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

Excipients - benzoic acid - 5.75 mg, glycerol 85% - 500,00 mg, sorbitol 70% - 2500,00 mg, hyetylose (hydroxyethyl cellulose 6000 mPas) - 5.00 mg, raspberry aroma - 5.00 mg, purified water - 2719.25 mg.

Description:Homogeneous, clear, colorless solution with a raspberry smell.

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 6-12 hours.

Pharmacokinetics:

Absorption is high (for any route of administration), the maximum concentration in the blood plasma (T_C_max) - after 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. 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%.

The elimination half-life increases with severe chronic renal failure, but does not change if the liver function is impaired.

Indications:

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

Contraindications:

Hypersensitivity to all components of the drug; pregnancy (I trimester).

Carefully:

Hepatic failure, renal failure, peptic ulcer of stomach and duodenum, pregnancy (II-III trimester), lactation period, children under 1 year.

Pregnancy and lactation:

Application in pregnancy (I trimester) - is contraindicated.

Pregnancy (II-III trimester) and during lactation - use with caution.

Dosing and Administration:

Syrup take inside after eating.

Syrup 15 mg / 5 ml (1 measuring spoon - 5 ml)

Adults and children over 12 years of age: in the first 2-3 days of the disease, 10 ml (2 measuring spoons) 3 times a day; then 10 ml (2 measuring spoons) 2 times a day.

AT severe cases of the disease do not decrease the dose throughout the course of treatment.

For children: from 5 to 12 years - 5 ml (1 measuring spoon) 2-3 times / day; from 2 to 5 years - 2.5 ml each (½ measuring spoon) 3 times / day; up to 2 years - 2.5 ml each (½measuring spoon) 2 times / day.

Children up to 1 year old the drug can be administered only after consultation with the doctor.

Ambroxol-Hemofarm in the form of a syrup should be taken orally, squeezed with a liquid.

The open vial should be stored for 4 weeks.

Taking the drug for more than 4-5 days only under the supervision of a doctor.

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, and other gastrointestinal disorders.

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

Interaction:

Joint use with antitussive drugs leads to difficulty in getting away from sputum while reducing the cough.

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

Special instructions:

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

Form release / dosage:

Syrup 15 mg / 5 ml.

Packaging:

To 100 ml of syrup in a bottle of dark glass III hydrolytic group, sealed with a screwed plastic cover with the control of the first opening, equipped with a system of protection from accidental opening by children. On the top side of the lid is a scheme for opening the vial. 1 bottle complete with a measuring spoon (volume 5 ml, with a risk for a volume of 2.5 ml) and instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children!

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:P N 015470/02

Date of registration:05.06.2009 / 28.12.2015

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp02.08.2017

Illustrated instructions

Instructions

Ambroxol-Hemofarm (Ambroxol-Hemofarm)