Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1218
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Gentamicin Sulfate (Injection, Solution, Concentrate)
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Gentamicin Sulfate Injection, USP is administered
by intravenous infusion only after dilution in a 50 or 100 mL ADD-Vantage
Flexible Diluent Container of 5% Dextrose Injection, USP or 0.9% Sodium
Chloride Injection, USP (See INSTRUCTIONS FOR USE). The patient's pretreatment body weight should be obtained
for calculation of correct dosage. The dosage of aminoglycosides in
obese patients should be based on an estimate of the lean body mass.
It is desirable to limit the duration of treatment with aminoglycosides
to short term. Patients with Normal Renal Function Adults: The recommended dosage
of gentamicin sulfate for patients with serious infections and normal
renal function is 3 mg/kg/day, administered in three equal doses every
eight hours (Table 1). For patients with
life-threatening infections, dosages up to 5 mg/kg/day may be administered
in three or four equal doses. The dosage should be reduced to 3 mg/kg/day
as soon as clinically indicated (Table 1). It
is desirable to measure both peak and trough serum concentrations
of gentamicin to determine the adequacy and safety of the dosage.
When such measurements are feasible, they should be carried out periodically
during therapy to assure adequate but not excessive drug levels. When
monitoring peak concentrations after intravenous administration, dosage
should be adjusted so that prolonged levels above 12 mcg/mL are avoided.
When monitoring trough concentrations (just prior to the next dose),
dosage should be adjusted so that levels above 2 mcg/mL are avoided.
Determination of the adequacy of a serum level for a particular patient
must take into consideration the susceptibility of the causative organism,
the severity of the infection, and the status of the patient's
host-defense mechanisms. In patients with extensive burns, altered
pharmacokinetics may result in reduced serum concentrations of aminoglycosides.
In such patients treated with gentamicin, measurement of serum concentrations
is recommended as a basis for dosage adjustment. NOTE: For further information concerning the use
of gentamicin in infants and children, see pediatric gentamicin sulfate
injection product information. The usual duration of treatment
for all patients is seven to ten days. In difficult and complicated
infections, a longer course of therapy may be necessary. In such cases
monitoring of renal, auditory, and vestibular functions is recommended,
since toxicity is more apt to occur with treatment extended for more
than ten days. Dosage should be reduced if clinically indicated. For Intravenous Administration The intravenous administration of gentamicin
may be particularly useful for treating patients with bacterial septicemia
or those in shock. It may also be the preferred route of administration
for some patients with congestive heart failure, hematologic disorders,
severe burns, or those with reduced muscle mass. For intermittent
intravenous administration in adults, a single dose of gentamicin
sulfate may be diluted in 50 or 100 mL of sterile 0.9% Sodium Chloride
Injection, USP or in a sterile solution of 5% Dextrose Injection,USP. The solution may be infused over a period of one-half to two
hours. Gentamicin sulfate should not be physically
premixed with other drugs, but should be administered separately in
accordance with the recommended route of administration and dosage
schedule. Patients with Impaired Renal Function Dosage must be adjusted in patients with impaired renal function
to assure therapeutically adequate, but not excessive blood levels.
Whenever possible, serum concentrations of gentamicin should be monitored.
One method of dosage adjustment is to increase the interval between
administration of the usual doses. Since the serum creatinine concentration
has a high correlation with the serum half-life of gentamicin, this
laboratory test may provide guidance for adjustment of the interval
between doses. The interval between doses (in hours) may be approximated
by multiplying the serum creatinine level (mg/100 mL) by 8. For example,
a patient weighing 60 kg with a serum creatinine level of 2.0 mg/100
mL could be given 60 mg (1 mg/kg) every 16 hours (2x8). In patients with serious systemic infections and renal
impairment, it may be desirable to administer the antibiotic more
frequently but in reduced dosage. In such patients, serum concentrations
of gentamicin should be measured so that adequate, but not excessive
levels result. A peak and trough concentration measured intermittently
during therapy will provide optimal guidance for adjusting dosage.
