Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2298
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Gentamicin Sulfate (Injection, Solution, Concentrate)
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Gentamicin Sulfate Injection,
USP may be given intramuscularly or by intravenous infusion. 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 after intramuscular injection) is expected to be in the
range of 4 to 6 mcg/mL. When monitoring peak concentrations after intramuscular
or 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
fora 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. * The dosage of aminoglycosides in obese patients should
be based on an estimate of the lean body mass. ** For
q6h schedules, dosage should be recalculated. Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered
every 8 hours). Infants and
Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every 8 hours). Premature or Full-Term Neonates One Week of Age or Less: 5 mg/kg/day (2.5 mg/kg administered every 12 hours). 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 to 200 mL of sterile isotonic saline solution or in a
sterile solution of 5% dextrose in water, in infants and children, the volume
of diluent should be less. The solution may be infused over a period of one-half
to two hours. The recommended dosage for intravenous
and intramuscular administration is identical. 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 (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 2.0 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. In children, a dose of 2 mg/kg may be administered. 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.
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Gentamicin Sulfate Injection, USP is a sterile, nonpyrogenic
solution of gentamicin sulfate in water for injection. It is administered
by the intramuscular or intravenous route. Each milliliter
(mL) contains gentamicin sulfate equivalent to 40 mg gentamicin base with
sodium metabisulfite 2.9 mg and edetate disodium anhydrous 0.1 mg added as
stabilizer, methylparaben 1.8 mg and propylparaben 0.2 mg added as preservatives.
Headspace nitrogen gassed. May contain sulfuric acid and/or sodium hydroxide
for pH adjustment. The pH is 3.8 (3.0 to 5.5). 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 thanin 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 and indole-negative); Pseudomonas aeruginosa, species of Klebsiella-Enterobacter-Serratia group; Citrobacter species, and Staphylococcusspecies (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. 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.
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, 80 mg/2 mL (40 mg/mL as
Gentamicin), is supplied in a 2 mL Fliptop Vial (List No. 1207). Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] August, 2005 ��Hospira 2005 EN-1004 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 Injection, USP 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 Injection, USP, 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. Aswith 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, dosageshould 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 section).
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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 (neuromuscular 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. Do
not administer unless solution is clear and package undamaged.<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 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 (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, transienthepatomegaly 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, 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, Citrobacter species, 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.
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Gentamicin Sulfate
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