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

Excipients: sorbitol - 35.000 glicerol (glycerin) 15,000 g, propylene glycol 3,000 g, benzoic acid 0.200 g, citric acid monohydrate 0.100 g, sodium hydroxide 0.051 g, food flavor Malina (containing: propylene glycol, ethanol, alpha-tocopherol, ascorbic acid, water) - 0.100 g, purified water - up to 100.0 ml.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration).Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

Pharmacokinetics:

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours. Absorption is high, the time to reach the maximum concentration in the blood (Cmah) - 2 hours, the connection with plasma proteins - 80%. It penetrates the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolized in the liver, forming dibromantranilic acid and glucuronic conjugates. Half-life (T_1/2) - 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%.

Half-life (T_1/2) increases with severe chronic renal failure, does not change if the liver function is impaired.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, bronchial asthma with difficulty in sputum discharge, bronchoectatic disease, chronic obstructive pulmonary disease.

Contraindications:

Hypersensitivity to the components of the drug, pregnancy (I trimester), fructose intolerance (the drug contains sorbitol).

Carefully:

Renal or hepatic insufficiency, peptic ulcer and duodenal ulcer, pregnancy period (II and III trimesters) and lactation, the patient's propensity to develop drug dependence, alcoholism, epilepsy, brain diseases, children's age.

Pregnancy and lactation:

It is not recommended to use in the first trimester of pregnancy and during lactation. In the II and III trimesters of pregnancy, use with caution.

Dosing and Administration:

Is ingested while eating, squeezed with a small amount of liquid. In the first 2-3 days, adults and children over 12 years of age are prescribed 10 ml (2 teaspoons) 3 times a day, then 5 ml (1 teaspoon) 3 times a day or 10 ml 2 times a day. In severe cases, the dose is not reduced throughout the course of treatment.

Children under 2 years are prescribed 2.5 ml (1/2 teaspoon) 2 times a day; from 2 to 5 years - 2.5 ml 3 times a day; from 5 to 12 years - 5 ml (1 teaspoon) 2-3 times a day.

It is not recommended to take the drug for more than 4-5 days without consulting a doctor.

Side effects:

Allergic reactions: often - skin rash, hives; very rarely - angio-neurotic edema, allergic contact dermatitis, anaphylactic shock.

From the digestive system: rarely - diarrhea, dryness of the oral mucosa, constipation. With prolonged use in high doses, gastralgia, nausea, and vomiting may occur.

From the respiratory system: rarely - dryness of the mucous membranes of the respiratory tract, rhinorrhea.

Other: rarely - weakness, headache, exanthema, dysuria.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

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

Interaction:

Increases the effectiveness of amoxicillin, cefuroxime, erythromycin and doxycycline by increasing their penetration into the bronchial secretion. Joint use with other antitussive drugs leads to difficulty in getting away from sputum while reducing cough. Compatible with drugs that inhibit labor.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

The drug does not contain sugar and can be used by patients with diabetes mellitus. The preparation contains ethanol (as part of the fragrance) in a final concentration of 0.018%, so caution should be given to patients with a tendency to develop drug dependence, alcoholism, epilepsy, brain diseases, and children.

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

The drug does not affect the ability to drive vehicles and engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. It should be taken into account that the preparation contains 0.018% ethanol.

Form release / dosage:

Syrup 15 mg / 5 ml.

Packaging:

For 100 ml of the drug in polymer bottles.

Each bottle, along with instructions for medical use, is put in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of 15 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

After opening the bottle, store in a cool place for no more than 30 days.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002279

Date of registration:21.10.2013

Expiration Date:21.10.2018

The owner of the registration certificate:HEALTH PHARMACEUTICAL COMPANY, LTD. HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine

Manufacturer: & nbsp

HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol-3T (Ambroxol-ZT)