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Pharmacological properties

The active substance of the drug abrol - Ambroxol hydrochloride - increases the secretion of the glands of the respiratory tract. Ambroxol enhances the release of pulmonary surfactant by directly acting on type II pneumocytes in the alveoli and clara cells in the bronchioles, and also stimulates ciliary activity. this helps to increase mucus secretion and improve mucociliary clearance. improvement of mucociliary clearance is proven during clinical and pharmacological studies.

Activation of fluid secretion and increased mucociliary clearance facilitate mucus excretion and reduce cough.

It is known that ambroxol hydrochloride has a local anesthetic effect, which may be explained by its ability to block sodium channels. Blocking of neural sodium channels was characterized by the fact that the binding was reversible and depended on the concentration.

Ambroxol hydrochloride has an anti-inflammatory effect. In vitro studies have shown that ambroxol hydrochloride significantly reduces the release of cytokine from the blood and tissue binding of mononuclear and polymorphononuclear cells.

As a result of clinical studies involving patients with pharyngitis, a significant decrease in the severity of pain and redness in the throat with the use of the drug was proved. Studies of the clinical efficacy of inhaled forms of ambroxol have also demonstrated that ambroxol hydrochloride is effective in treating the upper respiratory tract, as it contributes to a rapid reduction in the severity of pain and associated discomfort in the nasal cavity, in the ear and trachea when inhaling.

After the use of ambroxol hydrochloride, concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) increase in bronchopulmonary secretion and in sputum.

Pharmacokinetics Absorption. The absorption of ambroxol hydrochloride from oral forms of non-prolonged action is fast and quite complete, with a linear dependence in the therapeutic range. Cmax in plasma is achieved after 1–2.5 hours with oral administration of dosage forms of rapid release and on average after 6.5 hours with the use of slow release forms. The relative bioavailability of capsules with prolonged action is 95%.

Distribution. When taken orally, the distribution of ambroxol hydrochloride from the blood into the tissue is quick and pronounced, with a high concentration of the active substance in the lungs. The volume of distribution for oral administration is 552 liters. In the blood plasma in the therapeutic range, about 90% of the drug binds to proteins.

Metabolism and excretion. About 30% of the dose after oral administration is excreted by a presystemic metabolism. Ambroxol hydrochloride is metabolized in the liver by glucuronidation and digestion to dibromanthranilic acid (about 10% of the dose). It is known that in human liver microsomes, CYP 3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.

For 3 days of oral administration, about 6% of the dose is excreted unchanged, while about 26% is in conjugated form with urine.

T½ from plasma is about 10 hours. The total clearance is within 660 ml / min along with renal clearance, which is about 83% of the total clearance.

Pharmacokinetics in special groups of patients. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which causes a 1.3–2 times higher level in blood plasma. Since the therapeutic range of ambroxol hydrochloride is wide enough, it is not necessary to change the dose.

Age and gender do not have a clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, so dose adjustment is not required.

Eating does not affect the bioavailability of ambroxol hydrochloride.

Indications

Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and weakened mucus progression.

Application

Abrol tablets. unless otherwise prescribed, the recommended dose of the drug abrol tablets is as follows:

children aged 6–12 years: the dose is ½ tablets 2-3 times a day (equivalent to 30–45 mg of ambroxol hydrochloride per day);

adults and children over the age of 12 years: the dose is 1 tablet 3 times a day for the first 2-3 days (equivalent to 90 mg of ambroxol hydrochloride per day). Continue treatment with 1 tablet 2 times a day (equivalent to 60 mg of Ambroxol hydrochloride per day).

If necessary, the therapeutic effect for adults and children over the age of 12 years can be enhanced by the use of 2 tablets 2 times a day (equivalent to 120 mg of Ambroxol hydrochloride per day).

Tablets should be swallowed whole with a sufficient amount of liquid (such as water, tea or fruit juice) after a meal.

In general, there are 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.

Abrol syrup 15 mg / 5 ml. Unless otherwise specified, the recommended dose of Abrol syrup 15 mg / 5 ml is as follows:

children under the age of 2 years: 2.5 ml (½ teaspoon) 2 times a day (equivalent to 15 mg of Ambroxol hydrochloride per day);

children aged 2–6 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 the age of 12 years: 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 the age of 12 can be enhanced by increasing the dose to 20 ml 2 times a day (equivalent to 120 mg of Ambroxol hydrochloride per day).

For adults and children over the age of 12, the use of a syrup with a higher concentration is recommended (Abrol syrup 30 mg / 5 ml).

