Data from FDA - Curated by EPG Health - Last updated 21 December 2016
PRECAUTIONS General: Although Cefuroxime for Injection rarely produces alterations in kidney function,
Cephalosporins should be given with
As with other antibiotics,
If superinfection occurs during therapy,
Broad-spectrum antibiotics should be prescribed with
Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins.
As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing
Cephalosporins may be associated with a fall in prothrombin activity.
Those at risk include patients with renal or hepatic
Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing Cefuroxime for Injection in
Information for Patients: Patients should be counseled that antibacterial drugs, including Cefuroxime for Injection, should only be used to treat bacterial
They do not treat
When Cefuroxime for Injection is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may: 1.
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Drug Interactions: In common with other antibiotics, cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and
Drug/Laboratory Test Interactions: A false-positive reaction for glucose in the
As a false-negative result may occur in the ferricyanide test,
Reproduction studies in mice at doses up to 3,200 mg/kg/day (3.1 times the
Reproductive studies revealed
Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 6,400 mg/kg/day (6.3 times the
There are, however,
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Since cefuroxime is excreted in human milk,
Accumulation of other members of the cephalosporin class in newborn infants (with resulting prolongation of drug half-life) has been reported.
Geriatric Use: Of the 1,914 subjects who received cefuroxime in 24 clinical studies of Cefuroxime for
Injection, 901 (47 %) were 65 years and older while 421 (22 %) were 75 years and older.
Because elderly patients are more likely to have
Local Reactions: Thrombophlebitis has occurred with IV administration in 1 in 60 patients.
Gastrointestinal: Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and
The onset of pseudomembranous colitis may occur during or after antibacterial treatment (see WARNINGS).
Hypersensitivity Reactions: Hypersensitivity reactions have been reported in fewer than 1 % of the patients treated with Cefuroxime for Injection and include rash (1 in 125).
Pruritus, urticaria, and
Less common reactions seen were transient neutropenia (fewer than 1 in 100 patients) and leukopenia (1 in 750 patients).
A similar pattern and incidence were seen with other cephalosporins used in
As with other cephalosporins, there have been
Hepatic: Transient rise in SGOT and SGPT (1 in 25 patients), alkaline phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in 500 patients) levels has been noted.
Kidney: Elevations in serum creatinine and/or
Postmarketing Experience with Cefuroxime for Injection: In addition to
Non-site specific: Angioedema.
Several cephalosporins, including Cefuroxime for Injection, have been implicated in triggering seizures, particularly in
If seizures associated with drug therapy should occur,
Anticonvulsant therapy can be given if clinically indicated.
Altered Laboratory Tests Prolonged prothrombin time, pancytopenia, agranulocytosis.
To report SUSPECTED
DOSAGE AND ADMINISTRATION The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only.
Dosing reference to the intramuscular route of administration is for informational purposes only.
Dosage: Adults: The usual adult dosage range for Cefuroxime for Injection is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days.
In bone and joint
In clinical trials, surgical
A course of oral antibiotics was administered when
In bacterial meningitis,
For preventive use for clean-contaminated or potentially
Thereafter, give 750 mg intravenously or intramuscularly 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
Dosage should be determined by the degree of renal
Dosage of Cefuroxime for Injection 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 for Injection is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.
The serum creatinine should represent a
Males: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL) Females: 0.85 x male value NOTE: As with antibiotic therapy in general, administration of Cefuroxime for Injection 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;
and doses smaller than those indicated above should not be used.
In staphylococcal and other
Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to
The higher dosage of 100 mg/kg/day (not to
In bone and joint
In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of Cefuroxime for Injection.
In cases of bacterial meningitis,
Preparation of Solution and Suspension: The directions for preparing Cefuroxime for Injection, Pharmacy Bulk Package, are summarized in Table 5.
THIS PHARMACY BULK PACKAGE IS NOT TO BE DISPENSED AS A UNIT FOR DIRECT INFUSION For Intravenous Use: The 7.5 gram pharmacy bulk package should be reconstituted with 77 mL of Sterile Water for Injection; the constituted solution occupies a volume of about 82.5 mL and contains approximately 750 mg of cefuroxime per 8 mL. Not for direct infusion.
Disperse aliquots from the vial via a
Preparation of Solution Strength Amount of Diluent to Be Added (mL) Volume to Be Withdrawn Approximate Cefuroxime Concentration (mg/mL) 7.5 gram Pharmacy Bulk Package 77 (IV) Amount Needed8 mL of solution contains 750 mg of cefuroxime; 16 mL of solution contains 1.5 grams of cefuroxime.
95 Administration: After constitution, Cefuroxime for Injection may be given intravenously or intramuscularly.
However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only.
However, during infusion of the solution containing Cefuroxime for Injection, it is advisable to
For continuous IV infusion,
Solutions of Cefuroxime for Injection, like those of most beta-lactam antibiotics, should not be
However, if concurrent therapy with Cefuroxime for Injection and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Such use could result in air embolism due to residual air being drawn from the primary container before
Preparation for Administration: Suspend container from eyelet support.
Remove protector from outlet port at bottom of container.
Attach administration set.
|Date Last Revised||27-04-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||West-Ward Pharmaceutical Corp|