Professional Information
Cefuroxime (Systemic)
VA CLASSIFICATION
Primary: AM117
Commonly used brand name(s): Zinacef.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antibacterial (Systemic) —
Indications
Accepted
Bone and joint infections (treatment)—Cefuroxime is indicated for the treatment of bone and joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains).{01}
Gonorrhea (treatment)—Cefuroxime is indicated for the treatment of uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains) in both males and females.{01}
Lower respiratory tract infections, including pneumonia (treatment) — Cefuroxime is indicated for the treatment of lower respiratory tract infections, including pneumonia, caused byStreptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, and Escherichia coli.{01}
Meningitis (treatment)— Cefuroxime is indicated for the treatment of Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase and non-penicillinase producing strains).{01}
Septicemia (treatment){2.}1— Cefuroxime is indicated for the treatment of Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.{01}
Skin and Skin-Structure Infections (treatment)— Cefuroxime is indicated for the treatment of skin and skin-structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.1{01}{2.}
Urinary Tract Infections (treatment)— Cefuroxime is indicated for the treatment of urinary tract infections caused by Escherichia coli, and Klebsiella spp.{01}
Note: The preoperative prophylactic administration of cefuroxime may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean-contaminated or potentially contaminated procedures.{01}
In the absence of microbiological study results, cefuroxime may be started. Cefuroxime has been shown to be effective in treating susceptible mixed infections of strains of both aerobic and anaerobic organisms.{01}
In 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 may be used concomitantly with an aminoglycoside.{01}
The perioperative use of cefuroxime has been effective during open heart surgery.{01}
Unaccepted
Gram positive aerobes—Most strains of enterococci, e.g., Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillin-resistant staphylococci and Listeria monocytogenes are resistant to cefuroxime.{01}
Gram negative aerobes—Some strains of Morganella morganii, Enterobacter cloacae and Citrobacter spp. have been shown by in vitro tests to be resistant to cefuroxime. Pseudomonas, Campylobacter spp., Acinetobacter calcoaceticus and most strains of Serratia spp. and Proteus vulgaris are resistant to most first and second generation cephalosporins.{01}
Anaerobes—Clostridium difficile and most strains of Bacteroides fragilis are resistant to cefuroxime.{01}
1 Not included in Canadian product labeling.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
446.4{01}
pH
6 to 8.5– freshly reconstituted solutions{01}
5 to 7.5– thawed solutions.{01}
Osmolality
Solution 300 mOsmol per kg{01}
Mechanism of action/Effect:
Bactericidal against a wide range of gram positive and gram negative aerobes and anaerobic organisms; the action of cefuroxime results from inhibition of cell-wall synthesis and is highly stable in the presence of beta-lactamases. Cefuroxime is detectable in therapeutic concentrations in cerebrospinal fluid, pleural fluid, joint fluid, bile, sputum, bone and aqueous humor.{01}
Protein binding:
Moderate: 50% to serum protein{01}
Half-life:
80 minutes following either intramuscular or intravenous injections{01}
There was no evidence of accumulation of cefuroxime in the serum following intravenous administration of 1.5 gm dose every 8 hours to normal volunteers.{01}
Time to peak concentration:
Intramuscular: 45 minutes following a 750 mg dose{01}
Intravenous: 15 minutes following doses of 750 mg and 1.5 gm{01}
Peak serum concentration:
Intramuscular: 27 mcg per mL following a 750 mg dose{01}
Intravenous: 50 mcg per mL following a 750 mg dose; 100 mcg per mL following a 1.5 gm dose{01}
Elimination:
Renal— approximately 89%{01}
Dialysis—cefuroxime is dialyzable via hemodialysis and peritoneal dialysis.{01}
Concomitant use with probenecid
Concomitant administration with probenecid slows tubular secretion, decreases renal clearance by approximately 40%, increases peak serum levels by approximately 30%, and increases the serum half life by approximately 30%.{01}
Precautions to Consider
Cross-sensitivity and/or related problems
Patients allergic to one cephalosporin or cephamycin may be allergic to other cephalosporins or cephamycins also.{01}
Patients allergic to penicillins, penicillin derivatives, or penicillamine may be allergic to cephalosporins or cephamycins also. Cephalosporin cross reactivity is approximately 3 to 7 % in patients with a documented history of penicillin allergy. Although cephalosporins have been administered without incident to some patients with rash type penicillin allergy, caution is recommended when cephalosporins are administered to patients with a history of penicillin anaphylaxis since anaphylaxis may also occur after cephalosporin administration.
