Ceftriaxone bottle, 1 g (Ceftriaxone)

Release form

Powder for preparation of solution for infusion of white or white with a yellowish tint.

Packaging

Bottle 1 g

Pharmacological action

Ceftriaxone is a third-generation cephalosporin antibiotic for parenteral use, has a bactericidal effect, inhibits the synthesis of the cell membrane, in vitro inhibits the growth of most Gram-positive and Gram-negative microorganisms. Ceftriaxone is resistant to beta-lactamase enzymes (both penicillinase and cephalosporinase produced by most Gram-positive and Gram-negative bacteria). In vitro and in clinical practice, ceftriaxone is usually effective against the following microorganisms:

Gram-positive:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus A (Str.pyogenes), Streptococcus V (Str. bovis.

Note: Staphylococcus spp., resistant to methicillin, is resistant to cephalosporins, including ceftriaxone. Most enterococcal strains (e.g. Streptococcus faecalis) are also resistant to ceftriaxone.

Gram-negative:

Aeromonas spp., Alcaligenes spp., Branhamella catarrhalis, Citrobacter spp., Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp. (including Kl. pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa (some strains are resistant), Salmon. (including S. typhi), Serratia spp. (including S. marcescens), Shigella spp., Vibrio spp. (including V. cholerae), Yersinia spp. (including Y. enterocolitica)

Note: Many strains of these microorganisms, which in the presence of other antibiotics, such as penicillins, cephalosporins of the first generations and aminoglycosides, stably reproduce, sensitive to ceftriaxone. Treponema pallidum is sensitive to ceftriaxone both in vitro and in animal experiments. According to clinical data, with primary and secondary syphilis, a good efficacy of ceftriaxone is noted.

Anaerobic pathogens:

Bacteroides spp. (including some strains of B. fragilis), Clostridium spp. (including CI. difficile), Fusobacterium spp. (except F. mostiferum. F. varium), Peptococcus spp., Peptostreptococcus spp.

Note: Some strains of many Bacteroides spp. (e.g. B. fragilis) that produce beta-lactamase are resistant to ceftriaxone. To determine the sensitivity of microorganisms, it is necessary to use disks containing ceftriaxone, as shown that in vitro certain strains of pathogens may be resistant to classical cephalosporins.

Pharmacokinetics:

With parenteral administration, ceftriaxone penetrates well into tissues and body fluids. In healthy adult subjects, ceftriaxone is characterized by a long, about 8 hours, half-life. The area under the concentration-time curve in the blood serum coincides with intravenous and intramuscular administration. This means that the bioavailability of ceftriaxone for intramuscular administration is 100%. With intravenous administration, ceftriaxone rapidly diffuses into the interstitial fluid, where it retains its bactericidal action against pathogens sensitive to it for 24 hours.

The elimination half-life in healthy adult subjects is about 8 hours. In newborns up to 8 days old and in older people over 75 years, the average half-life is approximately twice as long. In adults, 50-60% of ceftriaxone is excreted in unchanged form with urine, and 40-50% - also in unchanged form with bile. Under the influence of the intestinal flora, ceftriaxone turns into an inactive metabolite. In newborns, approximately 70% of the administered dose is excreted by the kidneys. With kidney failure or liver pathology in adults, the pharmacokinetics of ceftriaxone is almost unchanged, the elimination half-life is slightly increased. If renal function is impaired, excretion with bile increases, and if liver pathology occurs, then excretion of ceftriaxone by the kidneys increases.

Ceftriaxone reversibly binds to albumin and this binding is inversely proportional to concentration: for example, when the concentration of the drug in the blood serum is less than 100 mg / l, the binding of ceftriaxone to proteins is 95%, and at a concentration of 300 mg / l, only 85%. Due to the lower albumin content in the interstitial fluid, the concentration of ceftriaxone in it is higher than in blood serum.

