Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017

Indication(s)

INDICATIONS AND USAGE Cefepime for injection, USP is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION): Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

Empiric Therapy for Febrile Neutropenic Patients.

Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients.

In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate.

Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.

(See CLINICAL STUDIES.)

Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

(See CLINICAL STUDIES.

) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection, USP and other antibacterial drugs, cefepime 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.

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Advisory information

contraindications
CONTRAINDICATIONS Cefepime for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.
Special warnings and precautions

PRECAUTIONS General Prescribing cefepime 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.

As with other antimicrobials, prolonged use of cefepime for injection may result in overgrowth of non-susceptible microorganisms.

Repeated evaluation of the patient 's condition is essential.

Should superinfection occur during therapy, appropriate measures should be taken.

Many cephalosporins, including cefepime, have been 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.

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

Positive direct Coombs ' tests have been reported during treatment with cefepime for injection.

In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs ' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs ' test may be due to the drug.

Cefepime for injection should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of cefepime for injection.

The effect of lower doses is not presently known.

Information for Patients Before therapy with cefepime for injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other drugs.

Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10 % of patients with a history of penicillin allergy.

If an allergic reaction to cefepime for injection occurs, discontinue the drug.

Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.

Patients should be counseled that antibacterial drugs including cefepime for injection should only be used to treat bacterial infections.

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

When cefepime 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 cefepime 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 two or more months after having taken the last dose of the antibiotic.

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

Patients should be advised of neurological adverse events that could occur with cefepime for injection use.

Patients should be instructed to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and non-convulsive status epilepticus for immediate treatment, dosage adjustment, or discontinuation of cefepime for injection.

Drug Interactions Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with cefepime for injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positive reaction for glucose in the urine when using Clinitest™ tablets.

It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix™) be used.

Carcinogenesis, Mutagenesis, Impairment of Fertility No animal carcinogenicity studies have been conducted with cefepime.

In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells.

In other in_vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in_vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity.

No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a mg/ m2 basis).

Pregnancy Teratogenic Effects Pregnancy Category B Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a mg/ m2 basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a mg/ m2 basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a mg/ m2 basis).

There are, however, no adequate and well-controlled studies of cefepime use 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 Cefepime is excreted in human breast milk in very low concentrations (0.5 mcg/mL).

Caution should be exercised when cefepime is administered to a nursing woman.

Labor and Delivery Cefepime has not been studied for use during labor and delivery.

Treatment should only be given if clearly indicated.

Pediatric Use The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years.

Use of cefepime for injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials (see CLINICAL PHARMACOLOGY).

Safety and effectiveness in pediatric patients below the age of 2 months have not been established.

There are insufficient clinical data to support the use of cefepime for injection in pediatric patients under 2 months of age or for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is Haemophilus influenzae type b. IN THOSE PATIENTS IN WHOM MENINGEAL SEEDING FROM A DISTANT INFECTION SITE OR IN WHOM MENINGITIS IS SUSPECTED OR DOCUMENTED, AN ALTERNATE AGENT WITH DEMONSTRATED CLINICAL EFFICACY IN THIS SETTING SHOULD BE USED. Geriatric Use Of the more than 6400 adults treated with cefepime for injection in clinical studies, 35 % were 65 years or older while 16 % were 75 years or older.

When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients.

Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures.

(See WARNINGS and ADVERSE REACTIONS.

) 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 renal function should be monitored.

(See CLINICAL PHARMACOLOGY: Specific Populations, WARNINGS, and DOSAGE AND ADMINISTRATION.

)

Adverse reactions

ADVERSE REACTIONS Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials using multiple doses of cefepime, 4137 patients were treated with the recommended dosages of cefepime (500 mg to 2 g intravenous every 12 hours).

There were no deaths or permanent disabilities thought related to drug toxicity.

Sixty-four (1.5 %) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity.

Thirty-three (51 %) of these 64 patients who discontinued therapy did so because of rash.

The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse events was very similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8 %, 1.1 %, and 2 %, respectively).

However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse events (Table 8) were thought to be probably related to cefepime during evaluation of the drug in clinical trials conducted in North America (n=3125 cefepime-treated patients).

Table 8: Adverse Reactions Cefepime Multiple-Dose Dosing Regimens Clinical Trials - North America INCIDENCE EQUAL TO OR GREATER THAN 1 % Local reactions (3 %), including phlebitis (1.3 %), pain and/or inflammation (0.6 %)Local reactions, irrespective of relationship to cefepime in those patients who received intravenous infusion (n=3048).

