30.09.2018
Following the results of the first meeting in 2018, the Ministry of Health's Commission on the Formation of Lists of Essential Medicines decided to include two antibiotics—international nonproprietary names (INN) ampicillin + sulbactam and fosfomycin—into the List of Essential Medicines (LLE).
Ampicillin/sulbactam is one of the most important inhibitor-protected penicillins. Its clinical application is vast due to its broad spectrum of activity, the possibility of monotherapy use, and its effectiveness against a wide range of pathogens resistant to both penicillins and antibiotics from other classes.
Ampicillin/sulbactam, as a drug of choice, is included in the treatment regimens for most moderate to severe mixed infections, including in gynecology and surgery. Its high activity against pneumococci also allows its use for treating community-acquired pneumonia, pleural empyema, and lung abscesses. The antibiotic is optimally used for perioperative antibiotic prophylaxis.
With low toxicity and an optimal safety profile, ampicillin/sulbactam is included in the treatment regimens for infections in children, starting from the neonatal period, and in pregnant women.
Fosfomycin is an antimicrobial agent that combines the unique properties of an antibiotic, immunomodulator, and proven ability to mitigate the toxic effects of nephrotoxic antimicrobial and anticancer agents. Over a long period of clinical use, a substantial body of clinical data has been accumulated, allowing an assessment of the effectiveness of this antibiotic for infections of various localizations and etiologies. Today, there is evidence of the clinical effectiveness of the sodium salt of fosfomycin for treating respiratory tract infections, urinary tract infections, including nosocomial and chronic, bacterial meningitis, and complications after neurosurgical procedures, bone and joint infections, bacterial endocarditis, bacteremias of various etiologies, catheter-associated infections, and infections in obstetrics and gynecology.
Special interest and practical significance are attached to the promising results of using fosfomycin to treat infections caused by multi-resistant Gram-positive cocci (staphylococci and enterococci) and Gram-negative aerobic bacteria (especially enterobacteria with multiple resistance to other antibiotics). Additionally, resistance to fosfomycin develops very slowly. The rational use of fosfomycin in combination with antimicrobial agents from other classes allows for achieving clinical and bacteriological effectiveness in cases where prior therapy has been unsuccessful.
Undoubtedly, the inclusion of these antibiotics in the List of Essential Medicines is an important and timely measure aimed at combating the spread of microbial resistance in hospitals and optimizing the treatment of infections caused by the most problematic bacterial pathogens.
PJSC "Krasfarma" is a Russian manufacturer of hospital antibiotics. In addition to "traditional" cephalosporins of the I-IV generations, aminoglycosides, and parenteral fluoroquinolones, its product portfolio includes leading drugs such as Ampicillin + sulbactam powder for the preparation of intravenous and intramuscular injection solutions in dosages of 0.5 g + 0.25 g, 1.0 g + 0.5 g, and 2.0 g + 1.0 g, and Fosfomycin powder for preparing intravenous solutions in dosages of 0.5 g (for pediatric practice), 1 g, 2 g, and 4 g. These drugs, with their proven effectiveness and safety, are widely used in clinical practice for the treatment and prevention of infections of various localizations.