Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/414
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Tazicef (Injection, Powder, For Solution)
|
| dailymed-instance:dosage |
NOTE: This insert is
for a Pharmacy Bulk Package and is intended for preparing IV admixtures only.
Dosage recommendations for intramuscular or intravenous injection and intraperitoneal
use are for informational purposes only. Dosage: The usual adult dosage is 1 gram administered intravenously every
8 or 12 hours. The dosage and route should be determined by the susceptibility
of the causative organisms, the severity of infection and the condition and
renal function of the patient. The guidelines for dosage
of Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following
dosage schedule is recommended. Impaired Hepatic Function: No adjustment in dosage is
required for patients with hepatic dysfunction. Impaired Renal Function: Ceftazidime is
excreted by the kidneys, almost exclusively by glomerular filtration. Therefore,
in patients with impaired renal function (glomerular filtration rate [GFR]<50 mL/min.), it is recommended that the dosage of ceftazidime be reduced
to compensate for its slower excretion. In patients with suspected renal insufficiency,
an initial loading dose of 1 gram of ceftazidime may be given. An estimate
of GFR should be made to determine the appropriate maintenance dose. The recommended
dosage is presented in Table 4. When only serum creatinine is available, the following
formula (Cockcroft's equation)may be used to estimate
creatinine clearance. The serum creatinine should represent a steady state
of renal function: In patients with severe infections who would normally receive
6 grams of Tazicef daily were it not
for renal insufficiency, the unit dose given in the table above may be increased
by 50% or the dosing frequency increased appropriately. Further dosing should
be determined by therapeutic monitoring, severity of the infection and susceptibility
of the causative organism. In pediatric patients as
for adults, the creatinine clearance should be adjusted for body surface area
or lean body mass and the dosing frequency reduced in cases of renal insufficiency. In
patients undergoing hemodialysis, a loading dose of 1 gram is recommended,
followed by 1 gram after each hemodialysis period. Tazicef
(ceftazidime for injection, USP) can also be used in patients undergoing intra-peritoneal
dialysis and continuous ambulatory peritoneal dialysis. In such patients,
a loading dose of 1 gram of Tazicef may
be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis
fluid at a concentration of 250 mg for 2 liters of dialysis fluid. Note: Generally Tazicef should be continued for 2 days after the signs and symptoms of
infection have disappeared, but in complicated infections longer therapy may
be required. Administration: See above NOTE concerning the proper use of Pharmacy Bulk Packages. Intravenous Administration: The IV route
is preferable for patients with bacterial septicemia, bacterial meningitis,
peritonitis, or other severe or life-threatening infections, or for patients
who may be poor risks because of lowered resistance resulting from such debilitating
conditions as malnutrition, trauma, surgery, diabetes, heart failure or malignancy,
particularly if shock is present or pending. Intermittent intravenous infusion with a Y-type administration
set can be accomplished with compatible solutions. However, during
infusion of a solution containing ceftazidime it is desirable to discontinue
the other solution. All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure
develops. See RECONSTITUTION. Solutions of Tazicef, 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 Tazicef and an aminoglycoside
is indicated, each of these antibiotics can be administered separately to
the same patient. RECONSTITUTION Directions for
Proper Use of Pharmacy Bulk Packages: Note: The Pharmacy Bulk Package is for use in a
pharmacy admixture service only. Using aseptic technique, the closure should
be penetrated only 1 time after reconstitution using a sterile dispensing
set which allows measured dispensing of the contents. Use of a syringe and
needle is not recommended as it may cause leakage. The withdrawal of container
contents should be accomplished without delay. THE ENTIRE CONTENTS OF THE
VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY. A
plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging
device while dispensing in the pharmacy. Reconstitute
with Sterile Water for Injection according to the following table. The vacuum may assist entry of the diluent. SHAKE WELL. Insert
a gas relief needle through the vial closure to relieve the internal pressure.
Remove the gas relief needle before extracting any solution. COMPATIBILITY AND STABILITY IMPORTANT:
The following chemical stability information in no way indicates that it would
be acceptable practice to use this product well after the preparation time.
Good professional practice suggests that compounded admixtures should be administered
as soon after preparation as is feasible. Intravenous:Tazicef (ceftazidime for injection, USP) when reconstituted as
directed with Sterile Water for Injection, maintains satisfactory potency
for 24 hours at room temperature or for 7 days under refrigeration (5��C).
