Data from FDA - Curated by EPG Health - Last updated 21 December 2016

Indication(s)

INDICATIONS AND USAGE Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase - and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli.

Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.

Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase - and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.

Septicemia caused by Staphylococcus aureus (penicillinase - and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.

Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase - and non-penicillinase-producing strains).

Gonorrhea: uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase - and non-penicillinase-producing strains) in both males and females.

Bone and Joint Infections caused by Staphylococcus aureus (penicillinase - and non-penicillinase-producing strains).

Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms.

Cefuroxime for Injection, USP has been used successfully in these mixed infections in which several organisms have been isolated.

In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Cefuroxime for Injection, USP may be used concomitantly with an aminoglycoside (see PRECAUTIONS).

The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient 's condition.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime for Injection, USP and other antibacterial drugs, Cefuroxime for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Prevention: The preoperative prophylactic administration of Cefuroxime for Injection, USP may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures.

Effective prophylactic use of antibiotics in surgery depends on the time of administration.

Cefuroxime for Injection, USP should usually be given one-half to 1 hour before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissues during the procedure.

The dose should be repeated intraoperatively if the surgical procedure is lengthy.

Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hours.

In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance.

The perioperative use of Cefuroxime for Injection, USP has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk.

For these patients it is recommended that therapy with Cefuroxime for Injection, USP be continued for at least 48 hours after the surgical procedure ends.

If an infection is present, specimens for culture should be obtained for the identification of the causative organism, and appropriate antimicrobial therapy should be instituted.

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Advisory information

contraindications
CONTRAINDICATIONS Cefuroxime for Injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Special warnings and precautions

PRECAUTIONS General: Although Cefuroxime for Injection rarely produces alterations in kidney function, evaluation of renal status during therapy is recommended, especially in seriously ill patients receiving the maximum doses.

Cephalosporins should be given with caution to patients receiving concurrent treatment with potent diuretics as these regimens are suspected of adversely affecting renal function.

The total daily dose of Cefuroxime for Injection should be reduced in patients with transient or persistent renal insufficiency (see DOSAGE AND ADMINISTRATION), because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.

As with other antibiotics, prolonged use of Cefuroxime for Injection may result in overgrowth of non-susceptible organisms.

Careful observation of the patient is essential.

If superinfection occurs during therapy, appropriate measures should be taken.

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

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 loss has been reported in a few pediatric patients treated with cefuroxime.

Persistence of positive CSF (cerebrospinal fluid) cultures at 18 to 36 hours has also been noted with cefuroxime injection, as well as with other antibiotic therapies; however, the clinical relevance of this is unknown.

Cephalosporins may be associated with a fall in prothrombin activity.

Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy.

Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.

Prescribing Cefuroxime for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients: Patients should be counseled that antibacterial drugs, including Cefuroxime for Injection, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When Cefuroxime for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may: 1.

decrease the effectiveness of the immediate treatment and, 2.

increase the likelihood that bacteria will develop resistance and will not be treatable by Cefuroxime for Injection or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

Drug Interactions: In common with other antibiotics, cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined estrogen/progesterone oral contraceptives.

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 for Injection.

Cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity was found for cefuroxime in the mouse lymphoma assay and a battery of bacterial mutation tests.

Positive results were obtained in an in_vitro chromosome aberration assay, however, negative results were found in an in_vivo micronucleus test at doses up to 10 g/kg.

Reproduction studies in mice at doses up to 3,200 mg/kg/day (3.1 times the recommended maximum human dose based on mg/ m2) have revealed no impairment of fertility.

Reproductive studies revealed no impairment of fertility in animals.

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 recommended maximum human dose based on mg/ m2) and rabbits at doses up to 400 mg/kg/day (2.1 times the recommended maximum human dose based on mg/ m2) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime.

There are, however, no adequate and well-controlled studies in pregnant women.

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, caution should be exercised when Cefuroxime for Injection is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below 3 months of age have not been established.

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.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects can not be ruled out.

This drug is known to be substantially excreted by the kidney, and 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, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).

Adverse reactions

ADVERSE REACTIONS Cefuroxime for 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 for 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.

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 blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to cefuroxime is unknown.

Postmarketing Experience with Cefuroxime for 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 for Injection and were reported spontaneously.

Data are generally insufficient to allow an estimate of incidence or to establish causation.

Immune System Disorders: Cutaneous vasculitis.

Neurologic: Seizure.

Non-site specific: Angioedema.

Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime, 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, hemorrhage.

Several cephalosporins, including Cefuroxime for 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.

Altered Laboratory Tests Prolonged prothrombin time, pancytopenia, agranulocytosis.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration

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 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 therapy with Cefuroxime for Injection.

A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of Cefuroxime for

Injection.

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.

The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscularly as a single dose at 2 different sites together with 1 gram of oral probenecid.

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 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 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 4).

Table 4.

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.

When only serum creatinine is available, the following formula4 (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) 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; 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 for Injection.

In cases of bacterial meningitis, a larger dosage of Cefuroxime for Injection 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.

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 suitable dispersing device into infusion fluids under a laminar flow hood using aseptic technique.

DISCARD VIALS 4 HOURS AFTER INITIAL ENTRY. Color changes in solution do not affect potency.

Table 5.

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.

Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

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 for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

For continuous IV infusion, a solution of Cefuroxime for Injection may be added to an IV infusion pack containing one of the following fluids: 0.9 % Sodium Chloride Injection; 5 % Dextrose Injection; 10 % Dextrose Injection; 5 % Dextrose and 0.9 % Sodium Chloride Injection; 5 % Dextrose and 0.45 % Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.

Solutions of Cefuroxime for Injection, 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 for Injection and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

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.

Preparation for Administration: Suspend container from eyelet support.

Remove protector from outlet port at bottom of container.

Attach administration set.

Refer to complete directions accompanying set.

Pregnancy and lactation
Nursing Mothers: Since cefuroxime is excreted in human milk, caution should be exercised when Cefuroxime for Injection is administered to a nursing woman.

More information

Category Value
Authorisation number ANDA065046
Orphan designation No
Product NDC 0143-9976
Date Last Revised 27-04-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 309101
Marketing authorisation holder West-Ward Pharmaceutical Corp