Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/898
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ZINACEF (Injection, Solution)
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Dosage:<br/>Adults: The usual adult dosage range for ZINACEF 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 ZINACEF. A course of
oral antibiotics was administered when appropriate following the completion
of parenteral administration of ZINACEF. 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.<br/>Impaired Renal Function: A reduced dosage must be employed when renal functionis impaired. Dosage should be determined by the degree of renal impairment
and the susceptibility of the causative organism (see Table 2). When only serum creatinine is available, the following
formula(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. Females: 0.85 x male value Note: As with antibiotic therapy
in general, administration of ZINACEF 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 necessaryduring 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.<br/>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
ZINACEF. In cases of bacterial meningitis,
a larger dosage of ZINACEF 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.<br/>Preparation of Solution and Suspension: The directions
for preparing ZINACEF for both IV and IM use are summarized in Table
3.<br/>For Intramuscular Use: Each 750-mg vial of ZINACEF should be constituted
with 3.0 mL of Sterile Water for Injection. Shake gently to disperse
and withdraw completely the resulting suspension for injection.<br/>For Intravenous Use: Each 750-mg vial should be constituted with 8.3 mL
of Sterile Water for Injection. Withdraw completely the resulting
solution for injection. Each 1.5-gram vial
should be constituted with 16.0 mL of Sterile Water for Injection,
and the solution should be completely withdrawn for injection. The 7.5-gram pharmacy bulk vial should be constituted
with 77 mL of Sterile Water for Injection; each 8 mL of
the resulting solution contains 750 mg of cefuroxime. Each 750-mg and 1.5-gram infusion pack should be constituted
with 100 mL of Sterile Water for Injection, 5% Dextrose Injection,
0.9% Sodium Chloride Injection, or any of the solutions listed under
the Intravenous portion of the COMPATIBILITY AND STABILITY section.<br/>Administration: After constitution,
ZINACEF may be given intravenously or by deep IM injection into a
large muscle mass (such as the gluteus or lateral part of the thigh).
Before injecting intramuscularly, aspiration is necessary to avoid
inadvertent injection into a blood vessel.<br/>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 direct intermittent IV administration, slowly inject the solution into a vein over a period of 3 to 5 minutes
or give it through the tubing system by which the patient is also
receiving other IV solutions. 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 ZINACEF, it is
advisable to temporarily discontinue administration of any other solutions
at the same site. ADD-Vantage vials are to
be constituted only with 50 or 100 mL of 5% Dextrose Injection,
0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection
in Abbott ADD-Vantage flexible diluent containers (see Instructions
for Constitution). ADD-Vantage vials that have been joined to Abbott
ADD-Vantage diluent containers and activated to dissolve the drug
are stable for 24 hours at room temperature or for 7 days
under refrigeration. Joined vials that have not been activated may
be used within a 14-day period; this period corresponds to that for
use of Abbott ADD-Vantage containers following removal of the outer
packaging (overwrap). Freezing solutions of
ZINACEF in the ADD-Vantage system is not recommended. For continuous IV infusion, a solution of ZINACEF 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 ZINACEF,
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 ZINACEF and an aminoglycoside
is indicated, each of these antibiotics can be administered separately
to the same patient.<br/>Directions for Use of ZINACEF Frozen
in Galaxy Plastic Containers: ZINACEF supplied
as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic
containers is to be administered after thawing either as a continuous
or intermittent IV infusion. The thawed solution of the premixed product
is stable for 28 days if stored under refrigeration (5��C)
or for 24 hours if stored at room temperature (25��C). Do not refreeze. 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. 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. Mix after solution has reached
room temperature. Check for minute leaks by squeezing bag firmly.
Discard bag if leaks are found as sterility may be impaired. Do not
add supplementary medication. Do not use unless solution is clear
and seal is intact. Use sterile equipment.<br/>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.<br/>Preparation for Administration:
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Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin
antibiotic for parenteral administration. It is the sodium salt of
(6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate,
and it has the following chemical structure: The empirical formula is CHNNaOS, representing a molecular weight
of 446.4. ZINACEF contains approximately 54.2 mg
(2.4 mEq) of sodium per gram of cefuroxime activity. ZINACEF in sterile crystalline form is supplied in vials
equivalent to 750 mg, 1.5 g, or 7.5 g of cefuroxime
as cefuroxime sodium and in ADD-Vantage vials equivalent
to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions
of ZINACEF range in color from light yellow to amber, depending on
the concentration and diluent used. The pH of freshly constituted
solutions usually ranges from 6 to 8.5. ZINACEF
is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution
with 750 mg or 1.5 g of cefuroxime as cefuroxime sodium.
