Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4218
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Pipracil (Injection, Powder, Lyophilized, For Solution)
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PIPRACIL may be administered by the intramuscular
route (see NOTE) or intravenously as a three- to five-minute intravenous
injection or as a 20- to 30-minute infusion. The usual dosage of PIPRACIL
for serious infections is 3 to 4 g given every four to six
hours as a 20- to 30-minute infusion. For serious infections, the
intravenous route should be used. PIPRACIL should
not be mixed with an aminoglycoside in a syringe or infusion bottle
since this can result in inactivation of the aminoglycoside. The maximum daily dose for adults is usually 24 g/day,
although higher doses have been used. Intramuscular
injections (see NOTE) should be limited to 2 g per injection site.
This route of administration has been used primarily in the treatment
of patients with uncomplicated gonorrhea and urinary tract infections. The average duration of PIPRACIL treatment is from
seven to ten days, except in the treatment of gynecologic infections,
which is from three to ten days; the duration should be guided by
the patient's clinical and bacteriological progress. For most
acute infections, treatment should be continued for at least 48 to
72 hours after the patient becomes asymptomatic. Antibiotic therapy
for S. pyogenes infections
should be maintained for at least ten days to reduce the risk of rheumatic
fever. When PIPRACIL is given concurrently with
aminoglycosides, both drugs should be used in full therapeutic doses.<br/>Renal Impairment: For patients on hemodialysis, the maximum daily
dose is 6 g/day (2 g every 8 hours). In addition, because
hemodialysis removes 30% to 50% of piperacillin in 4 hours, a 1-g
additional dose should be administered following each dialysis period. For patients with renal failure and hepatic insufficiency,
measurement of serum levels of piperacillin will provide additional
guidance for adjusting dosage.<br/>Prophylaxis: When possible, PIPRACIL should be administered as
a 20- to 30-minute infusion just prior to anesthesia. Administration
while the patient is awake will facilitate identification of possible
adverse reactions during drug infusion. Pediatric patients. Dosages in pediatric patients under 12 years of age have not been
studied in adequate and well-controlled clinical trials .<br/>Intravenous Administration: Reconstitution Directions
for Conventional Vials: Reconstitute each gram of PIPRACIL
with at least 5 mL of a suitable diluent (except Lidocaine HCl
0.5%-1% without epinephrine) listed above. Shake well until dissolved.
Reconstituted solution may be diluted to the desired volume (eg, 50
or 100 mL) in the above listed intravenous solutions and admixtures. DIRECTIONS FOR ADMINISTRATIONIntermittent IV InfusionInfuse
diluted solution over period of about 30 minutes. During infusion,
it is desirable to discontinue the primary intravenous solution. Intravenous Injection (Bolus)Reconstituted solution should be injected slowly over a 3-to
5-minute period to help avoid vein irritation.<br/>Intramuscular Administration: Reconstitution Directions:Reconstitute each gram of PIPRACIL with 2 mL of a suitable diluent
listed above to achieve a concentration of 1 g per 2.5 mL. Shake
well until dissolved. DIRECTIONS FOR ADMINISTRATIONWhen indicated by clinical and bacteriological findings, intramuscularadministration of 6 to 8 g daily of PIPRACIL, in divided doses,
may be utilized for initiation of therapy. In addition, intramuscular
administration of the drug may be considered for maintenance therapy
after clinical and bacteriologic improvement has been obtained with
intravenous piperacillin sodium treatment. Intramuscular administration
should not exceed 2 g per injection at any one site. The preferred site is the upper outer quadrant of the buttock (ie, gluteus maximus). The deltoid area should be used only if well-developed, and then
only with caution to avoid radial nerve injury. Intramuscular injections
should not be made into the lower or mid-third of the upper arm.<br/>Stability of PIPRACIL Following Reconstitution: PIPRACIL is stable in both glass and plastic containers
when reconstituted with recommended diluents and when diluted with
the intravenous solutions and intravenous admixtures indicated above. Pharmacy vials should be used immediately after reconstitution.
