Instructions Ambroxol syrup 15 mg/5 ml bottle 100 ml
Composition
active ingredient: ambroxol hydrochloride;
5 ml of syrup contains: ambroxol hydrochloride 15 mg;
excipients: aspartame (E 951), sorbitol (E 420), benzoic acid (E 210), glycerin (E 422), hypromellose (E 464), "Red Berry" flavoring, purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent or almost transparent, colorless or almost colorless, slightly viscous syrup with a berry flavor.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics.
The active ingredient of Ambroxol syrup – ambroxol hydrochloride – increases the secretion of the respiratory glands. Ambroxol enhances the secretion of pulmonary surfactant by directly affecting type II pneumocytes in the alveoli and Clara cells in the bronchioles, and also stimulates ciliary activity. This leads to increased secretion and mucus discharge and improved mucociliary clearance. Improved mucociliary clearance has been proven in clinical and pharmacological studies.
Activation of fluid secretion and increased mucociliary clearance facilitate mucus clearance and reduce coughing.
The local anesthetic effect of ambroxol hydrochloride, which may be attributed to its sodium channel blocking properties, has been observed in a rabbit eye model. In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration-dependent.
Ambroxol hydrochloride has demonstrated anti-inflammatory effects in vitro. Thus, ambroxol hydrochloride significantly reduces cytokine release from mononuclear and polymorphonuclear blood cells and tissues.
Clinical trials involving patients with pharyngitis demonstrated a significant reduction in pain and redness in the throat when using the drug.
Due to the pharmacological properties of ambroxol, pain was quickly relieved during the treatment of upper respiratory tract diseases, which was observed during studies of the clinical efficacy of inhaled forms of ambroxol.
After the use of ambroxol hydrochloride, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum increase.
Pharmacokinetics.
Absorption: Absorption of ambroxol hydrochloride from oral immediate-release formulations is rapid and fairly complete, with a linear relationship in the therapeutic range. Peak plasma levels are reached after 1-2.5 hours with oral immediate-release formulations and on average after 6.5 hours with slow-release formulations.
Distribution. When administered orally, the distribution of ambroxol hydrochloride from the blood to the tissues is rapid and pronounced, with the highest concentration of the active substance in the lungs. The volume of distribution when administered orally is 552 l. In the blood plasma in the therapeutic range, approximately 90% of the drug is bound to proteins.
Metabolism and elimination. Approximately 30% of the dose after oral administration is eliminated by first pass metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromanthranilic acid (approximately 10% of the dose). Clinical studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.
After 3 days of oral administration, about 6% of the dose is excreted unchanged, while approximately 26% of the dose is excreted in the urine as conjugated form.
The plasma half-life is about 10 hours. Total clearance is about 660 ml/min. Renal clearance is about 8% of the total. After 5 days, about 83% of the total dose is excreted in the urine.
Pharmacokinetics in special patient groups. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which results in a 1.3-2 times higher level in the blood plasma. Since the therapeutic range of ambroxol hydrochloride is quite wide, it is not necessary to change the dosage.
Age and gender have no clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, therefore no dose adjustment is required.
Food intake does not affect the bioavailability of ambroxol hydrochloride.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with disorders of bronchial secretion and impaired mucus movement.
Contraindication
Ambroxol, syrup 15 mg/5 ml, should not be used in patients with known hypersensitivity to ambroxol hydrochloride or to any of the other ingredients of the drug.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Ambroxol, syrup, 15 mg/5 ml, and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, 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
There have been a few reports of severe skin lesions: Stevens-Johnson syndrome and Lyell's syndrome, which coincided in time with the use of ambroxol. Most of them can be explained by the severity of the underlying disease and/or the simultaneous use of another drug. Also, in the initial stage of Stevens-Johnson syndrome or Lyell's syndrome, patients may have non-specific, flu-like symptoms such as fever, aches, rhinitis, cough and sore throat. Symptomatic treatment with cough and cold medicines may be mistakenly used for such non-specific, flu-like symptoms. Therefore, if new skin or mucous membrane lesions appear, medical help should be sought immediately and treatment with ambroxol hydrochloride should be discontinued.
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), Ambroxol syrup 15 mg/5 ml should be used with caution, since ambroxol may increase mucus secretion.
Patients with impaired renal function or severe hepatic insufficiency should take Ambroxol, syrup 15 mg/5 ml, only after consulting a doctor. When using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites formed in the liver in patients with severe renal insufficiency.