Solutions in 0.9% Sodium Chloride Injection in Viaflex small
volume containers that are frozen immediately after reconstitution are stable
for 3 months when stored at -20��C. 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. Frozen solutions should only
be thawed at room temperature. Do not force thaw by immersion in water baths
or by microwave irradiation. For larger volumes where it may be necessary
to warm the frozen product (to a maximum of 40��C), care should be taken
to avoid heating after thawing is complete. Once thawed, solutions should
not be refrozen. Thawed solutions may be stored for up to 8 hours at room
temperature or for 4 days in a refrigerator (5��C). Tazicef
(ceftazidime for injection, USP) is compatible with the more commonly used
IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL
in the following infusion fluids may be stored for up to 24 hours at room
temperature or 7 days if refrigerated: 0.9% Sodium Chloride Injection; Ringer's
Injection USP; Lactated Ringer's Injection USP; 5% Dextrose Injection;
5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium
Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose
Injection. Tazicef is
less stable in Sodium Bicarbonate Injection than in other IV fluids. It is
not recommended as a diluent. Solutions of Tazicef in 5% Dextrose and 0.9% Sodium Chloride Injection are stable for
at least 6 hours at room temperature in plastic tubing, drip chambers and
volume control devices of common IV infusion sets. Ceftazidime
at a concentration of 20 mg/mL has been found physically compatible for 24
hours at room temperature or 7 days under refrigeration in Sterile Water for
Injection when admixed with: cefazolin sodium 330 mg/mL; heparin 1000 units/mL;
and cimetidine HCl 150 mg/mL. Ceftazidime at a concentration
of 20 mg/mL has been found physically compatible for 24 hours at room temperature
or 7 days under refrigeration in 5% Dextrose Injection when admixed with potassium
chloride 40 mEq/L. Vancomycin solution exhibits a physical
incompatibility when mixed with a number of drugs, including ceftazidime.
The likelihood of precipitation with ceftazidime is dependent on the concentrations
of vancomycin and ceftazidime present. It is therefore recommended, when both
drugs are to be administered by intermittent IV infusion, that they be given
separately, flushing the IV lines (with one of the compatible IV fluids) between
the administration of these two agents. Note: Parenteral drug products should be inspected visually for particulate
matter prior to administration whenever solution and container permit. As
with other cephalosporins, Tazicef (ceftazidime for injection, USP) powder,
as well as solutions, tends to darken depending on storage conditions; within
the stated recommendations, however, product potency is not adversely affected.
|
| dailymed-instance:descripti... |
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam
antibiotic for parenteral administration. It is the pentahydrate of pyridinium,
1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methyl-ethoxy) imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo
(4.2.0.)oct-2-en-3-yl] methyl]-,hydroxide, inner salt, [6R-[6��,7��(Z)]].
It has the following structure: The molecular formula is CHNOS,
representing a molecular weight of 636.6. Tazicef (ceftazidime
for injection, USP) is a sterile, dry, powdered mixture of ceftazidime pentahydrate
and sodium carbonate. The sodium carbonate at a concentration of 118 mg/gram
of ceftazidime activity has been admixed to facilitate dissolution. The total
sodium content of the mixture is approximately 54 mg (2.3 mEq)/gram of ceftazidime
activity. Solutions of Tazicef range
in color from light yellow to amber, depending on the diluent and volume used.
The pH of freshly reconstituted solutions usually ranges from 5.0 to 7.5. Tazicef is available in a 6 gram Pharmacy Bulk
Package. The contents of this Pharmacy Bulk Package are intended for use by
a pharmacy admixture service for addition to suitable parenteral fluids in
the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS
REQUIRED BEFORE USE.
|
| dailymed-instance:clinicalP... |
This drug product can be administered intramuscularly, intraperitoneally
or by direct intravenous infusion. HOWEVER THE INTENT OF THIS PHARMACY BULK
PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY. After
IV administration of 500-mg and 1-gram doses of ceftazidime over 5 minutes
to normal adult male volunteers, mean peak serum concentrations of 45 mcg/mL
and 90 mcg/mL, respectively, were achieved. After IV infusion of 500-mg, 1-gram
and 2-gram doses of ceftazidime over 20 to 30 minutes to normal adult male
volunteers, mean peak serum concentrations of 42 mcg/mL, 69 mcg/mL and 170
mcg/mL, respectively, were achieved. The average serum concentrations following
IV infusion of 500-mg, 1-gram and 2-gram doses to these volunteers over an
8-hour interval are given in Table 1. The absorption and elimination of ceftazidime were directly
proportional to the size of the dose. The half-life following IV administration
was approximately 1.9 hours. Less than 10% of ceftazidime was protein bound.
