recommended to be mixed with cromoglicic acid and alkaline solutions.
Patients on a hyposodium diet should keep in mind that 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years of age contains 120 mg of sodium.
Impact on the ability to drive vehicles and machinery
To date, no cases of the drug affecting the ability to drive vehicles and machinery have been identified.
Overdose
Symptoms: heartburn, dyspepsia, diarrhea, nausea, vomiting, pain in the upper abdomen. There are reports of short-term anxiety. In case of severe overdose, a significant decrease in blood pressure is possible.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods, symptomatic therapy.
Side effects Beraxol-solopharm 7.5 mg/ml 100 ml solution for oral administration and inhalation
The frequency of side effects is presented in the following gradation: very often (≥ 1/10); often (≥ 1/100 to
Gastrointestinal disorders: often – nausea, decreased sensitivity in the oral cavity and pharynx; uncommon – dyspepsia, pain in the upper abdomen, vomiting, diarrhea; rarely - heartburn, dryness of the mucous membrane of the mouth and pharynx, constipation.
Disorders of the respiratory system, chest and mediastinal organs: rarely - dry mucous membrane of the respiratory tract, rhinorrhea.
Nervous system disorders: often – dysgeusia (impaired sense of taste).
Immune system disorders: rarely - hypersensitivity reactions, skin rash, urticaria, itching, angioedema; very rarely - anaphylactic reactions, including anaphylactic shock.
Disorders of the skin and subcutaneous tissues: very rarely - Stevens-Johnson syndrome, Lyell's syndrome.
Other: rarely – adynamia, fever.
special instructions
Beraxol-SOLOpharm should not be taken simultaneously with antitussive drugs that may inhibit the cough reflex.
Beraxol-SOLOpharm should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
Patients taking ambroxol should not be advised to perform breathing exercises; in patients with severe disease, aspiration of liquefied sputum should be performed.
In patients with bronchial asthma, ambroxol may increase cough.
You should not take ambroxol immediately before bed.
In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, it is possible to erroneously prescribe mucolytic drugs such as ambroxol. There are isolated reports of the identification of Stevens-Johnson syndrome and Lyell's syndrome, which coincided with the prescription of the drug, but there is no cause-and-effect relationship with the drug.
If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help.
If kidney function is impaired, ambroxol should be used only on the recommendation of a doctor.
Ambroxol solution is not recommended to be mixed with cromoglicic acid and alkaline solutions.
Patients on a hyposodium diet should keep in mind that 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years of age contains 120 mg of sodium.
To date, no cases of the drug affecting the ability to drive vehicles and machinery have been identified.
Sodium chloride-SOLOpharm 0.9% solution for inf fl 200ml packs of cards. N1
Registration Certificate Holder
GROTEX (Russia)
Dosage form
Medicine – Sodium chloride (Sodium chloride-SOLOpharm)
Description
Solution for infusion
transparent, colorless.
1 l
sodium chloride 9 g
Excipients
: water for d/i - up to 1 l.
100 ml - polypropylene bottles (1) - cardboard packs. 200 ml - polypropylene bottles (1) - cardboard packs. 250 ml - polypropylene bottles (1) - cardboard packs. 400 ml - polypropylene bottles (1) - cardboard packs. 500 ml - polypropylene bottles (1) - cardboard packs. 1000 ml - polypropylene bottles (1) - cardboard packs. 100 ml - polypropylene bottles (30) - cardboard boxes (for hospitals). 200 ml - polypropylene bottles (20) - cardboard boxes (for hospitals). 250 ml - polypropylene bottles (20) - cardboard boxes (for hospitals). 400 ml - polypropylene bottles (20) - cardboard boxes (for hospitals). 500 ml - polypropylene bottles (20) - cardboard boxes (for hospitals). 1000 ml - polypropylene bottles (10) - cardboard boxes (for hospitals).
Indications
Isotonic solution: dehydration of various origins. To maintain blood plasma volume during and after surgery. As a solvent for various drugs.
Hypertonic solution: disturbances of water-electrolyte metabolism: deficiency of sodium and chlorine ions; hypoosmolar dehydration of various origins (due to prolonged vomiting, diarrhea, burns; gastric fistula, pulmonary hemorrhage, intestinal bleeding).
Eye drops and ointment: irritation of the cornea in inflammatory and allergic diseases (as part of combination therapy).
Contraindications for use
Hypernatremia, states of hyperhydration, threat of pulmonary and cerebral edema.
pharmachologic effect
Sodium and chloride ions are the most important inorganic components of the extracellular fluid, maintaining the appropriate osmotic pressure of the blood plasma and extracellular fluid. An isotonic solution replenishes fluid deficiency in the body during dehydration. Hypertonic sodium chloride solution, when administered intravenously, provides correction of the osmotic pressure of extracellular fluid and blood plasma. When applied topically in ophthalmology, sodium chloride has an anti-edematous effect.
Dosage regimen
Isotonic sodium chloride solution is administered intravenously, subcutaneously and in enemas, and is also used for washing wounds, eyes, and nasal mucosa. More often it is administered intravenously, depending on the clinical situation - up to 3 l/day.
Hypertonic sodium chloride solution is administered intravenously. A single dose for intravenous jet administration can be 10-30 ml. For conditions requiring immediate replenishment of sodium and chloride ions, the drug is administered intravenously in a dose of 100 ml.
It is used locally and externally depending on the dosage form used and the treatment regimen.
Side effect
Maybe:
nausea, vomiting, diarrhea, stomach cramps, thirst, lacrimation, sweating, fever, tachycardia, arterial hypertension, renal dysfunction, edema, shortness of breath, headache, dizziness, anxiety, weakness, twitching and muscle hypertonicity.
For external and local use
Adverse reactions have not been established to date.
special instructions
Large volumes of sodium chloride should be used with caution in patients with impaired renal excretory function and hypokalemia. The introduction of large quantities of solution can lead to chloride acidosis, overhydration, and increased excretion of potassium from the body.
Hypertonic solution is not used subcutaneously or intramuscularly.
With long-term use, monitoring of plasma electrolyte concentrations and daily diuresis is necessary.
The temperature of the infusion solution should be 38°C.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Large volumes of sodium chloride should be used with caution in patients with impaired renal excretory function.
