Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4207
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FORTAZ (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:dosage |
Dosage: The usual adult dosage is 1 gram administered intravenously
or intramuscularly every 8 to 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 FORTAZ are listed in Table 3. The following
dosage schedule is recommended. Although clinical improvement
has been shown, bacteriologic cures cannot be expected in patients with chronic
respiratory disease and cystic fibrosis. The
higher dose should be reserved for immunocompromised pediatric patients or
pediatric patients with cystic fibrosis or meningitis.<br/>Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic
dysfunction.<br/>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 FORTAZ may be given. An estimate of GFR should be made to determine
the appropriate maintenance dosage. The recommended dosage is presented in
Table 4. NOTE: IF THE DOSE
RECOMMENDED IN TABLE 3 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH
RENAL INSUFFICIENCY AS OUTLINED IN TABLE 4, THE LOWER DOSE SHOULD BE USED. 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: Females: 0.85 x male value In patients
with severe infections who would normally receive 6 grams of FORTAZ daily
were it not for renal insufficiency, the unit dose given in the table above
may be increased by 50% or the dosing frequency may be 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 should be
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. FORTAZ
can also be used in patients undergoing intraperitoneal dialysis and continuous
ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram
of FORTAZ may be given, followed by 500 mg every 24 hours. In addition
to IV use, FORTAZ can be incorporated in the dialysis fluid at a concentration
of 250 mg for 2 L of dialysis fluid. Note: Generally FORTAZ should be continued for
2 days after the signs and symptoms of infection have disappeared, but
in complicated infections longer therapy may be required.<br/>Administration: FORTAZ may be given intravenously or by deep IM injection
into a large muscle mass such as the upper outer quadrant of the gluteus maximus
or lateral part of the thigh. Intra-arterial administration should be avoided
(see PRECAUTIONS).<br/>Intramuscular Administration: For IM administration, FORTAZ should be constituted with
one of the following diluents: Sterile Water for Injection, Bacteriostatic
Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer
to Table 5.<br/>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. For direct intermittent IV administration, constitute
FORTAZ as directed in Table 5 with Sterile Water for Injection. Slowly
inject directly into the vein over a period of 3 to 5 minutes or give
through the tubing of an administration set while the patient is also receiving
one of the compatible IV fluids (see COMPATIBILITY AND STABILITY). For IV infusion, constitute the 1- or 2-gram
infusion pack with 100 mL of Sterile Water for Injection or one of the
compatible IV fluids listed under the COMPATIBILITY AND STABILITY section.
Alternatively, constitute the 500-mg, 1-gram, or 2-gram vial and add an appropriate
quantity of the resulting solution to an IV container with one of the compatible
IV fluids. Intermittent
IV infusion with a Y-type administration setcan be accomplished with compatible solutions. However, during infusion
of a solution containing ceftazidime, it is desirable to discontinue the other
solution. 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 FORTAZ in the ADD-Vantage system is not recommended. To obtain a dose of 500
mg, withdraw 5.0 mL from the vial following reconstitution. To obtain a dose of 1 g, withdraw
10.0 mL from the vial following reconstitution. To obtain a dose of 2 g, withdraw
11.5 mL from the vial following reconstitution. Note:
Addition should be in 2 stages (see Instructions for Constitution). All
vials of FORTAZ as supplied are under reduced pressure. When FORTAZ is dissolved,
carbon dioxide is released and a positive pressure develops. For ease of use
please follow the recommended techniques of constitution described on the
detachable Instructions for Constitution section of this insert. Solutions
of FORTAZ, 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 FORTAZ and an aminoglycoside is indicated, each
of these antibiotics can be administered separately to the same patient.<br/>Directions for Use of FORTAZ Frozen in Galaxy':<br/>Plastic Containers: FORTAZ 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 is stable for 24 hours at room temperature
or for 7 days if stored under refrigeration. 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. 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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| 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-methylethoxy)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
empirical formula is CHNOS,
representing a molecular weight of 636.6. FORTAZ is
a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate.
