Kalfoxim Dosage/Direction for Use



Kalbe Farma
Full Prescribing Info
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.
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