After the usual initial dose, a rough guide for determining reduced
dosage at eight-hour intervals is to divide the normally recommended
dose by the serum creatinine level (Table 2). For example, after an
initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum
creatinine level of 2.0 mg/100 mL could be given 30 mg every eight
hours (60��2). It should be noted that the status of renal function
may be changing over the course of the infectious process. It is important to recognize that deteriorating renal
function may require a greater reduction in dosage than that specified
in the above guidelines for patients with stable renal impairment. In adults with renal failure undergoing hemodialysis,
the amount of gentamicin removed from the blood may vary depending
upon several factors including the dialysis method used. An eight-hour
hemodialysis may reduce serum concentrations of gentamicin by approximately
50%. The recommended dose at the end of each dialysis period is 1
to 1.7 mg/kg depending upon the severity of infection. The above dosage schedules are not intended as rigid recommendations
but are provided as guides to dosage when the measurement of gentamicin
serum levels is not feasible. A variety of methods
are available to measure gentamicin concentrations in body fluids;
these include microbiologic, enzymatic and radioimmunoassay techniques. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. INSTRUCTIONS FOR USE To Open Diluent Container: Peel
overwrap from the corner and remove container. Some opacity of the
plastic due to moisture absorption during the sterilization process
may be observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique) To Prepare Admixture: Preparation for Administration (Use Aseptic
Technique) WARNING: Do not use flexible
container in series connections.
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Gentamicin Sulfate Injection, USP is a sterile, nonpyrogenic
solution of gentamicin sulfate in water for injection. Each milliliter
(mL) contains gentamicin sulfate equivalent to 10 mg gentamicin base
in water for injection. The pH is 4.5 (3.0 to 5.5). Gentamicin Sulfate
Injection, USP is oxygen sensitive. The solutions
contain no bacteriostat, antimicrobial agent (except gentamicin) or
buffer and are intended for use as a single-dose injection only with
the ADD-Vantage Flexible Diluent Container. Gentamicin Sulfate Injection, USP in the ADD-Vantage system is intended
for intravenous administration only after dilution. Gentamicin is classified as an aminoglycoside antibiotic and
is derived from Micromonospora purpurea , an actinomycete. The chemical name for gentamicin
C1A is: 0-3-Deoxy-4-C-methyl-3-(methylamino)-��-L-arabinopyranosyl-(1���6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-��-D-erythro-hexopyranosyl-(1���4)]-2-deoxy-D-streptamine. Gentamicin
Sulfate, USP is chemically designated gentamicin sulfate, a white
to buff powder soluble in water. It has the following structural formula:
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After intramuscular administration of gentamicin
sulfate, peak serum concentrations usually occur between 30 to 60
minutes and serum levels are measurable for 6 to 8 hours. When gentamicin
is administered by intravenous infusion over a two-hour period, the
serum concentrations are similar to those obtained by intramuscular
administration. In patients with normal renal
function, peak serum concentrations of gentamicin (mcg/mL) are usually
up to four times the single intramuscular dose (mg/kg); for example,
a 1 mg/kg injection in adults may be expected to result in a peak
serum concentration up to 4 mcg/mL; a 1.5 mg/kg dose may produce levels
up to 6 mcg/mL. While some variation is to be expected due to a number
of variables such as age, body temperature, surface area and physiologic
differences, the individual patient given the same dose tends to have
similar levels in repeated determinations. Gentamicin administered
at 1 mg/kg every eight hours for the usual 7- to 10-day treatment
period to patients with normal renal function does not accumulate
in the serum. Gentamicin, like all aminoglycosides,
may accumulate in the serum and tissues of patients treated with higher
doses and for prolonged periods, particularly in the presence of impaired
renal function. In adult patients, treatment with gentamicin dosages
of 4 mg/kg/day or higher for seven to ten days may result in a slight,
progressive rise in both peak and trough concentrations. In patients
with impaired renal function, gentamicin is cleared from the body
more slowly than in patients with normal renal function. The more
severe the impairment, the slower the clearance. Dosage must be adjusted. Since gentamicin is distributed in extracellular fluid,
peak serum concentrations may be lower than usual in adult patients
who have a large volume of this fluid. Serum concentrations of gentamicin
in febrile patients may be lower than those in afebrile patients given
the same dose. When body temperature returns to normal, serum concentrations
