Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/227
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Ampicillin and Sulbactam (Injection, Powder, For Solution)
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Ampicillin and
Sulbactam for Injection may be administered by either the IV or the IM
routes. For IV
administration, the dose can be given by slow intravenous injection over
at least 10-15 minutes or can also be delivered in greater dilutions
with 50-100 mL of a compatible diluent as an intravenous infusion over
15-30 minutes. Ampicillin and
Sulbactam for Injection may be administered by deep intramuscular
injection. (See Preparation for
Intramuscular Injection.) The recommended
adult dosage of ampicillin and sulbactam is 1.5 g (1 g ampicillin as the
sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g
ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)
every six hours. This 1.5 to 3 g range represents the total of
ampicillin content plus the sulbactam content of Ampicillin and
Sulbactam for Injection, and corresponds to a range of 1 g
ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total
dose of sulbactam should not exceed 4 grams per day.<br/>Pediatric Patients
1 Year of Age or Older: The
recommended daily dose of Ampicillin and Sulbactam for Injection
in pediatric patients is 300 mg per kg of body weight
administered via intravenous infusion in equally divided doses
every 6 hours. This 300 mg/kg/day dosage represents the total
ampicillin content plus the sulbactam content of Ampicillin and
Sulbactam for Injection, and correspondsto 200 mg
ampicillin/100 mg sulbactam per kg per day. The safety and
efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been
established. Pediatric
patients weighing 40 kg or more should be dosed according to
adult recommendations, and the total dose of sulbactam should
not exceed 4 grams per day. The course of intravenous therapy
should not routinely exceed 14 days. In clinical trials, most
children received a course of oral antimicrobials following
initial treatment with intravenous Ampicillin and Sulbactam for
Injection. (See CLINICAL
STUDIES section.)<br/>Impaired Renal
Function: In patients
with impairment of renal function the elimination kinetics of
ampicillin and sulbactam are similarly affected, hence the ratio
of one to the other will remain constant whatever the renal
function. The dose of Ampicillin and Sulbactam for Injection in
such patients should be administered less frequently in accordance with the usual practice for ampicillin and according
to the following recommendations: When only
serum creatinine is available, the following formula (based on
sex, weight, and age of the patient) may be used to convert this
value into creatinine clearance. The serum creatinine should
represent a steady state of renal function.<br/>Compatibility,
Reconstitution and Stability: Prior to
reconstitution store Ampicillin and Sulbactam for Injection
sterile dry powder at 20��-25��C (68��-77��F) [see USP Controlled
Room Temperature]. When
concomitant therapy with aminoglycosides is indicated,
ampicillin and sulbactam and aminoglycosides should be
reconstituted and administered separately, due to the in vitro inactivation of
aminoglycosides by any of the aminopenicillins.<br/>Directions for Use:<br/>General
Dissolution Procedures: Ampicillin and Sulbactam for Injection sterile powder
for intravenous and intramuscular use may be
reconstituted with any of the compatible diluents
described in this insert. Solutions should be allowed to
stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for
complete solubilization.<br/>Preparation
for Intravenous Use:<br/>Preparation
for Intramuscular Injection:
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Ampicillin and
Sulbactam for Injection, USP is an injectable antibacterial combination
consisting of the semisynthetic antibiotic ampicillin sodium and the
beta-lactamase inhibitor sulbactam sodium for intravenous and
intramuscular administration. Ampicillin sodium
is derived from the penicillin nucleus, 6-aminopenicillanic acid.
Chemically, it is Monosodium
D-(���)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
and has a molecular weight of 371.39. Its chemical formula is
CHNNaOS. The
structural formula is: Sulbactam sodium is
a derivative of the basic penicillin nucleus. Chemically, sulbactam
sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
4,4-dioxide. Its chemical formula is
CHNNaOS with a molecular weight
of 255.22. The structural formula is: Ampicillin and
Sulbactam for Injection is available as a white to off-white dry powder
for reconstitution. Ampicillin and Sulbactam for Injection dry powder is
freely soluble in aqueous diluents to yield pale yellow to yellow
solutions containing ampicillin sodium and sulbactam sodium equivalent
to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the
solutions is between 8.0 and 10.0. Dilute solutions
(up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially
colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin
and Sulbactam for Injection (1 g ampicillin as the sodium salt plus 0.5
g sulbactam as the sodium salt) parenteral contains approximately 115 mg
(5 mEq) of sodium. 3 g of Ampicillin
and Sulbactam for Injection (2 g ampicillin as the sodium salt plus 1 g
sulbactam as the sodium salt) parenteral contains approximately 230 mg
(10 mEq) of sodium.
