Indications & Usage

AGEX-SL 375 (Ceftriaxone 250 mg & Sulbactam 125 mg) Injection is indicated for susceptible pathogens causing: Complicated intra-abdominal infections.

• Recurrent Urinary Tract Infections (UTIs) since sensitivity of E coli to ceftriaxone alone maybe 74%.
• Endocarditis due to ESBL elaborated by the pathogens.
• Confirmed staphylococcal, K pneumoniae or P mirabilis infections.
• Acinetobacter (banumannii) spp infections like nosocomial meningitis.
• Gram negative infections in ICU patients: 97% maybe cross-resistant to ceftriaxone because of marked loss of ceftriaxone's activity on account of production of class A and C ß-lactamases.
• Pediatric respiratory infections because H influenzae is a common pathogen, and nearly 15% are ß-lactamases producers.
• Critically ill patients with any ceftriaxone-susceptible infecting pathogens.
• Elderly patients with comorbid illness.
• Neonatal septicemia.
• Nosocomial infections since these bacteria are frequently ß-lactamases producers (especially ESBL).
• Necrotizing surgical site infection.
• Resistant plague infection.

Contraindications

AGEX-SL is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics. In patients hypersensitive to penicillin, consider the possibility of allergic cross-reactions. The use of sulbactam is contraindicated in individuals with a history of hypersensitivity reactions to any of the penicillins.

Special Precautions

Pregnancy and lactation

Other Drug Interactions

With aminoglycosides: Concomitant administration may increase risk of nephrotoxicity.
With heparin/warfarin: Concurrent use may cause marked hypoprothrombinemia and/or prolonged bleeding time.

Dosage & Administration

Parenteral (IM/IV): Adults: 1-2 gm ceftriaxone per day as AGEX – SL IM / IV once daily (or in equally divided doses twice a day) depending up on the type and severity of the infection. The total daily dose of ceftriaxone should not exceed 4 gm.

AGEX-SL therapy should generally be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 4 to 14 days; in complicated infections longer therapy may be required. While treating infections caused by Streptococcus pyogenes, the therapy should be continued for at least ten days.

Surgical Prophylaxis: 1 gm ceftriaxone single dose as AGEX – SL IV ½ to 2 hours before surgery.
Uncomplicated Gonococcal Infections: 250 mg ceftriaxone single dose as AGEX – SL IM.
Children: 50 to 75 mg ceftriaxone/kg body-weight per day (not exceeding 2 gm) as AGEX – SL IM / IV in 2 divided doses every 12 hours.

Meningitis: 100 mg ceftriaxone/kg body-weight per day (not exceeding 4 gm) as AGEX – SL IV initially; thereafter, 100 mg ceftriaxone/kg body-weight per day (maximum 4 gm/day) as AGEX- SL IV as single dose or in equally 2 divided doses every 12 hours for 7-14 days.

Acute Bacterial Otitis Media: 50 mg ceftriaxone/kg body-weight per day (not exceeding 1 gm) as AGEX – SL IM single dose.

Presentations

AGEX-SL 350
Twin pack: Vial & sterile water for injection as diluents.