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
bacteria.
Ampicillin and Sulbactam Description
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. HOWEVER, THE
INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS
FOR IV INFUSION ONLY.
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
C16H18N3NaO4S. 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
C8H10NNaO5S 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.
Each sterile
Pharmacy Bulk Package contains 15 g Ampicillin and Sulbactam for
Injection (10 g ampicillin as the sodium salt plus 5 g sulbactam as the
sodium salt) and approximately 1150 mg (50 mEq) sodium. Ampicillin and
Sulbactam for Injection Pharmacy Bulk Package is a vial containing a
sterile preparation of ampicillin sodium and sulbactam sodium for
parenteral use that contains many single doses. The Pharmacy Bulk
Package is for use in a pharmacy admixture setting; it provides many
single doses of ampicillin/sulbactam for addition to suitable parenteral
fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR
PROPER USE OF PHARMACY BULK PACKAGE.) FURTHER DILUTION IS
REQUIRED BEFORE USE.
Ampicillin and Sulbactam - Clinical Pharmacology
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 37 mcg/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:
TABLE A
Concentration of Ampicillin/Sulbactam in Various Body Tissues and
Fluids
Concentration
Dose (grams)
(mcg/mL or
mcg/g)
Fluid or Tissue
Ampicillin/Sulbactam
Ampicillin/Sulbactam
Peritoneal Fluid
0.5/0.5 IV
7/14
Blister Fluid (Cantharides)
0.5/0.5 IV
8/20
Tissue Fluid
1/0.5 IV
8/4
Intestinal Mucosa
0.5/0.5 IV
11/18
Appendix
2/1
IV
3/40
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.
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.
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
faecalis1 (Enterococcus), Streptococcus
pneumoniae1 (formerly D. pneumoniae),Streptococcus pyogenes1, Streptococcus viridans1.
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).
Anaerobes
Clostridium
species1, Peptococcus species1, Peptostreptococcus species, Bacteroides species,
including B.fragilis.
These
are not beta-lactamase producing strains and, therefore, are susceptible to ampicillin
alone.
Susceptibility
Testing
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-A4.1 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.
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-A2.2 Tubes should be
inoculated to contain 105 to 106organisms/mL or plates "spotted" with 104organisms.
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.
The non-beta-lactamase producing
organisms which are normally susceptible
to ampicillin, such as Streptococci, will have
similar zone sizes as for ampicillin
disks.
Gram(-) and
Staphylococcus
Bauer/Kirby Zone Sizes MIC (mcg of
ampicillin/mL)
≤ 11 mm
≥ 32
12-13 mm
16
≥ 14 mm
≤8
Hemophilus
influenzae
Bauer/Kirby Zone Sizes MIC (mcg of
ampicillin/mL)
≤ 19
≥4
—
—
≥ 20
≤ 2
Disks
Mode
MIC (mcg/mL ampicillin/mcg/mL
sulbactam)
E.
coli
(ATCC 25922)
20-24 mm
2/1
S.
aureus
(ATCC 25923)
29-37 mm
0.12/0.06
E.
coli
(ATCC 35218)
13-19 mm
8/4
Indications and Usage for Ampicillin and Sulbactam
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 ,2Klebsiella spp.2
(including K. pneumoniae 2),Proteus mirabilis,2Bacteroides fragilis,2Enterobacter
spp.,2 andAcinetobacter calcoaceticus 2.
Intra-Abdominal Infections caused by
beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae 2),Bacteroides spp. (includingB. fragilis), and Enterobacter spp.2
Gynecological Infections caused by
beta-lactamase producing strains of Escherichia coli 2 and Bacteroides spp.2
(including B. fragilis2).
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.
Efficacy for this
organism in this organ system was studied in fewer than 10
infections.
Contraindications
The use of
Ampicillin and Sulbactam for Injection is contraindicated in individuals
with a history of hypersensitivity reactions to any of the
penicillins.
Warnings
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.
Precautions
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.
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.
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.
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.
Carcinogenesis and
Mutagenesis and Impairment of Fertility
Long-term
studies in animals have not been performed to evaluate
carcinogenic or mutagenic potential.
Pregnancy
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.)
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.
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.
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.
Adverse Reactions
Adult Patients
Ampicillin
and Sulbactam for Injection is generally well tolerated. The
following adverse reactions have been reported.
Local
Adverse Reactions
Pain at IM injection site–16%
Pain at IV injection site–3%
Thrombophlebitis–3%
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.
