Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/709
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Gentamicin Sulfate in Sodium Chloride (Injection, Solution)
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Gentamicin Sulfate
in 0.9% Sodium Chloride Injection is administered by intravenous infusiononly. 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. For example, the peak concentration
(at 30 to 60 minutes following cessation of infusion) is expected to be in
the range of 4 to 6 mcg/mL. When monitoring peak concentrations, 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 areavoided. 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 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. 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 multiple intravenousadministration in adults, a single dose
of Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered
according to individual patient requirements from a premixed flexible bag.
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 mg/100 mL could be given 60 mg (1
mg/kg) every 16 hours (2 x 8). 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 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. Gentamicin
Sulfate Injection is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING
IS REQUIRED. If the prescribed dose is exactly 60,
70, 80, 90 or 100 mg, use the appropriate container. If the prescribed dose
is higher or lower than that of the supplied container, adjustments can be
made in either container. If the dose is higher than the contents of the 100
mg container, the additional amount should be removed from a container of
gentamicin sulfate (40 mg/mL) and added to the 100 mg container. If the prescribed
dose is less, decrements can be made by removing and discarding the appropriate
amount from either unit. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. See CONTRAINDICATIONS. INSTRUCTIONS FOR USE To Open Tear outer wrap at
notch and remove solution container. If supplemental medication is desired,
follow directions below before preparing for administration. 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. Preparation for Administration (Use aseptic technique) WARNING: DO NOT USE FLEXIBLE CONTAINER
IN SERIES CONNECTIONS.
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Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a
sterile, nonpyrogenic solution of gentamicin sulfate in 0.9% sodium chloride
injection. It is administered by the intravenous route as an antibiotic infusion. Each milliliter (mL) of the 50 mL size contains gentamicin sulfate equivalent
to 1.2, 1.4, 1.6 or 2 mg gentamicin base with sodium chloride 9 mg in water
for injection. Each milliliter (mL) of the 100 mL size
contains gentamicin sulfate equivalent to 0.6, 0.8, 0.9 or
1 mg gentamicin base with sodium chloride 9 mg in water for injection. For the 50 and 100 mL sizes, the osmolar concentration is 317 mOsmol/liter
(calc.); pH is 3.8 (3.0 to 5.5). May contain sulfuric acid and/or sodium
hydroxide for pH adjustment. The solutions contain
no bacteriostat, antimicrobial agent (except gentamicin) or buffer and are
intended only for use as a single-dose injection. When smaller doses are required
the unused portion should be discarded. Gentamicin
is classified as an aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete. The chemical name for gentamicin Cis: 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 whohave 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 dependentupon 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
and indole-negative); Pseudomonas aeruginosa, species of Klebsiella-Enterobacter-Serratia group; 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: Streptococcuspneumoniae, 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. faecalisvar.liquifaciens, S. faecalisvar.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; Federal Register 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. Zonesgreater
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. Do not administer
unless solution is clear and container is undamaged. Discard unused portion.
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Gentamicin Sulfate in 0.9% Sodium Chloride Injection is supplied
in a single-dose flexible container as follows: Exposure of pharmaceutical products to heat should be
minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] October, 2004 ��Hospira 2004 EN-0581 (10/04) Printed
in USA HOSPIRA, INC., LAKE
FOREST, IL 60045 USA
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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, hemodialysis
may 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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Do not use additives or premix with other drugs. See DOSAGE
AND ADMINISTRATION. 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 or a prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of the development of
drug-resistant bacteria.<br/>Information for Patients: Patients should be counseled that antibacterial drugs including
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, 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 gentamicin or other antibacterial drugs in the future.
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In the event of overdose or toxic reactions, hemodialysis
may 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.
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Gentamicin Sulfate and Sodium Chloride
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Gentamicin Sulfate in Sodium Chloride (Injection, Solution)
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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, primarilyin patients with renal impairment (especially if dialysis is required) 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. While local tolerance of gentamicin sulfate is generally excellent, there
has been an occasional report of pain at the injection site. Subcutaneous
atrophy or fat necrosis suggesting local irritation has been reported rarely.
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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, theyshould 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 in 0.9% Sodium Chloride Injection 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 Staphylococcusspecies (coagulase-positive
and coagulase-negative). Clinical studies have shown
gentamicin sulfate 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 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 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 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 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.
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Gentamicin Sulfate in Sodium Chloride
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