Approximately 1.4 g of Dextrose Hydrous, USP has been added to
the 750-mg dose to adjust the osmolality. Sodium Citrate Hydrous,
USP has been added as a buffer (300 mg and 600 mg to the
750-mg and 1.5-g doses, respectively). ZINACEF contains approximately
111 mg (4.8 mEq) and 222 mg (9.7 mEq) of sodium
in the 750-mg and 1.5-g doses, respectively. The pH has been adjusted
with hydrochloric acid and may have been adjusted with sodium hydroxide.
Solutions of premixed ZINACEF range in color from light yellow to
amber. The solution is intended for intravenous (IV) useafter thawing
to room temperature. The osmolality of the solution is approximately
300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to
7.5. The plastic container for the frozen solution
is fabricated from a specially designed multilayer plastic, PL 2040.
Solutions are in contact with the 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 beenconfirmed in tests in animals according to USP biological
tests for plastic containers as well as by tissue culture toxicity
studies.
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After intramuscular (IM) injection of a 750-mg dose
of cefuroxime to normal volunteers, the mean peak serum concentration
was 27 mcg/mL. The peak occurred at approximately 45 minutes
(range, 15 to 60 minutes). Following IV doses of 750 mg
and 1.5 g, serum concentrations were approximately 50 and 100 mcg/mL,
respectively, at 15 minutes. Therapeutic serum concentrations
of approximately 2 mcg/mL or more were maintained for 5.3 hours
and 8 hours or more, respectively. There was no evidence of accumulation
of cefuroxime in the serum following IV administration of 1.5-g doses
every 8 hours to normal volunteers. The serum half-life after
either IM or IV injections is approximately 80 minutes. Approximately 89% of a dose of cefuroxime is excreted
by the kidneys over an 8-hour period, resulting in high urinary concentrations. Following the IM administration of a 750-mg single dose,
urinary concentrations averaged 1,300 mcg/mL during the first
8 hours. Intravenous doses of 750 mg and 1.5 g produced
urinary levels averaging 1,150 and 2,500 mcg/mL, respectively,
during the first 8-hour period. The concomitant
oral administration of probenecid with cefuroxime slows tubular secretion,
decreases renal clearance by approximately 40%, increases the peak
serum level by approximately 30%, and increases the serum half-life
by approximately 30%. Cefuroxime is detectable in therapeutic concentrations
in pleural fluid, joint fluid, bile, sputum, bone, and aqueous humor. Cefuroxime is detectable in therapeutic concentrations
in cerebrospinal fluid (CSF) of adults and pediatric patients with
meningitis. The following table shows the concentrations of cefuroxime
achieved in cerebrospinal fluid during multiple dosing of patients
with meningitis. Cefuroxime is approximately 50% bound to serum
protein.<br/>Microbiology: Cefuroxime has
in vitro activity against a wide range of gram-positive and gram-negative
organisms, and it is highly stable in the presence of beta-lactamases
of certain gram-negative bacteria. The bactericidal action of cefuroxime
results from inhibition of cell-wall synthesis. Cefuroxime is usually active against the following organisms in
vitro.<br/>Aerobes, Gram-positive: Staphylococcus aureus,
Staphylococcus epidermidis, Streptococcus pneumoniae, and Streptococcus pyogenes (and other streptococci). NOTE: Most strains of enterococci, e.g., Enterococcusfaecalis (formerly Streptococcus
faecalis), are resistant to cefuroxime. Methicillin-resistant
staphylococci and Listeriamonocytogenes are resistant to cefuroxime.<br/>Aerobes, Gram-negative: Citrobacter spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae (including ampicillin-resistant
strains), Haemophilus parainfluenzae,
Klebsiella spp. (including Klebsiella pneumoniae), Moraxella (Branhamella) catarrhalis (including ampicillin- and
cephalothin-resistant strains), Morganella
morganii (formerly Proteus
morganii), Neisseria gonorrhoeae (including penicillinase- and non���penicillinase-producing
strains), Neisseria meningitidis, Proteus
mirabilis, Providencia rettgeri (formerly Proteus rettgeri), Salmonella spp., and Shigella spp. NOTE: Some strains of Morganella morganii,
Enterobacter cloacae, and Citrobacter spp. have been shown by in vitro tests to be resistant to cefuroxime
and other cephalosporins. Pseudomonas and Campylobacter spp., Legionella spp., Acinetobacter calcoaceticus, and most