Carcinogenicity and Mutagenicity
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 gm per kg.{01}
Pregnancy/Reproduction
Fertility—
Reproduction studies in mice at doses up to 3200 mg per kg per day (3.1 times the recommended maximum human dose based on mg per m2 of body surface area) have revealed no impairment of fertility. Other reproductive studies have revealed no impairment of fertility in animals.{01}
Pregnancy—
Adequate and well controlled studies in humans have not been done.{01}
In mice and rabbits, reproductive studies have shown that cefuroxime causes no adverse effects on the fetus. In mice, doses up to 6400 mg per kg of body weight per day (6.3 times the recommended maximum human dose based on mg per m2 of body surface area) where administered. In rabbits, doses up to 400 mg per kg of body weight per day (2.1 times the recommended maximum human dose based on mg per m 2 of body surface area) where administered.{01}
FDA Pregnancy Category B{01}
Breast-feeding
Cefuroxime is distributed into breast milk{01} in low concentrations 0.5 mg per L{2.}. Caution should be used when cefuroxime is administered to nursing mothers.{01}
Pediatrics
US product information is approved for use in children over 3 months of age. Safety and effectiveness in pediatric patients three months of age and below has not been established. However, it is known that other members of the cephalosporin class have a prolonged drug half-life resulting from accumulation of drug in newborn infants.{01}
Canadian product information is approved for use in neonates up to one month of age and children age 1 month to 12 years. Noting that in the first few weeks of life, the serum half life can be 3 to 5 times that in adults.{2.}
Geriatrics
In clinical studies of 1914 subjects, 47% were aged 65 and older and 22% were 75 years of age and over, there were no overall differences in safety or effectiveness between these subjects and younger subjects. 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 cannot be ruled out. 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.{01}
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
» Aminoglycoside antibiotics (may result in nephrotoxicity{01})
» Diuretics, potent (administration may adversely affect renal function thereby affecting cefuroxime elimination{01})
» Probenecid (concomitant administration with probenecid slows tubular secretion, decreases renal clearance by approximately 40%, increases peak serum levels by approximately 30%, and increases the serum half life by approximately 30%.{01})
Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
With diagnostic test results
» Coombs' tests (a positive reaction may occur{01})
» Copper reduction tests including:
Benedict's solution or
CLINITEST® tablets or
Fehling's solution (a false positive reaction for glucose in the urine may occur; enzyme based tests for glycosuria are reliable.{01})
» Ferricyanide test (a false negative result for blood plasma glucose may occur; blood plasma glucose levels should be determined by using either the glucose oxidase or hexokinase method.{01})
With physiology/laboratory test values
Alanine aminotransferase (ALT[SGPT]) or
Alkaline phosphatase or
Aspartase aminotransferase (AST[SGOT]) or
Bilirubin, serum or
Lactate dehydrogenase (LDH) (transient rise in values has been reported{01})
Blood urea nitrogen (BUN) or
Creatinine clearance or
Creatinine, serum (elevations in serum creatinine and /or BUN and a decreased creatinine clearance; relationship to cefuroxime is unknown{01})
Cerebrospinal fluid (persistence of positive cultures have been noted at 18 to 36 hours; clinical relevance is unknown)
{01}
Hemoglobin or
Hematocrit (a decrease in values has been observed along with transient eosinophilia{01})
» Prothrombin (cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairments, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy and patients previously stabilized on anticoagulant therapy{01}.)