; rash (1.1 %) INCIDENCE LESS THAN 1 % BUT GREATER THAN 0.1 % Colitis (including pseudomembranous colitis), diarrhea, erythema, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting, anemia At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of cefepime.

They consisted of rash (4 %), diarrhea (3 %), nausea (2 %), vomiting (1 %), pruritus (1 %), fever (1 %), and headache (1 %).

The following (Table 9) adverse laboratory changes, irrespective of relationship to therapy with cefepime, were seen during clinical trials conducted in North America.

Table 9: Adverse Laboratory Changes Cefepime Multiple-Dose Dosing Regimens Clinical Trials - North America INCIDENCE EQUAL TO OR GREATER THAN 1 % Positive Coombs ' test (without hemolysis) (16.2 %); decreased phosphorus (2.8 %); increased ALT/SGPT (2.8 %), AST/SGOT (2.4 %), eosinophils (1.7 %); abnormal PTT (1.6 %), PT (1.4 %) INCIDENCE LESS THAN 1 % BUT GREATER THAN 0.1 % Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calciumHypocalcemia was more common among elderly patients.

Clinical consequences from changes in either calcium or phosphorus were not reported., hematocrit, neutrophils, platelets, WBC A similar safety profile was seen in clinical trials of pediatric patients (see PRECAUTIONS: Pediatric Use).

Postmarketing Experience In addition to the events reported during North American clinical trials with cefepime, the following adverse experiences have been reported during worldwide postmarketing experience.

Encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and non-convulsive status epilepticus have been reported.

Although most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules, some cases of neurotoxicity occurred in patients receiving an appropriate dosage adjustment for their degree of renal impairment.

If neurotoxicity associated with cefepime therapy occurs, consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

(see WARNINGS.

) As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.

Cephalosporin-Class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION The recommended adult and pediatric dosages and routes of administration are outlined in the following table 10.

Cefepime for injection should be administered intravenously over approximately 30 minutes.

Table 10: Recommended Dosage Schedule for Cefepime for Injection in Patients with CrCL Greater Than 60 mL/minAdjust dose in patients with CrCL less than or equal to 60 mL/min Site and Type of Infection Dose Frequency Duration (days) Adults Moderate to Severe Pneumonia due to S. pneumoniae including cases associated with concurrent bacteremia., P. aeruginosa For Pseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years), K. pneumoniae, or Enterobacter species 1 to 2 g IV Every 8 to 12 hours 10 Empiric therapy for febrile neutropenic patients (See INDICATIONS AND USAGE and CLINICAL STUDIES.

) 2 g IV Every 8 hours 7 or until resolution of neutropenia.

In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.

Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis 0.5 to 1 g IV/IMIntramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.

Every 12 hours 7 to 10 Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis.

(See CLINICAL STUDIES.

) 2 g IV Every 8 to 12 hours 7 to 10 Pediatric Patients (2 months up to 16 years) The maximum dose for pediatric patients should not exceed the recommended adult dose.

The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Patients with Hepatic Impairment No adjustment is necessary for patients with hepatic impairment.

Patients with Renal Impairment In patients with creatinine clearance less than or equal to 60 mL/min, the dose of cefepime for injection should be adjusted to compensate for the slower rate of renal elimination.

The recommended initial dose of cefepime for injection should be the same as in patients with normal renal function except in patients undergoing hemodialysis.

The recommended doses of cefepime for injection in patients with renal impairment are presented in Table 11.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)4 may be used to estimate 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?

above value Table 11: Recommended Dosing Schedule for Cefepime for Injection in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) Creatinine Clearance (mL/min) Recommended Maintenance Schedule Greater than 60 Normal recommended dosing schedule 500 mg every 12 hours 1 g every 12 hours 2 g every 12 hours 2 g every 8 hours 30 to 60 500 mg every 24 hours 1 g every 24 hours 2 g every 24 hours 2 g every 12 hours 11 to 29 500 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours 2 g every 24 hours Less than 11 250 mg every 24 hours 250 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours CAPD 500 mg every 48 hours 1 g every 48 hours 2 g every 48 hours 2 g every 48 hours HemodialysisOn hemodialysis days, cefepime should be administered following hemodialysis.

Whenever possible, cefepime should be administered at the same time each day.

1 g on day 1, then 500 mg every 24 hours thereafter 1 g every 24 hours In patients undergoing continuous ambulatory peritoneal dialysis, cefepime for injection may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 11).

