"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Cefuroxime (cefuroxime (cefuroxime injection) injection) is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely.
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 nausea (1 in 440 patients). 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 (cefuroxime (cefuroxime injection) injection) and include rash (1 in 125). Pruritus, urticaria, and positive Coombs' test each occurred in fewer than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred.
Blood: A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. 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 controlled studies. As with other cephalosporins, there have been rare reports of thrombocytopenia.
Kidney: Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to cefuroxime (cefuroxime (cefuroxime injection) injection) is unknown.
Postmarketing Experience with Cefuroxime (cefuroxime (cefuroxime injection) injection) : In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with cefuroxime (cefuroxime (cefuroxime injection) injection) and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.
Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime (cefuroxime (cefuroxime injection) injection) , the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including vaginal candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, and hemorrhage.
Several cephalosporins, including cefuroxime (cefuroxime (cefuroxime injection) injection) , have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION). If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Read the Cefuroxime (cefuroxime injection) Side Effects Center for a complete guide to possible side effects
Drug/Laboratory Test Interactions
A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution or with Clinitest® tablets) but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood plasma glucose levels in patients receiving cefuroxime (cefuroxime injection) .
Cefuroxime (cefuroxime (cefuroxime injection) injection) does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Cefuroxime Information
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