Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3395
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Tobramycin (Injection, Solution, Concentrate)
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Tobramycin Injection, USP may be given intramuscularly
or intravenously. Recommended dosages are the same for both routes.
The patient's pretreatment body weight should be obtained for
calculation of correct dosage. It is desirable to measure both peak
and trough serum concentrations (see WARNINGS box and PRECAUTIONS). Administration for Patients
with Normal Renal Function���Adults with Serious Infections: 3 mg/kg/day in 3 equal
doses every 8 hours (see Table 1). Adults with Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see
Table 1). The dosage should be reduced to 3 mg/kg/day as soon as clinically
indicated. To prevent increased toxicity due to excessive blood levels,
dosage should not exceed 5 mg/kg/day unless serum levels are monitored
(see WARNINGS box and PRECAUTIONS). Pediatric Patients
(Greater Than 1 Week of Age): 6 to 7.5 mg/kg/day in 3 or
4 equally divided doses (2 to 2.5 mg/kg every 8 hours or 1.5 to 1.89
mg/kg every 6 hours). Premature or Full-Term Neonates 1 Week of Age or Less: Up
to 4 mg/kg/day may be administered in 2 equal doses every 12 hours. It is desirable to limit treatment to a short term. The
usual duration of treatment is 7 to 10 days. A longer course of therapy
may be necessary in difficult and complicated infections. In such
cases, monitoring of renal, auditory, and vestibular functions is
advised, because neurotoxicity is more likely to occur when treatment
is extended longer than 10 days. Dosage in
Patients with Cystic Fibrosis���In patients with
cystic fibrosis, altered pharmacokinetics may result in reduced serum
concentration of aminoglycosides. Measurement of tobramycin serum
concentration during treatment is especially important as a basis
for determining appropriate dose. In patients with severe cystic fibrosis,
an initial dosing regimen of10 mg/kg/day in 4 equally divided doses
is recommended. This dosing regimen is suggested only as a guide.
The serum levels of tobramycin should be measured directly during
treatment due to a wide interpatient variability. Administration for Patients With
Impaired Renal Function���Whenever possible, serum
tobramycin concentrations should be monitored during therapy. Following a loading dose of 1 mg/kg, subsequent dosage
in these patients must be adjusted, either with reduced doses administered
at 8-hour intervals or with normal doses given at prolonged intervals.
Both of these methods are suggested as guides to be used when serum
levels of tobramycin cannot be measured directly. They are based on
either the creatinine clearance or the serum creatinine of the patient,
because these values correlate with the half-life of tobramycin. The
dosage schedules derived from either method should be used in conjunction
with careful clinical and laboratory observations of the patient and
should be modified as necessary. Neither method should be used when
dialysis is being performed. Reduced dosage
at 8-hour intervals: When the creatinine clearance rate is 70 mL or
less per minute or when the serum creatinine value is known, the amount
of the reduced dose can be determined by multiplying the normal dose
from Table 1 by the percent of normal dose from the accompanying nomogram. An alternate rough guide for determining reduced dosage
at 8-hour intervals (for patients whose steady-state serum creatinine
values are known) is to divide the normally recommended dose by the
patient's serum creatinine. Normal dosage at prolonged intervals: If the creatinine clearance
rate is not available and the patient's condition is stable,
a dosage frequency in hours for the dosage given in Table 1 can be determined by multiplying
the patient's serum creatinine by 6. Dosage in Obese Patients���The appropriate
dose may be calculated by using the patient's estimated lean
body weight plus 40% of the excess as the basic weight on which to
figure mg/kg. Intramuscular Administration���Tobramycin injection
may be administered by withdrawing the appropriate dose directly from
a vial. Tobramycin Sulfate in 0.9% Sodium Chloride is not intended
for intramuscular administration. Intravenous Administration���For intravenous administration, the usual volume of diluent (0.9% Sodium