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problem exists:
» Hypersensitivity to cefuroxime or any other cephalosporin.{01}
Risk-benefit should be considered when the following medical problems exist
» Colitis, history of or
» Gastrointestinal disease, history of (may aggravate symptoms{01})
Hepatic impairment or
Poor nutritional state or
Renal impairment (may be associated with a fall in prothrombin activity; exogenous Vitamin K should be administered as indicated{01})
» Hypersensitivity to penicillins or
» Allergic reaction to other agents or other drugs (previous hypersensitivity reactions to penicillins must be identified prior to administration; give cautiously to penicillin-sensitive patients; give cautiously to any patient with demonstrated any allergic reaction, particularly to any drug.{01})
» Renal insufficiency, transient or persistent (may lead to high and prolonged serum antibiotic concentrations; the total daily dose should be reduced{01})
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
Bacteriologic appraisal (frequent appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months post therapy{01})
Prothrombin time (may reduce prothrombin activity; patients with renal or hepatic impairment, poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy are at high risk)
» Pseudomembranous colitis (monitor patient for development of diarrhea subsequent to cefuroxime therapy{01})
» Renal function evaluation (rarely produces alterations in kidney function; evaluations are especially recommended in seriously ill patients receiving the maximum doses{01})
» Superinfection (prolonged use may result in overgrowth of nonsusceptible organisms; careful observation is essential{01})
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Note: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefuroxime, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents{01}
Those indicating need for medical attention
Incidence more frequent
Eosinophilia ( black, tarry stools; chest pain; chills; cough; fever; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness)
{01}
Incidence less frequent
hypersensitivity reaction (difficulty in breathing or swallowing; fast heartbeat; shortness of breath; skin itching, rash, or redness; swelling of face, throat, or tongue){01}
pseudomembranous colitis (abdominal or stomach cramps; pain; bloating; abdominal tenderness; diarrhea, watery and severe, which may also be bloody; fever; increased thirst; nausea or vomiting; unusual tiredness or weakness; unusual weight loss)
seizure (muscle spasm or jerking of all extremities; sudden loss of consciousness)
thrombophlebitis (bluish color; changes in skin color; pain, tenderness, swelling of foot or leg)
urticaria ( hives or welts; itching; redness of skin; skin rash)
{01}
Incidence rare
Anaphylaxis (cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing)
epidermal necrolysis, toxic (redness, tenderness, itching, burning, or peeling of skin; red or irritated eyes; sore throat; fever; chills)
erythema multiforme (blistering, peeling, loosening of skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red, irritated eyes; sore throat; sores; ulcers or white spots in mouth or on lips; unusual tiredness or weakness)
hearing loss, mild to moderate
interstitial nephritis (bloody or cloudy urine; greatly decreased frequency of urination or amount of urine)
leukopenia or neutropenia (black, tarry stools; chest pain; chills; cough; fever ; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness)
Stevens-Johnson syndrome ( blistering, peeling, loosening of skin; chills; cough; diarrhea; itching; joint or muscle pain; red, irritated eyes; red skin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in mouth or on lips; unusual tiredness or weakness)
thrombocytopenia (black, tarry stools; chest pain; chills; cough; fever; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness)
{01}
Incidence unknown- reported during post marketing
Agranulocytosis (cough or hoarseness; fever with or without chills; general feeling of tiredness or weakness; lower back or side pain; painful or difficult urination; sore throat; sores, ulcers, or white spots on lips or in mouth; unusual bleeding or bruising)
angioedema ( large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs)
seizures
pancytopenia ( high fever; chills; unexplained bleeding or bruising; bloody, black, or tarry stools; pale skin; unusual tiredness or weakness; cough; shortness of breath; sores, ulcers, or white spots on lips or in mouth; swollen glands)
{01}
Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
Diarrhea
gastrointestinal problems (bloating; diarrhea; gas; loss of appetite; nausea; stomach pain; vomiting){01}
nausea
pruritis (itching skin)
{01}
Incidence rare
Drug fever {01}
Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).
