Ambrobene - instructions for use, doses, side effects, contraindications

100 ml of the preparation contain: active substance Ambroxol hydrochloride 0.750 g; Excipients: potassium sorbate 0.100 g, hydrochloric acid (25%) 0.060 g, purified water 99.190 g.

Description:Transparent from colorless to light yellow with a brownish hue of color solution, odorless.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is a benzylamine - a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and by the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring.Has a secreto-motor, secretolitic and expectorant action.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Pre-clinical studies have shown that ambroxol stimulates serous cells of the glands of the bronchial mucosa. Activating cells of the ciliary epithelium and reducing the viscosity of phlegm, ambroxol improves mucociliary transport.

Ambroxol activates the formation of a surfactant, having a direct effect on alveolar pneumocytes of type 2 and Clara cells of small airways. Research on cell cultures and research in vivo on animals have shown that ambroxol stimulates the formation and secretion of a substance (surfactant), active on the surface of the alveoli and bronchi of the embryo and adult.

Also, in preclinical studies, the antioxidant effect of ambroxol was demonstrated. Ambroxol when combined with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases their concentration in sputum and bronchial secretion.

Pharmacokinetics:

Ingestion ambroxol almost completely absorbed from the gastrointestinal tract.The maximum concentration is achieved 1-3 hours after ingestion. Due to presystemic metabolism, the absolute bioavailability of ambroxol after oral administration decreases approximately 1/3. The resulting metabolites (such as dibromantranilic acid, glucuronides) are eliminated in the kidneys. The plasma protein binding is about 85% (80-90%). The half-life of the plasma is from 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours. It is excreted mainly by kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high connection with plasma proteins, a large volume of distribution and a slow redistribution from tissues to the blood, there is no significant removal of ambroxol in dialysis or forced diuresis.

In patients with severe liver disease, ambroxol clearance is reduced by 20-40%. In patients with severe impairment of renal function, the half-life of metabolites of ambroxol is increased.

Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and also excretes into breast milk.

Indications:

Acute and chronic diseases of the respiratory tract, accompanied by a violation of education and sputum discharge.

Contraindications:

Hypersensitivity to ambroxol or to one of the excipients; pregnancy (I trimester).

Carefully:

Disturbance of motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum during the exacerbation, pregnancy (II-III trimester), the period of breastfeeding. Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing large intervals between doses or taking the drug in a smaller dose.

Pregnancy and lactation:

Pregnancy. There is insufficient data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Studies conducted on animals did not reveal a teratogenic effect.

The use of Ambrobene during pregnancy (II-III trimester) is possible only according to the doctor's prescription, after a thorough assessment of the risk / benefit ratio.

The period of breastfeeding. Studies conducted on animals have shown that ambroxol penetrates into breast milk. Due to insufficient study of the use of the drug in women during lactation, the use of Ambrobe is possible only according to the doctor's prescription, after a thorough assessment of the risk / benefit ratio.

Dosing and Administration:

Application of the preparation inside

Inside the drug is taken after a meal, adding water, juice or tea with the attached measuring cup.

Children up to 2 years old should take 1 ml of the drug 2 times a day (15 mg ambroksola in day).

Children from 2 to 6 years old should take 1 ml of the drug 3 times a day (22.5 mg ambroksola per day).

Children from 6 to 12 years old should take 2 ml of the drug 2-3 times a day (30-45 mg ambroksola per day).

Adults and children over 12 years of age in the first 2-3 days of treatment should take 4 ml of the drug 3 times a day (90 mg ambroksola per day). If therapy is ineffective, adults can increase the dose to 8 ml of the drug 2 times a day (120 mg ambroksola per day). In the following days, take 4 ml of the drug 2 times a day (60 mg ambroksola per day).

Application of the drug in the form of inhalations

When using Ambrobene in the form of inhalation, any modern equipment (except steam inhalers) can be used.Before inhalation, the preparation is mixed with 0.9% sodium chloride solution (for optimal humidification, the air can be diluted 1: 1) and heated to body temperature. Since inhalation therapy can cause a deep breath to cause coughing, inhalation should be performed in the usual breathing mode. Patients with bronchial asthma can be recommended to perform inhalation after taking bronchodilator drugs.

For inhalations, the following dosages are used (1 ml of the solution contains 7.5 mg of ambroxol):

children up to 2 years: 1 ml of solution 1-2 times a day (7.5-15 mg ambroksola per day); children from 2 to 6 years: 2 ml solution 1-2 times a day (15-30 mg ambroksola per day); Children over 6 years and adults: 2-3 ml of solution 1-2 times a day (15-45 mg ambroksola per day).

The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's appointment for more than 4-5 days.

The mucolytic effect of the drug is manifested when taking a large amount of fluid, so during treatment is recommended a plentiful drink.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%,but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%.

From the immune system: infrequently - hypersensitivity reaction, frequency not established - anaphylactic reactions, including rash, itching, urticaria, angioedema, anaphylactic shock.

From the nervous system: often - a violation of taste perception.

From the digestive tract: often - nausea; infrequent - dryness of the mucous membrane of the mouth and throat, vomiting, indigestion, abdominal pain, diarrhea.

Overdose:

Symptoms. Signs of intoxication with an overdose of ambroxol have not been identified. There is information about nervous arousal and diarrhea.

Ambroxol is well tolerated when ingested at a dose of up to 25 mg / kg / day.

In the case of severe overdose, excessive salivation, nausea, vomiting, and lowering of blood pressure are possible.

Treatment. Intensive therapies, such as vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is indicated.

Interaction:

With the simultaneous use of ambroxol and antitussives due to the suppression of the cough reflex, stasis may arise. It is necessary to select such combinations with caution.

With the joint administration of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretion increases.

Special instructions:

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

In children under 2 years of age, the drug can be administered only as directed by a doctor.

Very rarely, severe skin reactions were observed, such as Stevens-Johnson syndrome and Lyell's syndrome, with ambroxol. When changing skin or mucous membranes, you should urgently consult a doctor and stop taking the drug.

Effect on the ability to drive transp. cf. and fur:Studies on the influence of Ambrobene on the ability to manage transport and work with technology were not conducted. With the development of side effects, care should be taken when performing actions requiring increased concentration of attention and rapidity of psychomotor reactions.

Form release / dosage:

Solution for ingestion and inhalation 7.5 mg / ml.

Packaging:

For 40 or 100 ml of the drug in a bottle of dark glass,Corked with a stopper and a plastic screw cap. One bottle with instructions for use and a measuring cup is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

5 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014731 / 02

Date of registration:15.01.2009 / 13.03.2014

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp27.07.2017

Illustrated instructions

Instructions

Ambroben (Ambrobene)