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General: Immediately
after completion of a 15-minute intravenous infusion of Ampicillin and Sulbactam for Injection, peak serum
concentrations of ampicillin and sulbactam are attained.
Ampicillin serum levels are similar to those produced by the
administration of equivalent amounts of ampicillin alone. Peak
ampicillin serum levels ranging from 109 to 150 mcg/mL are
attained after administration of 2000 mg of ampicillin plus 1000
mg sulbactam and 40 to 71 mcg/mL after administration of 1000 mg
ampicillin plus 500 mg sulbactam. The corresponding mean peak
serum levels for sulbactam range from 48 to 88 mcg/mL and 21 to
40 mcg/mL, respectively. After an intramuscular injection of
1000 mg ampicillin plus 500 mg sulbactam, peak ampicillin serum
levels ranging from 8 to 37mcg/mL and peak sulbactam serum
levels ranging from 6 to 24 mcg/mL are attained. The mean
serum half-life of both drugs is approximately 1 hour in healthy
volunteers. Approximately 75 to 85% of both ampicillin and sulbactam are
excreted unchanged in the urine during the first 8 hours after
administration of Ampicillin and Sulbactam for Injection to
individuals with normal renal function. Somewhat higher and more
prolonged serum levels of ampicillin and sulbactam can be achieved with the concurrent administration of probenecid. In patients
with impaired renal function the elimination kinetics of
ampicillin and sulbactam are similarly affected, hence the ratio
of one to the other will remain constant whatever the renal
function. The dose of Ampicillin and Sulbactam for Injection in
such patients should be administered less frequently in
accordance with the usual practice for ampicillin (see DOSAGE AND
ADMINISTRATION). Ampicillin
has been found to be approximately 28% reversibly bound to human
serum protein and sulbactam approximately 38% reversibly bound. The
following average levels of ampicillin and sulbactam were
measured in the tissues and fluids listed: Penetration
of both ampicillin and sulbactam into cerebrospinal fluid in the
presence of inflamed meninges has been demonstrated after IV
administration of Ampicillin and Sulbactam for Injection. The
pharmacokinetics of ampicillin and sulbactam in pediatric
patients receiving ampicillin and sulbactam are similar to those
observed in adults. Immediately after a 15-minute infusion of 50
to 75 mg ampicillin and sulbactam/kg body weight, peak serum and
plasma concentrations of 82 to 446 mcg ampicillin/mL and 44 to
203 mcg sulbactam/mL were obtained. Mean half-life values were
approximately 1 hour.<br/>Microbiology: Ampicillin
is similar to benzyl penicillin in its bactericidal action
against susceptible organisms during the stage of active
multiplication. It acts through the inhibition of cell wall
mucopeptide biosynthesis. Ampicillin has a broad spectrum of
bactericidal activity against many gram-positive and
gram-negative aerobic and anaerobic bacteria. (Ampicillin is,
however, degraded by beta-lactamases and therefore the spectrum
of activity does not normally include organisms which produce
these enzymes.) A wide
range of beta-lactamases found in microorganisms resistant to
penicillins and cephalosporins have been shown in biochemical
studies with cell free bacterial systems to be irreversibly
inhibited by sulbactam. Although sulbactam alone possesses
little useful antibacterial activity except against the Neisseriaciae, whole organism
studies have shown that sulbactam restores ampicillin activity
against beta-lactamase producing strains. In particular,
sulbactam has good inhibitory activity against the clinically
important plasmid mediated beta-lactamases most frequently
responsible for transferred drug resistance. Sulbactam has no effect on the activity of ampicillin against ampicillin
