AMBROGEKSAL

Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): J15, J20, J42, J44, J45, J47, J80
When CSF: 12.02.02
Manufacturer: Hexal AG (Germany)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Pills white, round, flat, with beveled edges and a notch on one side.

Excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide.

10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

◊ Capsules of the prolonged action hard gelatin, and the housing lid white; contents of capsules – pellets white and pale pink.

Excipients: microcrystalline cellulose, eudragit RL30D (polyethyl acrylate:methyl methacrylate:trimethylammonioethyl methacrylate chloride [1:2:0.2]), eudragit RS30D (polyethyl acrylate:methyl methacrylate:trimethylammonioethyl methacrylate chloride [1:2:0.1]), triэtiltsitrat, magnesium stearate, Titanium dioxide, iron oxide red dye.

Ingredients of the capsule shell: gelatin, Titanium dioxide.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

◊ Solution for oral and inhalation clear, colorless.

Excipients: metilparagidroksiʙenzoat, propilparagidroksibenzoat, sodium bisulfite, lemon acid, Sodium hydroxide, water.

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

◊ Syrup colorless or slightly yellow, clear or almost clear.

Excipients: benzoic acid, sodium bisulfite (sodium metabisulfite), citric acid monohydrate, Sodium hydroxide, povidone, sorbitol 70%, glycerol 85%, sodium cyclamate, raspberry flavor, Purified water.

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

Pharmacological action

Mucolytic drug with expectorant action. It has sekretomotornym, sekretoliticheskim and expectorant.

A decrease in the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides, that, in turn, associated with the rupture of disulfide bonds in their molecules. Ambroxol increases the motor activity of the cilia of the ciliated epithelium, increases mucociliary transport, normalizes the ratio of serous and mucous components of sputum.

By activating the hydrolyzing enzymes and increasing the release of lysosomes from cells Clarke, ambroxol reduces the viscosity of sputum, facilitating its removal from the respiratory tract.

As a result of chronic diseases of the respiratory system, the properties of (due to the formation of bonds between surface active phospholipids and inflammatory proteins) and the synthesis of surfactant decreases. Ambroxol stimulates prenatal lung development by increasing the synthesis and secretion of surfactant in the alveoli.

Action of Ambrohexal^® begins 30 minutes and lasts 6-12 no. The maximum therapeutic effect is manifested on 3 day of treatment.

Pharmacokinetics

Absorption

After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract.. T_max is 0.5-3 no. Bioavailability is about 80%.

Distribution

The binding to plasma proteins – 80-90%. Ambroxol penetrates the BBB, placenta, excreted in breast milk.

Metabolism

The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid, glucuronic conjugates).

Deduction

Write mainly with urine – 90% as metabolites, 10% in unchanged form. T_1/2 from 7 to 12 no. When using Ambrohexal^® in the form of capsules of prolonged action T_1/2 ambroxol and blood plasma metabolites – about 22 no.

Testimony

Acute and chronic respiratory disease, accompanied by the formation of a viscous secretions:

- Acute and chronic bronchitis;

- Pneumonia;

- COPD;

- Bronchial asthma with obstruction of sputum discharge;

- Bronchiectasis;

- Treatment and prevention of respiratory distress syndrome (for syrup and solution for oral administration and inhalation).

Dosage regimen

Pills

Adults and children over the age of 12 years appoint 1 tab. (30 mg) 3 times / day during the first 2-3 days. Then the dose of the drug should be reduced to 1 tab. 2 times / day.

Children aged 6 to 12 years appoint 1/2 tab. (15 mg) 2-3 times / day.

Capsules of the prolonged action

Adults and children over the age of 12 years appoint 1 caps. (75 mg) 1 once / day in the morning or in the evening after meals, without chewing, drinking plenty of fluids.

Syrup

Adults and children over the age of 12 years appoint 2 measuring spoons (30 mg) 2-3 times/day for the first 2-3 day. Then by 2 measuring spoons 2 times / day. In severe cases, the dose does not decrease during the course of treatment. The maximum dose – by 4 dimensional spoons (60 mg) 2 time / day.

Children aged 5 to 12 years appoint 1 measuring spoon (15 mg) 2-3 times / day.

Children aged 2 to 5 years appoint 1/2 measuring spoon (7.5 mg) 3 times / day.

Children under 2 years appoint 1/2 measuring spoon (7.5 mg) after meal 2 times / day. The drug is prescribed only under the supervision of a physician..

