AMBROBENE

Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): J15, J20, J42, J45, J47, P22
When CSF: 12.02.02
Manufacturer: Merckle GmbH (Germany)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Pills white, round, lenticular, with unilateral break line.

Excipients: lactose monohydrate, corn starch, magnesium stearate, Silicon dioxide highly.

10 PC. – packings Valium planimetric (2) – cardboard boxes.
10 PC. – packings Valium planimetric (5) – cardboard boxes.

◊ Retard Capsules with an opaque upper portion and a brown clear, colorless bottom part; contents of capsules – from white to slightly yellow balls.

Excipients: microcrystalline cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, methylhydroxypropylcellulose, eudragit RS 30D, triэtiltsitrat, colloidal silica, precipitated, gelatin, Titanium dioxide, iron oxide (yellow, red, black).

10 PC. – packings Valium planimetric (1) – cardboard boxes.
10 PC. – packings Valium planimetric (2) – cardboard boxes.

◊ Solution for oral and inhalation clear, Colorless to slightly yellowish, without smell.

Excipients: potassium sorbate, hydrochloric acid, Purified water.

40 ml – dark glass bottles with cork-dropper (1) complete with a measured glass – cardboard boxes.
100 ml – dark glass bottles with cork-dropper (1) complete with a measured glass – cardboard boxes.

◊ Syrup clear, Colorless to slightly yellowish, with the smell of raspberries.

Excipients: Sorbitol liquid (noncrystallizing), propylene glycol, raspberry flavor, saxarin, Purified water.

100 ml – vials of dark glass (1) complete with a measured glass – packs cardboard.

Solution for injection clear, Colorless to slightly yellowish, without smell.

Excipients: citric acid monohydrate, sodium chloride, disodium monogïdrogenfosfat geptagïdrat, water d / and.

2 ml – vials of dark glass (5) – Plastic trays (1) – cardboard boxes.

Pharmacological action

Mucolytic and expectorant drugs.

Amʙroksol – the active metabolite of bromhexine improves the rheological properties of sputum, reduces its viscosity and adhesive properties, facilitating its removal from the airways.

Ambroxol stimulates the activity of cells of the serous membrane of the bronchi glands, production of enzymes, break down the relationship between the polysaccharides of sputum, education surfactant and activity of the cilia of the bronchi directly, preventing them from sticking together.

After oral administration, the therapeutic effect occurs 30 minutes and persists for 6-12 no (depending on the dose).

For parenteral administration, the active drug comes quickly and lasts for 6-10 no.

Pharmacokinetics

Absorption and distribution

For parenteral administration ambroxol rapidly penetrates tissue. The highest concentration found in the lungs. C_max plasma levels achieved after 1-3 no.

The plasma protein binds about 80% product. Ambroxol penetrates the blood-brain barrier and the placental barrier, excreted in breast milk.

Metabolism and excretion

The drug is metabolized in the liver by conjugation with pharmacologically inactive metabolites.

About 90% Ambroxol is excreted in the urine: of them 90% as metabolites and 10% in unchanged form.

Pharmacokinetics in special clinical situations

At severe liver disease clearance reduced by ambroxol 20-40%.

At severe renal impairment increases T_1/2 ambroxol and its metabolites.

Testimony

All forms of the drug used in diseases of the respiratory tract with viscous mucus release and discharge of its difficulty:

- Acute and chronic bronchitis;

- Pneumonia;

- Bronchial asthma;

- Bronchiectasis;

- In the complex therapy to stimulate the synthesis of surfactant for respiratory distress syndrome in premature infants and newborns (injection).

Dosage regimen

The drug is taken orally after meal with plenty of fluids (glass of water, tea or juice).

Pills adults and children over the age of 12 years first 2-3 days appoint 1 tab. 3 times / day (90 mg / day). In the subsequent transition to the 2-single dose of the drug 1/2 tab. / day (30 mg / day).

Children aged 6 to 12 years first 2-3 days appoint 1/2 tab. 2-3 times / day (30-45 mg / day). In a subsequent move to twice-on the drug 1/2 tab. / day (30 mg / day).

Retard Capsules adults and children over the age of 12 years appoint 1 caps. / day (75 mg / day).

Syrup should be taken with a measuring cup: in 1 ml syrup contains 3 mg ambroxol.

Children under 2 years prescribers on 2.5 ml syrup 2 times / day (15 mg / day).

Children aged 2 to 6 years prescribers on 2.5 ml syrup 3 times / day (22.5 mg / day).

Children aged 6 to 12 years prescribers on 5 ml syrup 2-3 times / day (30-45 mg / day).

Adults and children over the age of 12 years during the first days 10 ml syrup 3 times / day (90 mg / day). Subsequently, by 10 ml syrup 2 times / day (60 mg / day).

Ambrobene in syrup form is the most convenient dosage form for the treatment of pediatric patients.

Solution for oral and inhalation the inside should be using the measuring cup: in 1 ml solution contains 7.5 mg ambroxol.

Children under 2 years prescribers on 1 ml 2 times / day (15 mg / day).

Children aged 2 to 6 years prescribers on 1 ml 3 times / day (22.5 mg / day).

