Instructions for use Mucolvan solution for injection 7.5 mg/ml ampoule 2 ml No. 5
Composition
active ingredient: ambroxol;
1 ml of solution contains 7.5 mg of ambroxol hydrochloride;
Excipients: sodium chloride; citric acid, monohydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: colorless transparent liquid.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
Ambroxol hydrochloride, the active ingredient of the drug, has been shown to increase mucus secretion in the respiratory tract. It also increases the secretion of pulmonary surfactant and stimulates the activity of the ciliary epithelium. These actions improve mucus separation and excretion (mucociliary clearance). Activation of fluid secretion and increased mucociliary clearance facilitate mucus excretion and relieve cough.
It is known that under the influence of ambroxol hydrochloride, the number of cytokines decreases, as well as the number of circulating and tissue-associated mononuclear and polymorphonuclear cells.
Antioxidant effects of ambroxol have also been observed.
After the use of ambroxol hydrochloride, the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum increases.
Pharmacokinetics
Ambroxol hydrochloride is approximately 90% bound to plasma proteins in adults and 60–70% in neonates. The drug crosses the placental barrier and reaches the fetal lungs. The large volume of distribution of 410 l indicates greater tissue accumulation than plasma, with lung tissue concentrations exceeding plasma concentrations by a factor of > 17.
Metabolism and elimination: Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and to a lesser extent by cleavage to dibromanthranilic acid (the latter accounting for approximately 10% of the dose); other minor metabolites are also formed. Studies in human liver microsomes have shown that the enzyme CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.
3 days after intravenous administration, 4.6% of the dose is excreted unchanged, while 35.6% of the dose is excreted in the urine as conjugated form.
The plasma half-life of ambroxol hydrochloride is approximately 10 hours. In newborns, after repeated intravenous administration, the half-life increases approximately twofold, indicating a decrease in clearance.
In severe liver disease, ambroxol clearance is reduced by 20-40%. In severe renal impairment, accumulation of ambroxol metabolites, namely dibromantranilic acid and glucuronides, is possible.
Ambroxol penetrates the blood-brain and placental barriers and is excreted in breast milk.
Indication
To enhance pulmonary surfactant production in premature infants and newborns with respiratory distress syndrome.
Contraindication
Hypersensitivity to ambroxol hydrochloride or other components of the drug.
Interaction with other medicinal products and other types of interactions
To date, no clinically significant interactions of the drug with other drugs have been identified.
The simultaneous use of the drug and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex; such a combination is possible only after a careful assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
Application features
Since ambroxol may increase mucus secretion, the drug should be used with caution in cases of impaired bronchial motility and increased mucus secretion (for example, in rare diseases such as primary ciliary dyskinesia).
The drug should be used with caution in patients with impaired renal function or severe liver disease. When using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, accumulation of metabolites formed in the liver is observed in patients with severe renal insufficiency.
Very rarely, severe skin reactions such as Stevens-Johnson syndrome or Lyell's syndrome have developed, sometimes occurring with the use of ambroxol. Most of these cases are associated with the underlying disease or with the simultaneous use of another drug. If any changes appear on the skin or mucous membranes, ambroxol should be discontinued and a doctor should be consulted immediately.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine is used in premature babies and newborns.
Use during pregnancy or breastfeeding
The medicine is used in premature babies and newborns.
Method of administration and doses
It has been proven that a total daily dose of 30 mg of ambroxol hydrochloride per 1 kg of body weight is effective.
The dose should be administered in 4 divided doses by slow intravenous infusion; it is recommended that each individual dose be administered by intravenous infusion using an infusion pump over at least 5 minutes.
The contents of 1–6 ampoules should be diluted in 250–500 ml of saline or Ringer's solution.
From a microbiological point of view, if opening the ampoules and reconstitution involves a risk of microbiological contamination, the solution should be used immediately after preparation. If this is not the case, the user is responsible for the storage conditions and times. If none of these solvents are available, 5% glucose solution may be used as an alternative. When using 5% glucose solution, the contents of the ampoules should be diluted immediately before use. If the solution is not used immediately after preparation, it should be discarded.
Duration of treatment is 5 days.
Children
Use in premature infants and newborns as indicated.
Overdose
There are currently no reports of specific symptoms of overdose. Symptoms observed in case of accidental overdose or medical error are similar to known adverse reactions when used at recommended doses and may require symptomatic treatment.
Adverse reactions
Immune system, skin and subcutaneous fat: erythema; anaphylactic reactions (including shock); angioedema, skin rash, urticaria, itching and other hypersensitivity reactions, severe skin lesions: Stevens-Johnson syndrome and Lyell's syndrome.
Gastrointestinal: dry mouth, constipation, drooling, dry throat; nausea, vomiting, diarrhea, dyspepsia, abdominal pain.
From the respiratory system, chest organs and mediastinum: rhinorrhea, dyspnea (as a symptom of a hypersensitivity reaction).
Renal and urinary disorders: urination disorders.
General disorders and administration site conditions: fever and chills, mucosal reactions.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
2 ml in ampoules, 5 ampoules in a package.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Research Plant "GNTSLS". Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61057, Kharkiv region, Kharkiv city, Vorobyovy street, building 8. (Limited Liability Company "Research Plant "GNTSLS"). Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22. (Limited Liability Company "Pharmaceutical Company "Zdorovya").
