Instructions Abrol tablets 30 mg blister No. 20
Composition
active ingredient: ambroxol hydrochloride;
1 tablet contains ambroxol hydrochloride 30 mg;
excipients: colloidal anhydrous silicon dioxide, croscarmellose sodium, microcrystalline cellulose, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round white tablets with a score line on one side.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
Ambroxol hydrochloride is a substituted benzylamine and a metabolite of bromhexine. Ambroxol hydrochloride has been shown to increase the secretion of airway glands and enhance the secretion of pulmonary surfactant by directly affecting type II pneumocytes in the alveoli and Clara cells in the bronchioles. Ambroxol hydrochloride also stimulates ciliary activity, which facilitates the secretion and excretion of mucus (mucociliary clearance). Activation of fluid secretion and increased mucociliary clearance facilitate the excretion of mucus and relieve cough.
Ambroxol hydrochloride has a local anesthetic effect due to reversible and concentration-dependent blockade of neuronal sodium channels. There is also evidence that ambroxol hydrochloride has an anti-inflammatory effect (due to a significant reduction in cytokine release from the blood and tissue binding of mononuclear and polymorphonuclear cells).
In patients with pharyngitis, the use of ambroxol hydrochloride resulted in a significant reduction in pain and redness in the throat.
The use of ambroxol hydrochloride increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, and doxycycline) in bronchopulmonary secretions and sputum.
Pharmacokinetics
Absorption. Absorption of ambroxol hydrochloride from oral non-prolonged-release formulations is rapid and complete, with a linear dose dependence in the therapeutic range. Maximum plasma levels are reached after 1-2.5 hours with oral administration of 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 expected volume of distribution when administered orally is 552 l. In the blood plasma in the therapeutic dose range, approximately 90% of the drug is bound to proteins.
Metabolism and excretion. Approximately 30% of the dose after oral administration is excreted by presystemic metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromanthranilic acid (approximately 10% of the dose). The metabolism of ambroxol hydrochloride to dibromanthranilic acid occurs with the participation of CYP3A4. After 3 days of oral administration, about 6% of the dose is excreted in the urine in unchanged form, about 26% of the dose in conjugated form.
The plasma half-life is about 10 hours. Total clearance is within 660 ml/min. Renal clearance is approximately 83% of the total.
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
Abrol® should not be used in patients with known hypersensitivity to ambroxol hydrochloride or to any other component of the drug.
Abrol®, 30 mg tablets, is not intended for use in children under 6 years of age due to its potency. For children under 6 years of age, ambroxol is recommended in the appropriate dosage.
Interaction with other medicinal products and other types of interactions
The simultaneous use of the drug Abrol®, 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.
Application features
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), Abrol® should be used with caution, since ambroxol may increase mucus secretion.
Patients with impaired renal function or severe hepatic insufficiency should take abrol® tablets only after consulting a doctor. When using ambroxol hydrochloride, as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites that are formed in the liver in patients with severe renal insufficiency.
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.
Clinical studies on the use of ambroxol hydrochloride after the 28th week of pregnancy have not revealed any harmful effects on the fetus. However, the usual precautions for taking medications during pregnancy should be observed. It is especially not recommended to use abrol® tablets in the first trimester of pregnancy.
Breastfeeding. Ambroxol hydrochloride passes into breast milk. Abrol® tablets are not recommended for use during breastfeeding.
Fertility: Preclinical studies do not indicate direct or indirect harmful effects of ambroxol hydrochloride on fertility.
Method of administration and doses
Unless otherwise prescribed, the recommended dose of Abrol® tablets is as follows:
children aged 6 to 12 years: the dose is 1/2 tablet 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 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 tablets should be swallowed whole with sufficient liquid (e.g. water, tea or fruit juice) regardless of meals.
There are generally no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.
Abrol® tablets should not be used for longer than 4-5 days without consulting a doctor.
Children
Use in children over 6 years of age who cannot tolerate syrup.
Overdose
There are currently no reports of overdose. The symptoms known from isolated reports of overdose and/or cases of medication errors correspond to the known side effects of ambroxol hydrochloride at recommended doses and require symptomatic treatment.
Adverse reactions
Immune system and skin and subcutaneous tissue disorders: pruritus, erythema, skin rash, urticaria, angioedema, anaphylactic reactions (including anaphylactic shock), other hypersensitivity reactions, severe skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis).
Nervous system: dysgeusia (changes in taste).
Gastrointestinal: diarrhea, nausea, vomiting, dyspepsia, abdominal pain, dry mouth, heartburn, constipation, drooling, dry throat.
On the part of the respiratory system, chest organs and mediastinum: decreased sensitivity in the pharynx, dyspnea (including as a symptom of a hypersensitivity reaction), bronchospasm, rhinorrhea, dry respiratory tract.
From the urinary system: dysuria.
General disorders: mucous membrane reactions, fever.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
"KUSUM FARM" LLC.
Location of the manufacturer and its business address
40020, Ukraine, Sumy region, Sumy city, Skryabina st., 54.
