Properties
What is it?
CEFTRIAXONE ABC 1g-3.5ml Powder and Solvent for Solution for Injection for Intramuscular Use Equivalent preparation Antibiotic, beta-lactam antibacterial for systemic use. Composition: CEFTRIAXONE ABC 1g-3.5ml Powder and Solvent for Solution for Injection for Intramuscular Use Powder vial contains: Active substance: Dinatrium ceftriaxon 3.5H2O 1.193g equivalent to Ceftriaxone 1g; Solvent vial contains 1% lidocaine. Indication: For specific use in acute bacterial infections, confirmed or suspected to be caused by "difficult" gram-negative or mixed flora, with the presence of gram-negative bacteria resistant to most common antibiotics. In particular, the preparation is intended for weakened and/or immunosuppressed patients with the above-mentioned infections. For the prevention of surgical infections. Contraindication: CEFTRIAXONE ABC is contraindicated in patients with hypersensitivity to beta-lactam antibiotics. Increased sensitivity to cephalosporins or excipients. In case of increased sensitivity to penicillins, the possibility of cross-allergy should be considered. Use in pregnant women and young children is permitted only when necessary and under medical supervision. Treatment of newborns with hyperbilirubinemia and premature infants with ceftriaxone is not permitted. In vitro studies have shown that ceftriaxone can partially interact with the binding sites of bilirubin to plasma albumin. The development of bilirubin encephalopathy is possible in such patients. Treatment with calcium due to the risk of calcium-ceftriaxone precipitates in newborns. In addition, ceftriaxone is contraindicated in the following cases: Premature newborns at a corrected age of 41 weeks (gestation week + life week); full-term infants (up to 28 days); jaundice or hypoalbuminemia or acidosis, conditions where bilirubin levels may be altered; if intravenous calcium treatment or infusion of calcium-containing solutions is required, due to the risk of ceftriaxone precipitation with calcium (see Precautions for use, Side effects and Dosage and method of administration). When lidocaine is used as a solvent, contraindications to lidocaine must be ruled out before intramuscular injection of ceftriaxone. Precautions for use: As with other cephalosporins, anaphylactic shock cannot be ruled out, even after careful patient history taking. Each gram of CEFTRIAXONE ABC contains 3.6 mmol of sodium. This should be taken into account by patients on a low-sodium diet. The use of antibacterial agents, including CEFTRIAXONE ABC, may cause diarrhea associated with Clostridium difficile (CDAD), the severity of which can range from mild diarrhea to fatal colitis. Treatment with antibacterial agents disrupts the normal intestinal flora, leading to overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Strains of C. difficile that produce hypertoxin cause increased mortality and morbidity, as these infections may be refractory to antimicrobial therapy and colectomy may be necessary. CDAD should be considered in all patients who develop diarrhea after taking antibiotics. A careful history should be taken, as CDAD can manifest up to 2 months after treatment with antibacterial drugs. If CDAD is confirmed or suspected, it may be necessary to discontinue treatment with antibiotics. Depending on the clinical condition, adequate fluid and electrolyte intake, protein supplementation, treatment of C. difficile with antibiotics, and surgical evaluation should be performed.