Ambroxol syrup 15 mg/5 ml contains 4.0 mg sorbitol per 5 ml (equivalent to 32 mg at the maximum recommended daily dose). Patients who have been told by their doctor that they have an intolerance to some sugars should contact their doctor before taking this medicinal product.
Ambroxol, syrup 15 mg/5 ml, contains aspartame, which is a derivative of phenylalanine; the drug should not be used in patients with phenylketonuria.
Use during pregnancy or breastfeeding
Pregnancy: There are insufficient data on the use of ambroxol in pregnant women, especially up to 28 weeks of gestation. Ambroxol has not shown any teratogenic effects in animal studies.
However, the usual precautions for taking medications during pregnancy should be observed. Ambroxol is not recommended, especially in the first trimester of pregnancy.
Breastfeeding: Ambroxol hydrochloride passes into breast milk.
Ambroxol, syrup 15 mg/5 ml, is not recommended for use during breastfeeding.
Fertility: Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect on the reaction speed when driving vehicles or working with other mechanisms. Studies on the effect on the reaction speed when driving vehicles or working with other mechanisms have not been conducted.
Method of administration and doses
Unless otherwise prescribed, the recommended dose of Ambroxol, syrup, 15 mg/5 ml is as follows:
- children under 2 years of age: 2.5 ml (½ teaspoon) 2 times a day (equivalent to 15 mg of ambroxol hydrochloride per day);
- children aged 2-5 years: 2.5 ml (½ teaspoon) 3 times a day (equivalent to 22.5 mg of ambroxol hydrochloride per day);
- children aged 6-12 years: 5 ml (1 teaspoon) 2-3 times a day (equivalent to 30-45 mg of ambroxol hydrochloride per day);
- Adults and children over 12 years of age: the dose is 10 ml (2 teaspoons) 3 times a day (equivalent to 90 mg of ambroxol hydrochloride per day) for the first 2-3 days and then 10 ml (2 teaspoons) 2 times a day (equivalent to 60 mg of ambroxol hydrochloride per day).
If necessary, the therapeutic effect for adults and children over 12 years of age can be enhanced by increasing the dose to 20 ml 2 times a day (equivalent to 120 mg ambroxol hydrochloride/day).
Ambroxol, syrup 15 mg/5 ml, can be taken regardless of food intake. The dose of Ambroxol, syrup 15 mg/5 ml can be measured using the measuring cup or measuring spoon provided.
In general, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.
Ambroxol, syrup 15 mg/5 ml, should not be used for longer than 4-5 days without consulting a doctor.
Ambroxol syrup 15 mg/5 ml is suitable for use in patients with diabetes mellitus; 5 ml contains 4.0 mg of carbohydrates.
Ambroxol, syrup 15 mg/5 ml, does not contain alcohol.
Children.
The drug can be used in pediatric practice. For children under 2 years of age, use as prescribed by a doctor.
Overdose
There are no reports of specific symptoms of overdose. The symptoms known from isolated reports of overdose and/or cases of medication errors correspond to the known side effects of Ambroxol, syrup 15 mg/5 ml, at recommended doses and require symptomatic treatment.
Adverse reactions
The following classification was used to assess the frequency of adverse events:
very common ≥1/10;
often ≥1/100 - <1/10;
uncommon ≥1/1000 - <1/100;
rarely ≥1/10,000 - <1/1,000;
very rare <1/10,000;
unknown cannot be estimated based on available data.
- On the part of the immune system, on the part of the skin and subcutaneous tissue:
unknown - angioedema, pruritus, anaphylactic reactions (including anaphylactic shock), other hypersensitivity reactions; severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), erythema.
often – dysgeusia (taste disorder).
- From the gastrointestinal tract:
often - nausea, decreased sensitivity in the oral cavity;
infrequently - vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth;
rarely - dry throat;
very rarely - drooling.
- From the respiratory system, chest organs and mediastinum:
often - decreased sensitivity in the throat;
unknown - dyspnea (as a symptom of a hypersensitivity reaction).
uncommon – fever, mucous membrane reactions.
Expiration date
2 years.
Storage conditions
Keep out of reach of children.
Store in the original packaging at a temperature not exceeding 25 °C.
Shelf life after first opening is 6 months.
Do not use after the expiration date.
Packaging
100 ml in polymer jars No. 1 in a pack together with a measuring cup or measuring spoon.
100 ml in glass jars No. 1 in a pack together with a measuring cup or measuring spoon.
Vacation category
Without a prescription.
Producer
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Location of the manufacturer and address of its place of business.
Ukraine, 61010, Kharkiv region, Kharkiv city, Hordienkivska street, building 1.
