Powder for injection "Sanaxon-1000" is indicated for the treatment of the following infections in adults and children, including newborns:
bacterial meningitis; community-acquired pneumonia; hospital-acquired pneumonia; acute otitis media; intra-abdominal infections; complicated urinary tract infections (including pyelonephritis); bone and joint infections; complicated skin and soft tissue infections; gonorrhea; syphilis; bacterial endocarditis.
The drug can be used for:
treatment of acute complications of chronic obstructive pulmonary disease in adults; for the treatment of disseminated Lyme disease (early (stage II) and late (stage III)) in adults and children, including newborns from 15 days of age; preoperative prophylaxis of infections at the surgical site; for the management of neutropenic patients who have developed fever with suspected bacterial infection; for the treatment of patients with bacteremia that has occurred in connection with any of the above infections or if any of the above infections are suspected.
Composition
Active ingredient: ceftriaxone.
1 vial contains ceftriaxone sodium equivalent to ceftriaxone 1000 mg or 2000 mg.
Contraindication
Hypersensitivity to ceftriaxone or to any other cephalosporin. History of severe hypersensitivity reactions (e.g. anaphylactic reactions) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
Ceftriaxone is contraindicated:
Premature newborns ≤ 41 weeks of age, taking into account the term of intrauterine development (gestational age + age after birth).
For full-term newborns (age ≤ 28 days):
with hyperbilirubinemia, jaundice, hypoalbuminemia or acidosis, since in such conditions bilirubin binding is likely to be impaired; who require (or are expected to require) intravenous calcium preparations or infusions of calcium-containing solutions, since there is a risk of precipitation of the calcium salt of ceftriaxone.
Method of application
The dose of the drug depends on the severity, sensitivity, location and type of infection, as well as the patient's age and liver and kidney function.
Application features
Pregnant women
Ceftriaxone crosses the placental barrier. There are limited data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects on embryonal/fetal, peri- and postnatal development. Ceftriaxone should be used during pregnancy, particularly in the first trimester, only if the benefit outweighs the risk.
Children
Apply to children from the first days of life.
Drivers
During treatment with ceftriaxone, side effects such as dizziness may occur, which may affect the ability to drive or operate machinery. Patients should be careful when driving or operating machinery.
Overdose
Overdose may cause nausea, vomiting, diarrhea. In case of overdose, hemodialysis or peritoneal dialysis will not reduce excessive plasma drug concentrations. There is no specific antidote. Treatment of overdose is symptomatic.
Adverse reactions
The most common adverse reactions observed with ceftriaxone are eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, and elevated liver enzymes.
Interaction
False-positive Coombs test results are possible in patients taking ceftriaxone.
Ceftriaxone, like other antibiotics, may cause false-positive test results for galactosemia.
Similarly, non-enzymatic methods for determining urine glucose may give false positive results. For this reason, enzymatic methods should be used during ceftriaxone therapy.
No renal dysfunction has been observed after concomitant use of high doses of ceftriaxone and potent diuretics (e.g. furosemide).
Concomitant use of probenecid does not reduce the excretion of ceftriaxone.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging. Store the prepared solution for no more than 6 hours at a temperature not exceeding 25 °C and for no more than 24 hours in a refrigerator (2–8 °C). Keep out of the reach of children.
Shelf life - 2 years.