Abrol syrup 30 mg / 5 ml. Unless otherwise specified, this regimen is recommended for taking the drug Abrol syrup 30 mg / 5 ml:

children under the age of 2 years: 1.25 ml 2 times a day (equivalent to 15 mg of ambroxol hydrochloride per day);

children aged 2–5 years: 1.25 ml 3 times a day (equivalent to 22.5 mg of ambroxol hydrochloride per day);

children aged 6–12 years: 2.5 ml up to 3 times a day (equivalent to 30–45 mg of ambroxol hydrochloride per day);

adults and children over the age of 12 years: the usual dose is 5 ml 3 times a day (equivalent to 90 mg of ambroxol hydrochloride per day) for the first 2-3 days and then 5 ml 2 times a day (equivalent to 60 mg of ambroxol hydrochloride per day )

If necessary, the therapeutic effect for adults and children over the age of 12 can be enhanced by increasing the dose to 10 ml 2 times a day (equivalent to 120 mg of Ambroxol hydrochloride per day).

Abrol syrup can be used regardless of food intake. Syrup can be measured using a measuring cup, which is attached. It should be noted that the measuring cup is not designed to measure the dose of 1.25 ml of syrup (for children aged 2–5 years). To measure a dose of 1.25 ml, you can use a plastic disposable syringe without a needle with a capacity of 2 ml.

Basically, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.

Abrol syrup should not be used for longer than 4–5 days without consulting a doctor.

Abrol syrup can be used in patients with diabetes; 5 ml contains 1.2 g of carbohydrates.

Abrol syrup does not contain alcohol.

Abrol SR.Unless otherwise specified, the following administration of the drug Abrol SR is recommended:

adults: 1 tablet 1 time per day (equivalent to 75 mg / day of Ambroxol hydrochloride) in the morning or in the evening after a meal. The tablets should be swallowed whole with a sufficient amount of water.

In general, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.

Abrol SR should not be used for longer than 4–5 days without consulting a doctor.

Children. Abrol tablets are prescribed for children over 6 years of age who cannot take syrup.

The drug Abrol syrup can be used in pediatric practice. In children under the age of 2 years, apply as directed by a doctor.

Abrol SR is not used in pediatric practice.

Contraindications

The drug should not be used in patients with a known hypersensitivity to ambroxol hydrochloride or other components of the drug.

Abrol tablets are not intended for use in children under the age of 6 years due to the strength of the action. Children under the age of 6 are recommended to use Ambroxol in the appropriate dose.

Abrol SR is not intended for use in children and adolescents.

Side effects

From the immune system, skin and subcutaneous tissue: skin rash, urticaria, angioedema, itching, anaphylactic reactions (including anaphylactic shock), other hypersensitivity reactions, erythema, severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome) .

From the nervous system: dysgeusia (taste disorder).

From the digestive system: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth, constipation, salivation, dry throat.

From the respiratory system, chest and mediastinal organs: decreased sensitivity in the pharynx, rhinorrhea, shortness of breath (as a symptom of a hypersensitivity reaction).

From the urinary system: dysuria.

Common disorders: fever, reactions from the mucous membranes.

special instructions

There were only a few reports of severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome) - associated with the use of expectorants, such as Ambroxol hydrochloride. they could mainly be explained by the severity of the underlying disease in patients and / or the simultaneous use of another drug. Also at the initial stage of Stevens-Johnson Syndrome or Lyell Syndrome, patients may have non-specific flu-like symptoms such as fever, aches, rhinitis, cough and sore throat. mistakenly, with such nonspecific symptoms of the onset of influenza, symptomatic treatment with cough and cold preparations can be used. therefore, when new lesions of the skin or mucous membranes appear, you should immediately seek medical help and stop treatment with Ambroxol hydrochloride.

In case of impaired bronchial motility and increased secretion of mucus (for example, with such a rare disease as primary ciliary dyskinesia), the drug should be used with caution, since Ambroxol can enhance mucus secretion.

Patients with impaired renal function or severe liver failure should take the drug only after consulting a doctor. When Ambroxol is used, like any substance that is metabolized in the liver and then excreted by the kidneys, the metabolites that form in the liver in patients with severe renal failure accumulate.

Abrol syrup, 15 mg / ml and 30 mg / 5 ml, contains 1.225 g of sorbitol in 5 ml (equivalent to 9.8 and 4.9 g, respectively, when using the maximum daily dose). If you are intolerant of certain sugars, you should consult your doctor before taking this medication.

Use during pregnancy or lactation. Pregnancy. Ambroxol hydrochloride crosses the placental barrier. There were no harmful effects on the fetus when using the drug after the 28th week of pregnancy. However, you should take the usual precautions when taking medication during pregnancy. In the first trimester of pregnancy, it is not recommended to use the drug.

Lactation. Ambroxol hydrochloride passes into breast milk. The drug is not recommended for use during lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms. There is no evidence of an effect on the ability to drive vehicles or other mechanisms. No studies have been conducted.

Interactions

The simultaneous use of ambroxol and drugs that inhibit coughing can lead to excessive accumulation of mucus due to the 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.

Overdose

There are currently no reports of specific overdose symptoms. symptoms known from single reports of overdose and / or cases of erroneous use of drugs correspond to known side effects of the drug in recommended doses and require symptomatic treatment.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° c in a dark place. after opening the bottle, store the drug for no more than 4 weeks.

Tags: Ambroxol