Efmerin (ceftriaxone) powder for solution for injections 2 g. №1 vial

Description

Efmerin 2 g Composition
active substance: ceftriaxone;

1 vial contains ceftriaxone sodium equivalent to 1 g of ceftriaxone.

Efmerin 2 g Dosage form
Powder for injection.

Basic physical and chemical properties: white to yellowish crystalline powder.

Efmerin 2 g Pharmacotherapeutic group
Antibacterial agents for systemic use. The rest are beta-lactam antibiotics. Third generation cephalosporins. Ceftriaxone.

ATX code J01D D04.

Pharmacodynamics
Mechanism of action

Ceftriaxone inhibits bacterial cell wall synthesis after attachment to penicillin-binding proteins. As a result, the biosynthesis of the cell wall (peptidoglycan) stops, which in turn leads to the lysis of the bacterial cell and its death.

Resistance

Bacterial resistance to ceftriaxone can develop as a result of one or more mechanisms:

Hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases, carbapenemases, and Amp C enzymes, which can be induced or sustained in some aerobic gram-negative bacteria.
decreased affinity of penicillin-binding proteins for ceftriaxone.
impermeability of the outer membrane in gram-negative bacteria.
bacterial efflux pump.

Indications
Treatment of the following infections in adults and children, including full-term newborns (from birth):

bacterial meningitis;
community-acquired pneumonia;
hospital pneumonia;
acute otitis media;
intra-abdominal infections;
complicated urinary tract infections (including pyelonephritis);
infections of bones and joints;
complicated infections of the skin and soft tissues;
gonorrhea;
syphilis;
bacterial endocarditis.
Efmerin can be used for:

treatment of acute complications of chronic obstructive pulmonary disease in adults;
treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children, including newborns aged 15 days;
preoperative prevention of infections at the surgical site;
management of neutropenic patients who develop fever with suspected bacterial infection;
treatment of patients with bacteremia due to any of the above infections or if there is a suspicion of any of the above infections.
Efmerin should be prescribed together with other antibacterial drugs, if the possible range of bacterial pathogens does not fall within the spectrum of action (see section “Peculiarities of use”).

Consideration should be given to official recommendations for the appropriate use of antibacterial agents.

Contraindications
Hypersensitivity to ceftriaxone or any other cephalosporin. A history of severe hypersensitivity reactions (eg, anaphylactic reactions) to any other type of beta-lactam antibacterial agents (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated:

Premature infants ≤ 41 weeks of gestational age (gestational age + age after birth) *

Term infants (≤ 28 days of age):

with hyperbilirubinemia, jaundice, hypoalbuminemia or acidosis, since in such conditions the binding of bilirubin is probably impaired *;
requiring (or expected need) intravenous administration of calcium preparations or infusion of calcium-containing solutions, since there is a risk of precipitates of the calcium salt of ceftriaxone (see sections “Peculiarities of use” and “Adverse reactions”).
* – In vitro studies have shown that ceftriaxone can displace bilirubin due to serum albumin, which leads to the risk of developing bilirubin encephalopathy in these patients.

Before intramuscular administration of ceftriaxone, it is imperative to exclude the presence of contraindications to the use of lidocaine, if it is used as a solvent (see section “Peculiarities of use”). See the section on the instructions for medical use of lidocaine, especially the section “Contraindications”.

Ceftriaxone solutions containing lidocaine should not be administered intravenously.