Index of drugs

Treatment of serious infections (if known or likely to be caused by ceftriaxone-sensitive microorganisms and parenteral therapy is needed): bacterial meningitis, pneumonia, intra-abdominal infections (peritonitis, cholangitis); in combination with another antibiotic acting on anaerobic microorganisms), skin and soft tissue infections, bone and joint infections, late stages of Lyme disease (stage II and III), gonorrhea. Ceftriaxone can be used alone or in combination with another antibacterial agent to prevent post-operative infections in heart and vessel surgery or during urological procedures and rectal and colonic procedures. For rectal and colonic surgery, ceftriaxone should be given with another antibiotic acting on anaerobic organisms.

1 vial contains 1.0 g or 2.0 g ceftriaxone as the disodium salt.

Β-lactam antibiotic, 3rd generation cephalosporin. The bactericidal effect of ceftriaxone is due to the inhibition of bacterial cell wall synthesis. Species usually sensitive: aerobic Gram-positive bacteria -Streptococcus pyogenes, S. pneumoniae, S. agalactiae, Staphylococcus aureus MSSA; aerobic Gram-negative bacteria -Borrelia burgdorferi, Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, N. meningitidis, Proteus mirabilis. Species that have a problem of acquired resistance: Gram-positive aerobic bacteria -Staphylococcus aureus, S. epidermidis, S. haemolyticus, S. hominis; aerobic Gram-negative bacteria -Acinetobacter baumanii, Citrobacter freundii, Enterobacter aerogenes, E. cloacae, Klebsiella pneumoniae, K. oxytoca, Morganella morganii, P. vulgaris, Serratia marcescens; Anaerobic bacteria -Bacteroides fragilis. Organisms with congenital resistance:Enterococcus spp., Listeria monocytogenes, Staphylococcus aureus MRSAPseudomonas aeruginosa, Stenotrophomonas maltopia, Clostridium difficile, Chlamydia spp., Chlamydiophila spp., Legionella pneumophila, Mycoplasma spp., Treponema pallidum. The drug administered intravenously quickly penetrates into tissue fluids where (if used at the recommended doses) reaches a bactericidal concentration, persisting for at least 24 h. Ceftriaxone also penetrates the placental barrier and in small concentrations into breast milk. It is reversibly bound to plasma proteins, especially albumin; the degree of binding decreases with the increasing concentration of ceftriaxone. Cefrtiakson is transformed by the intestinal flora to inactive metabolites. It is excreted unchanged by the kidneys (60%) and liver (40%). In healthy adults T_0,5 in the serum is about 6 to 9 hours. In infants up to 8 days of age and those over 75 years, the average elimination half-life is usually 2-3 times longer than in young adults.

Known hypersensitivity to beta-lactam antibiotics (in patients with hypersensitivity to penicillin one should consider the possibility of cross-allergic reaction). Premature infants up to an adjusted age of 41 weeks (gestational weeks + weeks of life). Reported newborns (up to 28 days old) with jaundice or hypoalbuminemia or acidosis (because these are conditions in which the binding of biblirubin may be attenuated) or if it is necessary (or is expected to be necessary) intravenous Calcium therapy or administration infusions containing calcium (due to the risk of precipitation of the ceftriaxone compound with calcium). The ceftraikson should not be treated with newborns and premature infants with hyperbilirubinemia (ceftriaxone may displace bilirubin from serum albumin binding sites, which may lead to bilirubin encephalopathy in this group of patients). Before administering ceftriaxone together with Lidocaine in intramuscular injection, contraindications to the use of lidocaine should be considered.

If you suspect or report diarrhea associated with infectionClostridium difficaleyou may need to discontinue the antibiotic you are currently using.Bleeding was observed in ultrasound examination of the gallbladder - it was deposits of ceftriaxone calcium salt. They disappear when ceftriaxone is discontinued or discontinued and rarely cause symptoms; however, if clinical symptoms occur, conservative treatment is recommended (no surgical procedure). When ceftriaxone is administered, it should not be mixed or administered simultaneously intravenously with any solution containing Calcium, even if other infusion lines are used or given elsewhere. Carefully use in patients with risk factors for cholestasis and formation of deposits, e.g. previous surgery, severe disease or total parenteral nutrition. Ceftriaxone may displace bilirubin from its combination with serum albumin, which should be taken into account especially in newborns, infants and children. Do not use in neonates (especially premature babies) with the risk of developing bilirubin encephalopathy. If a solution of lidocaine is used as a solvent, ceftriaxone solutions should only be given by intramuscular injection.

Ceftriaxone crosses the placenta and in small concentrations into breast milk. Caution should be exercised when prescribing to a pregnant woman and breastfeeding mother.