Discard any unused portion after 24 hours if stored at room temperature
(20��to 25��C [68��to 77��F]), or after 48 hours
if stored at refrigerated temperature (2��to 8��C [36��to 46��F]).
Vials should not be frozen after reconstitution.
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| dailymed-instance:descripti... |
PIPRACIL, sterile piperacillin sodium, is a semisynthetic
broad-spectrum penicillin for parenteral use derived from D(-)-��-aminobenzylpenicillin.
The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,-3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
The chemical formula is CHNNaOS, and the molecular weight is 539.54. Its structural formula
is: Piperacillin sodium powder is a white to off-white
solid having the characteristic appearance of products prepared by
freeze-drying. It is freely soluble in water and in alcohol. The pH
of an aqueous solution containing 400 milligrams per milliliter ranges
from 5.5 to 7.5. One g contains 1.85 mEq (42.5 mg)
of sodium (Na).
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Intravenous Administration:: In healthy adult volunteers, mean serum piperacillin
concentrations immediately after a two���to three���minute
intravenous injection of 2, 4, or 6 g were 305, 412, and 775��g/mL,
respectively. Serum concentrations lack dose proportionality. A 30-minute infusion of 6 g every 6 h
gave, on the fourth day, a mean peak serum concentration of 420��g/mL.<br/>Intramuscular Administration:: PIPRACIL is rapidly absorbed after intramuscular
injection. In healthy volunteers, the mean peak serum concentration
occurs approximately 30 minutes after a single dose of 2 g and
is about 36��g/mL. The oral administration of 1 g probenecid
before injection produces an increase in piperacillin peak serum level
of about 30%. The area under the curve (AUC) is increased by approximately
60%.<br/>Pharmacokinetics:: PIPRACIL is not absorbed when given orally. Peak
serum concentrations are attained approximately 30 minutes after intramuscular
injections and immediately after completion of intravenous injection
or infusion. The serum half-life in healthy volunteers ranges from
36 minutes to one hour and 12 minutes. The mean elimination half-life
of PIPRACIL in healthy adult volunteers is 54 minutes following
administration of 2 g and 63 minutes following 6 g. As with
other penicillins, PIPRACIL is eliminated primarily by glomerular
filtration and tubular secretion; it is excreted rapidly as unchanged
drug in high concentrations in the urine. Approximately 60% to 80%
of the administered dose is excreted in the urine in the first 24
hours. Piperacillin urine concentrations, determined by microbioassay,
are as high as 14,100��g/mL following a 6-g intravenous
dose and 8,500��g/mL following a 4-g intravenous dose.
These urine drug concentrations remain well above 1,000��g/mL
throughout the dosing interval.<br/>Distribution:: PIPRACIL binding to human serum proteins is 16%.
The drug is widely distributed in human tissues and body fluids, including
bone, prostate, and heart, and reaches high concentrations in bile.
After a 4-g bolus injection, maximum biliary concentrations average
3,205��g/mL. It penetrates into the cerebrospinal fluid
in the presence of inflamed meninges.<br/>Special Populations:: Renal Insufficiency: The elimination half-life is increased twofold in mild to moderate
renal impairment and fivefold to sixfold in severe impairment. Because
PIPRACIL is excreted by the biliary route as well as by the renal
route, it can be used safely in appropriate dosage in patients with
severely restricted kidney function. Pediatric Patients: After intravenous administration of 50 mg/kg (5-minute infusion)
in neonates, the mean plasma concentration of piperacillin extrapolated
to time zero was 141��g/mL, and the apparent volume of
distribution averaged 101 mL/kg. In premature
neonates, the mean elimination half-life has been reported to range
from 147 to 258 minutes following administration of
a single intravenous dose of 75 mg/kg, the half���life decreasing
with increasing postnatal age. The changes in half-life appeared to
be caused by an immature renal system during the first weeks
of life. In one study in neonates, the mean elimination half-life
ranged from 127 to 217 minutes following a single intravenous dose
of 50 mg/kg. As in premature neonates, the half-life in neonates
decreased with increasing postnatal age. The mean total body clearance
in neonates has been reported to range from 32 to 41 mL/min/1.73 mafter an intravenous dose of 50 mg/kg. Following administration of an intravenous dose of 50 mg/kg
in older pediatric patients (from 1 month up to 15 years
of age), the mean elimination half-life has been reported to range
from 31 to 37 minutes, and the mean total body clearance has
been reported to range from 124 to 160 mL/min/1.73 m. As in adults, PIPRACIL elimination
tends to be prolonged in pediatric patients with renal impairment.
