Ambroxol tablets 30mg, No. 20

Acute and chronic diseases of the respiratory tract with the production of viscous sputum:

• acute and chronic bronchitis,

• pneumonia,

• chronic obstructive pulmonary disease,

• bronchial asthma with difficulty in sputum discharge,

• bronchiectasis.

Inside.

Children from 6 to 12 years old: 15 mg (1/2 tablet) 2-3 times a day.

Adults and children over 12 years old: 30 mg (1 tablet) 3 times a day.

If necessary, to enhance the therapeutic effect, you can prescribe 60 mg (2 tablets) 2 times a day.

The drug is taken with a liquid.

You can take the tablets with or without food.

If the symptoms of the disease persist within 4 - 5 days from the start of admission, it is recommended to consult a doctor.

One tablet contains:

active substance: ambroxol hydrochloride in terms of 100% substance - 30.00 mg;

excipients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate.

• Hypersensitivity to ambroxol or any other components of the drug,

• pregnancy (I trimester),

• breastfeeding period,

• children under 6 years old,

• lactase deficiency

• lactose intolerance,

• glucose-galactose malabsorption.

• Use ambroxol with caution during pregnancy (II - III trimester), with renal and / or hepatic failure, impaired motor function of the bronchi and increased mucus secretion (for example, with a rare syndrome of primary ciliary dyskinesia), gastric ulcer and duodenal ulcer during an exacerbation ...

Pharmacodynamics

Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Enhancing mucociliary clearance improves sputum flow and relieves coughing. In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) led to a significant decrease in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmokinetics

Suction

All dosage forms of immediate release ambroxol are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. The maximum plasma concentration (Cmax) with oral administration is achieved after 1 - 2.5 hours. The absolute bioavailability of Ambroxol after taking tablets at a dose of 30 mg is 79%.

Distribution

The volume of distribution is 552 liters. In the therapeutic concentration range, plasma protein binding is approximately 90%.

The transition of ambroxol from blood to tissue with oral administration occurs quickly. The highest concentrations of the active ingredient of the drug are observed in the lungs.

Metabolism

Approximately 30% of the taken oral dose undergoes the effect of the primary passage through the liver. Studies on human liver microsomes have shown that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites.

Withdrawal

The terminal half-life of ambroxol is about 10 hours. The total clearance is in the range of 660 ml / min, renal clearance accounts for approximately 8% of the total clearance. Using the method of radioactive labeling, it was calculated that after a single dose of the drug over the next 5 days, about 83% is excreted by the kidneys.

Special patient groups

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select a dose for these signs.

Overdose

There are no specific symptoms of an overdose in humans.

There have been reports of accidental overdose and / or medical error resulting in symptoms of known side effects of Ambroxol: nausea, dyspepsia, vomiting, abdominal pain. In this case, the need for symptomatic therapy is possible.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Side effects

Immune system disorders

Rarely: hypersensitivity reactions, skin rash, urticaria;

Frequency unknown: anaphylactic reactions (including anaphylactic shock), angioedema, pruritus;

Nervous system disorders

Often: taste disturbance;

Respiratory, Chest and Mediastinal Disorders

Often: numbness in the throat;

Very rare: rhinorrhea;

Frequency unknown: shortness of breath (as a sign of a hypersensitivity reaction);

Gastrointestinal disorders

Often: nausea, numbness of the oral mucosa;

Uncommon: dyspepsia, vomiting, diarrhea, abdominal pain, feeling of dryness in the mouth;

Rarely: dry throat;

Very rare: constipation, hypersalivation (profuse salivation);

Skin and subcutaneous tissue disorders

Frequency unknown: exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exentematous pustulosis;

From the kidneys and urinary tract

Very rare: dysuria;

General disorders and disorders at the injection site

Uncommon: fever.

Special conditions

Should not be combined with antitussives that impede the excretion of sputum.

If the motor function of the bronchi is impaired (for example, in the rare syndrome of primary ciliary dyskinesia), Ambroxol should be used with caution because of a possible increase in secretion.

One tablet contains 164.83 mg of lactose. The maximum daily dose (4 tablets) contains 659.32 mg of lactose.

Patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - may develop fever, body pain, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, it is possible that mucolytic agents such as ambroxol are mistakenly prescribed. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, which coincided with the appointment of the drug.

With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical attention.

In case of impaired renal function, Ambroxol should be used only on the advice of a doctor.

The effect of the drug on the ability to drive vehicles and mechanisms

There were no cases of the effect of the drug on the ability to drive vehicles and mechanisms. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions have not been conducted.

Drug interactions

No clinically significant adverse drug interactions have been reported. With the simultaneous use of Ambroxol with antitussive drugs, it may be difficult to discharge sputum as a result of suppression of the cough reflex. Increases penetration into the bronchial secretions of amoxicillin, cefuroxime, erythromycin.