Clinical effects of overdose
Overdose can cause cerebral irritation leading to convulsions.{01}
Treatment of overdose
Specific treatment:
Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.{01}
Supportive care:
Treatment should be symptomatic and supportive{01}
Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Cefuroxime (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to cefuroxime, other cephalosporins, penicillins or allergy to other drugs or agents
Breast-feeding—Distributed into breast milk
Use in children—U.S. product information— safety and effectiveness not established in pediatric patients age 3 months and younger.
Canadian product information— is approved in neonates under one month of age and in infants and children 1 month to 12 years of age
Other medications, especially aminoglycoside antibiotics, potent diuretics, probenecid
Other medical problems, especially history of colitis or gastrointestinal disease, and transient or persistent renal insufficiency
Proper use of this medication
Patient monitoring, especially pseudomembranous colitis, renal function evaluation and signs of superinfection
» Proper dosing, especially reduced dosing in renal insufficiency.
Taking as soon as possible; not taking if almost time for next dose; do not double dose
Proper storage
Precautions while using this medication
» Laboratory tests especially possible interference with test results including Coombs test, copper reductions tests (including Benedict's solution, Clinitest or Fehling's solution), ferricyanide test, and prothrombin levels.
Notifying physician immediately if diarrhea develops subsequent to administration of cefuroxime; may be symptomatic of pseudomembranous colitis.
Side/adverse effects
Signs of potential side effects, especially anaphylaxis, agranulocytosis, angioedema, eosinophilia, epidermal necrolysis, erythema multiforme, mild to moderate hearing loss, interstitial nephritis, leukopenia, neutropenia, pancytopenia, pseudomembranous colitis, seizure, Stevens-Johnson syndrome, thrombocytopenia, thrombophlebitis, toxic epidermal necrolysis, and urticaria
General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.{01}
May be administered intravenously or by deep intramuscular injections into a large muscle mass such as the gluteus or lateral part of the thigh.{01}
The intravenous route is preferred 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.{01}
For direct intermittent intravenous administration (bolus), slowly inject the solution into a vein over a period of 3 to 5 minutes, or give through the tubing system by which the patient is also receiving other intravenous solutions.{01}
For short intravenous infusion administer over a period of approximately 30 minutes.{2.}
Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime has been used successfully in these mixed infections in which several organisms have been isolated. Appropriate cultures and susceptibility studies should be performed to determine the susceptibility of the causative organisms to cefuroxime. Therapy may be started while awaiting the results of these studies; however, once these results become available, the antibiotic treatment should be adjusted accordingly.{01}
A course of oral antibiotics may be administered when appropriate following the completion of parenteral administration of cefuroxime.{01}
As with antibiotic therapy in general, administration of cefuroxime 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.{01}
In the treatment of chronic urinary tract infection, frequent bacteriologic and clinical appraisal 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 should not be used.{01}
In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.{01}
Treatment of side and adverse effects
Pseudomembranous colitis—mild cases usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile, which is one primary cause of antibiotic associated colitis. Other causes of colitis should also be considered.{01}
Parenteral Dosage Forms
Note: The dosing and strengths of the dosage forms available are expressed in terms of cefuroxime base (not the sodium salt).
CEFUROXIME FOR INJECTION USP
Note: For adults: a reduced dosage must be employed when renal function is impaired.
| Creatinine clearance (mL/min)/(mL/sec) |
Dose (base) |
|---|---|
| > 20/0.33 | 750 mg to 1.5 grams every 8 hours |
| 10–20/0.17–0.33 | 750 mg every 12 hours |
| < 10/0.17 | 750 mg every 24 hours |
| Hemodialysis patients | 750 mg at the end of each dialysis period |
Usual Adult Dose
Intravenous or intramuscular, 750 mg to 1.5 gm of cefuroxime every 8 hours, usually for 5 to 10 days.{01}
Canadian product information suggests a duration for 5 to 14 days.{2.}
Bone and joint infections (treatment),{01}{2.}
Gonococcal infections, disseminated, severe or complicated (treatment)1,
Pneumonia, severe or complicated (treatment),
Skin and skin-structure infections, severe or complicated (treatment)1,
Urinary tract infections, severe or complicated (treatment)1
Intravenous, 1.5 gm every 8 hours
{01}
Gonococcal infections, disseminated (treatment),1
Pneumonia, uncomplicated (treatment),
Skin and skin-structure infections (treatment),
Urinary tract infections, uncomplicated (treatment)
Intravenous, 750 mg every 8 hours
{01}{2.}
Gonococcal infection, uncomplicated (treatment)
Intramuscular, 1.5 gm given as one dose at 2 different sites; administer with 1 gm of oral probenecid{01}{2.}
Meningitis, bacterial (treatment)
Intravenous, up to 3 gm every 8 hours{01}{2.}
Perioperative prophylaxis
Open heart surgery patients: Intravenous, 1.5 gm at the induction of anesthesia, then 1.5 grams every twelve hours, for a total of 6 grams {01}{2.}.
