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

Refers to a group of mucolytic agents, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration).Has a secreto-motor, secretolitic and expectorant action. It is a metabolite of bromhexine and gives a more pronounced expectorant effect. Stimulates the 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 cilia of ciliated epithelium, increases mucociliary transport.

Pharmacokinetics:

When ingested, the drug is quickly and almost completely absorbed from the gastrointestinal tract.

Time to reach the maximum concentration in the blood plasma (TC_m_Oh) is about 0.5-2 hours. Do not cumulate. Binding to plasma proteins is about 80%. Do not undergo additional biotransformation in the liver to form an active form. Metabolized in the liver with the formation of dibromantranilic acid and glucuronic conjugates. Half-life (T_1/2) is 7-12 hours.Penetrates through the blood-brain barrier (GEB) and placental barrier, excreted in breast milk. It is excreted mainly by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%. T_1/2 increases with severe chronic renal failure (CRF), but does not change if the liver function is impaired.

Indications:

Infectious-inflammatory diseases of the respiratory system, accompanied by the formation of viscous sputum:

- acute and chronic bronchitis, pneumonia;

- chronic obstructive pulmonary disease (COPD);

- bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity, I trimester of pregnancy, lactation period, rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption; children's age till 6 years.

Carefully:

Hepatic insufficiency, renal failure, peptic ulcer of stomach and duodenum, pregnancy (II and III trimester).

Pregnancy and lactation:

If you need to use the drug in the II and III trimesters of pregnancy, you should evaluate the potential benefits of therapy for the mother with a possible risk to the fetus.When prescribing the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Inside, during meals, with a small amount of liquid.

Adults and children over 12 years of age are prescribed 30 mg (1 tablet) 3 times a day for the first 2-3 days, then 30 mg twice a day or 15 mg (1/2 tablet) 3 times a day. Children 6-12 years - 15 mg 2-3 times a day.

The maximum daily dose for adults and children over 12 years is 90 mg, for children 6-12 years - 45 mg.

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

Side effects:

The following classification of undesirable reactions is used depending on the frequency of occurrence: very often (> 1/10), often (<1/100, <1/10), sometimes (> 1/1000, <1/100), rarely (> 1 /10.000, <1/1000), very rarely (<1 / 10,000).

From the digestive system: rarely - diarrhea, constipation, with prolonged use in high doses - gastralgia, nausea, vomiting.

On the part of the respiratory system: rarely - rhinorrhea, dryness of the oral mucosa and respiratory tract.

Allergic reactions: rarely - skin rash, hives, allergic dermatitis; very rarely - angioedema, anaphylactic shock.

From the nervous system: rarely - weakness, headache.

From the genitourinary system: rarely - dysuria.

Overdose:

The range between the therapeutic and toxic doses of the drug is very wide, so there is practically no possibility of overdosing it.

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:

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

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

Special instructions:

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

If there is a violation of bronchial motility, accompanied by an increased formation of surfactant, the drug should be administered with caution.

With renal failure, severe hepatic insufficiency, gastric ulcer and duodenal ulcer, during pregnancy (II and III trimester), the drug should be used with caution.

Form release / dosage:Tablets of 30 mg.

Packaging:

For 10 tablets in a blister of PVC / aluminum foil.

Two blisters are placed in a cardboard box together with instructions for use.

Storage conditions:

In a dry, dark place at a temperature of 15-25 ° 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:П N015405 / 01

Date of registration:15.12.2008

Expiration Date:Unlimited

The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic

Manufacturer: & nbsp

PRO.MED.CS Praha, a.s. Czech Republic

Representation: & nbspPRO.MED.CS Prague as. PRO.MED.CS Prague as. Czech Republic

Information update date: & nbsp03.08.2017

Illustrated instructions

Instructions

Ambrosan® (Ambrosan®)