Ambroxol

Package leaflet (information for patients)

Tradename
Ambroxol

Dosage form
Tablets 30 mg.

Description
Round, flat, beveled to the edge white tablets with an imprint in the form of the brand name "V" on one side.

Structure
Active ingredient: Ambroxol 30 mg.
Excipients: microcrystalline cellulose 102, calcium stearate, aerosil ® 200 (hydrophilic pyrogenic silicon dioxide).

Pharmacotherapeutic group
Drugs used for coughs and colds. Mucolytic agents.

Pharmacological properties
Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its breakdown). It has a secretory , secretolytic and expectorant effect; stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretions and the release of a surfactant ( surfactant ) in the alveoli and bronchi; normalizes the impaired ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clarke cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport. After oral administration, the action occurs after 30 minutes, with rectal administration - after 10-30 minutes and lasts for 6-12 hours. With parenteral administration, the action occurs quickly and lasts for 6-10 hours.
Pharmacokinetics
Absorption - high (for any routes of administration), TCmax - 2 hours, the connection with plasma proteins - 80%. Penetrates the BBB, placental barrier, excreted in breast milk. Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates . T1 / 2 - 7-12 hours. Excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%. T1 / 2 increases with severe chronic renal failure, does not change with impaired liver function.

Indications for use
Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, COPD, bronchial asthma with difficulty in sputum discharge, bronchiectasis.
Stimulation of prenatal lung maturation.
Treatment and prevention (with the threat of preterm birth and with indicated artificial preterm birth in the period between 28 and 34 weeks of pregnancy, if the clinical picture suggests an extension of pregnancy by 3 days) of respiratory distress syndrome in premature infants and newborns.

Method of administration and dosage
Inside, during meals, with a small amount of liquid. Adults and children over 12 years of age are prescribed - tablets: 30 mg 3 times a day for the first 2-3 days, then 30 mg 2 times or 15 mg 3 times a day, or 1 retard capsule (75 mg) in the morning; children 6-12 years old - 15 mg 2-3 times a day.
Solution for oral administration (7.5 mg / ml) for adults during the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day; children under 2 years old - 1 ml 2 times a day, 2-5 years old - 1 ml 3 times a day, 5-12 years old - 2 ml 2-3 times a day.
Syrup (3 mg / ml) for adults - in the first 2-3 days, 10 ml, and then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases of the disease, the dose is not reduced during the entire course of treatment. Children 5-12 years old are prescribed 15 mg 2-3 times a day, 2-5 years old - 7.5 mg 3 times a day, up to 2 years old - 7.5 mg 2 times a day. In the form of inhalation, it is prescribed for adults and children over 5 years old at 15-22.5 mg, for children under 2 years old - 7.5 mg, for children from 2-5 years old - 15 mg 1-2 times a day. In the case when it is not possible to carry out more than one inhalation per day, tablets, solution or syrup are additionally used orally. Parenterally injected intramuscularly , intravenously (slowly, jet or drip ) or s / c: adults - 15 mg, in severe cases - 30 mg 2-3 times a day; children - 1.2-1.6 mg / kg 3 times a day.
Usually for children under 2 years old - 7.5 mg 2 times a day, from 2 to 5 years old - 7.5 mg 3 times a day, from 5 years old - 15 mg 2-3 times a day. For the treatment of respiratory distress syndrome in premature and newborn infants, 10 mg / kg / day is administered intravenously or intramuscularly , the frequency of administration is 3-4 times, if necessary, the dose can be increased to 30 mg / kg / day . For intravenous drip injection, 50 ml is diluted in 500 ml of infusion solution (0.9% NaCl solution , 5% dextrose solution, Ringer- Locke solution or other basic solution with a pH not higher than 6.3 are used as a solvent ), injected over 2 hours at a speed of 84 drops / min. Repeated treatment according to the above scheme can be carried out after 14 days (while maintaining the indications).
Parenteral administration is terminated after the disappearance of acute manifestations of the disease (switch to oral administration or rectal administration).
Rectally, adults and children over 12 years old - 1 suppository (30 mg) 3 times a day for 2-3 days, then 60 mg 2 times a day, the maximum daily dose is 0.12 g; children 6-12 years old - 15 mg 2-3 times a day. It is not recommended to use it without a medical prescription for more than 4-5 days.