In one study in pediatric patients (age range, 3.3 to 14.3 years),
the mean elimination half-life in patients with decreased renal function
was approximately 60 minutes versus 37 minutes in patients with normal
renal function. The elimination half-life has been reported to range
from 3.5 to 14 hours in neonates with severe renal impairment. Pharmacokinetic data have indicated that among pediatric
patients below 12 years of age, those with cystic fibrosis have increased
bioavailability, lower serum concentrations, and increased total body
clearance of piperacillin compared to young, healthy pediatric volunteers
under 12 years of age.
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PIPRACIL is contraindicated in patients with a history
of allergic reactions to any of the betalactams, including penicillins
and/or cephalosporins.
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| dailymed-instance:supply |
PIPRACIL (piperacillin for injection)
is available in vials containing freeze-dried piperacillin sodium
powder equivalent to two, three, and four g of piperacillin. One g
of piperacillin (as a monosodium salt) contains 1.85 mEq (42.5 mg)
of sodium. Product
Numbers2 gram/Vial-10 per box-NDC 0206-3879-163
gram/Vial-10 per box-NDC 0206-3882-554 gram/Vial-10 per box-NDC
0206-3880-25 Store
at controlled room temperature 20��C-25��C(68��F-77��F).
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General: Bleeding manifestations
have occurred in some patients receiving��-lactam antibiotics,
including piperacillin. These reactions have sometimes been associated
with abnormalities of coagulation tests such as clotting time, platelet
aggregation, and prothrombin time and are more likely to occur in
patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued
and appropriate therapy instituted. The possibility of the emergence of resistant organisms which might
cause superinfections should be kept in mind, particularly during
prolonged treatment. If this occurs, appropriate measures should be
taken. As with
other penicillins, patients may experience neuromuscular excitability
or convulsions if higher than recommended doses are given intravenously. PIPRACIL is a monosodium
salt containing 1.85 mEq of Naper g (42.5 mg
of Naper g). This should be considered when
treating patients requiring restricted salt intake. Periodic electrolyte
determinations should be made in patients with low potassium reserves,
and the possibility of hypokalemia should be kept in mind with patients
who have potentially low potassium reserves and who are receiving
cytotoxic therapy or diuretics. Leukopenia and neutropenia may occur during prolonged therapy. As with other semisynthetic
penicillins, PIPRACIL therapy has been associated with an increased
incidence of fever and rash in cystic fibrosis patients. Prescribing PIPRACIL 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 PIPRACIL should only
be used to treat bacterial infections. They do not treat viral infections
(eg, the common cold). When PIPRACIL 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 PIPRACIL or other antibacterial drugs
in the future. Diarrhea is a common problem
caused by antibiotics which usually ends when the antibiotic is discontinued.
Sometimes after starting treatment with antibiotics, patients can
develop watery and bloody stools (with or without stomach cramps and
fever) even as late as two or more months after having taken the last
dose of antibiotic. If this occurs, patients should contact their
physician as soon as possible.<br/>Laboratory Tests: While piperacillin
possesses the characteristic low toxicity of the penicillin group
of antibiotics, periodic assessment of organ system functions, including
renal, hepatic, and hematopoietic, during prolonged therapy is advisable. All patients with gonorrhea
should have a serologic test for syphilis at the time of diagnosis.