The degree of protein binding was independent of concentration. There was
no evidence of accumulation of ceftazidime in theserum in individuals with
normal renal function following multiple IV doses of 1 gram and 2 grams every
8 hours for 10 days. Following IM administration of
500-mg and 1-gram doses of ceftazidime to normal adult volunteers, the mean
peak serum concentrations were 17 mcg/mL and 39 mcg/mL, respectively, at approximately
1 hour. Serum concentrations remained above 4 mcg/mL for 6 and 8 hours after
the IM administration of 500-mg and 1-gram doses, respectively. The half-life
of ceftazidimein these volunteers was approximately 2 hours. The
presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime
in individuals administered 2 grams intravenously every 8 hours for 5 days.
Therefore, a dosage adjustment from the normal recommended dosage is not required
for patients with hepatic dysfunction, provided renal function is not impaired. Approximately
80% to 90% of an IM or IV dose of ceftazidime is excreted unchanged by the
kidneys over a 24-hour period. After the IV administration of single 500-mg
or 1-gram doses, approximately 50% of the dose appeared in the urine in the
first 2 hours. An additional 20% was excreted between 2 and 4 hours after
dosing, and approximately another 12% of the dose appeared in the urine between
4 and 8 hours later. The elimination of ceftazidime by the kidneys resulted
in high therapeutic concentrations in the urine. The
mean renal clearance of ceftazidime was approximately 100 mL/min. The calculated
plasma clearance of approximately 115 mL/min. indicated nearly complete elimination
of ceftazidime by the renal route. Administration of probenecid before dosing
had no effect on the elimination kinetics of ceftazidime. This suggested that
ceftazidime is eliminated by glomerular filtration and is not actively secreted
by renal tubular mechanisms. Since ceftazidime is eliminated
almost solely by the kidneys, its serum half-life is significantly prolonged
in patients with impaired renal function. Consequently, dosage adjustments
in such patients as described in the DOSAGE AND ADMINISTRATION section are
suggested. Therapeutic concentrations of ceftazidime
are achieved in the following body tissues and fluids. Microbiology: Ceftazidime is bactericidal in action, exerting its effect by
inhibition of enzymes responsible for cell-wall synthesis. A wide range of
gram-negative organisms is susceptible to ceftazidime in
vitro , including strains resistant to gentamicin and other aminoglycosides.
In addition, ceftazidime has been shown to be active against gram-positive
organisms. It is highly stable to most clinically important beta-lactamases,
plasmid or chromosomal, which are produced by both gram-negative and gram-positive
organisms and, consequently, is active against many strains resistant to ampicillin
and other cephalosporins. Ceftazidime has been shown
to be active against the following organisms both in
vitro and in clinical infections (see INDICATIONS AND USAGE). Aerobes, Gram-Negative:Citrobacter spp. (including Citrobacter freundii and Citrobacterdiversus); Enterobacter spp. (including Enterobacter cloacae and Enterobacter aerogenes); Escherichia coli; Haemophilus
influenzae, including ampicillin-resistant strains, Klebsiella spp. (including Klebsiella pneumoniae); Neisseria meningitidis; Proteus mirabilis; Proteus
vulgaris; Pseudomonas spp.
(including Pseudomonas aeruginosa);and Serratia spp. Aerobes, Gram-Positive:Staphylococcus
aureus, including penicillinase- and non-penicillinase-producing
strains; Streptococcus agalactiae (group
B streptococci); Streptococcus pneumoniae,
and Streptococcus pyogenes (group A
beta-hemolytic streptococci). Anaerobes:Bacteroides spp. (NOTE:
Many strains of Bacteroides fragilis are
resistant). Ceftazidime has been shown to be active in vitro against most strains of the following
organisms; however, the clinical significance of these data is unknown: Acinetobacter spp., Clostridium spp. (not including Clostridium difficile); Haemophilus parainfluenzae; Morganellamorganii (formerly Proteus morganii); Neisseria gonorrhoeae; Peptococcus spp.; Peptostreptococcus spp.; Providencia spp. (including Providencia
rettgeri, formerly Proteus rettgeri); Salmonella spp.; Shigella spp.; Staphylococcus
epidermidis; and Yersinia enterocolitica. Ceftazidime and the aminoglycosides have
been shown to be synergistic in vitro against Pseudomonas aeruginosa and the enterobacteriaceae.
