Medaxone

Ceftriaxone Na

Adults & childn including term neonates (from birth) w/ bacterial meningitis; community- & hospital-acquired pneumonia; acute otitis media; intra-abdominal, complicated urinary tract (including pyelonephritis), bones & joints, complicated skin & soft tissue infections; gonorrhoea. Acute exacerbations of COPD in adults. Disseminated Lyme borreliosis (stages II & III) in adults & childn including neonates ≥15 days. Pre-op prophylaxis of surgical site infections. Infections in patients w/ impaired defense mechanisms.

IM/IV Adult, childn >12 yr & weighing ≥50 kg 1-2 g every 24 hr over 2-4 min IV or at least 30 min infusion. Lyme borreliosis 50 mg/kg once daily for 14 days. Max: 2 g. Gonorrhea (penicillinase- & nonpenicillinase-producing strains) 250 mg IM as single dose. Childn & infant Meningitis 100 mg/kg once daily. Max: 4 g. Duration of therapy: 4 days for Neisseria meningitidis; 6 days for Haemophilus influenza; 7 days for Strep pneumoniae. Childn, infant & neonate 15 days-12 yr 20-80 mg/kg once daily. Neonate ≤14 days 20-50 mg/kg once daily. Max daily dose: 50 mg/kg. Renal impairment (CrCl <10 mL/min) Max: 2 g daily. Pre-op prophylaxis 1-2 g single dose 30-90 min prior to surgery.

Hypersensitivity to ceftriaxone or any other cephalosporins. History of severe hypersensitivity (eg, anaphylactic reaction) to β-lactams (penicillins, monobactams & carbapenems). Premature (up to postmenstrual age of 41 wk) & full-term (≤28 days) neonates w/ hyperbilirubinemia, jaundice or who are hypoalbuminaemic or acidotic; requiring IV Ca treatment or Ca-containing infusions. Do not administer ceftriaxone soln containing lidocaine intravenously.

Possible serious & occasionally fatal hypersensitivity reactions; severe cutaneous AR (eg, SJS, Lyell's syndrome/TEN & DRESS). Immediately discontinue treatment in case of severe hypersensitivity reactions & initiate adequate emergency measures. Patients w/ history of non-severe hypersensitivity to other β-lactams. Not to be mixed or administered simultaneously w/ any Ca-containing IV soln. Patients w/ spirochete infections may experience Jarisch-Herxheimer reaction. Possible immune-mediated haemolytic anaemia; consider diagnosis of cephalosporin-associated anaemia & discontinue ceftriaxone until aetiology is determined. Perform CBC at regular intervals during prolonged treatment. Possible antibacterial agent-associated & pseudo-membranous colitis; consider this diagnosis in patients w/ diarrhoea during or subsequent to ceftriaxone administration; discontinue therapy & administer specific treatment for Clostridium difficile; do not give peristalsis-inhibiting medicinal products; superinfections w/ non-susceptible microorganisms may occur. Consider additional antibiotic administration in polymicrobial infections where suspected pathogens include organisms resistant to ceftriaxone. Possible appearance of Ca ceftriaxone precipitates on sonograms; conservative nonsurgical management is recommended & consider discontinuation of ceftriaxone based on specific benefit risk assessment. Patients w/ risk factors for biliary stasis & sludge (eg, preceding major therapy, severe illness & TPN). Patients w/ history of renal lithiasis or w/ hypercalciuria. May lead to false +ve results for Coombs test, galactosaemia & non-enzymatic methods for glucose determination in urine. May falsely lower estimated blood glucose values obtained w/ some blood glucose monitoring systems. Contains Na 3.6 mmol; consider patients on a controlled Na diet. Dizziness may occur; may influence ability to drive & use machines. Close clinical monitoring for safety & efficacy in patients w/ severe renal & hepatic insufficiency. Pregnancy (1st trimester) & lactation.

Eosinophilia, leukopenia, thrombocytopenia; diarrhoea, loose stools; increased hepatic enzyme; rash.

Not to be reconstituted w/ Ca-containing diluents (eg, Ringer's or Hartmann's soln) due to potential precipitation. May increase anti-vit K effect & bleeding risk w/ oral anticoagulants. Potential increase in renal toxicity of aminoglycosides. Possible antagonistic effects w/ chloramphenicol.

Cephalosporins

J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

POM