POWDER FOR PREPARATION OF INJECTION SOLUTION
(Ceftriaxone & Sulbactam For Injection)
Each Vial contains:
Ceftriaxone Sodium USP
Equivalent to Ceftriaxone 1000 mg
Sulbactam Sodium USP
Equivalent to Sulbactam 500 mg
Infections caused by pathogens sensitive to Ceftriaxone Injection, e.g.:
– abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts);
– infections of the bones, joints, soft tissue, skin and of wounds;
– infections in patients with impaired defence mechanisms;
– renal and urinary tract infections;
– respiratory tract infections, particularly pneumonia, and ear, nose and throat infections;
– genital infections, including gonorrhoea.
Perioperative prophylaxis of infections.
Dosage and Administration
The recommended adult dosage is 1.5 g (1 g Ceftriaxone as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g Ceftriaxone as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of Ceftriaxone content plus the sulbactam content and corresponds to a range of 1 g Ceftriaxone /0.5 g sulbactam to 2 g Ceftriaxone /1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
Neonates, infants and children up to 12 years:
The following dosage schedules are recommended for once daily administration. Neonates (up to 14 days): 20 to 50 mg/kg bodyweight once daily. The daily dose should not exceed 50 mg/kg. It is not necessary to differentiate between premature and term infants. Infants and children (15 days to 12 years): 20 to 80 mg/kg once daily. For children with bodyweights of 50 kg or more, the usual adult dosage should be used. Intravenous doses of NLT 50 mg/kg bodyweight should be given by infusion over at least 30 minutes.
Ceftriaxone Injection 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.
Vial of 1.5 gm