Ceftazidime and carbenicillin have also been shown to be synergistic in vitro against Pseudomonas
aeruginosa. Ceftazidime is not active in vitro against: methicillin-resistant staphylococci, Streptococcus faecalis and many other enterococci, Listeria monocytogenes, Campylobacter spp., or Clostridiumdifficile. Susceptibility
Tests:Diffusion Techniques: Quantitative
methods that require measurement of zone diameters give an estimate of antibiotic
susceptibility. One such procedurehas been recommended for
use with disks to test susceptibility to ceftazidime. Reports
from the laboratory giving results of the standard single-disk susceptibility
test with a 30 mcg ceftazidime disk should be interpreted according to the
following criteria: Susceptible
organisms produce zones of 18 mm or greater, indicating that the test organism
is likely to respond to therapy. Organisms
that produce zones of 15 mm to 17 mm are expected to be susceptible if high
dosage is used or if the infection is confined to tissues and fluids (e.g.,
urine) in which high antibiotic levels are attained. Resistant
organisms produce zones of 14 mm or less, indicating that other therapy should
be selected. Organisms should be tested with the ceftazidime
disk, since ceftazidime has been shown by in
vitro tests to be active against certain strains found resistant
when other beta-lactam disks are used. Standardized
procedures require the use of laboratory control organisms. The 30 mcg ceftazidime
disk should give zone diameters between 25 mm and 32 mm for Escherichia
coli ATCC 25922. For Pseudomonas aeruginosa ATCC 27853, the zone diameters should be between 22 mm and 29
mm. For Staphylococcus aureus ATCC
25923, the zone diameters should be between 16 mm and 20 mm. Dilution Techniques: In other susceptibility
testing procedures, e.g., ICS agar dilution or the equivalent, a bacterial
isolate may be considered susceptible if the minimum inhibitory concentration
(MIC) value for ceftazidime is not more than 16 mcg/mL. Organisms are considered
resistant to ceftazidime if the MIC is���64 mcg/mL. Organisms having
an MIC value of<64 mcg/mL but>16 mcg/mL are expected to be susceptible
if high dosage is used or if the infection is confined to tissues and fluids
(e.g., urine) in which high antibiotic levels are attained. As
with standard diffusion methods, dilution procedures require the use of laboratory
control organisms. Standard ceftazidime powder should give MIC values in the
range of 4 mcg/mL to 16 mcg/mL for Staphylococcus
aureus ATCC 25923. For Escherichia
coli ATCC 25922, the MIC range should be between 0.125 mcg/mL and
0.5 mcg/mL. For Pseudomonas aeruginosa ATCC
27853, the MIC range should be between 0.5 mcg/mL and 2 mcg/mL.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Tazicef is contraindicated
in patients who have shown hypersensitivity to ceftazidime or the cephalosporin
group of antibiotics.
|
| dailymed-instance:supply |
Tazicef in the dry
state should be stored at 20��to 25��C (68��to 77��F) [See
USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime
for injection, USP) is a dry, white to off-white powder supplied in vials
as follows: Pharmacy Bulk
Vials: equivalent to 6 grams of ceftazidime. 6
gram (tray of 10) NDC 0409-5086-11 Also available as: Vials: equivalent to 1 gram and 2 grams of ceftazidime. 1
gram (tray of 25) NDC 0409-5082-16 2 gram (tray of 10)
NDC 0409-5084-11 ���Piggyback���Vials for IV admixture: equivalent to 1 gram of ceftazidime. 1
gram (tray of 10) NDC 0409-5083-11 ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime. 1
gram: NDC 0409-5092-16 2 gram: NDC 0409-5093-11
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General:: Ceftazidime has not been shown to be nephrotoxic; however,
high and prolonged serum antibiotic concentrations can occur from usual dosages
in patients with transient or persistent reduction of urinary output because
of renal insufficiency. The total daily dosage should be reduced when ceftazidime
is administered to patients with renal insufficiency (see DOSAGE AND ADMINISTRATION).
