Claraxim Dosage/Direction for Use

Preparation and administration: For intramuscular injection (IM): The contents of Cefotaxime 1 g are dissolved in 4 ml sterile water for injection or 1% lidocaine HCl injection. Intravenous injection must be prohibited if 1% lidocaine HCl applied. It should be made deeply into gluteal muscles and advisable not to inject more than 4 ml into each side (If an IM dose of 2 g of Cefotaxime is indicated, the dose should be divided and administration at 2 different injection sites or recommend be given IV).
Cefotaxime 2 g should not be given IM.
For intravascular injection (IV bolus injection): The contents of Cefotaxime 500 mg, 1 g and 2 g are dissolved in 2 ml and 4 ml and 10 ml sterile water for injection, respectively. The solution must be inject slowly over a period 3-5 minutes. During post-marketing surveillance, potentially life-threatening arrhythmia has been reported in a very few patients who received rapid intravenous administration of Cefotaxime over less than 1 minute.
For intravascular infusion (IV infusion): Dissolved the contents of Cefotaxime as same as for intravascular injection and then mixed with 40-100 ml of intravascular fluids including 0.9% sodium chloride injection, sodium lactate solution, 5% dextrose injection, lactated Ringer's injection. The concentration of final solution is 20-50 mg/ml.
Intravenous infusion (IV infusion): In the case giving high dose of Cefotaxime.
Intermittent intravenous infusion: dissolve the contents of Cefotaxime 2 g with 40 ml of compatible solvent for IV infusion (see the preparation section). Intermittent IV infusion of Cefotaxime is generally infused over 20 minutes; solutions should preferably be infused via butterfly or scalp vein-type needles.
Continuous intravenous infusion: dissolve the contents of Cefotaxime 2 g with 100 ml of compatible solvent for IV infusion (see the preparation section). Continuous IV infusion of cefotaxime is generally infused over 50-60 minutes; solutions should preferably be infused via butterfly or scalp vein-type needles.
A pale yellowish color of the solution does not indicate impairment of antibiotic activity.
To avoid septic complication on injection care should be taken during reconstitution to ensure aseptic handling. The solution should be used immediately after reconstitution.
Before use the drug should consider precipitate or discoloration of the drug.
Note: Sodium bicarbonate injection is not recommended as a diluent.
Cefotaxime must not be mixed with other antibiotics including aminoglycosides.
Stability: Cefotaxime sterile powder after reconstitution in sterile water for injection is chemically stable: up to 12 hours at room temperature (not exceeding +25 °C/indoor light).
Up to 24 hours under refrigerating condition (+2 °C - +8 °C/protected from light).
Cefotaxime sterile powder after reconstitution in lidocain HCl injection solution 1% is chemically stable: up to 24 hours under refrigerating condition (+2 °C - +8 °C/protected from light).
Cefotaxime sterile powder after reconstitution in infusion fluids including 0.9% sodium chloride injection, sodium lactate solution, 5% dextrose injection is chemically stable: up to 12 hours at room temperature (not exceeding +25 °C/indoor light).
Up to 24 hours under refrigerating condition (+2 °C - +8 °C/protected from light).
Dosage: See table.

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The maximum adult dosage recommended is 12 g daily.
Dosage in surgical prophylaxis: the administration of 1-2 g Cefotaxime (IM or IV) 30-60 minutes before the start of surgery is recommended. Doses may be repeated according to the risk of infections.
Dosage in prophylactically in patients undergoing cesarean section: the administration of 1 g given IV as soon as the umbilical cord is clamped, followed by 1 g IM or IV 6 and 12 hours after the first dose.
Dosage in infants and children up to 12 years old (weights less than 50 kg): 50-180 mg/kg/day in equally divided dose every 4-6 hours (IM or IV) and a dosage of 150-200 mg/kg/day for severe infections. The higher dose should be used for more severe or serious infections, including meningitis.
Children weighing 50 kg or more should receive the adult dose, but dose should not exceed 12 g daily. Premature or full-term neonates less than 1 week of age is 50 mg/kg every 12 hours and the usual dose for neonate 1-4 weeks of age is 50 mg/kg every 8 hours.
Dosage in patients with renal and hepatic impairment: Dosage in patients undergoing renal impairment: In patient with creatinine clearance less than 20 ml/min per 1.73 m², dose and/or frequency of administration should be modified in response to the degree of renal impairment. Half of the usual dose is recommended.
Dosage in patients undergoing hemodialysis: 0.5-2 g daily is given after each dialysis period.
Dosage in patients with hepatic impairment: Modification of the usual dosage of Cefotaxime is unnecessary for patient with impaired hepatic function.