Fotax 1g Inj.
Cefotaxime sodium 1g
Injection, powder for reconstitution
Antibiotic, Cephalosporin (Third Generation).
Treatment of susceptible infection in respiratory tract, skin and skin structure, bone and joint, urinary tract, gynecologic as well as septicemia, and documented or suspected meningitis. Active against most gram-negative bacilli (not Pseudomonas) and gram-positive cocci (not enterococcus). Active against many penicillin-resistant pneumococci
Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.
The suitable dosage for each patient should be prescribed by a doctor.
Method of Administration:
Administer by IV injection or infusion or by deep IM injection into large muscle mass.
Large IM doses may be painful; IV administration may be preferred when large doses are indicated.
Inject direct I.V. over 3-5 minutes. Infuse intermittent infusion over 30 minutes.
During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter.
IV route preferred in patients with septicemia, bacteremia, peritonitis, meningitis, or other severe or life-threatening infections or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly if shock is present.
Cefotaxime, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of cefotaxime responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of cefotaxime may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.
Administration: I.V. Detail
pH: 5.0-7.5 (injectable solution)
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of MAXIPIME. The effect of lower doses is not presently known.
One gram of cefotaxime (sodium) contains 2.2 mEq of sodium.
Usual dosage range:
Children >12 years and Adults: I.M., I.V.: 1-2 g every 4-12 hours
Children >12 years and Adults:
Arthritis (septic): I.V.: 1 g every 8 hours
Brain abscess, meningitis: I.V.: 2 g every 4-6 hours
Caesarean section: I.M., I.V.: 1 g as soon as the umbilical cord is clamped, then 1 g at 6- and 12-hour intervals
Epiglottitis: I.V.: 2 g every 4-8 hours
Gonorrhea: I.M.: 1 g as a single dose
Disseminated: I.V.: 1 g every 8 hours
Life-threatening infections: I.V.: 2 g every 4 hours
Liver abscess: I.V.: 1-2 g every 6 hours
Lyme disease: Cardiac manifestations: I.V.: 2 g every 4 hours
CNS manifestations: I.V.: 2 g every 8 hours for 14-28 days
Moderate-to-severe infections: I.M., I.V.: 1-2 g every 8 hours
Orbital cellulitis: I.V.: 2 g every 4 hours
Peritonitis (spontaneous): I.V.: 2 g every 8 hours, unless life-threatening then 2 g every 4 hours
Septicemia: I.V.: 2 g every 6-8 hours
Skin and soft tissue: Mixed, necrotizing: I.V.: 2 g every 6 hours, with metronidazole or clindamycin
Bite wounds (animal): I.V.: 2 g every 6 hours
Surgical prophylaxis: I.M., I.V.: 1 g 30-90 minutes before surgery
Uncomplicated infections: I.M., I.V.: 1 g every 12 hours
Concerns related to adverse effects:
• Arrhythmia: A potentially life-threatening arrhythmia has been reported in patients who received a rapid bolus injection via central line.
• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop during prolonged treatment (>10 days).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when needed.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Teratogenic effects were not observed in animal studies; therefore, cefotaxime is classified as pregnancy category B. Cefotaxime crosses the placenta and can be found in fetal tissue. An increased risk of teratogenic effects has not been observed following maternal use. During pregnancy, peak cefotaxime serum concentrations are decreased and the serum half-life is shorter.
Dermatologic: Rash, pruritus
Gastrointestinal: Diarrhea, nausea, vomiting, colitis
Local: Pain at injection site
Serious ADR (<1%)
Anaphylaxis, arrhythmia (after rapid I.V. injection via central catheter), BUN increased, creatinine increased, eosinophilia, erythema multiforme, fever, headache, interstitial nephritis, neutropenia, phlebitis, pseudomembranous colitis, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis
Reactions reported with other cephalosporins: Agranulocytosis, aplastic anemia, cholestasis, hemolytic anemia, hemorrhage, pancytopenia, renal dysfunction, seizure, superinfection, toxic nephropathy