Plot 122-132, Apapa-Oshodi Expressway, Afprint Ind. Est., Iyano-Osolo B/stop, Lagos Nigeria.
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Tel: 0805-6292409; 0803-6761764
Sai Mirra Innopharm Pvt. Ltd, 288, SIDCO Estate, Chennai - 600 098, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection (NRN: A4-1618): Ceftriaxone 250 mg, 1000 mg; in vials.
Odicef 125 mg: Vial containing dry substance equivalent to Ceftriaxone 125 mg
Odicef 0.25 g: Vial containing dry substance equivalent to Ceftriaxone 250 mg
Odicef 0.5 g: Vial containing dry substance equivalent to Ceftriaxone 500 mg
Odicef 1 g: Vial containing dry substance equivalent to Ceftriaxone 1000 mg
Mode of Action:
The bactericidal activity of ceftriaxone results from inhibition of bacterial cell wall synthesis.This antimicrobial agent inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Ceftriaxone is bactericidal as it acts by inhibition of cell wall synthesis. Ceftriaxone has a high degree of stability in the presence of beta-lactamases (both penicillinases and cephalosporinases) of Gram negative and Gram positive bacteria. Spectrum of activity of Ceftriaxone in vitro usually includes the following micro-organisms:
Gram positive bacteria:
Staphylococcus aureus (including penicillinase producing strains) Staphylococcus epidermidis
Streptococcus pyogenes (Group A beta-haemolytic streptococci)
Streptococci agalactiae (Group B streptococci)
(Note: Methicillin resistant Staphylococci (MRSA) are resistant to Cephalosporins, including Ceftriaxone. Most strains of Enterococci, Streptococcus faecalis and Group D Streptococci are also resistant to Ceftriaxone)
Gram negative bacteria:
Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Klebsiella species (including Klebsiella pneumoniae), Neisseria gonorrhoeae (including penicillinase and non-penicillinase producing strains), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Serratia marcescens (Many strains of the above organisms that are multi-resistant to other antibiotics e.g. Penicillins, Cephalosporins and Aminoglycosides, are susceptible to Ceftriaxone).
Many strains of Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter diversus, Providencia species (including Providencia rettgeri), Salmonella species (including S. typhi), Shigella species, Acinetobacter calcoceticus.
Ceftriaxone also shows activity in vitro against Bacteroides species and Clostridium species (most strains of C. difficile are resistant).
Odicef can be used for the following disease conditions:
- Lower respiratory tract infections
- Urinary tract infections
- Pelvic inflammatory disease
- Uncomplicated gonorrhoea
- Skin and soft tissue infections
- Bacterial septicaemia
- Bone and joint infections
- Surgical prophylaxis
Ceftriaxone is contraindicated in patients with known alergy to the Cephalosporin group of drugs.
Dosage adjustments should not be necessary in patients with hepatic dysfunction. However, in patients with both hepatic dysfunction and significant renal disease. Ceftriaxone dosage should not exceed 2 g daily without close monitoring of serum concentrations.
Patients with impaired Vitamin K synthesis or low Vitamin K stores (e.g. chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during Ceftriaxone therapy. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.
Prolonged use of Ceftriaxone may result in overgrowth of non-susceptible organisms.
Ceftriaxone is excreted in breast milk in low concentration hence caution should be exercised when it is administered to a nursing woman.
Ceftriaxone should be used cautiously in patients sensitive to pencillin.
Ceftriaxone therapy should be discontinued in patients who develop signs or symptoms suggestive of gall bladder disease and conservative management considered.
Many electrolyte solutions or injections have been reported to have major interactions with Ceftriaxone. Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form.
Precipitation of Ceftriaxone-calcium can also occur when Ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.
In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of Ceftriaxone-calcium.
The side effects reported include:
- Gastrointestinal disturbances (diarrhoea, nausea, vomiting)
- Local reactions (pain, induration or tenderness at the site of injection and rarely phlebitis after IV administration)
- Hypersensitivity (rash, rarely pruritus, fever or chills)
- Haematologic disturbances (eosinophilia, thrombocytosis and leucopenia, rarely anaemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of prothrombin time)
- Hepatic disturbances (elevations of SGOT, SGPT and rarely elevations of alkaline phosphatase and bilirubin),
- Renal (elevations of BUN and uncommonly elevations of creatinine)
- Headache, dizziness,vaginitis in females and flushing have also been reported
- Other rarely observed reactions may include leucocytosis, lymphocytosis, monocytosis, basophillia, jaundice, glycosuria, haematuria, anaphylaxis, bronchospasm serum sickness, abdominal pain, colitis, flatulence, palpitations and epistaxis.
Dosage & Administration
Usual daily dose of Odicef is 1 to 2 gm (IM/IV) administered once a day (or in equally divided doses twice a day) depending on the type and severity of the infection. The total daily dose should not exceed 4 gm.
Odicef 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.
Uncomplicated gonococcal infection: Odicef 0.25 g IM as a single dose.
Surgical prophylaxis: Odicef 1 gm ½ to 2 hours before surgery.
While treating infections caused by Streptococcus pyogenes, the therapy should be continued for at least ten days.
No dosage adjustment is necessary for patients with impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal impairment (e.g. dialysis patients) and in patients with both renal and hepatic dysfunctions.
For the treatment of serious infections in children, other than meningitis, the recommended total daily dose is 50 to 75 mg/kg. (not exceeding 2 gm) given in divided doses every 12 hours.
Meningitis: A daily dose of 100 mg/kg (not exceeding 4 gm) given in divided doses every 12 hours, should be administered with or without a loading dose of 75 mg/kg.
The injection is available in four strengths i.e. 125 mg, 0.25 g, 0.5 g and 1.0 g. Each strength can be injected either intramuscularly or intravenously. For intramuscular injection, the diluting fluid is Lignocaine Hydrochloride 1% (w/v) solution IP and for intravenous injection, the diluting fluid is Sterile WFI (water for injection). The use of freshly prepared solution is recommended. The dilution pattern to be followed is given below.
For intramuscular injection: Odicef 125 mg is dissolved in 1 mL, Odicef 0.25 g or 0.5 g is dissolved in 2 mL and Odicef 1 g in 3.5 mL of 1% (w/v) Lignocaine Hydrochloride solution IP and administered by deep intragluteal injection. It is recommended that not more than 1 g be injected on either side. The Lignocaine solution must never be administered intravenously.
For Intravenous injection: Odicef 125 mg is dissolved in 2 mL, Odicef 0.25 g or 0.5 g is dissolved in 5 mL and Odicef 1 g is dissolved in 10 mL of Sterile water for injection IP and then administered by direct intravenous injection lasting 2-4 minutes.
Store in a cool dry place protected from moisture.
Keep all medicines out of the reach of children.