Patients treated with piperacillin should have a follow-up serologic
test for syphilis after 3 months.<br/>Drug Interactions:<br/>Aminoglycosides: The mixing
of piperacillin with an aminoglycoside in vitro can result in substantial inactivation of the
aminoglycoside.<br/>Vecuronium: When used
in the perioperative period, piperacillin has been implicated in the
prolongation of the neuromuscular blockade of vecuronium. Caution
is indicated when piperacillin is used perioperatively. In one controlled
clinical study, the ureidopenicillins, including piperacillin, were
reported to prolong the action of vecuronium. Due to their similar
mechanism of action, it is expected that the neuromuscular blockade
produced by any of the non-depolarizing muscle relaxants could be
prolonged in the presence of piperacillin.<br/>Probenecid: The oral
combination of probenecid before intramuscular injection of PIPRACIL
produces an increase in piperacillin peak serum level of about 30%.<br/>Anticoagulants: Coagulation
parameters should be tested more frequently and monitored regularly
during simultaneous administration of high doses of heparin, oral
anticoagulants, or other drugs that may affect the blood coagulation
system or the thrombocyte function.<br/>Methotrexate: Piperacillin
sodium may reduce the excretion of methotrexate. Therefore, serum
levels of methotrexate should be monitored in patients to avoid drug
toxicity.<br/>Drug/Laboratory Test Interactions: As with other penicillins,
the administration of PIPRACIL may result in a false-positive reaction
for glucose in the urine using a copper-reduction method. It is recommended
that glucose tests based on enzymatic glucose oxidase reactions be
used. There
have been reports of positive test results using the Bio-Rad Laboratories
Platelia Aspergillus EIA test
in patients receiving piperacillin/tazobactam injection who were subsequently
found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with the
Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving piperacillin
should be interpreted cautiously and confirmed by other diagnostic
methods.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Carcinogenesis: Long-term
studies in animals have not been performed to evaluate carcinogenic
potential.<br/>Mutagenesis: Piperacillin
was negative in the Ames Salmonella reversion test at concentrations up to 10��g/plate. There
was no DNA damage in bacteria (Rec assay) exposed to piperacillin
at concentrations up to 200��g/disc. In a mammalian point
mutation (mouse lymphoma cells) assay, piperacillin was positive at
concentrations���2500��g/mL. Piperacillin was
negative in a cell (BALB/c-3T3) transformation assay at concentrations
up to 3000��g/mL. In vivo, piperacillin did not induce chromosomal aberrations in the bone
marrow cells of mice at I.V. doses up to 2000 mg/kg/day or rats
at I.V. doses up to 1500 mg/kg/day. These doses are half (mice)
or three���fourths (rats) the maximum recommended human daily
dose based on body-surface area (mg/m). In another in vivo test, there was no dominant
lethal effect when piperacillin was administered to rats at I.V. doses
up to 2000 mg/kg/day, which is similar to the maximum recommended
human daily dose based on body-surface area (mg/m). When
piperacillin was administered to mice at I.V. doses up to 2000 mg/kg/day,
which is half the maximum recommended human daily dose based on body-surface
area (mg/m), urine from these animals was not mutagenic
when tested in the Ames assay using Salmonella strain TA-98 in the absence of��-glucuronidase.<br/>Impairment of Fertility: Reproduction
studies have been performed in mice (SQ) and rats (I.P.) and have
revealed no evidence of impaired fertility due to piperacillin administered
up to a dose which is half (mice) or similar (rats) to the maximum
recommended human daily dose based on body-surface area (mg/m). The plasma/serum concentrations at the highest daily dose
administered to rats in reproduction studies were comparable to the
maximum serum concentration seen in man, based on a toxicology study
in rats in which similar doses of piperacillin (in combination with
a beta���lactamase inhibitor, tazobactam) were administered I.P.and based on extrapolations from an animal pharmacokinetic study using
lower doses of piperacillin alone.<br/>Pregnancy:<br/>Teratogenic effects���Pregnancy Category B: Teratology
studies have been performed in mice (I.V.) and rats (I.V., I.P. and
SQ) and have revealed no evidence of harm to the fetus due to piperacillin
administered up to a dose which is approximately half the maximum
recommended human daily dose based on body-surface area (mg/m). In pharmacokinetic studies in pregnant and nonpregnant
rats, in which piperacillin was administered I.V. at a dose which
is half the maximum daily dose administered in teratology studies,
serum concentrations in rats were approximately 10 times the maximum