susceptible strains. The
presence of sulbactam in the injection formulation effectively
extends the antibiotic spectrum of ampicillin to include many
bacteria normally resistant to it and to other beta-lactam
antibiotics. Thus, ampicillin and sulbactam possesses the
properties of a broad-spectrum antibiotic and a beta-lactamase
inhibitor. Whilein vitro studies have
demonstrated the susceptibility of most strains of the following
organisms, clinical efficacy for infections other than those
included in the indications section has not been
documented.<br/>Gram-Positive Bacteria: Staphylococcus aureus (beta-lactamase and non-beta-lactamase
producing), Staphylococcus
epidermidis (beta-lactamase and
non-beta-lactamase producing), Staphylococcus saprophyticus(beta-lactamase and non-beta-lactamase
producing), Streptococcus
faecalis(Enterococcus),Streptococcus
pneumoniae(formerly D. pneumoniae),Streptococcus
pyogenes, Streptococcus
viridans.<br/>Gram-Negative Bacteria: Hemophilus
influenzae (beta-lactamase and
non-beta-lactamase producing), Moraxella (Branhamella)
catarrhalis (beta-lactamase and
non-beta-lactamase producing), Escherichia coli(beta-lactamase and non-beta-lactamase
producing), Klebsiella species (all known strains are
beta-lactamase producing), Proteus mirabilis (beta-lactamase and
non-beta-lactamase producing), Proteus vulgaris, Providencia
rettgeri, Providencia stuartii, Morganella morganii,and Neisseria
gonorrhoeae (beta-lactamase and
non-beta-lactamase producing).<br/>Anaerobes: Clostridium
species, Peptococcus species, Peptostreptococcus species, Bacteroides species,
including B.fragilis.<br/>Susceptibility
Testing:<br/>Diffusion
Technique: For
the Kirby-Bauer method of susceptibility testing, a 20
mcg (10 mcg ampicillin + 10 mcg sulbactam) diffusion
disk should be used. The method is one outlined in the
NCCLS publication M2-A4.With this
procedure, a report from the laboratory of "Susceptible"
indicates that the infecting organism is likely to
respond to ampicillin/sulbactam therapy and a report of
"Resistant" indicates that the infecting organism is not
likely to respond to therapy. An "Intermediate" susceptibility report suggests that the infecting
organism would be susceptible to Ampicillin and
Sulbactam for Injection if a higher dosage is used or if
the infection is confined to tissues or fluids (e.g.,
urine) in which high antibiotic levels are
attained.<br/>Dilution
Techniques: Broth or agar dilution methods may be used to determine the minimal inhibitory concentration (MIC) value for
susceptibility of bacterial isolates to
ampicillin/sulbactam. The method used is one outlined in
the NCCLS publication M7-A2.Tubes should be
inoculated to contain 10to 10organisms/mL or plates "spotted" with 10organisms. The
recommended dilution method employs a constant
ampicillin/sulbactam ratio of 2:1 in all tubes with
increasing concentrations of ampicillin. MICs are
reported in terms of ampicillin concentration in the
presence of sulbactam at a constant 2 parts ampicillin
to 1 part sulbactam.
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The use of
Ampicillin and Sulbactam for Injection is contraindicated in individuals
with a history of hypersensitivity reactions to any of the
penicillins.
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Ampicillin and
Sulbactam for Injection, USP is supplied as a sterile white to off-white
dry powder in the following: 1.5 gram Vial
(equivalent to 1 gram ampicillin as the sodium salt plus 0.5 gram
sulbactam as the sodium salt) packaged in 10s (NDC 10019-631-01) 3 gram Vial
(equivalent to 2 grams ampicillin as the sodium salt plus 1 gram
sulbactam as the sodium salt) packaged in 10s (NDC
10019-630-02)<br/>Storage: Prior to reconstitution store dry
powder at 20��-25��C (68��-77��F) [see USP Controlled Room
Temperature].