The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity
has been admixed to facilitate dissolution. The total sodium content of the
mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. FORTAZ
in sterile crystalline form is supplied in vials equivalent to 500 mg,
1 g, 2 g, or 6 g of anhydrous ceftazidime and in ADD-Vantage vials
equivalent to 1 or 2 g of anhydrous ceftazidime. Solutions of FORTAZ
range in color from light yellow to amber, depending on the diluent and volume
used. The pH of freshly constituted solutions usually ranges from 5 to 8. FORTAZ
is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with
1 or 2 g of ceftazidime as ceftazidime sodium premixed with approximately
2.2 or 1.6 g, respectively, of Dextrose Hydrous, USP. Dextrose has been
added to adjust the osmolality. Sodium hydroxide is used to adjust pH and
neutralize ceftazidime pentahydrate free acid to the sodium salt. The pH may
have been adjusted with hydrochloric acid. Solutions of premixed FORTAZ range
in color from light yellow to amber. The solution is intended for intravenous
(IV) use after 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 been confirmed
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 IV administration of 500-mg and 1-g doses of ceftazidime
over 5 minutes to normal adult male volunteers, mean peak serum concentrations
of 45 and 90 mcg/mL, respectively, were achieved. After IV infusion of
500-mg, 1-g, and 2-g doses of ceftazidime over 20 to 30 minutes to normal
adult male volunteers, mean peak serum concentrations of 42, 69, and 170 mcg/mL,
respectively, were achieved. The average serum concentrations following IV
infusion of 500-mg, 1-g, and 2-g 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 the serum in individuals
with normal renal function following multiple IV doses of 1 and 2 g every
8 hours for 10 days. Following intramuscular
(IM) administration of 500-mg and 1-g doses of ceftazidime to normal adult
volunteers, the mean peak serum concentrations were 17 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-g doses, respectively. The half-life of ceftazidime in these
volunteers was approximately 2 hours. The presence
of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime
in individuals administered 2 g intravenously every 8 hours for
5 days. Therefore, a dosage adjustment from the normal recommended dosageis 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-g 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.<br/>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).<br/>Aerobes, Gram-negative: Citrobacter spp.,
including Citrobacter freundii and Citrobacter diversus; Enterobacter spp., including Enterobacter cloacae and Enterobacter aerogenes; Escherichia coli; Haemophilusinfluenzae, including ampicillin-resistant
strains; Klebsiella spp. (including Klebsiella pneumoniae); Neisseria
meningitidis; Proteus mirabilis; Proteus vulgaris; Pseudomonas spp. (including Pseudomonas aeruginosa); and Serratia spp.<br/>Aerobes, Gram-positive: Staphylococcus aureus,
including penicillinase- and non���penicillinase-producingstrains; Streptococcus agalactiae (group
B streptococci); Streptococcus pneumoniae;
and Streptococcuspyogenes (group A beta-hemolytic streptococci).<br/>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 Clostridiumdifficile ), Haemophilus
parainfluenzae, Morganella morganii (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 Pseudomonasaeruginosa 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 Clostridium difficile.<br/>Susceptibility Tests:<br/>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 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 and 32 mm for Escherichia
coli ATCC 25922. For Pseudomonasaeruginosa ATCC 27853,
the zone diameters should be between 22 and 29 mm. For Staphylococcus
aureus ATCC 25923, the zone diameters should be between 16 and 20 mm.<br/>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 to 16 mcg/mL for Staphylococcus aureus ATCC 25923. For Escherichia
coli ATCC 25922, the MIC range should be between 0.125 and
0.5 mcg/mL. For Pseudomonas aeruginosa ATCC 27853, the MIC range should be between 0.5 and 2 mcg/mL.
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FORTAZ is contraindicated in patients who have shown hypersensitivity
to ceftazidime or the cephalosporin group of antibiotics.