of the drug may rise. Febrile and anemic states may be associated
with a shorter than usual serum half-life. (Dosage adjustment is usually
not necessary.) In severely burned patients, the half-life may be
significantly decreased and resulting serum concentrations may be
lower than anticipated from the mg/kg dose. Protein binding studies have indicated that the degree of gentamicin
binding is low. Depending upon the methods used for testing, this
may be between 0 and 30%. After initial administration
to patients with normal renal function, generally 70% or more of the
gentamicin dose is recoverable in the urine in 24 hours; concentrations
in urine above 100 mcg/mL may be achieved. Little, if any, metabolic
transformation occurs; the drug is excreted principally by glomerular
filtration. After several days of treatment, the amount of gentamicin
excreted in the urine approaches the daily dose administered. As with
other aminoglycosides, a small amount of the gentamicin dose may be
retained in the tissues, especially in the kidneys. Minute quantities
of aminoglycosides have been detected in the urine weeks after drug
administration was discontinued. Renal clearance of gentamicin is
similar to that of endogenous creatinine. In
patients with marked impairment of renal function, there is a decrease
in the concentration of aminoglycosides in urine and in their penetration
into defective renal parenchyma. This decreased drug excretion, together
with the potential nephrotoxicity of aminoglycosides, should be considered
when treating such patients who have urinary tract infections. Probenecid does not affect renal tubular transport of
gentamicin. The endogenous creatinine clearance
rate and the serum creatinine level have a high correlation with the
half-life of gentamicin in serum. Results of these tests may serve
as guides for adjusting dosage in patients with renal impairment (See
DOSAGE AND ADMINISTRATION). Following parenteral
administration, gentamicin can be detected in serum, lymph, tissues,
sputum, and in pleural, synovial, and peritoneal fluids. Concentrations
in renal cortex sometimes may be eight times higher than the usual
serum levels. Concentrations in bile, in general, have been low and
have suggested minimal biliary excretion. Gentamicin crosses the peritoneal
as well as the placental membranes. Since aminoglycosides diffuse
poorly into the subarachnoid space after parenteral administration,
concentrations of gentamicin in cerebrospinal fluid are often low
and dependent upon dose, rate of penetration and degree of meningeal
inflammation. There is minimal penetration of gentamicin into ocular
tissues following intramuscular or intravenous administration. Microbiology In vitro tests have demonstrated that gentamicin is a bactericidal antibiotic
which acts by inhibiting normal protein synthesis in susceptible microorganisms.
It is active against a wide variety of pathogenic bacteria including Escherichia coli, Proteus species (indole-positive andindole-negative), Pseudomonas aeruginosa, species of Klebsiella-Enterobacter-Serratiagroup, Citrobacter species, and Staphylococcus species (including penicillin- and methicillin-resistant strains).
Gentamicin is also active in vitro against species of Salmonella and Shigella. The following
bacteria are usually resistant to aminoglycosides: Streptococcus pneumoniae, most species
of streptococci, particularly group D and anaerobic organisms, such
as Bacteroides species or Clostridium species. In vitro studies have shown
that an aminoglycoside combined with an antibiotic that interferes
with cell wall synthesis may act synergistically against some group
D streptococcal strains. The combination of gentamicin and penicillin
G has a synergistic bactericidal effect against virtually all strains
of Streptococcus faecalis and its varieties (S. faecalis var. liquifaciens, S. faecalis var. zymogenes ), S. faecium and S. durans. An enhanced killing effect against many of these
strains has also been shown in vitro with combinations of gentamicin and ampicillin, carbenicillin, nafcillin
or oxacillin. The combined effect of gentamicin
and carbenicillin is synergistic for many strains of Pseudomonas aeruginosa. In vitro synergism
against other gram-negative organisms has been shown with combinations
of gentamicin and cephalosporins. Gentamicin
may be active against clinical isolates of bacteria resistant to other
aminoglycosides. Bacteria resistant to one aminoglycoside may be resistant
to one or more other aminoglycosides. Bacterial resistance to gentamicin
is generally developed slowly. Susceptibility Testing If the disc method of susceptibility testing used is that
described by Bauer et al (Am J Clin Path 45:493,1966; FederalRegister 37:20527���20529, 1972), a disc containing
10 mcg of gentamicin should give a zone of inhibition of 15 mm or
more to indicate susceptibility of the infecting organism. Zones greater
than 12 mm and less than 15 mm indicate intermediate susceptibility.
