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

Excipients: sorbitol syrup (sorbitol), glycerol, sodium benzoate, propylene glycol, citric acid monohydrate, saccharin, sodium metabisulphite, vanillin, purified water.

Description:Transparent, colorless or slightly yellowish syrup with the smell of vanillin.

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 Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

After oral administration, the effect occurs after 30 minutes and lasts for 6-10 hours.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration in the blood (TSmah) - 2 hours, the connection with plasma proteins - 80%. Penetrates through the blood-brain barrier (GEB), the placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. The half-life (T1 / 2) is 7-12 hours. It is excreted by the kidneys: 90 % in the form of water-soluble metabolites, in unchanged form - 5%. T1 / 2 increases with severe chronic renal failure (CRF), 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, chronic obstructive pulmonary disease (COPD), bronchial asthma with difficulty in sputum discharge, bronchoectatic disease.

Stimulation of prenatal lung maturation, treatment and prevention (with the threat of premature birth and with shown artificial premature births between the 28th and 34th weeks of pregnancy, if the clinical picture suggests an extension of the pregnancy for 3 days) respiratory distress syndrome in premature infants and newborns .

Contraindications:

Hypersensitivity, pregnancy (I trimester), children under 5 years (for syrup 30 mg / 5 ml), hereditary intolerance to fructose.

Carefully:

Renal insufficiency, hepatic insufficiency, peptic ulcer of the stomach and duodenum.

Pregnancy and lactation:

The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimester of pregnancy and during breastfeeding should evaluate the potential benefit to the mother with a possible risk to the fetus / child.

Dosing and Administration:

Inside, during meals, with a small amount of liquid. 1 measuring spoon or 1 measuring cup contains 5 ml of syrup.

Syrup 30 mg / 5 ml for adults and children over 12 years for 30 mg (5 ml) for the first 2-3 days, then 15 mg (2.5 ml) 2 times a day, children 5-12 years - 15 mg (2.5 ml) 2-3 times a day. In severe cases, the dose is not reduced throughout the course of treatment.

Syrup 15 mg / 5 ml is administered to children in the following doses: up to 2 years - 7.5 mg (2.5 ml) twice a day, 2-5 years - 7.5 mg (2.5 ml) 3 times a day, 5-12 years - 15 mg (5 ml) 2-3 times a day.

It is not recommended to use without medical appointment for more than 4-5 days.

Side effects:

Allergic reactions: skin rash, hives, 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.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

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

Interaction:

Joint use with antitussive drugs (LS) leads to difficulty in withdrawing sputum while reducing cough.

Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin, doxycycline.

Special instructions:

Do not combine with antitussive drugs, making it difficult to withdraw phlegm.

Ambroxol does not contain sugar, the syrup includes sweeteners, so it can be used in patients with diabetes, obesity.

Form release / dosage:

Syrup 30 mg / 5 ml or syrup 15 mg / 5 ml.

Packaging:

For 50 ml or 100 ml in bottles of dark color from polyethylene terephthalate or glass. Each bottle is placed along with the instructions for use, a measuring spoon for 5 ml or a measuring cup of 5 ml into individual cardboard packs.

Storage conditions:

Store in a dark place at a temperature of no higher than 20 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008609/09

Date of registration:28.10.2009 / 15.01.2016

Expiration Date:Unlimited

The owner of the registration certificate:ROSLEKS PHARM, LLCROSLEKS PHARM, LLC Russia

Manufacturer: & nbsp

ROSLEKS PHARM, LLC Russia

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)