Side effects
Allergic reactions: skin rash, urticaria, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock.
Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea , constipation, dysuria. With prolonged use in high doses - gastralgia , nausea, vomiting.
With a rapid intravenous injection - a feeling of numbness, weakness, intense headaches, decreased blood pressure, shortness of breath, hyperthermia, chills.
Overdose. Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing foods.

Contraindication
Hypersensitivity, pregnancy (I trimester), phenylketonuria (for dosage forms containing aspartame). Carefully. Liver failure, renal failure, gastric ulcer and 12 duodenal ulcer, pregnancy (II-III trimester), lactation.

Overdose
At this time, no specific symptoms of Ambroxol overdose are known . In case of accidental overdose and / or misuse, symptoms corresponding to the side effects of Ambroxol hydrochloride may occur . Treatment is symptomatic.

Precautions
Before starting treatment with Ambroxol, consult your doctor!
Do not use the preparation for longer than the prescribed period without consulting a specialist .
If the signs of the disease do not begin to disappear, or, conversely, the health condition deteriorates, or undesirable phenomena appear, it is necessary to stop taking it and consult a doctor regarding the further use of the drug.
With the use of mucolytic drugs such as ambroxol hydrochloride, isolated cases of severe skin lesions, such as erythema multiforme, Stevens- Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis ), acute generalized exanthematous pustulosis in patients have been reported . Basically, they could be explained by the severity of the underlying disease and / or concomitant therapy. In addition, at the initial stage of Stevens- Johnson syndrome or Lyell's syndrome , patients may experience flu-like nonspecific prodromal symptoms such as fever, body aches (aches), rhinitis, cough, sore throat. As a result of their erroneous assessment, patients could receive drugs for the symptomatic treatment of coughs and colds. For this reason, it is necessary to immediately stop taking the drug if symptoms of a progressive skin reaction appear (sometimes associated with the development of blisters and damage to the mucous membranes).

Interaction with other medicinal products
Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough. Increases penetration into the bronchial secretions of amoxicillin, cefuroxime , erythromycin and doxycycline .
Solution for injection must not be used with solutions with a pH higher than 6.3.

Special instructions
Should not be combined with antitussive drugs that impede the excretion of sputum. The inhalation solution can be applied using any modern inhalation equipment (except for steam inhalers). Before inhalation, the drug is mixed with a 0.9% NaCl solution (for optimal air humidification, it can be diluted in a 1: 1 ratio) and heated to body temperature. Inhalation should be carried out in normal breathing mode (so as not to provoke cough shocks). Patients suffering from bronchial asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm, before inhalation of ambroxol, it is necessary to use bronchodilators .
Patients with diabetes mellitus can be prescribed in the form of a syrup (5 ml of syrup contains sorbitol and saccharin in an amount corresponding to 0.18 XE). Children under 5 years old are not recommended to use 15 mg suppositories, up to 12 years old - 30 mg (15 mg suppositories are used for them).

Pregnancy and elbowing
The use of the drug is not recommended in the first trimester of pregnancy, in the second and third trimesters of pregnancy, the drug can be used after a careful assessment of the ratio of benefits to the mother and the possible risk to the fetus.
Ambroxol 30 is excreted in breast milk, therefore it is not recommended to use the drug during lactation.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect.

Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Vacation conditions
No prescription.

Packaging
Ambroxol 30 mg Tablets. There are 10 tablets in a blister. 3 blisters are packed in a cardboard box together with an enclosed leaflet.