Each vial contains: Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 g.
Ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous administration. Ceftriaxone (ceftriaxone sodium and dextrose injection) sodium is (6R,7R)-7-[2-(2- Amino-4- thiazolyl)glyoxylamido]-8-oxo-3- [[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia- 1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacid,72-(Z)-(0-methyloxime), disodium salt, sesquaterhydrate.
Its molecular weight is 661.60.
Ceftriaxone is white to yellowish-orange crystalline powder. Freely soluble in water; very slightly soluble in alcohol; sparingly soluble in methyl alcohol. pH of a 10% solution in water is between 6.0 and 8.0.
Pharmacology: Pharmacokinetics: Ceftriaxone demonstrates nonlinear dose-dependent pharmacokinetics because of its protein binding: about 85 to 95% is bound to plasma protein depending on the plasma concentration of Ceftriaxone. Mean peak plasma concentrations of about 40 and 80 μg per mL have been reported 2 hours after intramuscular injection of 0.5 and 1 gram of Ceftriaxone respectively. The plasma half-life of Ceftriaxone is not dependent on the dose and varies between 6 and 9 hours; it may be prolonged in neonates. It is widely distributed in body tissues and fluids. It crosses both inflamed and non-inflamed meninges, generally achieving therapeutic concentrations in the CSF. It crosses the placenta and low concentrations have been detected in breast milk. About 40 to 65% of a dose of Ceftriaxone is excreted unchanged in the urine, principally by glomerular filtration.
It is a third generation cephalosporin antibiotic used for the treatment of susceptible infections.
They include chancroid, endocarditis, gastro-enteritis, gonorrhea, Lyme disease, meningitis, septicaemia, syphilis, typhoid fever, and Whipple's disease. It is also used for surgical infection prophylaxis.
Adults: A dose of 1 to 2 gram daily as a single dose or in two divided doses.
In severe infections: up to 4 gram daily may be given.
Doses for infants and children (under 50 kg): 20 to 50 mg per kg body-weight once daily; for severe infections, up to 80 mg per kg daily may be given.
Neonates: the maximum dose should not exceed 50 mg per kg daily; intravenous doses in neonates should be given over 60 minutes.
Treatment for uncomplicated gonorrhea in adults: A single intramuscularly dose of 250 mg.
Surgical infection prophylaxis in adults: A single dose of 1 gram may administered 0.5 to 2 hours before surgery; a 2- gram dose is suggested before colorectal surgery.
Secondary cases of meningococcal meningitis: A single intramuscular dose of 250 mg may be used for adults and 125 mg for children. Or as prescribed by the physician.
Direction for Use: Dissolve the contents of the vial in 9.6 mL sterile water for injection for I.V. administration or in 3.6 mL sterile water for injection for I.M. administration. Use immediately after preparation. Discard any unused portion of the solution.
It is highly protein-bound and is able to displace bilirubin from albumin binding sites, causing hyperbilirubinemia; its use should be avoided in jaundiced neonates.
The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis.
There may be positive response to the Coombs' test although haemolytic anaemia rarely occurs.
Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis have been associated rarely with some cephalosporins.
Gastrointestinal adverse effects such as nausea, vomiting, and diarrhea have been reported rarely.
Prolonged use may result in overgrowth of non-susceptible organism and, as with other broad-spectrum antibiotics, pseudomembranous colitis may develop.
Ceftriaxone has an N-methylthiotriazine side-chain and may have the potential to increase the effects of anticoagulants and to cause a disulfiram-like reaction with alcohol. Probenecid does not affect the renal excretion of Ceftriaxone.
Store at temperatures not exceeding 30°C. Protect from light.
J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Tricexone powd for inj 1 g
10 mL x 1's
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