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Información de la droga para CefUROXime for Injection USP and Dextrose Injection USP (B. Braun): DOSAGE AND ADMINISTRATION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
This product is intended for intravenous administration only.
The usual adult dosage range for cefuroxime is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.
In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.
In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.
For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.
Impaired Renal Function
A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).
Table 2: Dosage of Cefuroxime in Adults with Reduced Renal Function Creatinine Clearance(mL/min) Dose Frequency >20 750 mg–1.5 grams q8h 10–20 750 mg q12h <10 750 mg q24hSince cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.
When only serum creatinine is available, the following formula2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Females: 0.85 × male value
Note: As with antibiotic therapy in general, administration of Cefuroxime for Injection USP and Dextrose Injection USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order 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 for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Pediatric Patients Above 3 Months of Age
Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.
In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.
In cases of bacterial meningitis, a larger dosage of cefuroxime is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.
In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.
Cefuroxime for Injection USP and Dextrose for Injection USP in the DUPLEX® Container is designed to deliver a 750 mg or 1.5 g dose of cefuroxime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose.
For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site.
Solutions of cefuroxime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.
However, if concurrent therapy with cefuroxime and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Use sterile equipment.
Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
DUPLEX® Drug Delivery System Directions for Use
- To avoid inadvertent activation, DUPLEX Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
- Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label.
- Unlatch side tab and unfold DUPLEX Container. (See Diagram 1.)
- Visually inspect diluent chamber for particulate matter.
- Use only if container and seals are intact.
- To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.)
- Protect from light after removal of foil strip.
Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
- The product should be re-folded and the side tab latched until ready to activate.
- Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
- Unfold the DUPLEX Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.)
- Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.
- Visually inspect the reconstituted solution for particulate matter.
- Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.)
- Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired.
- Using aseptic technique, remove the set port cover from the set port and attach sterile administration set.
- Refer to Directions for Use accompanying the administration set.
- As with other cephalosporins, reconstituted Cefuroxime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.
- Use only if prepared solution is clear and free from particulate matter.
- Do not use in series connection.
- Do not introduce additives into the DUPLEX® Container.
- Do not freeze.
- Drug Information Provided by National Library of Medicine (NLM).