Surgical procedures, clean-contaminated or potentially contaminated: Intravenous 1.5 gm dose just before surgery (0.5 to 1 hour prior to initial incision). Thereafter, 750 mg intravenously or intramuscularly every 8 hours when the procedure is prolonged.{01} .
In Canada after surgery, 750 mg intravenously or intramuscularly at 8 hours and 16 hours when the procedure is prolonged. Continued prophylactic administration of any antibiotic does not appear to be associated with a reduced incidence of subsequent infection, but will increase the possibility of adverse reactions and the development of bacterial resistance.{2.}
Other infections
Less susceptible organisms or life-threatening infections: 1 Intravenous, 1.5 gm every 6 hours {01}.
[Severe or life threatening infections:] Intravenous, 1.5 gm every 8 hours (4.5gm per day){2.}
Note: A minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyrogens in order to guard against the risk of rheumatic fever or glomerulonephritis.{01}{2.}
Usual adult prescribing limits
Bacterial Meningitis-Up to 3 gm of cefuroxime every 8 hours.{01}
Usual Pediatric Dose
For those three months of age and older: Intravenous, 50 to 150 mg per kg of body weight per day in equally divided doses every 6 to 8 hours. A higher dosage of 100 mg per kg of body weight per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.{01}
[Neonates (up to 1 month of age)]Intravenous, 30 to 100 mg per kg of body weight per day in 2 or 3 equally divided doses. Note that in the first few weeks of life, the serum half-life of cefuroxime can be 3 to 5 times that in adults.{2.}
[ Infants and children (1 month to 12 years)]Intravenous, 30 to 100 mg per kg of body weight per day in 3 or 4 equally divided doses. A dose of 60 mg per kg of body weight per day is appropriate for most infections.{2.}
Note: Pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.{01}
Bone and joint infections (treatment)
For those three months of age and older—Intravenous, 150 mg per kg of body weight per day (not exceeding the maximum adult dosage) 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{01}
[Infants and children (1 month to 12 years)]Intravenous, 70 to 150 mg per kg of body weight per day every 8 hours. In clinical trials a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration{2.}
Meningitis, bacterial (treatment)
For those 3 months of age and older—Intravenous, 200 to 240 mg per kg of body weight per day in equally divided doses every 6 to 8 hours.{01}
[Infants and children (1 month to 12 years)]Intravenous, 200 to 240 mg per kg of body weight per day in 3 or 4 equally divided doses.{2.}
[Neonates (up to 1 month of age)]Intravenous, 100 mg per kg of body weight per day in 2 or 3 equally divided doses.{2.}
Usual pediatric prescribing limits
For those three months of age and older: See Usual adult prescribing limits{01} .
Usual Geriatric Dose
See Usual adult dose.
Usual geriatric prescribing limits
See Usual adult prescribing limits.