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.
Adverse Laboratory
Changes
Adverse
laboratory changes without regard to drug relationship that were reported during clinical trials were:
Hepatic
Increased AST (SGOT), ALT (SGPT), alkaline phosphatase,
and LDH.
Hematologic
Decreased hemoglobin, hematocrit, RBC, WBC,
neutrophils, lymphocytes, platelets and increased
lymphocytes, monocytes, basophils, eosinophils, and
platelets.
Blood
Chemistry
Decreased serum albumin and total proteins.
Renal
Increased BUN and creatinine.
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.
Gastrointestinal
Gastritis,
stomatitis, black "hairy" tongue and enterocolitis. Onset of
pseudomembranous colitis symptoms may occur during or after
antibiotic treatment. (See WARNINGS.)
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. (See WARNINGS.)
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.
Overdosage
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 also be removed by hemodialysis.
Clinical Studies
Skin and Skin
Structure Infections in Pediatric Patients
Data from a
controlled clinical trial conducted in pediatric patients
provided evidence supporting the safety and efficacy of
Ampicillin and Sulbactam for Injection for the treatment of skin
and skin structure infections. Of 99 pediatric patients
evaluable for clinical efficacy, 60 patients received a regimen
containing intravenous Ampicillin and Sulbactam for Injection,
and 39 patients received a regimen containing intravenous
cefuroxime. This trial demonstrated similar outcomes (assessed
at an appropriate interval after discontinuation of all
antimicrobial therapy) for ampicillin/sulbactam- and
cefuroxime-treated patients:
Therapeutic
Regimen
Clinical Success
Clinical
Failure
Ampicillin/Sulbactam
51/60 (85%)
9/60 (15%)
Cefuroxime
34/39
(87%)
5/39 (13%)
Most patients received a course of oral antimicrobials following
initial treatment with intravenous administration of parenteral
antimicrobials. The study protocol required that the following
three criteria be met prior to transition from intravenous to
oral antimicrobial therapy: 1) receipt of a minimum of 72 hours
of intravenous therapy; 2) no documented fever for prior 24
hours; and 3) improvement or resolution of the signs and
symptoms of infection.
The choice
of oral antimicrobial agent used in this trial was determined by
susceptibility testing of the original pathogen, if isolated, to oral agents available. The course of oral antimicrobial therapy
should not routinely exceed 14 days.
Ampicillin and Sulbactam Dosage and Administration
Ampicillin and
Sulbactam for Injection may be administered by either the IV or deep IM
routes (following dilution).HOWEVER, THE INTENT OF THE PHARMACY BULK
PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION
ONLY.
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.
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.
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 corresponds to 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.)
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:
Ampicillin and Sulbactam for Injection Dosage Guide For
Patients With Renal Impairment
Creatinine
Clearance
Ampicillin/Sulbactam Half-Life
(Hours)
Recommended Ampicillin/Sulbactam Dosage
(mL/min/1.73m2)
≥30
1
1.5-3 g q 6h-q 8h
15-29
5
1.5-3 g q 12h
5-14
9
1.5-3 g q 24h
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.
Males
weight (kg) x (140 – age) 72 x serum creatinine
Females
0.85 x above value
Compatibility,
Reconstitution and Stability
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.
Directions for Use
General
Dissolution Procedures
Ampicillin and Sulbactam for Injection sterile powder
for intravenous 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.
Preparation
for Intravenous Use
Ampicillin and Sulbactam for Injection concentrations
between 3 and 45 mg Ampicillin and Sulbactam (2 to 30 mg
ampicillin/1 to 15 mg sulbactam/mL) are recommended for
intravenous use.
Directions
for Proper Use of Pharmacy Bulk Package
The
15 gram vial may be reconstituted with either 92 mL
Sterile Water for Injection or 0.9% Sodium Chloride
Injection. The diluent should be added in two separate
aliquots in a suitable work area, such as a laminar flow
hood. Add 50 mL of solution, shake to dissolve. Then add
an additional 42 mL and shake. The solution should be
allowed to stand after dissolution to allow any foaming
to dissipate in order to permit visual inspection for
complete solubilization. The resultant solution will
have a final concentration of approximately 100 mg/mL ampicillin and 50 mg/mL sulbactam. The closure may be
penetrated only one time after reconstitution, if
needed, using a suitable sterile transfer device or
dispensing set that allows for measured dispensing of
the contents.
