2010/09/20

Ambrohexal

Composition, structure and packing

Tablets are white, round, flat, beveled edges and a notch on one side.

1 tab. ambroxol hydrochloride 30 mg.

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

Capsules of prolonged action solid gelatine, with the body and white cap, the contents of capsules - pellets of white and pale pink.

1 capsule. ambroxol hydrochloride 75 mg.

Solution for oral and inhalation transparent, colorless.

1 ml (20 drops), ambroxol hydrochloride 7.5 mg.

Excipients: metilparagidroksibenzoat, propilparagidroksibenzoat, sodium disulfit, citric acid, sodium hydroxide and water.

The syrup is colorless or slightly yellow, transparent or nearly transparent.

5 ml (1 measuring. Spoon) ambroxol hydrochloride 15 mg.

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

Clinico-pharmacological group: Mucolytic and expectorant drug.

Pharmacological action

Mucolytic preparations with expectorant effects. It has sekretomotornym, sekretoliticheskim and expectorant action.

Reducing the viscosity of sputum is due to depolymerization of mucopolysaccharides, which, in turn, is connected with the rupture of disulfide bonds in their molecules. Ambroxol increases the motor activity of the cilia of 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 the cells of Clarke, ambroxole reduces the viscosity of sputum, facilitating its excretion from the respiratory tract.

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

Step Ambrogeksala begins after 30 minutes and lasts 6-12 hours

Maximum therapeutic effect is manifested on day 3 of treatment.

Pharmacokinetics

Absorption

Once inside ambroxole quickly and almost completely absorbed from the gastrointestinal tract. Tmax is 0.5-3 h. Bioavailability is about 80%.

Distribution

Linking to plasma proteins - 80-90%. Ambroxol penetrates through the BBB, placenta, excreted in breast milk.

Metabolism

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

Withdrawal

Write mainly in the urine - 90% as metabolites, 10% unchanged.

T1 / 2 from 7 to 12 pm In applying Ambrogeksala in capsule form prolonged action T1 / 2 ambroxol and metabolites from blood plasma - about 22 hours

Statement

Acute and chronic respiratory diseases, accompanied by the formation of a viscous secretion:
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 and inhalation).

Dosage regimen

Tablets

Adults and children over the age of 12 years, appoint 1 tablet (30 mg) 3 times / day during the first 2-3 days. Then the dose 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 prolonged action

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

Syrup: Adults and children over the age of 12 years, appointed to 2 scoops (30 mg) 2-3 times / day during the first 2-3 days. Then to 2 scoops 2 times / day. In severe cases, the dose does not decrease during the entire course of treatment. The maximum dose - 4 scoops (60 mg) 2 times / day.

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

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

Children under the age of 2 years each appoint 1 / 2 scoops (7.5 mg) after eating 2 times per day.

The drug is prescribed only under medical supervision.

Solution for oral and inhalation

Adults and children over the age of 12 years, appointed to 4 ml (30 mg) 3 times / day during the first 2-3 days. Then the dose should be reduced to 4 ml 2 times per day.

Children aged 5 to 12 years appointed to 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 the age of 2 years appoint 1 ml (7.5 mg) 2 times / day.

The drug, taken orally after a meal in a diluted form of tea, fruit juices, milk or water. Solution for oral administration can also be used as an inhalation.

Adults and kids over the age of 5 years is recommended that inhalation 1-2 times / day, 2-3 ml (40-60 drops, which corresponds to 15-22.5 mg ambroxol). Children under the age of 5 years is recommended that inhalation 1-2 times / d in 2 ml (40 drops, which corresponds to 15 mg ambroxol). For inhalation, use the appropriate device in compliance with the rules of use.

Patients with impaired renal function or with severe disorders of liver function should use lower concentrations, or increase the interval between doses of the drug. Ambrogeksal be taken by mouth after eating, drinking plenty of fluids.

During treatment should be consumed a lot of fluids (juice, tea, water) to enhance mucolytic effect of the drug. The duration of treatment is determined by the physician individually and depends on the severity of the disease.

If necessary, use of the drug over 4-5 days required medical supervision.

Side effect

On the part of the digestive system: rare - abdominal pain, nausea, constipation, dry mouth, rarely (<1%) - increased salivation.

On the part of the respiratory system: rare (<1%) - increased secretion of mucus in the nasal cavity, dryness of the respiratory tract.

Allergic reactions: skin rash, urticaria, angioedema, bronchospasm, fever and chills, very rarely (<0.01%) - anaphylactic shock.

Other: rare (<1%) - weakness, headache, difficulty in urination (dysuria).

For Ambrogeksala in the form of syrup and solution for oral and inhalation: due to the presence of the drug sodium metabisulfita (preservative), may develop hypersensitivity reactions (particularly in patients with bronchial asthma), manifested in the form of vomiting, diarrhea, acute asthmatic attacks , impairment of consciousness or shock. These reactions can proceed very individual, but also lead to life-threatening consequences.

Contraindications
I trimester of pregnancy;
Children under 6 years (tablets);
Children under 12 years (long-acting capsules);
Hypersensitivity to Ambroxole and other components of the dosage forms of the drug.

With care use in patients with gastric ulcer and duodenal ulcer (due to possible exacerbation), renal failure, liver failure.

Pregnancy and lactation

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

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

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

Application for violations of liver function

With care use in patients with hepatic insufficiency. In severe liver problems should use lower concentrations, or increase the interval between doses of the drug.

Application for violations of renal function

With care use in patients with renal insufficiency. In severely impaired renal function should use lower concentrations, or increase the interval between doses of the drug.

Cautions

Precautions should be applied ambroxole in patients with impaired cough reflex, or a violation mucocilliary transport because of the possibility of accumulation of phlegm. Patients receiving ambroxole not recommend the implementation of breathing exercises.

Patients in serious condition, should be carried aspiration attenuated sputum. Patients with asthma may increase ambroxole cough.

Do not take ambroxole immediately before bedtime. In severe liver problems, and / or kidney disease should use lower concentrations, or increase the interval between doses of the drug.

Patients with impaired tolerance to fructose before applying Ambrogeksala should consult with your doctor.

Overdose

Symptoms: nausea, vomiting, pain in the epigastric region. There are reports of the appearance of short-term anxiety, diarrhea. When expressed overdose may fall in blood pressure.

Treatment: removal of the drug. It is produced artificially vomiting during the first 2 h wash out the stomach, start to receive fat-containing products. Symptomatic therapy.

Drug Interactions

With simultaneous application Abrogeksala with antibiotics (including amoxicillin, cefuroxime, doxycycline, erythromycin) in the bronchial secretion increases the concentration of the latter.

With simultaneous application Abrogeksala with antitussives (including codeine) in connection with the suppression of the cough reflex may be difficulty in sputum discharge from the bronchial tree.

Terms and Conditions of storage

The drug 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 capsule form of prolonged action should be kept away from children at or above 25 ° C. Shelf life - 3 years.

The drug in the form of syrup should be stored out of reach of children, protected from light at temperatures below 25 ° C. Shelf life - 3 years.

The drug in solution for oral and inhalation should be stored out of reach of children, protected from light at temperatures below 25 ° C. Shelf life - 4 years.