serum concentration seen in man. In other studies in mice and rats,
in which piperacillin (in combination with a beta-lactamase inhibitor,
tazobactam) was administered I.V. at approximately half the maximum
daily dose administered in teratology studies, plasma concentrations
of piperacillin were approximately 2 times (mice) and 5 times (rats)
the serum concentrations seen in man. There are, however, no adequate and well-controlled studies with
piperacillin in pregnant women. Because animal reproduction studies
are not always predictive of the human response, this drug should
be used during pregnancy only if clearly needed.<br/>Nursing Mothers: Piperacillin is excreted in low concentrations in
human milk. Caution should be exercised when PIPRACIL is administered
to nursing mothers.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have
not been established. Data from published pharmacokinetics
studies indicate that the elimination half-life of piperacillin in
neonates is twofold to fourfold longer than that seen in pediatric
patients 1 month of age and above as well as in adults. In infants,
children, and adolescents, the elimination half-life of piperacillin
is shorter than that observed in adults. As in adults, the elimination
of piperacillin is decreased in pediatric patients with renal impairment.<br/>Geriatric Use: Clinical studies of PIPRACIL did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. In general,
dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy. PIPRACIL
contains 42.5 mg (1.85 mEq) of sodium per gram. At the usual
recommended doses, patients would receive between 255 and 765 mg/day
(11.1 and 33.3 mEq) of sodium. The geriatric population may respond
with a blunted natriuresis to salt loading. The total sodium content
from dietary and non-dietary sources may be clinically important with
regard to such diseases as congestive heart failure. 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.
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There is no specific information on overdose with
PIPRACIL. Other penicillin-class drugs in overdosage, however, have
the potential to cause neuromuscular hyperirritability or convulsive
seizures. In case of overdosage, discontinue medication, treat symptomatically,
and institute supportive measures as required. Piperacillincan be
removed by hemodialysis but not peritoneal dialysis.
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Piperacillin sodium
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Pipracil (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
PIPRACIL is generally well tolerated. The most common
adverse reactions have been local in nature, following intravenous
or intramuscular injection. The following adverse reactions may occur: Local Reactions: In clinical trials thrombophlebitis was noted in 4% of patients.
Pain, erythema, and/or induration at the injection site occurred in
2% of patients. Less frequent reactions including ecchymosis, deep
vein thrombosis, and hematomas have also occurred. Gastrointestinal: Diarrhea
and loose stools were noted in 2% of patients. Other less frequent
reactions included vomiting, nausea, increases in liver enzymes (LDH,
AST, ALT), hyperbilirubinemia, cholestatic hepatitis, bloody diarrhea,
and pseudomembranous colitis. The onset of pseudomembranous colitis
symptoms may occur during or after antibiotic treatment. Hypersensitivity
Reactions: Anaphylactic/anaphylactoid reactions (some leading
to shock and fatalities) have been reported. Rash was noted in 1% of patients. Other
less frequent findings included pruritus, vesicular eruptions, and
positive Coombs tests. Other dermatologic manifestations,
such as erythema multiforme, urticaria, toxic epidermal necrolysis
and Stevens-Johnson syndrome, have been reported. Renal: Elevations of creatinine
or BUN, renal failure and interstitial nephritis have been reported. Central Nervous System: Headache, dizziness, fatigue, and seizures have been reported. Hemic and Lymphatic: Hemolytic anemia, agranulocytosis, pancytopenia, prolonged bleeding
time, reversible leukopenia, neutropenia, thrombocytopenia, and/or
eosinophilia have been reported. As with other��-lactam antibiotics,
reversible leukopenia (neutropenia) is more apt to occur in patients
receiving prolonged therapy at high dosages or in association with
drugs known to cause this reaction. Serum Electrolytes: Individuals with
liver disease or individuals receiving cytotoxic therapy or diuretics
were reported to demonstrate a decrease in serum potassium concentrations
with high doses of piperacillin. Hypokalemia has been reported. Skeletal: Prolonged
muscle relaxation . Other: Fever, superinfection,
including candidiasis; hemorrhagic manifestations have been reported. Piperacillin therapy has been associated with an increased
incidence of fever and rash in cystic fibrosis patients.