After reconstitution, use within two hours if stored at
room temperature, or within four hours if stored under
refrigeration.
Reconstituted Bulk
Solution Should Not be Used For Direct
Infusion
If
the reconstituted bulk solution is stored for less than
one hour at room temperature (20°C/68°F) prior to further dilution, the use periods indicated in Table A
apply for the diluted solutions.
If
the bulk solution is stored for one to two hours at room
temperature (20°C/68°F) and then diluted with Sterile
Water for Injection or 0.9% Sodium Chloride Injection to
the following concentrations, the use periods indicated
in Table B apply.
Any
unused portions of solution that remain after the
indicated time periods should be discarded.
TABLE A Maximum
Concentration (mg/mL)
Diluent
Ampicillin/Sulbactam
Use
Periods
Sterile Water for Injection
45 (30/15)
8 hrs @ 21ºC
45 (30/15)
48 hrs @ 4ºC
30 (20/10)
72 hrs @ 4ºC
0.9% Sodium Chloride Injection
45 (30/15)
8 hrs @ 21ºC
45 (30/15)
48 hrs @ 4ºC
30 (20/10)
72 hrs @ 4ºC
5% Dextrose
Injection
30 (20/10)
2 hrs @ 21ºC
30 (20/10)
4 hrs @ 4ºC
3 (2/1)
2 hrs @ 21ºC
Lactated Ringer’s
Injection
45 (30/15)
8 hrs @ 21ºC
45 (30/15)
24 hrs @ 4ºC
M/6 Sodium
Lactate Injection
45 (30/15)
8 hrs @ 21ºC
45 (30/15)
12 hrs @ 4ºC
5% Dextrose in
0.45% Saline
3 (2/1)
4 hrs @ 21ºC
15 (10/5)
4 hrs @ 4ºC
10% Invert Sugar
3 (2/1)
4 hrs @ 21ºC
30 (20/10)
3 hrs @ 4ºC
TABLE B Maximum
Concentration (mg/mL)
IV
Solution
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ampicillin sodium/sulbactam sodium, ampicillin and sulactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbctam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbatam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactm injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacta injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactaminjection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam njection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam ijection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam inection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injction
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injetion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injecion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injecton
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectin
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectio
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
mpicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
apicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
amicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampcillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicllin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilln sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilli sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillinsodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin odium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sdium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin soium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodum/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodim/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiu/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiumsulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/ulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/slbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/subactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbctam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbatam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactm sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacta sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactamsodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam odium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sdium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam soium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodum, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodim, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodiu, mapicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, apmicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, amipcillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampciillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampiicllin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampiclilin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicililn and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillni and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicilli nand sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillina nd sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin nad sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin adn sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin an dsulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin ands ulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and uslbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and slubactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sublactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulabctam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbcatam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbatcam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacatm injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactma injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacta minjection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactami njection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam nijection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam ijnection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam inejction
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injcetion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injetcion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injeciton
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectoin
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectino
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectio
n ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
a mpicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
mapicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
apmicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
amipcillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampciillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiicllin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiclilin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicililn sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillni sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilli nsodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillins odium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin osdium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sdoium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin soidum/sulbactam sodium, ampicillin and sulbactam injection
ampicillin soduim/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodimu/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiu/msulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiums/ulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/uslbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/slubactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sublactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulabctam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbcatam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbatcam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacatm sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactma sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacta msodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactams odium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam osdium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sdoium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam soidum, ampicillin and sulbactam injection
ampicillin sodium/sulbactam soduim, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodimu, aampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ammpicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, amppicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampiicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampiccillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampiciillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicilllin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicilllin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicilliin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillinn and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin aand sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin annd sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin andd sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and ssulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and suulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sullbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbaactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacctam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbacttam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactaam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactamm injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam iinjection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam innjection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injjection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injeection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injecction
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injecttion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectiion
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectioon
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injectionn
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
aampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ammpicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
amppicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiccillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampiciillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilllin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilllin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicilliin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillinn sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin ssodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin soodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin soddium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiuum/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodiumm/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium//sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/ssulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/suulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sullbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbaactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacctam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbacttam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactaam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactamm sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam ssodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam soodium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam soddium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodiium, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodiuum, ampicillin and sulbactam injection
ampicillin sodium/sulbactam sodiumm, etc.