Elevated levels of ceftazidime in these patients can lead to seizures, encephalopathy,
asterixis and neuromuscular excitability. Continued dosage should be determined
by degree of renal impairment, severity of infection and susceptibility of
the causative organisms. As with other antibiotics,
prolonged use of Tazicef (ceftazidime for injection, USP) may result in overgrowth
of nonsusceptible organisms. Repeated evaluation of the patient's condition
is essential. If superinfection occurs during therapy, appropriate measures
should be taken. Inducible type-1 beta-lactamase resistance
has been noted with some organisms (e.g., Enterobacter spp., Pseudomonas spp.,
and Serratia spp.). As with other extended-spectrum
beta-lactam antibiotics, resistance can develop during therapy, leading to
clinical failure in some cases. When treating infections caused by these organisms,
periodic susceptibility testing should be performed when clinically appropriate.
If patients fail to respond to monotherapy, an aminoglycoside or similar agent
should be considered. 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. Prothrombin time should be monitored
in patients at risk and exogenous vitamin K administered as indicated. Tazicef should be prescribed with caution in
individuals with a history of gastrointestinal disease, particularly colitis. Distal
necrosis can occur after inadvertent intra-arterial administration of ceftazidime. Prescribing
Tazicef (ceftazidime) 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/>Drug Interactions:: Nephrotoxicity has been reported following concomitant administration
of cephalosporins with aminoglycoside antibiotics or potent diuretics, such
as furosemide. Renal function should be carefully monitored, especially if
higher dosages of the aminoglycosides are to be administered or if therapy
is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside
antibiotics. Nephrotoxicity and ototoxicity were not noted when ceftazidime
was given alone in clinical trials. Chloramphenicol
has been shown to be antagonistic to beta-lactam antibiotics, including ceftazidime,
based on in vitro studies and time
kill curves with enteric gram-negative bacilli. Due to the possibility of
antagonism in vivo, particularly when
bactericidal activity is desired, this drug combination should be avoided.<br/>Drug/Laboratory Test Interactions:: The administration of ceftazidime may result in a false-positive
reaction for glucose in the urine when using Clinitest tablets,
Benedict's solution or Fehling's solution. It is recommended
that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or
Tes-Tape) be used.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Long-term studies in animals have not been performed to evaluate
carcinogenic potential. However, a mouse micronucleus test and an Ames test
were both negative for mutagenic effects.<br/>Pregnancy:: Teratogenic Effects: Pregnancy
Category B. Reproduction studies have been performed in mice and rats at doses
up to 40 times the human dose and have revealed no evidence of impaired fertility
or harm to the fetus due to Tazicef.
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:: Ceftazidime is excreted in human milk in low concentrations.
Caution should be exercised when Tazicef is
administered to a nursing woman.<br/>Pediatric Use:: (See DOSAGE AND ADMINISTRATION).<br/>Information for Patients:: Patients should be counseled that antibacterial drugs including
Tazicef (ceftazidime) should only be used to treat bacterial infections. They
do not treat viral infections (e.g., the common cold). When Tazicef (ceftazidime)
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 Tazicef (ceftazidime) or other antibacterial
drugs in the future.
|
| dailymed-instance:overdosag... |
Ceftazidime overdosage has occurred in patients with renal
failure. Reactions have included seizure activity, encephalopathy, asterixis
and neuromuscular excitability. Patients who receive an acute overdosage should
be carefully observed and given supportive treatment. In the presence of renal
insufficiency, hemodialysis or peritoneal dialysis may aid in the removal
of ceftazidime from the body.
