Ambroxol-SOLOfarm - instructions for use, dose, side effects, contraindications

In studies it is shown that ambroxol increases secretion in the airways. It increases the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

In patients with chronic obstructive pulmonary disease, prolonged therapy with ambroxol (for at least 2 months) resulted in a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics:

For all immediate-release ambroxol dosage forms, rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose-dependence in the therapeutic range of concentrations is characteristic. Maximum concentration (FROMmOh) in blood plasma by oral intake is achieved after 1-2.5 hours.The volume of distribution is 552 liters. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.

The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the oral dose taken is exposed to the effect of a primary pass through the liver. Studies on microsomes of human liver showed that the isoenzyme SURCA4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml / min, the renal clearance is about 8% of the total clearance. With the radioactive label method, after taking a single dose of the drug for the next 5 days, about 83% of the dose taken is excreted in the urine.

Indications:

Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

Contraindications:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), the period of breastfeeding.

Carefully:

Disturbance of the motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum in the period of exacerbation, pregnancy (II-III trimester).

Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing large intervals between doses of the drug or taking the drug in a smaller dose.

Pregnancy and lactation:

The drug is contraindicated to apply during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimesters of pregnancy should evaluate the potential benefit to the mother and the possible risk to the fetus.

During the period of breastfeeding, the drug is contraindicated because it is excreted in breast milk.

Dosing and Administration:

The mucolytic effect of the drug manifests itself when a large amount of liquid is taken. Therefore, during treatment, a generous drink is recommended.

Application inside

Inside, use the drug from the tube-dropper A after eating, adding water, tea, milk or fruit juice.

Adults and children over 12 years of age: The first 2-3 days of 4 ml 3 times a day (corresponding to 90 mg ambroksola per day), then 4 ml 2 times a day (corresponding to 60 mg ambroksola per day).

Children from 6 up to 12 years: 2-ml 2-3 times a day (corresponding to 30 or 45 mg of ambroxol per day).

Children from 2 to 6 years: 1 ml 3 times a day (corresponding to 22.5 mg of ambroxol per day).

Children up to 2 years: 1 ml 2 times a day (which corresponds to 15 mg ambroksola per day).

Children younger than 2 years of age, the drug is prescribed only under the supervision of a doctor.

The maximum daily intake for ingestion: for adults - 90 mg, for children 6-12 years - 45 mg, for children 2-6 years - 22.5 mg, for children up to 2 years - 15 mg.

Application in the form of inhalation

The drug can be used using any modern equipment for inhalation (except for steam inhalers).Before inhalation, the drug from the tube-dropper A is mixed with 0.9% sodium chloride solution from the tube-dropper B (solvent) (for optimal air humidification - in the ratio 1: 1). Before inhalation it is recommended to warm the inhalation solution to body temperature.

Since inhalation therapy can cause a deep inhalation of a cough, inhalation should be performed in the usual breathing mode. Patients with bronchial asthma should be given inhalation after taking bronchodilators, in order to avoid nonspecific irritation of the respiratory tract and their spasm.

Dosage for inhalation

Adults and children over 6 years of age: 1-2 inhalations per day for 2-3 ml of solution (corresponding to 15-45 mg of ambroxol per day).

Children up to 6 years of age: 1-2 inhalations per day for 2 ml of solution (corresponding to 15-30 mg of ambroxol per day).

Taking the drug for more than 4-5 days is possible only on the advice of a doctor.

Side effects:

The frequency of side effects is presented in the following gradation: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); rarely (≥ 1/10000 to <1/1000); very rarely (<1/10000); Unknown (can not be estimated based on available data).

Disorders from the gastrointestinal tract: often - nausea, decreased sensitivity in the oral cavity and pharynx; infrequently - dyspepsia, pain in the upper abdomen, vomiting, diarrhea; rarely - heartburn, dryness of the mucous membrane of the mouth and throat, constipation.

Disturbances from the respiratory system, chest organs to the mediastinum: rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea.

Disorders from the nervous system: often - dysgeusia (a violation of taste sensations).

Immune system disorders: rarely - hypersensitivity reactions, skin rashes, hives, itching, angioedema; very rarely - anaphylactic reactions, including anaphylactic shock.

Disturbances from the skin and subcutaneous tissues: very rarely - Stevens-Johnson syndrome, Lyell's syndrome.

Other: rarely - adynamia, fever.

Overdose:

Symptoms: heartburn, indigestion, diarrhea, nausea, vomiting, pain in the upper abdomen. There are reports of short-term anxiety. With severe overdose, a significant reduction in blood pressure is possible.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products, symptomatic therapy.

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex. With simultaneous use with amoxicillin, doxycycline, cefuroxime, erythromycin ambroxol increases their concentration in the bronchial secretion. No clinically relevant adverse interactions with other drugs have been reported.

Special instructions:

Ambroxol-SOLOfarm should not be taken concurrently with antitussive drugs that can inhibit cough reflex.

Ambroxol-SOLOfarm should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport because of the possibility of sputum congestion.

Patients receiving ambroxol, do not recommend performing respiratory gymnastics; In patients with severe disease, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Inherits to take ambroxol just before bed.

In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell syndrome - in the early phase, temperature, body aches, rhinitis, cough and sore throat may appear.With symptomatic treatment, it is possible to erroneously designate mucolytic agents, such as ambroxol. There are isolated reports of the detection of Stevens-Johnson syndrome and Lyell's syndrome, coinciding with the appointment of the drug, but there is no causal relationship with the drug.

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

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

A solution of ambroxol is not recommended to be mixed with cromoglycic acid and alkaline solutions.

Patients who observe the hyponatric diet, it should be borne in mind that in 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years old contains 120 mg of sodium.

Effect on the ability to drive transp. cf. and fur:

The cases of the effect of the drug on the ability to drive vehicles and mechanisms have not been identified so far.

Form release / dosage:

Solution for ingestion and inhalation 7.5 mg / ml.

Packaging:

For 1 or 2 ml of the drug in a tube-dropper A and 1 or 2 ml of solvent in a tube-dropper B of low-density polyethylene or polypropylene.

On 10 tubes-droppers And in a package from the foil film and on 10 tubes-drippers B in a package from a foil film.

For 1 or 2 bags of foil film with tubes and drums A together with 1 or 2 packages of foil film with tube-drip B (kit) or without them, together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-004415

Date of registration:15.08.2017

Expiration Date:15.08.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp11.09.2017

Illustrated instructions

Instructions

Ambroxol-SOLOfarm (Ambroxol-SOLOpharm)