Kalfoxim

Kalfoxim

cefotaxime

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Cefotaxime sodium.
Description
Kalfoxim also contains sodium 48 mg/g.
Action
Microbiology: Kalfoxim is a 3rd generation cephalosporin with activity against gram-negative organisms eg, E. coli, H. influenzae (especially ampicillin-resistant strains), Klebsiella, Proteus (both indole-positive and indole-negative), Enterobacter, Neisseria (especially β-lactamase-producing strains of N. gonorrhoeae), Shigella, Providencia, Serratia, Citrobacter, Pseudomonas (some strains are less sensitive) and Bacteroides (some strains of B. fragilis are resistant). It has similar activity to older cephalosporin generations against gram-positive bacteria eg, Staphylococci (especially penicillinase-producing strains), Streptococci (S. pyogenes, S. viridans, S. pneumoniae), Clostridium. Many strains of Enterococci (S. faecalis) are relatively resistant.
Combinations with aminoglycosides eg, gentamicin produce synergistic effects against some species of gram-negative bacteria including some strains of Pseudomonas.
Pharmacokinetics: Kalfoxim is widely distributed in various tissues, including the cerebrospinal fluid in which levels above the MIC of common sensitive pathogens are attained when the meninges are inflamed. It is excreted mainly through the kidneys in the active form.
Indications/Uses
Treatment of the following serious and life-threatening infections caused by the aforementioned organisms: Lower respiratory tract infections, including pneumonia.
Genitourinary infections eg, urinary tract infections and gonorrhea (particularly if penicillin-resistant).
Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis.
Bacteremia and/or septicemia.
Skin and skin structure infections.
Intra-abdominal infections, including peritonitis.
Bone and/or joint infections.
Central nervous system infections eg, meningitis and ventriculitis.
Also for prophylaxis of certain postoperative infections in contaminated or potentially contaminated surgical procedures or in clean operations where infections would have serious effects.
Dosage/Direction for Use
Kalfoxim may be administered IM or IV. Dosage, route and frequency of administration should be determined by susceptibility of the causative organisms, severity of the infection and condition of the patient. Therapy may be started before the results of sensitivity tests are known.
Adults and Children >12 years: Usual Daily Dose: 2-6 g, with a maximum of 12 g. Mild to moderate or uncomplicated infections eg, urinary tract infection: 1 g every 12 hrs. Moderate to serious infections: 1 g every 8 hrs. Life-threatening infections: 2 g every 8 hrs.
Infections Caused by Pseudomonas aeruginosa: Usually >6 g daily, in severe and life-threatening infections up to 12 g daily (in divided doses) and the concurrent use of an aminoglycoside antibiotic may be indicated (must be administered separately in different syringes).
Gonorrhea: 1 g as a single dose (IM or IV).
Infants and Children (1 month to 12 years): Recommended Daily Dose: 50-180 mg/kg IM or IV in 4-6 equally divided dose. The higher dosage is used for more severe or serious infections, including meningitis.
Neonates and Premature Babies (birth to 1 month): Recommended Dose: 1-4 weeks: 50 mg/kg IV every 8 hrs; 0-1 week: 50 mg/kg IV every 12 hrs.
Impaired Renal Function: In severe renal failure (creatinine clearance ≤5 mL/min): Halve the maintenance dose without changing the initial dose and the frequency of dosing.
Contaminated or Potentially Contaminated Surgery: 1 g IM or IV 30-90 min prior to start of surgery.
Cesarean Section: 1st Dose: 1 g IV as soon as the umbilical cord is clamped; 2nd Dose: 1 g IV or IM 6 hrs later; 3rd Dose: 1 g IV or IM 12 hrs after the 1st dose. Duration of Treatment: In general, continue therapy for at least 48-72 hrs after the body temperature becomes normal or after evidence of bacterial eradication.
In infections caused by Group A β-hemolytic streptococci, a minimum therapy of 10 days is effective.
Persistent infections may require several weeks.
Administration: Dissolve the contents of Kalfoxim 0.5- and 1-g vials in 2 and 4 mL water for injection, respectively.
For IV injection, the previous solution should be injected slowly (over a period of 3-5 min).
For IM injection, the previous solution should be injected deep into the gluteus muscle. It is advisable not to inject >4 mL into either side. The pain of injection can be avoided by dissolving Kalfoxim in 1% lignocaine solution; this solution must not be injected IV.