Chloride Injection or 5% Dextrose Injection) is 50 to 100 mL for adult
doses. For pediatric patients, the volume of diluent should be proportionately
less than for adults. The diluted solution usually should be infused
over a period of 20 to 60 minutes. Infusion periods of less than 20 minutes
are not recommended because peak serum levels may exceed 12 mcg/mL
(see WARNINGS box). Tobramycin Injection should not be physically premixed
with other drugs but should be administered separately according to
the recommended dose and route. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
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Tobramycin Sulfate, a water-soluble antibiotic of
the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin
Injection, USP is a clear and colorless sterile aqueous solution for
parenteral administration. Each mL contains
tobramycin sulfate equivalent to 10 mg (pediatric) or 40 mg tobramycin;
sodium metabisulfite added as an antioxidant 3 mg; and edetate disodium
added as a stabilizer, 0.1 mg. Contains sulfuric acid and may
contain sodium hydroxide for pH adjustment. pH 4.0 (3.0 to 6.5). Tobramycin sulfate is O-3-amino-3-deoxy-��-D-glucopyranosyl-(1���4)-O-[2,6-diamino-2,3,6-trideoxy-��-D-ribo-hexopyranosyl-(1���6)]-2-deoxy-L-streptamine
sulfate (2:5)(salt) and has the chemical formula (CHNO)���5HSO. The molecular weight is 1,425.45. The structural
formula for tobramycin is as follows:
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Tobramycin is rapidly absorbed following intramuscular
administration. Peak serum concentrations of tobramycin occur between
30 and 90 minutes after intramuscular administration. Following an intramuscular dose of 1 mg/kg of body weight, maximum
serum concentrations reach about 4 mcg/mL, and measurable levels persist
for as long as 8 hours. Therapeutic serum levels are generally considered
to range from 4 to 6 mcg/mL. When tobramycin injection is administered
by intravenous infusion over a 1-hour period, the serum concentrationsare similar to those obtained by intramuscular administration. Tobramycin
is poorly absorbed from the gastrointestinal tract. In patients with normal renal function, except neonates, tobramycin
administered every 8 hours does not accumulate in the serum. However,
in those patients with reduced renal function and in neonates, the
serum concentration of the antibiotic is usually higher and can be
measured for longer periods of time than in normal adults. Dosage
for such patients must, therefore, be adjusted accordingly (see DOSAGE AND ADMINISTRATION). Following parenteral administration, little, if any, metabolic
transformation occurs, and tobramycin is eliminated almost exclusively
by glomerular filtration. Renal clearance is similar to that of endogenous
creatinine. Ultrafiltration studies demonstrate that practically no
serum protein binding occurs. In patients with normal renal function,
up to 84% of the dose is recoverable from the urine in 8 hours and
up to 93% in 24 hours. Peak urine concentrations
ranging from 75 to 100 mcg/mL have been observed following the intramuscular
injection of a single dose of 1 mg/kg. After several days of treatment,
the amount of tobramycin excreted in the urine approaches the daily
dose administered. When renal function is impaired, excretion of tobramycin
is slowed, and accumulation of the drug may cause toxic blood levels. The serum half-life in normal individuals is 2 hours.
An inverse relationship exists between serum half-life and creatinine
clearance, and the dosage schedule should be adjusted according to
the degree of renal impairment (see DOSAGE
AND ADMINISTRATION). In patients undergoing dialysis, 25%
to 70% of the administered dose may be removed, depending on the duration
and type of dialysis. Tobramycin can be detected
in tissues and body fluids after parenteral administration. Concentrations
in bile and stools ordinarily have been low, which suggests minimum
biliary excretion. Tobramycin has appeared in low concentration in
the cerebrospinal fluid following parenteral administration, and concentrations
are dependent on dose, rate of penetration, and degree of meningeal
inflammation. It has also been found in sputum, peritoneal fluid,
synovial fluid, and abscess fluids, andit crosses the placental membranes.