Penetration into the cerebrospinal fluid: In infants and children with inflammation of the cerebral membrane, ceftriaxone penetrates into the cerebrospinal fluid, while in case of bacterial meningitis, on average 17% of the concentration of the drug in the blood serum diffuses into the cerebrospinal fluid, which is about 4 times more than with aseptic meningitis. 24 hours after the intravenous administration of ceftriaxone at a dose of 50-100 mg / kg body weight, the concentration in the cerebrospinal fluid exceeds 1.4 mg / l. In adult patients with meningitis, 2–25 hours after the administration of ceftriaxone at a dose of 50 mg / kg body weight, the concentration of ceftriaxone was many times higher than the minimum inhibitory dose necessary to suppress the pathogens that most often cause meningitis.

Indications

Infections caused by ceftriaxone-sensitive pathogens: sepsis, meningitis, infections of the abdominal cavity (peritonitis, inflammatory diseases of the gastrointestinal tract, bile ducts), infections of bones, joints, connective tissue, skin, infections in patients with impaired immune system, kidney and urinary tract infections, respiratory tract infections, especially pneumonia, and ear, throat and nose, genital infections, including gonorrhea. Prevention of infections in the postoperative period.

Contraindications

Hypersensitivity to ceftriaxone and other cephalosporins.

Use during pregnancy and lactation

Adequate and strictly controlled studies of the safety of ceftriaxone during pregnancy have not been conducted.

The use of ceftriaxone during pregnancy and lactation is possible in cases where the intended benefits of therapy for the mother outweigh the potential risk to the fetus.

Ceftriaxone is excreted in breast milk with low concentrations.

In experimental animal studies, no teratogenic and embryotoxic effects of ceftriaxone were found.

Special instructions

Allergic reactions to cephalosporin antibiotics are possible in patients with hypersensitivity to penicillins.

Use with caution in cases of severe renal impairment.

Ceftriaxone solutions should not be mixed or administered simultaneously with other antimicrobials or solutions.

In infants with hyperbilirubinemia, especially in premature infants, use under strict medical supervision is possible.

Composition

One vial contains 1.0 g Ceftriaxone sodium salt.

Dosage and administration

Individual. Intravenously or intravenously, 1–2 g every 24 hours or 0.5–1 g every 12 hours are administered. Depending on the etiology of the disease, it may be administered once daily in a dose of 250 mg. The daily dose for newborns is 20-50 mg / kg for children aged 2 months to 12 years - 20-100 mg / kg, the frequency of administration is 1 time / day. The duration of the course is determined individually. In patients with impaired renal function, a correction of the dosage regimen is required taking into account QC values.

Maximum daily doses: for adults - 4 g, for children - 2 g.

Side effects

Systemic side effects: from the gastrointestinal tract (about 2% of patients): diarrhea, nausea, vomiting, stomatitis and glossitis.

Changes in the blood picture (about 2% of patients) in the form of eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.

Skin reactions (about 1% of patients) in the form of exanthema, allergic dermatitis, urticaria, edema, erythema multiforme.

Other rare side effects: headaches, dizziness, increased activity of liver enzymes, congestion in the gallbladder, oliguria, increased creatinine in the blood serum, mycoses in the genital area, chills, anaphylaxis, or anaphylactic reactions. Pseudomembranous enterocolitis and blood clotting disorders are extremely rare.

Local side effects:

Phlebitis has been reported in some cases after intravenous administration. This phenomenon can be prevented by slow (within 2-4 minutes) administration of the drug. The described side effects usually disappear after discontinuation of therapy.

Drug Interactions

Ceftriaxone, suppressing the intestinal flora, it prevents the synthesis of vitamin K. Therefore, with simultaneous use with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, with simultaneous use with anticoagulants, an increase in anticoagulant action is noted.

When used simultaneously with loop diuretics, the risk of developing nephrotoxicity increases.

Expiration

See packaging.

Deystvuyuschee substances

Ceftriaxone

Form of Treatment

simply entails dlya inaektsiy and infusing

Pregnant Purpose, Doctor , Adult doctor

Indications

From respiratory tract infections, From osteomyelitis, From intestinal infections, Vaginal infections, Bronchitis, From infectious diseases, From otitis media, From cholecystitis, From bile duct infections, From sinusitis, From pneumonia, From skin infections, From urinary tract infections

Possible product names

Ceftriaxone bottle, 1 g

Krasfarma, Russia



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