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General: Prescribing
Ampicillin and Sulbactam for Injection 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. A high
percentage of patients with mononucleosis who receive ampicillin
develop a skin rash. Thus, ampicillin class antibiotics should
not be administered to patients with mononucleosis. In patients
treated with ampicillin and sulbactam the possibility of
superinfections with mycotic or bacterial pathogens should be
kept in mind during therapy. If superinfections occur (usually
involving PseudomonasorCandida),
the drug should be discontinued and/or appropriate therapy
instituted.<br/>Information for
Patients: Patients
should be counseled that antibacterial drugs including
Ampicillin and Sulbactam for Injection should only be used to
treat bacterial infections. They do not treat viral infections
(e.g., the common cold). When Ampicillin and Sulbactam for
Injection 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 Ampicillin and
Sulbactam for Injection or other antibacterial drugs in the
future.<br/>Drug Interactions: Probenecid
decreases the renal tubular secretion of ampicillin and
sulbactam. Concurrent use of probenecid with ampicillin and
sulbactam may result in increased and prolonged blood levels of
ampicillin and sulbactam. The concurrent administration of
allopurinol and ampicillin increases substantially the incidence
of rashes in patients receiving both drugs as compared to
patients receiving ampicillin alone. It is not known whether
this potentiation of ampicillin rashes is due to allopurinol or
the hyperuricemia present in these patients. There are no data
with ampicillin and sulbactam and allopurinol administered
concurrently. Ampicillin and sulbactam and aminoglycosides
should not be reconstituted together due to the in vitro inactivation of
aminoglycosides by the ampicillin component of Ampicillin and
Sulbactam for Injection.<br/>Drug/Laboratory
Test Interactions: Administration of ampicillin and sulbactam will result in high
urine concentration of ampicillin. High urine concentrations of
ampicillin may result in false positive reactions when testing
for the presence of glucose in urine using Clinitest���,
Benedict's Solution or Fehling's Solution. It is recommended
that glucose tests based on enzymatic glucose oxidase reactions
(such as Clinistix���) be used. Following
administration of ampicillin to pregnant women, a transient
decrease in plasma concentration of total conjugated estriol,
estriol-glucuronide, conjugated estrone and estradiol has been
noted. This effect may also occur with ampicillin and
sulbactam.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Long-term
studies in animals have not been performed to evaluate
carcinogenic or mutagenic potential.<br/>Pregnancy:<br/>Pregnancy
Category B: Reproduction studies have been performed in mice, rats,
and rabbits at doses up to ten (10) times the human dose
and have revealed no evidence of impaired fertility or
harm to the fetus due to Ampicillin and Sulbactam for
Injection. 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. (See Drug/Laboratory Test
Interactions.)<br/>Labor and Delivery: Studies in
guinea pigs have shown that intravenous administration of
ampicillin decreased the uterine tone, frequency of
contractions, height of contractions, and duration of
contractions. However, it is not known whether the use of
Ampicillin and Sulbactam for Injection in humans during labor or
delivery has immediate or delayed adverse effects on the fetus,
prolongs the duration of labor, or increases the likelihood that
forceps delivery or other obstetrical intervention or
resuscitation of the newborn will be necessary.<br/>Nursing Mothers: Low
concentrations of ampicillin and sulbactam are excreted in the
milk; therefore, caution should be exercised when Ampicillin and
Sulbactam for Injection is administered to a nursing
woman.<br/>Pediatric Use: The safety
and effectiveness of Ampicillin and Sulbactam for Injection have
been established for pediatric patients one year of age and
older for skin and skin structure infections as approved in
adults. Use of Ampicillin and Sulbactam for Injection in
pediatric patients is supported by evidence from adequate and
well-controlled studies in adults with additional data from
pediatric pharmacokinetic studies, a controlled clinical trial
conducted in pediatric patients and post-marketing adverse
events surveillance. (See CLINICAL
PHARMACOLOGY,INDICATIONS
AND USAGE, ADVERSE
REACTIONS, DOSAGE AND
ADMINISTRATION, and CLINICAL
STUDIES sections.) The safety
and effectiveness of Ampicillin and Sulbactam for Injection have
not been established for pediatric patients for intra-abdominal
infections.
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Neurological
adverse reactions, including convulsions, may occur with the attainment
of high CSF levels of beta-lactams. Ampicillin may be removed from
circulation by hemodialysis. The molecular weight, degree of protein
binding and pharmacokinetics profile of sulbactam suggest that this
compound may alsobe removed by hemodialysis.