Concentrations in the renal cortex are several times higher than the
usual serum levels. Probenecid does not affect
the renal tubular transport of tobramycin. Microbiology���Tobramycin
acts by inhibiting synthesis of protein in bacterial cells. In vitro tests demonstrate that tobramycin
is bactericidal. Tobramycin has been shown to
be active against most strains of the following organisms both in vitro and in clinical infections:
(see INDICATIONS AND USAGE.) Gram-positive aerobes Staphylococcus
aureus Gram-negative
aerobes Citrobacter sp Enterobacter sp Escherichia coli Klebsiella sp Morganella morganii Pseudomonas aeruginosa Proteus mirabilis Proteus vulgaris Providencia sp Serratia sp Aminoglycosides have a low order of activity
against most gram-positive organisms, including Streptococcus pyogenes, Streptococcus pneumoniae, and enterococci. Although most strains of
enterococci demonstrate in vitro resistance, some strains in this group are susceptible. In vitro studies have shown that an
aminoglycoside combined with an antibiotic that interferes with cell-wall
synthesis affects some enterococcal strains synergistically. The combination
of penicillin G and tobramycin results in a synergistic bactericidal
effect in vitro against certain
strains of Enterococcus faecalis. However, this combination is not synergistic against other closely
related organisms, e.g., Enterococcus
faecium. Speciation of enterococci alone cannot be used
to predict susceptibility. Susceptibility testing and tests for antibiotic
synergism are emphasized. Cross-resistance between
aminoglycosides may occur. Susceptibility Tests: Diffusion Techniques: Quantitative methods that require measurement
of zone diameters give the most precise estimate of the susceptibility
of bacteria to antimicrobial agents. One such procedure is the National
Committee for Clinical Laboratory Standards (NCCLS) approved procedure. This method has been recommended for use with disks to test
susceptibility to tobramycin. Interpretation involves correlation
of the diameters obtained in the disk test with the minimum inhibitory
concentration (MIC) for tobramycin. Reports
from the laboratory giving results of the standard single-disk susceptibility
test with a 10-mcg tobramycin disk should be interpreted according
to the following criteria: A report of���Susceptible���indicates
that the pathogen is likely to be inhibited by generally achievable
blood levels. A report of���Intermediate���suggests that
the organism would be susceptible if high dosage is used or if the
infection is confined to tissues and fluids in which high antimicrobial
levels are attained. A report of���Resistant���indicates
that achievable concentrations are unlikely to be inhibitory, and
other therapy should be selected. Standardized
procedures require the use of laboratory control organisms. The 10-mcg
tobramycin disk should give the following zone diameters: Dilution Techniques: Broth and agar dilution methods, such as those recommended by the
NCCLS, may be used to determine the minimum inhibitory
concentration (MIC) of tobramycin. MIC tests results should be interpreted
according to the following criteria: As with standard diffusion methods, dilution procedures
require the use of laboratory control organisms. Standard tobramycin
powder should give the following MIC values:
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A hypersensitivity to any aminoglycoside is a contraindication
to the use of tobramycin. A history of hypersensitivity or serious
toxic reactions to aminoglycosides may also contraindicate the use
of any other aminoglycoside because of the known cross-sensitivity
of patients to drugs in this class.
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Tobramycin Injection, USP is available as: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.]
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WARNINGS Patients treated with Tobramycin Injection and other aminoglycosides
should be under close clinical observation, because these drugs have
an inherent potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested as both auditory and vestibular
ototoxicity, can occur. The auditory changes are irreversible, are
usually bilateral, and may be partial or total. Eighth-nerve impairment
and nephrotoxicity may develop, primarily in patients having pre-existing
renal damage and in those with normal renal function to whom aminoglycosides
are administered for longer periods or in higher doses than those
recommended. Other manifestations of neurotoxicity may include numbness,
skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced
hearing loss increases with the degree of exposure to either high
peak or high trough serum concentrations. Patients who develop cochlear
damage may not have symptoms during therapy to warn them of eighth-nerve
toxicity, and partial or total irreversible bilateral deafness may
continue to develop after the drug has been discontinued. Rarely,
nephrotoxicity may not become apparent until the first fewdays after
cessation of therapy. Aminoglycoside-induced nephrotoxicity usually
is reversible. Renal and eighth-nerve function
should be closely monitored in patients with known or suspected renal
impairment and also in those whose renal function is initially normal
but who develop signs of renal dysfunction during therapy. Peak and
trough serum concentrations of aminoglycosides should be monitored
periodically during therapy to assure adequate levels and to avoid
potentially toxic levels. Prolonged serum concentrations above 12
mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may
indicate tissue accumulation. Such accumulation, excessive peak concentrations,
advanced age, and cumulative dose may contribute to ototoxicity and
nephrotoxicity (see PRECAUTIONS). Urine should be examined for decreased specific gravity and increased
excretion of protein, cells, and casts. Blood urea nitrogen, serum
creatinine, and creatinine clearance should be measured periodically.