Solution for oral and inhalation

Adults and children over the age of 12 years appoint 4 ml (30 mg) 3 times/day for the first 2-3 day. Then the dose of the drug should be reduced to 4 ml 2 times / day.

Children aged 5 to 12 years appoint 2 ml (15 mg) 2-3 times / day.

Children aged 2 to 5 years appoint 1 ml (7.5 mg) 3 times / day.

Children under 2 years appoint 1 ml (7.5 mg) 2 times / day.

The drug should be taken orally after a meal, diluted with tea., fruit juices, milk or water.

Oral solution can also be taken by inhalation.

Adults and children over the age of 5 years inhalation is recommended 1-2 times / day for 2-3 ml (40-60 drops, corresponding 15-22.5 mg ambroxol).

Children under the age of 5 years inhalation is recommended 1-2 times / day for 2 ml (40 drops, corresponding 15 mg ambroxol).

For inhalation, use an appropriate device in accordance with the rules of use.

Patients with impaired renal function or severely impaired liver function lower doses of the drug should be used, or increase the interval between doses.

Ambrohexal^® should be taken orally after meals, drinking plenty of fluids.

Drink plenty of fluids during treatment (juices, tea, water) to enhance the mucolytic effect of the drug.

The duration of treatment is determined by the doctor individually and depends on the severity of the disease.. If it is necessary to use the drug more 4-5 days a doctor's supervision is required.

Side effect

From the digestive system: rarely – stomach ache, nausea, constipation, dry mouth; rarely (<1%) – increased salivation.

The respiratory system: rarely (<1%) – increased secretion of mucus in the nasal cavity, dry airways.

Allergic reactions: skin rashes, hives, angioedema, bronchospasm, fever and chills; rarely (<0.01%) – anaphylactic shock.

Other: rarely (<1%) – weakness, headache, difficulty urinating (dizurija).

To Ambrohexal^® in the form of a syrup and solution for oral administration and inhalation: due to the presence of sodium metabisulfite in the preparation (preservative), possible development of hypersensitivity reactions (especially in patients with bronchial asthma), manifested in the form of vomiting, diarrhea, acute asthmatic attacks, impaired consciousness or shock. These reactions can be very individual., and also lead to life-threatening consequences.

Contraindications

- I trimester of pregnancy;

- Children up to age 6 years (Pill);

- Children up to age 12 years (for extended-release capsules);

- hypersensitivity to ambroxol and other components of the dosage forms of the drug.

FROM caution the drug should be used for gastric ulcer and duodenal ulcer (due to possible exacerbation), renal failure, hepatic insufficiency.

Pregnancy and lactation

Do not use this drug in the I trimester of pregnancy.

Use of the drug in the II and III trimester of pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus.

Precautions should use the drug during breastfeeding, because ambroxol excreted in breast milk.

Cautions

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients, taking ambroxol, breathing exercises are not recommended. Patients, in serious condition, liquefied sputum should be aspirated.

In patients with bronchial asthma, ambroxol may aggravate cough.

Do not take ambroxol just before bed.

If liver and / or kidney function is severely impaired, lower concentrations should be used, or increase the interval between doses of the drug.

Patients with impaired fructose tolerance before using Ambrohexal^® Talk to your doctor.

Overdose

Symptoms: nausea, vomiting, epigastric pain. There are reports of short-term anxiety, diarrhea. With a pronounced overdose, a drop in blood pressure is possible..

Treatment: removal of the drug. Induce artificial vomiting, flush the stomach during the first 2 hours; the intake of fat-containing foods is shown. Symptomatic therapy.

Drug Interactions

With the simultaneous use of Abrohexal^® with antibiotics (incl. amoksiцillinom, tsefuroksymom, doxycycline, Erythromycin) in the bronchial secretion, the concentration of the latter increases.

With the simultaneous use of Abrohexal^® with antitussives (incl. codeine) due to suppression of the cough reflex, it is possible that sputum discharge from the bronchial tree may be difficult.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug is in the form of tablets should be stored out of reach of children at or above 25 ° C. Shelf life – 5 years.

The drug in the form of prolonged-release capsules should be stored out of the reach of children at a temperature not exceeding 25 ° С. Shelf life – 3 year.

The syrup should be kept out of the reach of children., dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.

The drug in the form of a solution for oral administration and inhalation should be kept out of the reach of children., dark place at a temperature no higher than 25 ° C. Shelf life – 4 year.