A zone of 12 mm or less indicates that the infecting organism is likely
to be resistant. In certain conditions it may be desirable to do additional
susceptibility testing by the tube or agar dilution method; gentamicin
is available for this purpose.
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Hypersensitivity to gentamicin is a contraindication
to its use. A history of hypersensitivity or serious toxic reactions
to other aminoglycosides may contraindicate use of gentamicin because
of the known cross-sensitivity of patients to drugs in this class.
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Gentamicin Sulfate Injection, USP is supplied as
10 mg Gentamicin/mL in an ADD-Vantage' vial as follows: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] October, 2004
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WARNINGS Patients treated with aminoglycosides should be under
close clinical observation because of the potential toxicity associated
with their use. As with other aminoglycosides,
gentamicin sulfate is potentially nephrotoxic. The risk of nephrotoxicity
is greater in patients with impaired renal function and in those who
receive high dosage or prolonged therapy. Neurotoxicity
manifested by ototoxicity, both vestibular and auditory, can occur
in patients treated with gentamicin sulfate primarily in those with
pre-existing renal damage and in patients with normal renal function
treated with higher doses and/or for longer periods than recommended.
Aminoglycoside-induced ototoxicity is usually irreversible. Other
manifestations of neurotoxicity may include numbness, skin tingling,
muscle twitching and convulsions. Renal and
eighth cranial nerve function should be closely monitored, especially
in patients with known or suspected reduced renal function at onset
of therapy and also in those whose renal function is initially normal
but who develop signs of renal dysfunction during therapy. Urine should
be examined for decreased specific gravity, increased excretion of
protein, and the presence of cells or casts. Blood urea nitrogen,
serum creatinine, or creatinine clearance should be determined periodically.
When feasible, it is recommended that serial audiograms be obtained
in patients old enough to be tested, particularly high-risk patients.
Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in
the ears or hearing loss) or nephrotoxicity requires dosage adjustment
or discontinuance of the drug. As with the other aminoglycosides,
on rare occasions changes in renal and eighth cranial nerve function
may not become manifest until soon after completion of therapy. Serum concentrations of aminoglycosides should be monitored
when feasible to assure adequate levels and to avoid potentially toxic
levels. When monitoring gentamicin peak concentrations, dosage should
be adjusted so that prolonged levels above 12 mcg/mL are avoided.
When monitoring gentamicin trough concentrations, dosage should be
adjusted so that levels above 2 mcg/mL are avoided. Excessive peak
and/or trough serum concentrations of aminoglycosides may increase
the risk of renal and eighth cranial nerve toxicity. In the event
of overdose or toxic reactions, hemodialysismay aid in the removal
of gentamicin from the blood, especially if renal function is, or
becomes, compromised. The rate of removal of gentamicin is considerably
lower by peritoneal dialysis than it is by hemodialysis. Concurrent and/or sequential systemic or topical use of
other potentially neurotoxic and/or nephrotoxic drugs, such as cisplatin,
cephaloridine, kanamycin, amikacin, neomycin, polymyxin B, colistin,
paromomycin, streptomycin, tobramycin, vancomycin, and viomycin, should
be avoided. Other factors which may increase
patient risk to toxicity are advanced age and dehydration. The concurrent use of gentamicin with potent diuretics,
such as ethacrynic acid or furosemide, should be avoided, since certain
diuretics by themselves may cause ototoxicity. In addition, when administered
intravenously, diuretics may enhance aminoglycoside toxicity by altering
the antibiotic concentration in serum and tissue. Aminoglycosides can cause fetal harm when administered to a pregnant
woman (See WARNINGS).