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Ampicillin sodium and Sulbactam sodium
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Ampicillin and Sulbactam (Injection, Powder, For Solution)
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Adult Patients: Ampicillin
and Sulbactam for Injection is generally well tolerated. The
following adverse reactions have been reported.<br/>Local
Adverse Reactions: Pain at IM injection site���16% Pain at IV injection site���3% Thrombophlebitis���3%<br/>Systemic
Adverse Reactions: The
most frequently reported adverse reactions were diarrhea
in 3% of the patients and rash in less than 2% of the
patients. Additional systemic reactions reported in less than 1%
of the patients were: itching, nausea, vomiting,
candidiasis, fatigue, malaise, headache, chest pain,
flatulence, abdominal distension, glossitis, urine
retention, dysuria, edema, facial swelling, erythema,
chills, tightness in throat, substernal pain, epistaxis
and mucosal bleeding.<br/>Pediatric Patients: Available
safety data for pediatric patients treated with Ampicillin and
Sulbactam for Injection demonstrate a similar adverse events
profile to those observed in adult patients. Additionally,
atypical lymphocytosis has been observed in one pediatric
patient receiving Ampicillin and Sulbactam for
Injection.<br/>Adverse Laboratory Changes: Adverse
laboratory changes without regard to drug relationship that were
reported during clinical trials were:<br/>Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase,
and LDH.<br/>Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC,
neutrophils, lymphocytes, platelets and increased
lymphocytes, monocytes, basophils, eosinophils, and
platelets.<br/>Blood
Chemistry: Decreased serum albumin and total proteins.<br/>Renal: Increased BUN and creatinine.<br/>Urinalysis: Presence of RBCs and hyaline casts in urine. The
following adverse reactions have been reported with
ampicillin-class antibiotics and can also occur with
Ampicillin and Sulbactam for Injection.<br/>Gastrointestinal: Gastritis,
stomatitis, black "hairy" tongue and enterocolitis. Onset of
pseudomembranous colitis symptoms may occur during or after
antibiotic treatment.<br/>Hypersensitivity
Reactions: Urticaria,
erythema multiforme, and an occasional case of exfoliative
dermatitis have been reported. These reactions may be controlled
with antihistamines and, if necessary, systemic corticosteroids.
Whenever such reactions occur, the drug should be discontinued,
unless the opinion of the physician dictates otherwise. Serious
and occasional fatal hypersensitivity (anaphylactic) reactions
can occur with a penicillin.<br/>Hematologic: In addition
to the adverse laboratory changes listed above for Ampicillin
and Sulbactam for Injection, agranulocytosis has been reported
during therapy with penicillins. All of these reactions are
usually reversible on discontinuation of therapy and are
believed to be hypersensitivity phenomena. Some individuals have
developed positive direct Coombs Tests during treatment with
Ampicillin and Sulbactam for Injection, as with other
beta-lactam antibiotics.
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SERIOUS AND
OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN
REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE APT
TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY
AND/OR HYPERSENSITIVITY REACTIONS 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 THERAPY WITH A PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE
CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS,
CEPHALOSPORINS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS,
AMPICILLIN AND SULBACTAM FOR INJECTION SHOULD BE DISCONTINUED AND THE
APPROPRIATE THERAPY INSTITUTED. SERIOUS
ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH
EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT,
INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Pseudomembranous colitis has been reported
with nearly all antibacterial agents, including Ampicillin and
Sulbactam for Injection, and has ranged 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 toxin produced byClostridium difficile is one
primary cause of "antibiotic-associated colitis." 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 antibacterial drug clinically effective against C. difficile colitis.
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To reduce the
development of drug-resistant bacteria and maintain the effectiveness of
Ampicillin and Sulbactam for Injection and other antibacterial drugs,
Ampicillin and Sulbactam for Injection 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. Ampicillin and
Sulbactam for Injection is indicated for the treatment of infections due
to susceptible strains of the designated microorganisms in the
conditions listed below. Skin and Skin Structure Infections caused
by beta-lactamase producing strains of Staphylococcus aureus, Escherichiacoli,Klebsiella spp.(including K.pneumoniae), Proteus mirabilis,Bacteroides fragilis ,Enterobacter
spp.,andAcinetobacter calcoaceticus. NOTE: For
information on use in pediatric patients see PRECAUTIONS���Pediatric Use and CLINICAL
STUDIES sections. Intra-Abdominal Infections caused by
beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp.
(including B. fragilis), andEnterobacter spp. Gynecological Infections caused by
beta-lactamase producing strains of Escherichia coli ,and Bacteroides
spp.(including B. fragilis). While Ampicillin
and Sulbactam for Injection is indicated only for the conditions listed
above, infections caused by ampicillin-susceptible organisms are also
amenable to treatment with Ampicillin and Sulbactam for Injection due to
its ampicillin content. Therefore, mixed infections caused by
ampicillin-susceptible organisms and beta-lactamase producing organisms
susceptible to Ampicillin and Sulbactam for Injection should not require
the addition of another antibiotic. Appropriate culture
and susceptibility tests should be performed before treatment in order
to isolate and identify the organisms causing infection and to determine
their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be
instituted prior to obtaining the results from bacteriological and
susceptibility studies, when there is reason to believe the infection
may involve any of the beta-lactamase producing organisms listed above
in the indicated organ systems. Once the results are known, therapy
should be adjusted if appropriate.
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Ampicillin and Sulbactam
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