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| dailymed-instance:warning |
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC/ANAPHYLACTOID)
REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE
REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF
PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE
ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF
PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS
WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH PIPRACIL,
CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN
ALLERGICREACTION OCCURS, PIPRACIL SHOULD BE DISCONTINUED AND APPROPRIATE
THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC/ANAPHYLACTOID
REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.
OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION,
SHOULD ALSO BE ADMINISTERED AS INDICATED. Clostridium difficile associated
diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including PIPRACIL, 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.
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Therapeutic: PIPRACIL is indicated for the treatment of serious infections caused
by susceptible strains of the designated microorganisms in the conditions
listed below: Intra-Abdominal
Infections including hepatobiliary and surgical infections
caused by E. coli, Pseudomonas aeruginosa, enterococci, Clostridium spp., anaerobic cocci, or Bacteroides spp., including B. fragilis. Urinary Tract Infections caused by E. coli, Klebsiella spp., P. aeruginosa, Proteus spp., including P. mirabilis, or enterococci. Gynecologic Infections including endometritis, pelvic inflammatory disease, pelvic cellulitis
caused by Bacteroides spp.,
including B. fragilis, anaerobic
cocci, Neisseria gonorrhoeae, or enterococci (E. faecalis). Septicemia including bacteremia caused by E. coli, Klebsiella spp., Enterobacter spp., Serratia spp., P. mirabilis, S. pneumoniae, enterococci, P. aeruginosa, Bacteroides spp., or anaerobic
cocci. Lower RespiratoryTract Infections caused by E. coli, Klebsiella spp., Enterobacter spp., P. aeruginosa, Serratia spp., H. influenzae, Bacteroides spp., or anaerobic cocci.
Although improvement has been noted in patients with cystic fibrosis,
lasting bacterial eradication may not necessarily be achieved. Skin and Skin Structure Infections caused by E. coli, Klebsiella spp., Serratia spp., Acinetobacter spp., Enterobacter spp., P. aeruginosa, Morganella morganii, Providencia rettgeri, Proteus vulgaris, P. mirabilis, Bacteroides spp., including B. fragilis, anaerobic cocci, or enterococci. Bone and Joint Infections caused by P. aeruginosa, enterococci, Bacteroides spp., or anaerobic cocci. Uncomplicated Gonococcal Urethritis caused by N. gonorrhoeae. PIPRACIL has also been shown to be clinically effective for the treatment
of infections at various sites caused by Streptococcus species including S. pyogenes and S. pneumoniae; however, infections caused by these organisms are ordinarily treated
with more narrow spectrum penicillins. Because of its broad spectrum
of bactericidal activity against gram-positive and gram-negative aerobic
and anaerobic bacteria, PIPRACIL isparticularly useful for the treatment
of mixed infections and presumptive therapy prior to the identification
of the causative organisms. Also, PIPRACIL
may be administered as single drug therapy in some situations where
normally two antibiotics might be employed. Piperacillin has been successfully used with aminoglycosides, especially
in patients with impaired host defenses. Both drugs should be used
in full therapeutic doses. Appropriate cultures
should be made for susceptibility testing before initiating therapy
and therapy adjusted, if appropriate, once the results are known. Prophylaxis: PIPRACIL
is indicated for prophylactic use in surgery including intra-abdominal
(gastrointestinal and biliary) procedures, vaginal hysterectomy, abdominal
hysterectomy, and cesarean section. Effective prophylactic use depends
on the time of administration; PIPRACIL should be given one-half to
one hour before the operation so that effective levels can be achieved
in the site prior to the procedure. The prophylactic use of piperacillin should be stopped within 24
hours, since continuing administration of any antibiotic increases
the possibility of adverse reactions, but in the majority of surgical
procedures, does not reduce the incidence of subsequent infections.
If there are signs of infection, specimens for culture and susceptibility
testing should be obtained for identification of the causative microorganism
sothat appropriate therapy can be instituted. To reduce the development of drug-resistant bacteria and maintain
the effectiveness of PIPRACIL and other antibacterial drugs, PIPRACILshould only be used 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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Pipracil
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