Instructions for Ambroxol-Teva tablets 30 mg blister No. 20
Composition
active ingredient: ambroxol hydrochloride;
1 tablet contains ambroxol hydrochloride 30 mg;
excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silicon dioxide.
Dosage form
Pills.
Main physicochemical properties: white, round, biconvex tablets with a break line on one side.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
Ambroxol is a substituted benzylamine and metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. Various studies have shown evidence of mucolytic and secretolytic activity.
The drug generally begins to act 30 minutes after oral administration; the effect persists for 6–12 hours, depending on the individual dose.
Ambroxol has been reported to increase the serous component of bronchial secretions. It is thought to enhance sputum clearance by reducing viscosity and activating the ciliated epithelium.
Ambroxol activates the surfactant system by acting directly on type II pneumocytes in the alveoli and Clara cells in the bronchioles. It stimulates the production and secretion of surfactant in the alveolar and bronchial regions of the fetal and adult lungs. These effects have been demonstrated in cell cultures and in vivo.
Ambroxol has been reported to have antioxidant effects. Ambroxol administration increases the concentration of the antibiotics amoxicillin, cefuroxime, erythromycin, and doxycycline in sputum and bronchopulmonary secretions.
Pharmacokinetics
Absorption. When administered orally, ambroxol is rapidly and almost completely absorbed. The maximum concentration (Tmax) after oral administration is reached after 1–3 hours. The absolute bioavailability of ambroxol is reduced by 1/3 after oral administration due to first-pass metabolism.
Distribution: Plasma protein binding is approximately 85%.
Ambroxol penetrates the cerebrospinal fluid, crosses the placental barrier and is excreted in breast milk.
Metabolism. The formation of metabolites (dibromoanthranilic acid, glucuronides) occurs in the liver.
Excretion: Almost 90% of the drug is excreted by the kidneys in the form of metabolites. Less than 10% of ambroxol is excreted by the kidneys in unchanged form.
Due to the high degree of protein binding, the large volume of distribution and the slow redistribution of the drug from tissues to the blood during dialysis or forced diuresis, significant elimination of ambroxol is unlikely. The terminal half-life from blood plasma is 7–12 hours. The half-life from plasma of ambroxol and its metabolites is almost 22 hours.
Liver and kidney dysfunction
In patients with severe liver disease, ambroxol clearance is reduced by 20–40%. In patients with severe renal impairment, the half-life of ambroxol metabolites is prolonged.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with disorders of bronchial secretion and impaired mucus movement.
Contraindication
Hypersensitivity to ambroxol and/or other components of the drug.
Rare hereditary conditions that may cause incompatibility with the excipient of the drug (see section "Special warnings and precautions for use").
Interaction with other medicinal products and other types of interactions
The simultaneous use of Ambroxol-Teva, tablets, 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.
The use of Ambroxol-Teva tablets in combination with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) can improve the delivery of antibiotics to the lung tissues. Such interaction with doxycycline is widely used for therapeutic purposes.
There are no reports of adverse interactions with other drugs.
Application features
In the early stages of Stevens-Johnson syndrome or Lyell syndrome, patients may have nonspecific flu-like symptoms, such as fever, aches, rhinitis, cough, and sore throat. Symptomatic treatment with cough and cold medications may be mistakenly used for such nonspecific flu-like symptoms.
Since ambroxol may increase mucus secretion, Ambroxol-Teva tablets 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).
In patients with severe renal insufficiency, accumulation of hepatic metabolites of ambroxol is possible. Patients with impaired renal function and severe liver disease should use ambroxol only after consultation with a doctor.
If the patient has been told by his doctor that he has an intolerance to some sugars, he should consult his doctor before taking this medicine. Patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect on the reaction rate when driving vehicles or working with other mechanisms. Studies on the effect on the reaction rate when driving vehicles or working with other mechanisms have not been conducted.
Use during pregnancy or breastfeeding
Pregnancy
Ambroxol hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Clinical studies of the use of the drug after the 28th week of pregnancy have not revealed any harmful effects on the fetus.
However, the usual precautions regarding the use of medications during pregnancy should be observed. This drug is not recommended for use in the first trimester of pregnancy.
Breast-feeding
Ambroxol hydrochloride passes into breast milk. Although no adverse effects on the infant are expected, ambroxol is not recommended during breast-feeding.
Fertility
Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Method of administration and doses
Ambroxol-Teva, tablets of 30 mg, are taken orally. The tablets should be swallowed whole with a sufficient amount of warm liquid (for example, tea or broth) after a meal. The mucolytic effect of Ambroxol is enhanced by drinking a large amount of liquid.
Children aged 6 to 12 years: the usual dose is 1/2 tablet 2–3 times a day (equivalent to 30–45 mg of ambroxol hydrochloride per day).
Children over 12 years of age and adults: the usual dose is 1 tablet 3 times a day for the first 2-3 days (equivalent to 90 mg ambroxol hydrochloride per day). Continue treatment with 1 tablet 2 times a day (equivalent to 60 mg ambroxol hydrochloride per day).
If necessary, the therapeutic effect for adults and children over 12 years of age can be enhanced by taking 2 tablets 2 times a day (equivalent to 120 mg of ambroxol hydrochloride per day).
The duration of treatment depends on the characteristics of the disease. In general, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.
Ambroxol-Teva tablets should not be used for longer than 4–5 days without consulting a doctor.
In case of impaired kidney function and severe liver disease, the drug can be taken only under the supervision of a doctor. In this case, it is recommended to reduce the dose and increase the time between doses of the drug.
Children
Use in children over 6 years of age who cannot tolerate syrup or solution for inhalation and oral administration.
Children under 6 years of age should use Ambroxol-Teva in the form of syrup and drops.
Overdose
There are currently no reports of specific symptoms of overdose in humans.
Symptoms known from isolated reports of overdose and/or cases of medication misuse correspond to the known side effects of ambroxol at recommended doses and require symptomatic treatment.
Adverse reactions
Adverse reactions are classified according to frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); not known (cannot be estimated from available data).
On the part of the immune system:
rarely - hypersensitivity reactions;
unknown - angioedema, itching, anaphylactic reactions, including anaphylactic shock, other allergic reactions.
Skin and subcutaneous tissue disorders:
rarely - skin rash, urticaria;
unknown - erythema, severe skin lesions (including Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme and acute generalized exanthematous pustulosis).
From the gastrointestinal tract:
often - nausea;
infrequently - vomiting, dyspepsia, abdominal pain, diarrhea;
very rarely - drooling.
On the part of the respiratory system:
unknown - dyspnea (as a hypersensitivity reaction).
infrequently - mucous membrane reactions, fever.
Expiration date
5 years.
Storage conditions
The medicine does not require any special storage conditions. Keep out of the reach of children.
Packaging
10 tablets in a blister, 2 blisters in a box.
Vacation category
Without a prescription.
Producer
Merkle GmbH.
Location of the manufacturer and its business address
Ludwig-Merkle-Strasse 3, 89143 Blaubeuren, Germany.