strains of Serratia spp. and Proteus vulgaris are resistant to most
first- and second-generation cephalosporins.<br/>Anaerobes: Gram-positive and gram-negative cocci (including Peptococcus and Peptostreptococcus spp.), gram-positive
bacilli (including Clostridium spp.), and gram-negative bacilli (including Bacteroides and Fusobacterium spp.). NOTE: Clostridium difficile and most strains of Bacteroides fragilis are resistant to cefuroxime.<br/>Susceptibility Tests:<br/>Diffusion Techniques: Quantitative methods that require measurement of
zone diameters give an estimate of antibiotic susceptibility. One
such standard procedurethat has been recommended for
use with disks to test susceptibility of organisms to cefuroxime uses
the 30-mcg cefuroxime disk. Interpretation involves the correlation
of the diameters obtained in the disk test with the minimum inhibitory
concentration (MIC) for cefuroxime. A report
of���Susceptible���indicates that the pathogen is likely
to be inhibited by generally achievable blood levels. A report of���Moderately Susceptible���suggests that the organism
would be susceptible if high dosage is used or if the infection is
confined to tissues and fluids in which high antibiotic levels are
attained. A report of���Intermediate���suggests an equivocable
or indeterminate result. A report of���Resistant���indicates
that achievable concentrations of the antibiotic are unlikely to be
inhibitory and other therapy should be selected. Reports from the laboratory giving results of the standard single-disk
susceptibility test for organisms other than Haemophilus spp. and Neisseriagonorrhoeae with a 30-mcg
cefuroxime disk should be interpreted according to the following criteria: Results for Haemophilus spp. should be interpreted according to the following criteria: Results for Neisseriagonorrhoeae should be interpreted
according to the following criteria: Organisms should be tested with the cefuroxime
disk since cefuroxime has been shown by in vitro tests to be active
against certain strains found resistant when other beta-lactam disks
are used. The cefuroxime disk should not be used for testing susceptibility
to other cephalosporins. Standardized procedures
require the use of laboratory control organisms. The 30-mcg cefuroxime
disk should give the following zone diameters. 1. Testing for organisms other than Haemophilus spp. and Neisseria
gonorrhoeae: 2. Testing for Haemophilus spp.: 3. Testing for Neisseria
gonorrhoeae:<br/>Dilution Techniques: Use a standardized dilution method(broth,
agar, microdilution) or equivalent with cefuroxime powder. The MIC
values obtained for bacterial isolates other than Haemophilus spp. and Neisseriagonorrhoeae should be interpreted according to the following
criteria: MIC values obtained for Haemophilus spp. should be interpreted according to the
following criteria: MIC values obtained for Neisseria gonorrhoeae should be interpreted according to
the following criteria: As with standard diffusion techniques, dilution
methods require the use of laboratory control organisms. Standard
cefuroxime powder should provide the following MIC values. 1. For organisms other than Haemophilus spp. and Neisseria
gonorrhoeae: 2. For Haemophilus spp.: 3. For Neisseria gonorrhoeae:
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ZINACEF is contraindicated in patients with known
allergy to the cephalosporin group of antibiotics.
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ZINACEF in the dry state should be stored between
15��and 30��C (59��and 86��F) and protected from
light. ZINACEF is a dry, white to off-white powder supplied in vials
and infusion packs as follows: NDC 0173-0352-10
750-mgVial (Tray of 10) NDC 0173-0354-10
1.5-gVial (Tray of 10) NDC 0173-0353-32
750-mgInfusion Pack (Tray of 10) NDC 0173-0356-32 1.5-gInfusion Pack (Tray of 10) NDC 0173-0400-00 7.5-gPharmacy Bulk Package
(Tray of 6) NDC 0173-0436-00 750-mg ADD-Vantage
Vial (Tray of 25) NDC 0173-0437-00 1.5-g ADD-Vantage
Vial (Tray of 10) (The above ADD-Vantage vials
are to be used only with Abbott ADD-Vantage diluent containers.) ZINACEF frozen as a premixed solution of cefuroxime injection
should not be stored above -20��C. ZINACEF is supplied frozen
in 50-mL, single-dose, plastic containers as follows: NDC 0173-0424-00 750-mgPlastic Container (Carton of
24) NDC 0173-0425-00 1.5-gPlastic
Container (Carton of 24) Equivalent
to cefuroxime.