When feasible, it is recommended that serial audiograms be obtained
in patients old enough to be tested, particularly high-risk patients.
Evidence of impairment of renal, vestibular, or auditory function
requires discontinuation of the drug or dosage adjustment. Tobramycin should be used with caution in premature
and neonatal infants because of their renal immaturity and the resulting
prolongation of serum half-life of the drug. Concurrent and sequential use of other neurotoxic and/or nephrotoxic
antibiotics, particularly other aminoglycosides (e.g., amikacin, streptomycin,
neomycin, kanamycin, gentamicin, and paromomycin), cephaloridine,
viomycin, polymyxin B, colistin, cisplatin, and vancomycin, should
be avoided. Other factors that may increase patient risk are advanced
age and dehydration. Aminoglycosides should
not be given concurrently with potent diuretics, such as ethacrynic
acid and furosemide. Some diuretics themselves cause ototoxicity,
and intravenously administered diuretics enhance aminoglycoside toxicity
by altering antibiotic concentrations in serum and tissue. Aminoglycosides can cause fetal harm when administered
to a pregnant woman (see PRECAUTIONS).
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Serum and urine specimens for examination should
be collected during therapy, as recommended in the WARNINGS box. Serum calcium, magnesium,
and sodium should be monitored. Peak and trough
serum levels should be measured periodically during therapy. Prolonged
concentrations above 12 mcg/mL should be avoided. Rising trough levels
(above 2 mcg/mL) may indicate tissue accumulation. Such accumulation,
advanced age, and cumulative dosage may contribute to ototoxicity
and nephrotoxicity. It is particularly important to monitor serum
levels closely in patients with known renal impairment. A useful guideline would be to perform serum level assays
after 2 or 3 doses, so that the dosage could be adjusted if necessary,
and also at 3- to 4-day intervals during therapy. In the event of
changing renal function, more frequent serum levels should be obtained
and the dosage or dosage interval adjusted according to the guidelines
provided in the DOSAGE AND ADMINISTRATION section. In order to measure the peak level,
a serum sample should be drawn about 30 minutes following intravenous
infusion or 1 hour after an intramuscular injection. Trough levels
are measured by obtaining serum samples at 8 hours or just prior to
the next dose of tobramycin. These suggested time intervals are intended
only as guidelines and may vary according to institutional practices.
It is important, however, that there be consistency within the individual
patient program unless computerized pharmacokinetic dosing programs
are available in the institution. These serum-level assays may be
especially useful for monitoring the treatment of severely ill patients
with changing renal function or of those infected with less sensitive
organisms or those receiving maximum dosage. Neuromuscular blockade and respiratory paralysis have been reported
in cats receiving very high doses of tobramycin (40 mg/kg). The possibility
of prolonged or secondary apnea should be considered if tobramycin
is administered to anesthetized patients who are also receiving neuromuscular
blocking agents, such as succinylcholine, tubocurarine, or decamethonium,
or to patients receiving massive transfusions of citrated blood. If
neuromuscular blockade occurs, it may be reversed by the administration
of calcium salts. Cross-allergenicity among
aminoglycosides has been demonstrated. In patients
with extensive burns or cystic fibrosis, altered pharmacokinetics
may result in reduced serum concentrations of aminoglycosides. In
such patients treated with tobramycin, measurement of serum concentration
is especially important as a basis for determination of appropriate
dosage. Elderly patients may have reduced renal
function that 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 aminoglycosides is particularly important in such patients. An increased incidence of nephrotoxicity has been reported
following concomitant administration of aminoglycoside antibiotics
and cephalosporins. Aminoglycosides should be
used with caution in patients with muscular disorders, such as myasthenia
gravis or parkinsonism, since these drugs may aggravate muscle weakness
because of their potential curare-like effect on neuromuscular function. Aminoglycosides may be absorbed in significant quantities
from body surfaces after local irrigation or application and may cause
neurotoxicity and nephrotoxicity. Aminoglycosides
have not been approved for intraocular and/or subconjunctival use.