If the daily dose exceeds 2 g, IV injection is preferred.
IV Infusion: Dissolve 1-2 g in 40-100 mL of water for injection, respectively, or in the following infusion fluids: Sodium chloride injection, 5% dextrose injection, dextrose and sodium chloride injection, compound sodium lactate injection (Ringer lactate injection) or in any of the current infusion solutions having a pH 5-7. Kalfoxim solutions have maximum stability in this pH range but not in sodium bicarbonate injection (pH >7.5). The prepared solution should be infused over 20-60 min.
Stability of Solutions: It is preferable to use only freshly prepared solutions for IV and IM injection and for IV infusion.
Kalfoxim solutions for IV and IM injection retain satisfactory potency for 24 hrs at room temperature (at or below 22°C), for 10 days in the refrigerator (below 5°C) and for at least 13 weeks in the frozen state. Solutions for IV infusion maintain potency for 24 hrs at room temperature (at or below 22°C), and at least 5 days under refrigeration. Some increase in colour of prepared solutions may occur on storage. However, in the recommended storage conditions, this does not indicate change in potency or safety. Do not heat frozen samples but thaw at room temperature before use. After the periods mentioned previously, discard any unused solutions or frozen materials. Do not re-freeze. When Kalfoxim is dissolved in 1% lignocaine solution for IM injection, only freshly prepared solutions should be used.
Overdosage
Serum levels of Kalfoxim may be reduced by peritoneal dialysis or hemodialysis.
Contraindications
Hypersensitivity to cephalosporins.
Special Precautions
Careful inquiry should be made before therapy with Kalfoxim to detect any previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
Kalfoxim should be given with caution to patients who are hypersensitive to penicillins, because cross-reactions have been reported. Special care is indicated in patients who have had an anaphylactic response to penicillin. If an allergic reaction to Kalfoxim occurs, discontinue the drug.
As with other broad-spectrum antibiotics, prolonged use of Kalfoxim may result in overgrowth of nonsusceptible bacteria and fungi (including C. difficile). If superinfections (including pseudomembranous colitis) occur during therapy, appropriate measures should be taken.
Use Kalfoxim with caution in patients with a history of gastrointestinal disease, particularly colitis.
In severe renal dysfunction, Kalfoxim dosage should be reduced (see Dosage & Administration).
Kalfoxim at high dosage may enhance the nephrotoxicity of aminoglycoside antibiotics or potent diuretics eg, furosemide; therefore, this combination should be given with caution. At recommended dosage, however, Kalfoxim is unlikely to cause this enhancement.
Use in pregnancy: Although in animal studies Kalfoxim has not been shown to produce harmful effects on the fetus, its safety in human pregnancy has not been established. Therefore, Kalfoxim should be used during pregnancy (especially during the 1st trimester of pregnancy) only if absolutely needed.
Use in lactation: Kalfoxim is excreted in human milk in low concentrations. Therefore, it should be used with caution in nursing mothers.
Adverse Reactions
Relatively infrequent and generally mild and transient. The most frequent are local reactions following IM or IV injection. IV injection may cause phlebitis; this can be avoided by slow injection (3-5 min). IM injection may cause transient pain at the site of injection, especially with higher doses; this can be avoided by addition of lignocaine.
Next in frequency are hypersensitivity reactions (rash, pruritus, fever) and gastrointestinal (colitis, diarrhea, nausea, vomiting).
Less frequent adverse reactions include transient leukopenia, eosinophilia and neutropenia; transient elevations in SGOT, SGPT, serum alkaline phosphatase and BUN; headache; moniliasis and vaginitis.
Anaphylactic shock is extremely rare, but it is a conceivable risk. If it occurs, generally within 30 min of drug administration.
Drug Interactions
Concurrent administration of Kalfoxim with aminoglycosides, potent diuretics and probenecid may result in an interaction.
Storage
Store below 30°C. Protect from light.
MIMS Class
ATC Classification
J01DD01 - cefotaxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
IM/IV vial 500 mg x 1's. 1 g x 1's.
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