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General: Although ZINACEF
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 ZINACEF 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 ZINACEF may result in overgrowth of nonsusceptible 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 ZINACEF
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.<br/>Information for Patients: Patients should be counseled
that antibacterial drugs, including ZINACEF, should only be used to
treat bacterial infections. They do not treat viral infections (e.g.,
the common cold). When ZINACEF 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 ZINACEF 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.<br/>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.<br/>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
ZINACEF. Cefuroxime does not interfere with
the assay of serum and urine creatinine by the alkaline picrate method.<br/>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/m) have revealed no impairment
of fertility. Reproductive studies revealed
no impairment of fertility in animals.<br/>Pregnancy:<br/>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/m) and
rabbits at doses up to 400 mg/kg/day (2.1 times the recommended
maximum human dose based on mg/m) 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.<br/>Nursing Mothers: Since cefuroxime
is excreted in human milk, caution should be exercised when ZINACEF
is administered to a nursing woman.<br/>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.<br/>Geriatric Use: : Of the 1,914 subjects
who received cefuroxime in 24 clinical studies of ZINACEF, 901
(47%) were 65 and over while 421 (22%) were 75 and over. 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 cannot 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).
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Overdosage of cephalosporins can cause cerebral
irritation leading to convulsions. Serum levels of cefuroxime can
be reduced by hemodialysis and peritoneal dialysis.
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cefuroxime
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ZINACEF (Injection, Solution)
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ZINACEF is generally well tolerated. The most common
adverse effects have been local reactions following IV administration.
Other adverse reactions have been encountered only rarely.<br/>Local Reactions: Thrombophlebitis
has occurred with IV administration in 1 in 60 patients.<br/>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).<br/>Hypersensitivity Reactions: Hypersensitivity
reactions have been reported in fewer than 1% of the patients treated
with ZINACEF 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.<br/>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.<br/>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.<br/>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.<br/>Postmarketing Experience with ZINACEF
Products: In addition
to the adverse events reported during clinical trials, the following
events have been observed during clinical practice in patients treated
with ZINACEF and were reported spontaneously. Data are generally insufficient
to allow an estimate of incidence or to establish causation.<br/>Immune System Disorders: Cutaneous vasculitis.<br/>Neurologic: Seizure.<br/>Non-site specific: Angioedema.<br/>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:<br/>Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including
vaginal candidiasis, toxic nephropathy, hepatic dysfunction including
cholestasis, aplastic anemia, hemolytic anemia, hemorrhage. Several cephalosporins, including ZINACEF, 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.<br/>Altered Laboratory Tests: Prolonged prothrombin time, pancytopenia, agranulocytosis.
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BEFORE THERAPY WITH ZINACEF IS INSTITUTED, CAREFUL
INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS
HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER
DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE
PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT
WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS.
IF AN ALLERGIC REACTION TO ZINACEFOCCURS, DISCONTINUE THE DRUG. SERIOUS
ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER
EMERGENCY MEASURES. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including ZINACEF, and may range in severity
from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alters the normal flora of the colon leading to overgrowth
of C. difficile. C. difficile produces toxins A
and B which contribute to the development of CDAD. Hypertoxin producing
strains of C. difficile cause increased morbidity and mortality, as these infections can
be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea
following antibiotic use. Careful medical history is necessary since
CDAD has been reported to occur over two months after the administration
of antibacterial agents. If CDAD is
suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management,
protein supplementation, antibiotic treatment of C. difficile, and surgical
evaluation should be instituted as clinically indicated. When the colitis is not relieved by drug
discontinuation or when it is severe, oral vancomycin is the treatment
of choice for antibiotic-associated pseudomembranous colitis produced
by Clostridium difficile. Other
causes of colitis should also be considered.
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ZINACEF is indicated for the treatment of patients
with infections caused by susceptible strains of the designated organisms
in the following diseases: Clinical microbiological studies in skin and skin��structure
infections frequently reveal the growth of susceptible strains of
both aerobic and anaerobic organisms. ZINACEF 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, ZINACEF 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 ZINACEF and other antibacterial
drugs, ZINACEF 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.<br/>Prevention: The preoperative
prophylactic administration of ZINACEF 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. ZINACEF
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 ZINACEF 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 ZINACEF 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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ZINACEF
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