Common: leukopenia, granulocytopenia, oesinophilia, hemolytic anemia, thrombocytopenia; diarrhea, nausea, vomiting, oral mucositis, inflammation of the tongue; rash, allergic dermatitis, pruritus, urticaria and edema. Rare: genital fungal infections, anaphylactic or anaphylactoid reactions, e.g. bronchospasm, fever, chills; headache, dizziness of central and peripheral origin; symptoms associated with the precipitation of ceftriaxone calcium salt in the gallbladder, reversible cholelithiasis, increased liver enzymes; hematuria, oliguria, increase in serum creatinine; phlebitis (after intravenous administration, reactions can be minimized by administering the drug in a slow injection, lasting 2 to 4 minutes); glycosuria. Very rare: coagulation disorders, pseudomembranous colitis, gastrointestinal bleeding; inflammation of the pancreas; extended clotting time. Not known: agranulocytosis (<500 / mm3); Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme; pain at the injection site. Severe and sometimes fatal adverse reactions in premature infants and full-term newborns (less than 28 days old) have been rarely reported, receiving ceftriaxone and calcium intravenously (ceftriaxone calcium in the lungs and kidneys was observed in deceased children). It is possible to develop superinfections with microorganisms insensitive to ceftriaxone (such as yeasts, fungi or other resistant microorganisms). A rare adverse reaction is pseudomembranous colitis, caused byClostridium dififcale; it may occur even after 2 months after administration of an antibacterial drug. Very rare cases of precipitation of ceftriaxone calcium in kidneys have been reported, mainly in children over 3 years, receiving either high doses (eg ≥ 80 mg / kg / day), or total doses exceeding 10 g and having additional risk factors ( e.g. limited supply of fluids, immobilization in bed). This phenomenon may occur with symptoms or asymptomatic, may lead to renal failure and anuria, but it is reversible after discontinuation of use. The precipitation of ceftriaxone in the gallbladder was observed, mainly in patients receiving doses higher than the recommended standard doses. Salt precipitation is usually asymptomatic, but it can rarely occur with symptoms such as pain, nausea, vomiting. It is usually reversible after discontinuation of the drug.

Intravenously or intramuscularly. Adults and children over 12 years (≥ 50 kg): usually 1-2 g once a day every 24 hours; in severe or moderate-diseased infections, the dose may be increased to 4g administered once a day. For the treatment of uncomplicated gonorrhea in adults and adolescents over 12 years of age and about at least 50 kg should be given intramuscularly in a single dose of 250 mg. In meningitis: the treatment starts at 100 mg / kg / day (but not more than 4g / day). After determining the sensitivity of the microorganism, the dose can be reduced accordingly. In newborns aged from 0 to 14 days, no dose greater than 50 mg / kg / day should be administered.In Lyme disease (stage II and III), in adults over the age of 12 years, the therapeutic dose is 50 mg / kg. up to a maximum of 2 g ceftriaxone for 14 days; in children, 50 to 100 mg / kg once a day to a maximum of 2 g a day for 14 days. Prevention of peri-operative infections: a single dose of 1 to 2 g (depending on the risk of infection) is recommended 30 to 90 min before surgery; in the case of rectal and colonic surgery, ceftriaxone should be administered together with an antibacterial agent acting on anaerobic microorganisms. Newborns (0-14 days old): 20 to 50 mg / kg intravenously once a day (every 24 hours); in severe infections a dose greater than 50 mg / kg / day can not be administered. Children from 15 days to 12 years of age, with a body weight of less than 50 kg: 20 to 80 mg / kg intravenously, once a day (every 24 hours); in severe infections do not administer a dose higher than 80 mg / kg / day. The exception is meningitis. Children with a body weight of 50 kg or more receive a regular dose for adults administered once a day. In patients with renal impairment and normal hepatic function, no dose adjustment is necessary, only in the case of extreme renal failure (creatinine clearance <10 ml / min) the daily dose of ceftriaxone should be limited to a maximum of 2 g. In patients with co-existing renal and hepatic insufficiency monitor plasma ceftriaxone concentrations on a regular basis and adjust the dose accordingly. In patients undergoing hemodialysis or peritoneal dialysis no additional dose is required after dialysis. However, plasma levels of ceftrimateone should be monitored to determine if a dose adjustment is necessary as the rate of excretion in these patients may be reduced.
Ceftriaxone can be given as a quick intravenous injection (after reconstitution with 10 ml of water for injections), by intravenous infusion (after reconstitution with 20 to 40 ml of one of the following intravenous solutions without calcium ions: 0.9% sodium chloride solution, 0.45 % solution of sodium chloride in 2.5% Glucose solution, 5% or 10% glucose solution, 6% dextran solution in 5% glucose solution, 6-10% hydroxyethyl starch solution, infusion should be administered for at least 30 min) or intramuscular injection (after dissolving in 3.5 ml of 1% lidocaine solution, doses greater than 1 g should be divided and injected in more than one place). Do not mix or administer with calcium containing solutions.