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FORTAZ in the dry state
should be stored between 15��and 30��C (59��and 86��F) and
protected from light. FORTAZ is a dry, white to off-white powder supplied
in vials and infusion packs as follows: NDC 0173-0377-10
500-mgVial (Tray of 10) NDC 0173-0378-10
1-gVial (Tray of 10) NDC 0173-0379-34 2-gVial
(Tray of 10) NDC 0173-0380-32 1-gInfusion
Pack (Tray of 10) NDC 0173-0381-32 2-gInfusion
Pack (Tray of 10) NDC 0173-0382-37 6-gPharmacy
Bulk Package (Tray of 6) NDC 0173-0434-00 1-g ADD-Vantage Vial
(Tray of 25) NDC 0173-0435-00 2-g ADD-Vantage Vial
(Tray of 10) (The above ADD-Vantage vials are to be
used only with Abbott ADD-Vantage diluent containers.) FORTAZ
frozen as a premixed solution of ceftazidime sodium should not be stored above
-20��C. FORTAZ is supplied frozen in 50-mL, single-dose, plastic containers
as follows: NDC 0173-0412-00 1-gPlastic
Container (Carton of 24) NDC 0173-0413-00 2-gPlastic
Container (Carton of 24) Equivalent to anhydrous
ceftazidime.
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| dailymed-instance:precautio... |
General: High and prolonged serum ceftazidime 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, coma, asterixis, neuromuscular excitability,
and myoclonia. 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 FORTAZ 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 I 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,
periodicsusceptibility 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
and 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. FORTAZ
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
FORTAZ 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
FORTAZ, should only be used to treat bacterial infections. They do not treat
viral infections (e.g., the common cold). When FORTAZ 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 FORTAZ 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: 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 aminoglycosidic
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. In
common with other antibiotics, ceftazidime may affect the gut flora, leading
to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone
contraceptives.<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)
be used. 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:<br/>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 FORTAZ. 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 FORTAZ is administered to a nursing woman.<br/>Pediatric Use: (see DOSAGE AND ADMINISTRATION).<br/>Geriatric Use: Of the 2,221 subjects who received ceftazidime in 11 clinical
studies, 824 (37%) were 65 and over while 391 (18%) 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 isknown 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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Ceftazidime overdosage has occurred in patients with renal
failure. Reactions have included seizure activity, encephalopathy, asterixis,
neuromuscular excitability, and coma. 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.
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| dailymed-instance:genericMe... |
ceftazidime sodium
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| dailymed-instance:fullName |
FORTAZ (Injection, Powder, Lyophilized, For Solution)
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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:<br/>Local Effects,: reported in fewer than 2% of patients, were phlebitis and
inflammation at the site of injection (1 in 69 patients).<br/>Hypersensitivity Reactions,: reported in 2% of patients, were pruritus, rash, and fever.
Immediate reactions, generally manifested by rash and/or pruritus, occurred
in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome,
and erythema multiforme have also been reported with cephalosporin antibiotics,
including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension)
have been reported very rarely.<br/>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).<br/>Central Nervous System Reactions: (fewer than 1%) included headache, dizziness, and paresthesia.
Seizures have been reported with several cephalosporins, including ceftazidime.
In addition, encephalopathy, coma, asterixis, neuromuscular excitability,
and myoclonia have been reported in renally impaired patients treated with
unadjusted dosing regimens of ceftazidime (see PRECAUTIONS: General).<br/>Less Frequent Adverse Events: (fewer than 1%) were candidiasis (including oral thrush)
and vaginitis.<br/>Hematologic: Rare cases of hemolytic anemia have been reported.<br/>Laboratory Test Changes: noted during clinical
trials with FORTAZ 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
(1 in 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.
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| dailymed-instance:warning |
BEFORE THERAPY WITH FORTAZ 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 TO BE 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 OFPENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO FORTAZ OCCURS, DISCONTINUE
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. Clostridium difficile associated
diarrhea (CDAD) has been reported with use of nearly all antibacterial agents,
including FORTAZ, 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. Elevated
levels of ceftazidime in patients with renal insufficiency can lead to seizures,
encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia
(see PRECAUTIONS).
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| dailymed-instance:indicatio... |
FORTAZ is indicated for the treatment of patients with infections
caused by susceptible strains of the designated organisms in the following
diseases: FORTAZ 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. FORTAZ 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 FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat
or prevent infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and susceptibility information are available,
they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns
may contribute to the empiric selection of therapy.
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FORTAZ
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