2010/09/20

Ambroxol Vramed

Composition, structure and packing Ambroxol 

Syrup: Clear, viscous, with the smell of raspberries, from colorless to light yellow.

5 ml ambroxol hydrochloride 15 mg.

Excipients: sorbitol, citric acid, metilparagidroksibenzoat, propilparagidroksibenzoat, glycerol, propylene glycol, sodium saccharin, raspberry essence, purified water.

Clinico-pharmacological group: Mucolytic and expectorant drug.

Pharmacological action

Mucolytic preparations. Has sekretomotornym, sekretoliticheskim and expectorant action; stimulates serous cells of glands of the mucous membrane of the bronchi, increases the content of mucous secretion and release of surface-active agent (surfactant) in the alveoli and bronchi; normalizes impaired ratio of serous and mucous components of sputum. By activating the hydrolyzing enzymes and increasing the release of lysosomes from the cells of Clara, reduces the viscosity of sputum. Increases motor activity of ciliated epithelium, increases mucociliary transport. Once inside the action develops within 30 minutes and lasts for 6-12 hours

Pharmacokinetics Ambroxol 

Absorption

After taking the drug inside the high absorption. Cmax plasma levels achieved after 0.5-3 hours

Distribution

Binding to plasma proteins - 80%. Penetrates through the BBB, placenta, excreted in breast milk.

Metabolism

Metabolised in the liver with the formation dibromantranilovoy glucuronic acid conjugates. Putting T1 / 2 of 1.3 h. Write kidney: 90% - in the form of water-soluble metabolites, 5% - unchanged.

Pharmacokinetics in special clinical situations

T1 / 2 increased in severe chronic renal failure, does not change with abnormal liver function.

Statement Ambroxol 

Diseases of the respiratory tract with separation of viscous sputum:
Acute and chronic bronchitis;
pneumonia;
chronic obstructive pulmonary disease;
bronchial asthma with obstruction of sputum discharge;
bronchiectasis.

Dosage regimen

The drug is prescribed by mouth, during a meal, washed down with a small amount of liquid.

Adults and children over 12 years, drug prescribed within the first 2-3 days in 10 ml (2 teaspoons), and then 5 ml (1 teaspoon) 3 times / day.

Children aged 5-12 years, appoint 5 ml (1 teaspoon) 2-3 times / day.

Children aged 2-5 years - 2.5 ml (1 / 2 teaspoon) 3 times / day.

When duration of treatment dose can be reduced by 2 times.

Side effect

Allergic reactions: skin rash, urticaria, angioedema, and in some cases - allergic contact dermatitis, anaphylactic shock.

On the part of the digestive system: rarely - diarrhea, dry mouth, constipation, long-term use at high doses - stomachalgia, nausea, vomiting.

On the part of the respiratory system: rarely - dry mucous membranes of the respiratory tract, running nose.

Other: rarely - weakness, headache, dysuria, rash.

Contraindications
I trimester of pregnancy;
Hypersensitivity to the drug's components;
Hypersensitivity to Bromhexine.

Precautions should be prescribed the drug in renal failure.

Pregnancy and lactation

Based on existing data suggest that the drug does not adversely affect pregnancy and during lactation. Nevertheless, the drug is not recommended for use in the I trimester of pregnancy. Ambroxol is excreted in breast milk in quantities which influence the baby missing.

Application for violations of renal function

Sostorozhnostyu should appoint a drug in renal failure.

Cautions

The drug can affect the clinical picture of patients with stomach ulcer and duodenal ulcer.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia. Treatment: artificial vomiting, gastric lavage in the first 1-2 h after medication; meal containing fat.

Drug Interactions

Ambroxol Vramed can be combined with other drugs. Data on adverse drug interactions manifestations are absent.

The combined use of antitussive drugs leads to difficulty sputum discharge on the background to reduce coughing. Increase penetration in bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

Terms and Conditions of storage

The product should be stored in dry, dark place at temperatures not above 25 ° C.

Shelf life - 2 years.