In patients undergoing hemodialysis, approximately 68 % of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period.

The dosage of cefepime for injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

Cefepime for injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11).

Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 10 and 11) are recommended for pediatric patients.

Administration For Intravenous Infusion Dilute with a suitable parenteral vehicle prior to intravenous infusion.

Constitute the 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection.

THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions.

However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

Intramuscular Administration For intramuscular administration, cefepime for injection should be constituted with one of the following diluents: Sterile Water for Injection, 0.9 % Sodium Chloride, 5 % Dextrose Injection, 0.5 % or 1 % Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 12).

Preparation of cefepime for injection solutions is summarized in Table 12.

Table 12: Preparation of Solutions of Cefepime for Injection Single-Dose Vials for Intravenous/Intramuscular Administration Amount of Diluent to be added (mL) Approximate Available Volume (mL) Approximate Cefepime Concentration (mg/mL) cefepime vial content 1 g (IV) 10 11.3 100 1 g (IM) 2.4 3.6 280 2 g (IV) 10 12.5 160 Compatibility and Stability Intravenous Cefepime for injection is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9 % Sodium Chloride Injection, 5 % and 10 % Dextrose Injection, M/6 Sodium Lactate Injection, 5 % Dextrose and 0.9 % Sodium Chloride Injection, Lactated Ringers and 5 % Dextrose Injection, Normosol™-R, and Normosol™-M in 5 % Dextrose Injection.

These solutions may be stored up to 24 hours at controlled room temperature 20° C to 25° C (68° F to 77° F) or 7 days in a refrigerator 2° C to 8° C (36° F to 46° F).

Cefepime for injection admixture compatibility information is summarized in Table 13.

Table 13: Cefepime Admixture Stability Stability Time for Cefepime for Injection Concentration Admixture and Concentration IV Infusion Solutions RT/L (20° to 25° C) Refrigeration (2° to 8° C) 40 mg /mL Amikacin 6 mg /mL NS or D5W 24 hours 7 days 40 mg /mL Ampicillin 1 mg /mL D5W 8 hours 8 hours 40 mg /mL Ampicillin 10 mg /mL D5W 2 hours 8 hours 40 mg /mL Ampicillin 1 mg /mL NS 24 hours 48 hours 40 mg /mL Ampicillin 10 mg /mL NS 8 hours 48 hours 4 mg /mL Ampicillin 40 mg/mL NS 8 hours 8 hours 4 to 40 mg /mL Clindamycin Phosphate 0.25 to 6 mg /mL NS or D5W 24 hours 7 days 4 mg /mL Heparin 10 to 50 units/mL NS or D5W 24 hours 7 days 4 mg /mL Potassium Chloride 10 to 40 mEq/L NS or D5W 24 hours 7 days 4 mg /mL Theophylline 0.8 mg /mL D5W 24 hours 7 days 1 to 4 mg /mL na Aminosyn™ II 4.25 % with electrolytes and

calcium 8 hours 3 days 0.125 to 0.25 mg /mL na Inpersol™ with 4.25 % dextrose 24 hours 7 days NS = 0.9 % Sodium Chloride Injection D5W = 5 % Dextrose Injection na = not applicable RT/L = Ambient room temperature and light Solutions of cefepime for injection, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction.

However, if concurrent therapy with cefepime for injection is indicated, each of these antibiotics can be administered separately.

Intramuscular Cefepime for injection constituted as directed is stable for 24 hours at controlled room temperature 20° C to 25° C (68° F to 77° F) or for 7 days in a refrigerator 2° C to 8° C (36° F to 46° F) with the following diluents: Sterile Water for Injection, 0.9 % Sodium Chloride Injection, 5 % Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5 % or 1 % Lidocaine Hydrochloride.

NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION. IF PARTICULATE MATTER IS EVIDENT IN RECONSTITUTED FLUIDS, THE DRUG SOLUTION SHOULD BE DISCARDED.

As with other cephalosporins, the color of cefepime for injection powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

Pregnancy and lactation
Nursing Mothers Cefepime is excreted in human breast milk in very low concentrations (0.5 mcg/mL). Caution should be exercised when cefepime is administered to a nursing woman.

Interactions

Drug Interactions Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with cefepime for injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

More information

Category Value
Authorisation number ANDA065441
Orphan designation No
Product NDC 0781-3223,0781-3222
Date Last Revised 16-04-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 1665093
Storage and handling Storage IN THE DRY STATE STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.
Marketing authorisation holder Sandoz Inc