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

Active substance:	Per 1 ml	50 ml	Per 100 ml
Ambroxol hydrochloride Excipients:	7.50 mg	0.3750 g	0.7500 g
Benzalkonium chloride 50% solution	0.45 mg	0.0225 grams	0.0450 g
Citric acid monohydrate	1.10 mg	0.0550 g	0.1100 g
Sodium cyclamate	2.00 mg	0.1000 g	0.2000 g
Sodium hydrophosphate dodecahydrate	3.42 mg	0.1710 g	0.3420 g
Sodium chloride	5.00 mg	0.2500 g	0.5000 g
Glycerol	100.00 mg	5,0000 g	10,0000 g
Sorbitol 70% solution	300.00 mg	15,0000 g	30,0000 g
Purified water	682.53 mg	34,1265 g	68.2530 g

Description:

Transparent colorless or light yellow solution.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Refers to the group of mucolytic agents.Has a secreto-motor, secretolitic and expectorant action. It is a metabolite of bromhexine. 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:

After ingestion, the effect comes in 30 minutes. 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 0.5-1 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. The half-life (T1 / 2) is 7-12 hours.Penetrates through the blood-brain barrier and placental barrier, excreted in breast milk. It is excreted mainly by the kidneys: 90% - in the form of water-soluble metabolites, unchanged - 5%. T1 / 2 increases with severe chronic renal failure, 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, chronic bronchitis in the acute stage, laryngitis, tracheitis, pneumonia;

- chronic obstructive pulmonary disease;
- bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity to the components of the drug, I trimester of pregnancy, lactation.

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 a meal, with a small amount of liquid:

- adults and children over the age of 12 years for the first 2-3 days - 4 ml, then 2 ml 3 times a day or 4 ml 2 times a day;

- Children aged 6 to 12 years - 2 ml 2-3 times a day or 70 drops 2-3 times a day;

- Children aged 2 to 6 years - 1 ml 3 times a day or 35 drops 3 times a day;

- Children under the age of 2 years - 1 ml 2 times a day or 35 drops 2 times a day.

The maximum daily dose for adults and children over 12 years is 12 ml, for children aged 6-12 years - 6 ml, for children from 2 to 6 beds - 3 ml, for children under 2 years - 2 ml.

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 to 1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000), very rarely (<1/10000).

From the nervous system: rarely - weakness, headache.

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

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

From the genitourinary system: rarely - dysuria.

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

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

Interaction:

The combined use of ambroxol with antitussive drugs leads to difficulty in withdrawing sputum while reducing cough.

The combined use of amoxicillin, cefuroxime, erythromycin and doxycycline with ambroxol increases their penetration into the bronchial secretion.

Special instructions:

Do not combine Ambrosan ® 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, peptic ulcer and duodenal ulcer, during pregnancy (II and III trimester), the drug should be used with caution.

Effect on the ability to drive transp. cf. and fur:The administration of Ambrosan® does not affect the ability to drive vehicles / moving mechanisms and engage in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Solution for oral administration, 7.5 mg / ml.

Packaging:

To 50, 100 ml in a bottle-dropper of dark glass with screw shutter, equipped with a measuring cup. A label is attached to the vial. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-001046

Date of registration:21.10.2011

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

Manufacturer: & nbsp

HAUPT PHARMA WOLFRATSHAUSEN, GmbH Czech Republic

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

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Ambrosan® (Ambrosan®)