|
| dailymed-instance:genericMe... |
Ceftazidime pentahydrate
|
| dailymed-instance:fullName |
Tazicef (Injection, Powder, For Solution)
|
| dailymed-instance:adverseRe... |
Ceftazidime is generally well-tolerated. The incidence of
adverse reactions associated with the administration of ceftazidime was low
in clinical trials. The most common were local reactions following IV injection
and allergic and gastrointestinal reactions. Other adverse reactions were
encountered infrequently. No disulfiram-like reactions were reported. The
following adverse effects from clinical trials were considered to be either
related to ceftazidime therapy or were of uncertain etiology: Local Effects, reported in fewer than 2% of patients,
were phlebitis and inflammation at the site of injection (1 in 69 patients). Hypersensitivity Reactions, reported in 2% of patients,
were pruritus, rash and fever. Toxic epidermal necrolysis, Stevens-Johnson
syndrome, and erythema multiforme have also been reported with cephalosporin
antibiotics, including ceftazidime. Immediate reactions, generally manifested
by rash and/or pruritus, occurred in 1 in 285 patients. Angioedema and anaphylaxis
(bronchospasm and/or hypotension) have been reported very rarely. Gastrointestinal Symptoms, reported in fewer than
2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in
500) and abdominal pain (1 in 416). The onset of pseudomembranous colitis
symptoms may occur during or after treatment (see WARNINGS). Central Nervous System Reactions (fewer than 1%)
include headache, dizziness and paresthesia. Seizures have been reported with
several cephalosporins, including ceftazidime. In addition, encephalopathy,
asterixis and neuromuscular excitabiIity have been reported in renally impaired
patients treated with unadjusted dosage regimens of ceftazidime (see PRECAUTIONS:
General). Less Frequent Adverse
Events (fewer than 1%) were candidiasis (including oral thrush)
and vaginitis. Hematologic: Rare cases of hemolytic anemia have been reported. Laboratory Test Changes noted during Tazicef (ceftazidime
for injection, USP) clinical trials were transient and included: eosinophilia
(1 in 13), positive Coombs' test without hemolysis (1 in 23), thrombocytosis
(1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate
aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT)
(1 in 15), LDH (1in 18), GGT (1 in 19) and alkaline phosphatase (1 in 23).
As with some other cephalosporins, transient elevations of blood urea, blood
urea nitrogen and/or serum creatinine were observed occasionally. Transient
leukopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis
were seen very rarely. Observed
During Clinical Practice: In addition to the adverse events reported
from clinical trials, the following events have been identified during post-approval
use of ceftazidime. Because they are reported voluntarily from a population
of unknown size, estimates of frequency cannot be made. These events have
been chosen for inclusion due to a combination of their seriousness, frequency
of reporting, or potential causal connection to ceftazidime. General: Anaphylactic or anaphylactoid reactions,
which, in rare instances, were severe (e.g., cardiopulmonary arrest), including
laryngeal edema, stridor, and urticaria; pain at injection site. Hepatobiliary Tract and Pancreas: Hyperbilirubinemia. Renal and Genitourinary: Renal impairment. Cephalosporin-Class Adverse Reactions: In addition
to the adverse reactions listed above that have been observed in patients
treated with ceftazidime, the following adverse reactions and altered laboratory
tests have been reported for cephalosporin-class antibiotics: Adverse Reactions: Urticaria, colitis,
renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis,
aplastic anemia, hemorrhage. Altered
Laboratory Tests: Prolonged prothrombin time, false-positive test
for urinary glucose, elevated bilirubin, pancytopenia.
|
| dailymed-instance:warning |
BEFORE THERAPY WITH TAZICEF IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER
THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS,
PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE
PATIENTS, CAUTION SHOULD BE EXERCISED 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 TAZICEF OCCURS, DISCONTINUE TREATMENT
WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT
WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS,
IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT,
AS CLINICALLY INDICATED. Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
ceftazidime, and may range in severity from mild to life-threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit,
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of���antibiotic-associated colitis.��� After
the diagnosis of pseudomembranous colitis has been established, appropriate
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
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 oral antibacterial drug clinically
effective against Clostridium difficile colitis. Elevated
levels of ceftazidime in patients with renal insufficiency can lead to seizures,
encephalopathy, asterixis and neuromuscular excitability (see PRECAUTIONS).
|
| dailymed-instance:indicatio... |
Tazicef (ceftazidime for injection, USP) is indicated for
the treatment of patients with infections caused by susceptible strains of
the designated organisms in the following diseases: Specimens for bacterial cultures should be obtained before
therapy in order to isolate and identify causative organisms and to determine
their susceptibility to ceftazidime. Therapy may be instituted before results
of susceptibility studies are known; however, once these results become available,
the antibiotic treatment should be adjusted accordingly. Tazicef
(ceftazidime for injection, USP) may be used alone in cases of confirmed or
suspected sepsis. Ceftazidime has been used successfully in clinical trials
as empiric therapy in cases where various concomitant therapies with other
antibiotics have been used. Tazicef may also be used concomitantly with other antibiotics, such as
aminoglycosides, vancomycin and clindamycin, in severe and life-threatening
infections and in the immunocompromised patient. When such concomitant treatment
is appropriate, prescribing information in the labeling for the other antibiotics
should be followed. The dose depends on the severity of the infection and
the patient's condition. To reduce the development
of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime)
and other antibacterial drugs, Tazicef (ceftazidime) 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.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Tazicef
|