Strength(s) usually available
U.S.—
Note: Zinacef contains 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.{01}
750 mg vial (Rx) [Zinacef ( sodium)]
1.5 gm vial (Rx) [Zinacef (sodium)]
7.5 gm vial (Rx) [Zinacef (sodium)]
750 mg ADD-Vantage vial (Rx) [Zinacef ( sodium)]
1.5 gm ADD-Vantage vial (Rx) [Zinacef ( sodium)]
750 mg infusion pack (Rx) [Zinacef ( sodium)]
1.5 gm infusion pack (Rx) [Zinacef ( sodium)]
Canada—
750 mg vial (Rx) [Zinacef]
1.5 gm vial (Rx) [Zinacef]
7.5 gm vial (Rx) [Zinacef (sodium)]{2.}
Packaging and storage:
When dry, store between 59 and 86°F (15 and 30°C). Protect from light.{01}
When frozen, store at or below -4°F ( -20°C){01}
Preparation of dosage form:
For intramuscular use: • Each 750 mg vial of cefuroxime should be constituted with 3 mL of Sterile Water for Injection. Shake gently to disperse. Results in 220 mg per mL suspension for injection.{01}
For intravenous use: • Each 750 mg vial should be constituted with 8 mL of Sterile Water for Injection. Results in 90 mg per mL solution for injection
• Each 1.5 gm vial should be constituted with 16 mL of Sterile Water for Injection. Results in 90 mg per mL solution for injection
• Each bulk 7.5 gm vial should be constituted with 77 mL of Sterile Water for Injection. Results in 95 mg per mL (750 mg per 8 mL) of solution for injection.
• Dilute solutions—Each 750 mg and 1.5 gm infusion packs should be constituted with 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection. The 750 mg infusion pack results in 7.5 mg per mL of solution for injection. The 1.5 gm infusion pack results in 15 mg per mL of solution for injection.
• Dilute solutions may be further diluted to concentrations between 1 and 30 mg per mL in the following solutions: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5 % Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10% Invert Sugar in Water for Injection.{01}
See the manufacturer's package insert for any additional instructions.
Stability:
Solutions of cefuroxime range in color from light yellow to amber, depending on the concentration and diluent used.{01}
ADD-Vantage diluent containers and activated to dissolve the drug are stable for 24 hours at room temperature or for 7 day under refrigeration (5° C). Joined vials that have not been activated may be used within a 14 day period. Freezing solutions in the ADD-Vantage system is not recommended.{01}
Suspensions and solutions of reconstituted 750 mg or 1.5 gm vials should be used within 24 hours when stored at room temperature and within 48 hours when stored in refrigeration (5° C). The 7.5 gm bulk containers are stable for 24 hours at room temperature and 7 days under refrigeration (5° C){01}
Frozen solutions of 750 mg, or 1.5 gm vials properly reconstituted or 8 or 16 mL from the 7.5 gm bulk vial, which are subsequently diluted to 50 or 100 mL in Baxter Viaflex Mini-bags are stable for 6 months when stored at -20° C.{01}
Thawed solutions may be stored for 24 hours at room temperature or for up to 7 days in refrigeration. Once thawed solutions should not be refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. {01}
Cefuroxime powder as well as solutions and suspensions tend to darken depending on conditions, without adversely affecting product potency.{01}
Bulk packages after initial withdrawal must be discarded within 24 hours.{01}
Solutions diluted to concentrations between 1 and 30 mg per mL will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration.{01}
Incompatibility
Solutions of cefuroxime should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy is indicated, each of these antibiotics can be administered separately.{01}
Sodium Bicarbonate Injection USP is not recommended for the dilution of cefuroxime.{01}
CEFUROXIME INJECTION USP
Note: For Adults: A reduced dosage must be employed when renal function is impaired.
| Creatinine clearance (mL/min)/(mL/sec) |
Dose (base) |
|---|---|
| > 20/0.33 | 750 mg to 1.5 grams every 8 hours |
| 10–20/0.17–0.33 | 750 mg every 12 hours |
| < 10/0.17 | 750 mg every 24 hours |
| Hemodialysis patients | 750 mg at the end of each dialysis period |
Patients on hemodialysis should receive a further dose at the end of the dialysis.{01}
Usual Adult Dose
Intravenous, 750 mg to 1.5 gm of cefuroxime every 8 hours, usually for 5 to 10 days.{01}
Canadian product information suggests a duration for 5 to 14 days.{2.}
Bone and joint infections (treatment),{01}{2.}
Gonococcal infections, disseminated, severe or complicated (treatment)1,
Pneumonia, severe or complicated (treatment),
Skin and skin-structure infections, severe or complicated (treatment)1,
Urinary tract infections, severe or complicated (treatment)1
Intravenous, 1.5 gm every 8 hours
{01}
Gonococcal infections, disseminated (treatment),1
Pneumonia, uncomplicated (treatment),
Skin and skin-structure infections (treatment),
Urinary tract infections, uncomplicated (treatment)
Intravenous, 750 mg every 8 hours
{01}{2.}
Meningitis, bacterial (treatment)
Intravenous, up to 3 gm every 8 hours{01}{2.}
Perioperative prophylaxis
Open heart surgery patients: Intravenous, 1.5 gm at the induction of anesthesia, then 1.5 grams every twelve hours, for a total of 6 grams {01}{2.}.
