Ceftriaxone has bactericidal activity resulting from the inhibition of bacterial cell wall synthesis, ultimately leading to cell death. Ceftriaxone is stable to a broad range of bacterial β-lactamases. Ceftriaxone is stable to a wide range of both Gram-positive and Gram-negative beta-lactamases, including those, which are able to hydrolyse advanced generation penicillin derivatives and other cephalosporins.
Each vial contains:
Sterile Ceftriaxone Sodium USP eq. to Ceftriaxone 1 g.
Bacterial infections caused by susceptible organisms:
• Abdominal infections (peritonitis, inflammatory diseases of the gastrointestinal tract, biliary tract, including cholangitis, empyema of the gallbladder);
• Diseases of the upper and lower respiratory tract infections (including pneumonia, lung abscess, empyema);
• Bone and joint infections;
infections of skin and soft tissues;
• Urinary tract infections (including pyelonephritis);
• Bacterial meningitis;
• Lyme disease (borreliosis), typhoid fever;
• Infected wounds and burns,
• Peri-operative prophylaxis of infections associated with surgery;
• Infections in people with weakened immune systems.
Dosage and directions for use:
Belacef may be administered by deep intramuscular injection, or as a slow intravenous injection, after reconstitution of the solution.
For adults and children over 12 years: the dose is 1 – 2 g 1 time / day or 0.5 – 1 g every 12 hours, maximum daily dose – 4 g.
For infants (aged 2 weeks): the dose is 20 – 50 mg / kg / day.
For infants and children up to 12 years: the daily dose is 20 – 80 mg / kg.
For children weighing is 50 kg or more, the dose is like for adults.
The dose of 50 mg / kg of body weight should be administered as infusion IV for 30 min. The duration of treatment depends on the nature and severity of the disease. In bacterial meningitis in infants and young children, the dose is 100 mg / kg 1 time / day. The maximum daily dose – 4 g.
Duration of therapy depends on the type of pathogen and can range from 4 days in meningitis caused by Neisseria meningitidis, and 10 – 14 days in meningitis caused by susceptible strains of Enterobacteriaceae.
For the treatment of gonorrhea, the dose is 250 mg intramuscularly, once.
Peri-operative prophylaxis: Usually one dose of 1g given by intramuscular or slow intravenous injection. In colorectal surgery, 2g should be given intramuscularly (in divided doses at different injection sites), by slow intravenous injection or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.
Children with infections of skin and soft tissue preparation is administered in a daily dose 50 – 75 mg / kg of body weight one time / day or 25 – 37.5 mg / kg every 12 hours, but not more than 2 g / day. In severe infections at other sites – at a dose of 25 – 37.5 mg / kg every 12 hours, but not more than 2 g / day.
Otitis media the drug is administered IM – 50 mg / kg of body weight, but not more than 1 g
In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided liver function is intact.
Only in cases of pre-terminal renal failure (creatinine clearance <10ml per minute) should the daily dosage be limited to 2g or less.
Terms of preparing and administering solution for injections:
Injections should be prepared immediately before use.
To prepare the solution for injection IM, 0.5 g dissolved in 2 ml and 1g of product – 3.5 ml of 1% lidocaine. It is recommended that not more than 1 g in one buttock.
To prepare the solution for IV injection, 0.5 g dissolved in 5 ml, and 1g of the preparation – 10 ml of sterile water for injection.
Injection solution administered IV (slowly) for 2 – 4 minutes.
To prepare the solution for IV infusion of 2 g of the drug dissolved in 40 ml of one of the following solutions containing calcium:
0.9% sodium chloride, 5 – 10% dextrose (glucose), levulose 5% solution. Preparation of 50 mg / kg and more to be administered IV drip for 30 min.