Tergamon SUL Injection

Tergamon sul

COMPOSITION:
Tergamon-SUL 750
Each vial contains:
Ceftriaxone Sodium USP eq. to Ceftriaxone 500 mg
Sulbactam Sodium USP eq. to Sulbactam 250 mg

Tergamon-SUL 1500
Each vial contains:
Ceftriaxone Sodium USP eq. to Ceftriaxone 1000 mg
Sulbactam Sodium USP eq. to Sulbactam 500 mg

INDICATIONS:
Tergamon-SUL is indicated for the treatment of sepsis, meningitis, abdominal infections (e.g. peritonitis, infections of the biliary tract e.g. cholecystitis), infections of the bones (osteomyelitis), joints, skin and soft tissue infections (e.g. cellulitis, erysipelas), wound infection, renal and urinary tract infections, respiratory tract infections (e.g. pneumonia, chronic supportive bacterial otitis media), sexually transmitted diseases (e.g. syphilis, chancroid and uncomplicated gonorrhoea), ear, nose and throat infections. It may also be used for peri-operative prophylaxis of infections. A single dose given preoperatively may reduce chances of postoperative infection.

DESCRIPTION:
Tergamon-SUL injection is a combination of a β-lactam antibiotic (Ceftriaxone) with an inhibitor of β-lactamase (Sulbactam) which exerts powerful antibacterial activity for the treatment of infections caused by antibiotic resistant microorganisms. Ceftriaxone inhibits the third and final stage of bacterial cell wall synthesis by preferentially binding to the specific Penicillin Binding Proteins (PBPs) located inside the bacterial cell wall, leading to cell lysis. Ceftriaxone is completely absorbed with peak plasma concentrations of 40 µg/mL and 80 µg/mL at 2 to 3 hours after IM injection of 500 mg and 1g dose of Ceftriaxone respectively. 33% to 67% of Ceftriaxone dose is excreted in urine as unchanged form and the remaining is secreted in the bile. The plasma half life of Ceftriaxone is 8 hours. Sulbactam is a derivative of basic Penicillin nucleus which prevents the destruction of β-lactam antibiotics by irreversibly binding to the beta-lactamase produced by the common Gram-positive or Gram-negative bacteria. Beta-lactamase inhibitors are most active against plasmid encoded β-lactamase. Sulbactam has a half-life of about 1 hour. Serum concentrations reached are proportional to the dose administered. It is predominantly eliminated through kidney in the unchanged form.

CONTRA-INDICATIONS:
Tergamon-SUL is contraindicated in patients with known allergy to Cephalosporin group of antibiotics. Hypersensitivity to Penicillin may pre-dispose the patient to the possibility of allergic cross-reactions.

SIDE EFFECTS:
The most common side effects are diarrhoea, stomatitis, elevations of SGOT/SGPT, headache and dizziness. If symptoms persist, please consult the physician.

PRECAUTIONS:
Super infections with non-susceptible microorganisms may occur with prolonged use of Tergamon-SUL. Ceftriaxone displace bilirubin from serum albumin hence, caution needs to be exercised when Tergamon-SUL is indicated for the treatment of neonates with hyper-bilirubinemia. Extreme caution needs to be exercised in penicillin-sensitive patients. Care should be taken in patients suffering from renal disease. Do not use if reconstituted solution contains visible particulate matter.
Check the expiry date on the pack and do not use after expiry.

DOSAGE:
Adults: 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. 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. 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.

STORAGE:
Store in a cool, dark & dry place. Keep out of reach of children.

PRESENTATION:
10 ml/20 ml vial packed in a mono carton with insert.