Surgical procedures, clean-contaminated or potentially contaminated: Intravenous 1.5 gm dose just before surgery (0.5 to 1 hour prior to initial incision). Thereafter, 750 mg intravenously every 8 hours when the procedure is prolonged.{01} .
In Canada after surgery, 750 mg intravenously at 8 hours and 16 hours when the procedure is prolonged. Continued prophylactic administration of any antibiotic does not appear to be associated with a reduced incidence of subsequent infection, but will increase the possibility of adverse reactions and the development of bacterial resistance.{2.}
Other infections
Less susceptible organisms or life-threatening infections: 1 Intravenous, 1.5 gm every 6 hours {01}.
[Severe or life threatening infections:] Intravenous, 1.5 gm every 8 hours (4.5gm per day){2.}
Note: A minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyrogens in order to guard against the risk of rheumatic fever or glomerulonephritis.{01}{2.}
Usual adult prescribing limits
See Usual adult prescribing limits: Cefuroxime for injection{01}
Usual Pediatric Dose
See Usual Pediatric Dose: Cefuroxime for injection{01}
Usual pediatric prescribing limits
For those three months of age and older See Usual adult prescribing limits: Cefuroxime for injection{01}
Usual Geriatric Dose
See Usual adult dose: Cefuroxime for injection.
Usual geriatric prescribing limits
See Usual adult prescribing limits: Cefuroxime for injection{01}.
Strength(s) usually available
U.S.—
750 mg as frozen, iso-osmotic, sterile, nonpyrogenic solution in a plastic container (Rx) [Zinacef (Dextrose Hydrous, USP 1.4 gm) (Sodium Citrate Hydrous, USP 300 mg) (sodium 111 mg (4.8 mEq)) (hydrochloric acid) (sodium hydroxide)]
1.5 gm as frozen, iso-osmotic, sterile, nonpyrogenic solution in a plastic container (Rx) [Zinacef (Sodium Citrate Hydrous, USP 600 mg) (sodium 222 mg (9.7 mEq)) (hydrochloric acid) (sodium hydroxide )]
Note: The plastic container is fabricated from a specially designed multilayer plastic, PL 2040. Solutions are in contact with polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.{01}
Canada—
Not commercially available
Packaging and storage:
Store frozen below -20° C.{01}
Preparation of dosage form:
Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. {01}
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 for the secondary container is complete.{01}
Mix after solution has reached room temperature. Check or minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. {01}
Do not add supplementary medication.{01}.
Do not use unless solution is clar and seal is intact.{01}
Stability:
Solutions of premixed cefuroxime range in color from light yellow to amber.{01}
Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected{01}.
Thawed solutions may be stored for 24 hours at room temperature or for up to 28 days in refrigeration. Once thawed, solutions should not be refrozen. {01}
Incompatibility
Solutions of cefuroxime should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy is indicated, each of these antibiotics can be administered separately.{01}
Developed: 11/21/2002
References
- Product Information: Zinacef®,cefuroxime.GlaxoSmithKline Inc., Research Triangle Park, NC, (PI revised 10/2001) reviewed 10/2002.
- Product Information: PrZinacef®,cefuroxime.GlaxoSmithKline Inc., Mississauga, Ontario, Canada, (PI revised 05/01/2002) reviewed 10/2002.
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