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Neurotoxic and nephrotoxic antibiotics may be almost
completely absorbed from body surfaces (except the urinary bladder)
after local irrigation and after topical application during surgical
procedures. The potential toxic effects of antibiotics administered
in this fashion (neuro-muscular blockade, respiratory paralysis, oto-
and nephrotoxicity) should be considered (See WARNINGS box). Increased nephrotoxicity has been reported following concomitant
administration of aminoglycoside antibiotics and cephalosporins. Neuromuscular blockade and respiratory paralysis have
been reported in the cat receiving high doses (40 mg/kg) of gentamicin.
The possibility of these phenomena occurring in man should be considered
if aminoglycosides are administered by any route to patients receiving
anesthetics, or to patients receiving neuromuscular blocking agents,
such as succinylcholine, tubocurarine, or decamethonium, or in patients
receiving massive transfusions of citrate anticoagulated blood. If
neuromuscular blockade occurs, calcium salts may reverse it. Aminoglycosides should be used with caution in patients
with neuromuscular disorders, such as myasthenia gravis or parkinsonism,
since these drugs may aggravate muscle weakness because of their potential
curare-like effects on the neuromuscular junction. During or following
gentamicin therapy, paresthesias, tetany, positive Chvostek and Trousseau
signs and mental confusion have been described in patients with hypomagnesemia,
hypocalcemia and hypokalemia. When this has occurred in infants, tetany
and muscle weakness has been described. Both adults and infants required
appropriate corrective electrolyte therapy. Elderly patients may have reduced renal function which may not be
evident in the results of routine screening tests, such as BUN or
serum creatinine. A creatinine clearance determination may be more
useful. Monitoring of renal function during treatment with gentamicin,
as with other aminoglycosides, is particularly important in such patients.
A Fanconi-like syndrome, with aminoaciduria and metabolic acidosis
has been reported in some adults and infants being given gentamicin
injections. Cross-allergenicity among aminoglycosides
has been demonstrated. Patients should be well
hydrated during treatment. Although the in vitro mixing of gentamicin and carbenicillin
results in a rapid and significant inactivation of gentamicin, this
interaction has not been demonstrated in patients with normal renal
function who received both drugs by different routes of administration.
A reduction in gentamicin serum half-life has been reported in patients
with severe renal impairment receiving carbenicillin concomitantly
with gentamicin. Treatment with gentamicin may
result in overgrowth of nonsusceptible organisms. If this occurs,
appropriate therapy is indicated. See���WARNINGS box���regarding concurrent use of potent diuretics and regarding concurrent
and/or sequential use of other neurotoxic and/or nephrotoxic antibiotics
and for other essential information.<br/>Pregnancy Category D.: (See WARNINGS section).<br/>General: Prescribing gentamicin in the absence of a proven
or strongly suspected bacterial infection of 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 gentamicin should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When gentamicin
is prescribed to treat a bacterial infection, the patient 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 gentamicin or other antibacterial drugs in the future.
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In the event of overdosage or toxic reactions, hemodialysis
may aid in the removal of gentamicin from the blood, and is especially
important if renal function is, or becomes compromised. The rate of
removal of gentamicin is considerably less by peritoneal dialysis
than it is by hemodialysis.
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Gentamicin Sulfate
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Gentamicin Sulfate (Injection, Solution, Concentrate)
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Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts,
cells or protein in the urine or by rising BUN, NPN, serum creatinine
or oliguria, have been reported. They occur more frequently in patients
with a history of renal impairment and in patients treated for longer
periods or with larger dosages than recommended. Neurotoxicity: Serious adverse
effects on both vestibular and auditory branches of the eighth nerve
have been reported, primarily in patients with renal impairment and
in patients on high doses and/or prolonged therapy. Symptoms include
dizziness, vertigo, tinnitus, roaring in the ears and also hearing
loss, which, as with the other aminoglycosides, may be irreversible.