Children aged 6 to 12 years prescribers on 2 ml 2-3 times / day (30-45 mg / day).

Adults and adolescents first 2-3 days appoint 4 ml 3 times / day (90 mg / day). In the following days – by 4 ml 2 times / day (60 mg / day).

When applied in the form Ambrobene inhalations using any modern equipment (except steam inhalation). Before inhalation, the drug should be mixed with 0.9% sodium chloride solution (for optimal humidification can be diluted at a ratio of 1:1) and heated to body temperature. Inhalation should be done in the usual mode of breathing, not to provoke cough shocks.

Patients with asthma to avoid non-specific respiratory irritation and spasm before the inhalation of ambroxol should be used bronchodilators.

Children under 2 years inhaled by 1 ml 1-2 times / day (7.5-15 mg / day).

Children aged 2 to 6 years inhaled by 2 ml 1-2 times / day (15-30 mg / day).

Adults and children over the age of 6 years inhaled by 2-3 ml 1-2 times / day (15-45 mg / day).

Solution for injection should be entered in / (slow bolus or infusion). The solvent used 0.9% sodium chloride, 5% Dextrose, Ringer-Locke or any other base solution with a pH above 6.3.

Babies Usually the drug is administered in a daily dose rate 1.2-1.6 mg / kg body weight.

Children under 2 years appoint 1 ml (1/2 amp.) 2 times / day (15 mg / day).

Children aged 2 to 6 years appoint 1 ml (1/2 amp.) 3 times / day (22.5 mg / day).

Children under the age of 6 years appoint 2 ml (1 amp.) 2-3 times / day (30-45 mg / day).

Adults appoint 1 amp. 2-3 times / day (30-45 mg / day). In severe cases, the dose can be increased to 2 amp. 2-3 times / day (60-90 mg / day).

At respiratory distress syndrome in newborn and premature children daily dose is 30 mg, usually, allocated to 4 separate administration.

Injection is stopped after the disappearance of acute manifestations of the disease and move on to the ingestion of other dosage forms Ambrobene.

Treatment children aged 2 years should only be undertaken under medical supervision.

While the drug is recommended to drink plenty of liquids.

The duration of treatment depends on the characteristics of the disease. Do not use the drug without a doctor's appointment 4-5 days.

Side effect

From the digestive system: rarely – drooling, gastralgia, nausea, vomiting, diarrhea, constipation.

The respiratory system: rarely – dry mouth and airways, rhinorrhea.

Allergic reactions: rarely – skin rash, angioneurotic edema of the face, respiratory failure, temperature reaction with chills; in some cases – contact dermatitis, anaphylactic shock.

Other: weakness, headache, dizurija, rash.

With the rapid on / in: intense headaches, feeling tired and heavy legs, stupor, increased blood pressure, breathlessness, hyperthermia, chills.

Contraindications

- Gastric ulcer and duodenal ulcer;

- Epileptic syndrome;

- Children under the age of 6 years (Pill, capsules retard, Injection Solution);

- Children under the age of 12 years (to retard capsules);

- Hypersensitivity to the drug.

FROM caution use in patients with impaired renal function and severe liver disease, reducing the dose and increasing the time between taking the drug (in such cases, the treatment should be carried out under medical supervision).

FROM caution and only under medical supervision should be applied at Ambrobene dysmotility bronchi and large volumes allocated secret in order to avoid the risk of congestion in the bronchial secretions.

Pregnancy and lactation

Because to date there are no reliable data about the negative effects of ambroxol on the fetus and newborn, Ambrobene used during pregnancy, especially in the I trimester, and during lactation is possible only in the case, when the intended benefits to the mother outweighs the potential risk to the fetus.

Cautions

Special instructions to the drug is not granted.

Overdose

Ambroxol well tolerated when administered at a dose of 25 mg / kg / day.

Symptoms: increase in saliva, nausea, vomiting, decrease in blood pressure.

Treatment: gastric lavage in the first 1-2 h after dosing, receiving fat-containing products. It should monitor hemodynamic parameters. If necessary spend symptomatic therapy.

Drug Interactions

Concomitant use of drugs with Ambrobene, having antitussive activity (eg, containing codeine), not recommended because of the difficulty of removing phlegm from the bronchial tubes in the background to reduce coughing.

The simultaneous use with antibiotics Ambrobene (incl. amoksiцillin, cefuroxime, Erythromycin, doxycycline) improves the delivery of antibiotics in pulmonary airways. Such interaction with doxycycline widely used for therapeutic purposes.

Can not be used for the injection of a mixture with solutions Ambrobene, having a pH above 6.3.

Conditions of supply of pharmacies

Drug in tablet form, capsules retard, solution for oral and inhalation, Syrup is resolved to application as an agent Valium holidays.

A preparation in the form of solution for injection by prescription.

Conditions and terms

Pills, retard capsules should be stored out of reach of children under normal conditions. Shelf life – 5 years.

Solution for oral and inhalation should be stored at a temperature no higher than 25 ° C. Shelf life – 5 years.

Shelf life syrup – 4 year.

List B. Injection should be stored under normal conditions. Shelf life – 4 year.