N-Trix S 1.5g Inj

Description

N-Trix S 1.5g Injection (Ceftriaxone 1g and Sulbactam 500mg) complete reference:
1. Pharmacokinetics
Absorption: Rapid after IV or IM administration. Peak plasma concentration is achieved within 1–2 hours.
Distribution: Broad tissue penetration, including CSF, bone, bile, lungs, pleural, and synovial fluid. 85–95% plasma protein binding.
Metabolism: Minimal hepatic metabolism.
Excretion: Mainly renal (33–67%) and biliary (~40%). Half-life: 6–9 hours.
Special Populations: Dose adjustment required in cases of renal or hepatic impairment. Not efficiently removed by hemodialysis.
2. Pharmacodynamics
Class: Third-generation cephalosporin.
Action: Bactericidal, inhibiting cell wall synthesis.
Spectrum: Effective against both Gram-positive and Gram-negative bacteria (e.g., Streptococcus, Staphylococcus, Neisseria, Haemophilus, E. coli).
3. Mechanism of Action
Targets: Penicillin-binding proteins (PBPs) on bacterial cell walls.
Effect: Prevents peptidoglycan cross-linking, leading to bacterial lysis and death.
4. Specifications
Form: Sterile lyophilized powder for injection.
Strength: 1.5g per vial (Ceftriaxone 1g and Sulbactam 500mg).
Appearance: White to off-white crystalline powder.
Reconstitution: With 1–4 mL of sterile water or 1% lidocaine (for IM use only). Avoid calcium-containing solutions.
5. Usage and Safety
Indications:
Severe infections: meningitis, sepsis, pneumonia, urinary tract infections, skin/soft tissue infections, gonorrhea, intra-abdominal infections.
Dosage:
Adults: 1.5g IV/IM once or twice daily, depending on the severity of the infection.
Pediatrics: 50–75 mg/kg once daily.
Administration:
IV push: 3–5 minutes.
Slow IV infusion: 30 minutes.
IM: Painful; may be mixed with lidocaine to reduce discomfort.
6. Precautions
Allergy: Contraindicated in patients allergic to cephalosporins or severe penicillin allergy.
Pregnancy & Lactation: Generally considered safe (Category B).
Renal/Hepatic Dysfunction: Dose adjustment is required in these conditions.
Drug Interactions: Avoid mixing with calcium-containing IV solutions as it may cause precipitation.
Laboratory Interference: May cause a false-positive Coombs test.
7. Warnings
Superinfection: Prolonged use may lead to fungal or resistant bacterial infections.
Clostridium difficile: May cause severe diarrhea or colitis.
Local Reactions: Pain, erythema, or swelling at the injection site.
Hematologic: Rare cases of hemolytic anemia or thrombocytopenia.
Neurological: Rarely, seizures may occur in patients with renal failure.
8. Side Effects
Common: Rash, diarrhea, nausea, vomiting, injection site pain.
Serious (rare): Anaphylaxis, hemolytic anemia, Stevens-Johnson syndrome, liver enzyme elevation, biliary sludge.
9. Storage and Stability
Storage: Store below 25°C, dry, and protected from light.
Shelf-life: 2–3 years.
Reconstituted Solution: Use immediately; can be stored at 2–8°C for up to 6 hours.
Do not freeze.
10. Overdose Management
Treatment: Supportive care; no specific antidote.
Dialysis: Hemodialysis removes small amounts of the drug.
Monitoring: Monitor renal function and electrolytes.
11. Additional Notes
Compatibility: Compatible with dextrose 5%, normal saline, or Ringer’s lactate.
Biliary Sludge: Prolonged high-dose therapy may cause reversible gallbladder pseudolithiasis, especially in children.
Monitoring: Regular liver and renal function tests are recommended for prolonged therapy.
Patient Advice: Report severe diarrhea, rash, jaundice, or unusual bruising immediately.