Hearing loss is usually manifested initially by diminution of high-tone
acuity. Other factors which may increase the risk of toxicity include
excessive dosage, dehydration and previous exposure to other ototoxic
drugs. Peripheral neuropathy or encephalopathy,
including numbness, skin tingling, muscle twitching, convulsions,
and a myasthenia gravis-like syndrome, have been reported. NOTE: The risk
of toxic reactions is low in patients with normal renal function who
do not receive gentamicin sulfate at higher doses or for longer periods
of time than recommended. Other reported adverse
reactions possibly related to gentamicin include: Respiratory depression,
lethargy, confusion, depression, visual disturbances, decreased appetite,
weight loss and hypotension and hypertension; rash, itching, urticaria,
generalized burning, laryngeal edema, anaphylactoid reactions, fever,
and headache; nausea, vomiting, increased salivation, and stomatitis;
purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary
fibrosis, alopecia, joint pain, transient hepatomegaly and splenomegaly. Laboratory abnormalities possibly related to gentamicin
include: Increased levels of serum transaminase (SGOT, SGPT), serum
LDH and bilirubin; decreased serum calcium, magnesium, sodium and
potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis,
eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia.
While clinical laboratory test abnormalities may be isolated findings,
they may also be associated with clinically related signs and symptoms.
For example, tetany and muscle weakness may be associated with hypomagnesemia,
hypocalcemia and hypokalemia.
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To reduce the development of drug-resistant bacteria
and maintain the effectiveness of gentamicin and other antibacterial
drugs, gentamicin 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. Gentamicin Sulfate Injection, USP is indicated in the
treatment of serious infections caused by susceptible strains of the
following microorganisms: Pseudomonas
aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli,
Klebsiella-Enterobacter-Serratia species, Citrobacterspecies , and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Sulfate Injection, USP to
be effective in bacterial neonatal sepsis; bacterial septicemia; and
serious bacterial infections of the central nervous system (meningitis),
urinary tract, respiratory tract, gastrointestinal tract (including
peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated
in uncomplicated initial episodes of urinary tract infections unless
the causative organisms are susceptible to these antibiotics and are
not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to
isolate and identify causative organisms and to determine their susceptibility
to gentamicin. Gentamicin sulfate may be considered
as initial therapy in suspected or confirmed gram-negative infections,
and therapy may be instituted before obtaining results of susceptibility
testing. The decision to continue therapy with this drug should be
based on the results of susceptibility tests, the severity of the
infection, and the important additional concepts contained in the���WARNINGS box���. If the causative organisms are resistant
to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are
unknown, gentamicin sulfate may be administered as initial therapy
in conjunction with a penicillin-type or cephalosporin-type drug before
obtaining results of susceptibility testing. If anaerobic organisms
are suspected as etiologic agents, consideration should be given to
using other suitable antimicrobial therapy in conjunction with gentamicin.
Following identification of the organism and its susceptibility, appropriate
antibiotic therapy should then be continued. Gentamicin sulfate has been used effectively in combination with
carbenicillin for the treatment of life-threatening infections caused
by Pseudomonas aeruginosa.
It has also been found effective when used in conjunction with a penicillin-type
drug for the treatment of endocarditis caused by group D streptococci. Gentamicin Sulfate Injection, USP has also been shown
to be effective in the treatment of serious staphylococcal infections.
While not the antibiotic of first choice, gentamicin may be considered
when penicillins or other less potentially toxic drugs are contraindicated
and bacterial susceptibility tests and clinical judgment indicate
its use. It may also be considered in mixed infections caused by susceptible
strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal
pneumonia, a penicillin-type drug is also usually indicated as concomitant
therapy with gentamicin. In this dosage form,
Gentamicin Sulfate Injection, USP is to be used with an ADD-Vantage
antibiotic diluent flexible plastic container. (See INSTRUCTIONS FOR
USE).
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Gentamicin Sulfate
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