Edit the instructions. Vancomycin in dosage forms for parenteral use

February 15, 2017
Active substances:
ICD-10:
I.A00-A09.A04.7    Enterocolitis caused by Clostridium difficile
I.A30-A49.A40    Streptococcal septicemia
I.A30-A49.A41    Other septicemia
VI.G00-G09.G00    Bacterial meningitis, not elsewhere classified
IX.I30-I52.I33    Acute and subacute endocarditis
X.J10-J18.J15    Bacterial pneumonia, not elsewhere classified
X.J85-J86.J85    Abscess of the lung and mediastinum
XIII.M86-M90.M86    Osteomyelitis
Vancomycin, sepsis, infectious diseases of severe course, endocarditis, lung abscess, meningitis, skin and soft tissue infections

The need to actualize instructions for the use of appropriate drugs has been identified.

For preparations containing as an active substance vancomycin in the section "Indication for use" it is necessary to additionally indicate: "For oral administration: pseudomembranous colitis caused by Clostridium difficile; enterocolitis caused by Staphylococcus aureus", and in the section "Method of administration and dosage" indicate dosing regimens for these conditions: "Vancomycin can be used orally for the treatment of pseudomembranous colitis caused by Clostridium difficile, due to the use of antibiotics, as well as for the treatment of staphylococcal enterocolitis. Intravenous administration of the drug has no advantages for the treatment of these diseases. The drug should be used in the following doses: adults 0.5-2 g 3-4 times / day, children 0.04 g / kg 3-4 times / day. The total daily dose should not exceed 2 g.The appropriate dose is prepared in 30 ml of water and given to the patient to drink or injected through the probe. To improve the taste of the solution, ordinary food syrups can be added to it. Duration of treatment is from 7 to 10 days. Vancomycin Ineffective in ingestion in case of other types of infections. ".

The dosage form for these drugs should be defined as "powder / lyophilizate for the preparation of a solution for infusion and oral administration".