Clatacef

Clatacef Dosage/Direction for Use

cefotaxime

Manufacturer:

T. P. Drug

Distributor:

T. P. Drug
Full Prescribing Info
Dosage/Direction for Use
Posology: General dosing considerations: If C. trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added because cefotaxime has no activity against this organism.
Dosage adjustment required for patients with renal function impairment.
Maximum dose: Adults and children weighing at least 50 kg: 12 g/day.
Adults: Infections: For a list of infections, refer to Indications/Uses.
Gonococcal urethritis/cervicitis: 0.5 g IM (single dose).
Gonorrhea: rectal (men) 1 g IM (single dose), rectal (women): 0.5 g IM (single dose).
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours.
More severe infections: For infections commonly needing antibiotics in higher dosage (eg, septicemia), 2 g IV every 6 to 8 hours.
Life-threatening infections: 2 g IV every 4 hours up to 12 g/day.
Perioperative prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 g IM or IV administered 30 to 90 minutes prior to start of surgery.
For Cesarean section patients, the first dose of 1 g is administered IV as soon as the umbilical cord is clamped. The second and third doses should be given as 1 g IV or IM at 6 and 12 hours after the first dose.
Uncomplicated infections: 1 g IM or IV every 12 hours.
Children: Infections: For a list of infections, refer to Indications/Uses. (See Table 1.)

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Elderly: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, take care in dose selection; it may be useful to monitor renal function.
Renal function impairment: Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dose should be reduced when cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime be halved in patients with estimated creatinine clearances (CrCl) of less than 20 mL/min/1.73 m2. Alternatively, the following dosage adjustments have been recommended.
CrCl 10 to 50 mL/min: Give doses every 12 to 24 hours.
CrCl less than 10 mL/min: Give doses every 24 hours.
Adults receiving continuous renal replacement therapy (CRRT): One reference suggests a dosage of 1 g every 12 hours. The following alternative recommendations assume ultrafiltration and dialysis flow rates of 1 to 2 L/h.
Continuous venovenous hemofiltration (CVVH): 1 to 2 g IV every 8 to 12 hours.
Continuous venovenous hemodialysis (CVVHD): 1 to 2 g IV every 8 hours.
Continuous venovenous hemodialfiltration (CVVHDF): 1 to 2 g IV every 6 to 8 hours.
Adults receiving intermittent hemodialysis (IHD): One dosing recommendation is to administer a 0.5 to 2 g supplement after dialysis. Alternatively, administer 1 to 2 g IV every 24 hours after dialysis on dialysis days. This dosing recommendation assumes the patient is receiving standard IHD 3 times per week and completes the full dialysis sessions.
Continuous ambulatory peritoneal dialysis: 0.5 to 1 g every 24 hours.
CrCl calculation: When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into CrCl. The serum creatinine should represent a steady state of renal function.
Men: Weight (kg) x 140 - age/72 x serum creatinine.
Women: 0.85 x previous value.
Duration of therapy: As with antibiotic therapy in general, administration of cefotaxime should be continued for a minimum of 48 to 72 hours after the patient defervescence or after evidence of bacterial eradication has been obtained. A minimum of 10 days of treatment is recommended for infections caused by group A beta-hemolytic streptococci to guard against the risk of rheumatic fever or glomerulonephritis.
Frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed. Persistent infections may require treatment of several weeks. Doses smaller than those previously indicated should not be used.
Preparation for administration: Powder for injection: Cefotaxime sterile powder for IM or IV administration should be reconstituted as follows: See Table 2.

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Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
A solution of cefotaxime 1 g in 14 mL of sterile water for injection is isotonic.
Preparation for IM administration: Reconstitute vials with sterile water for injection or bacteriostatic water for injection as previously described.
Preparation for IV administration: Reconstitute vials with at least 10 mL of sterile water for injection. Reconstitute infusion bottles with 50 or 100 mL of 0.9% sodium chloride injection or 5% dextrose injection. Reconstituted solutions may be further diluted up to 1,000 mL for other diluents.
Preparation of cefotaxime in ADD-Vantage system: Cefotaxime sterile powder for injection 1 or 2 g may be reconstituted in 50 or 100 mL of 5% dextrose or 0.9% sodium chloride in the ADD-Vantage diluent container. Refer to the manufacturer's instructions for ADD-Vantage system.
Method of administration: Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient. Cefotaxime sterile powder for injection may be administered IM or IV after reconstitution.
IM administration: Cefotaxime should be injected well within the body of a relatively large muscle, such as the upper outer quadrant of the buttock (ie, gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 g may be given if the dose is divided and administered in different IM sites.
IV administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
Intermittent IV: For intermittent IV administration, a solution containing 1 or 2 g in 10 mL of sterile water for injection can be injected over a period of 3 to 5 minutes. Cefotaxime should not be administered over a period of less than 3 minutes. With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to temporarily discontinue the administration of other solutions at the same site.
Continuous IV: For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed in this section.
Admixture compatibility: Compatibility: Reconstituted solutions may be further diluted up to 1,000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 25°C, and at least 3 days under refrigeration (at or below 2-8°C): 0.9% sodium chloride injection; 5% or 10% dextrose injection; Ringer's lactate solution; sodium lactate injection (M/6); 10% invert sugar injection, 8.5% Travasol amino acid injection without electrolytes.
Solutions of cefotaxime sterile powder for injection reconstituted in 0.9% sodium chloride injection or 5% dextrose injection in Viaflex plastic containers maintain satisfactory potency for 24 hours at or below 25°C, 3 days under refrigeration (at or below 2-8°C). Solutions of cefotaxime sterile powder for injection sterile reconstituted in 0.9% sodium chloride injection or 5% dextrose injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 25°C. Do not freeze.
Incompatibility: Solution of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
Cefotaxime solutions exhibit maximum stability in the pH 5 to 7 range. Do not prepare solutions of cefotaxime with diluents having a pH greater than 7.5, such as sodium bicarbonate injection.
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