Physicians are advised that macular necrosis has been reported following
administration of aminoglycosides, including tobramycin, by these
routes. See WARNINGS box regarding concurrent use of potent diuretics and concurrent
and sequential use of other neurotoxic or nephrotoxic drugs. The inactivation of tobramycin and other aminoglycosides
by��-lactam-type antibiotics (penicillins or cephalosporins)
has been demonstrated in vitro and in patients with severe renal impairment. Such inactivation
has not been found in patients with normal renal function who have
been given the drugs by separate routes of administration. Therapy with tobramycin may result in overgrowth of nonsusceptible
organisms. If overgrowth of nonsusceptible organisms occurs, appropriate
therapy should be initiated.<br/>Pregnancy Category D: Aminoglycosides can cause fetal harm when administered
to a pregnant woman. Aminoglycoside antibiotics cross the placenta,
and there have been several reports of total irreversible bilateral
congenital deafness in children whose mothers received streptomycin
during pregnancy. Serious side effects to mother, fetus, or newborn
have not been reported in the treatment of pregnant women with other
aminoglycosides. If tobramycin is used during pregnancy or if the
patient becomes pregnant while taking tobramycin, she should be apprised
of the potential hazard to the fetus.<br/>Pediatric Use: See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.<br/>Geriatric Use: Elderly patients may be at a higher risk of developing
nephrotoxicity and ototoxicity while receiving tobramycin (see WARNINGS, PRECAUTIONS and OVERDOSAGE). Other factors
that may contribute to nephrotoxicity and ototoxicity are rising trough
levels, excessive peak concentrations, dehydration, concomitant use
of other neurotoxic or nephrotoxic drugs, and cumulative dose. Peak
and trough serum levels should be measured periodically during therapy
to assure adequate levels and to avoid potentially toxic levels (see WARNINGS and PRECAUTIONS). Tobramycin is known
to be substantially excreted by the kidney, and the risk of toxic
reactions to this drug may be greater in patients with impaired renal
function. Dose reduction is required for patients with impaired renal
function (see DOSAGE AND ADMINISTRATION). Elderly patients may have reduced renal function that 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 aminoglycosides
is particularly important in the elderly (see PRECAUTIONS). Tobramycin 20 mg/2
mL and 80 mg/2 mL vials each contain 1.4 mg (0.06 mEq) of sodium.<br/>General: Prescribing tobramycin 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 tobramycin should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When tobramycin
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 betaken 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
tobramycin or other antibacterial drugs in the future.
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Signs and Symptoms���The severity of the
signs and symptoms following a tobramycin overdose are dependent on
the dose administered, the patient's renal function, state of hydration,
and age and whether or not other medications with similar toxicities
are being administered concurrently. Toxicity may occur in patients
treated more than 10 days, in adults given more than 5 mg/kg/day,
pediatric patients given more than 7.5 mg/kg/day, or patients with
reduced renal function whose dose has not been appropriately adjusted. Nephrotoxicity following the parenteral administration
of an aminoglycoside is most closely related to the area under the
curve of the serum concentration versus time graph. Nephrotoxicity
is more likely if trough blood concentrations fail to fall below 2
mcg/mL and is also proportional to the average blood concentration.
Patients who are elderly, have abnormal renal function, are receiving
other nephrotoxic drugs, or are volume depleted are at greater risk
for developing acute tubular necrosis. Auditory and vestibular toxicity
has been associated with aminoglycoside overdose; these toxicities
occur in patients treated longer than 10 days, in patients with abnormal
renal function, in dehydrated patients, or in patients receiving medications
with additive auditory toxicities. These patients may not have signs
or symptoms or may experience dizziness, tinnitus, vertigo, and a
loss of high-tone acuity, as ototoxicity progresses. Ototoxicity signs
and symptoms may not begin to occur until long after the drug has
been discontinued. Neuromuscular blockade or
respiratory paralysis may occur following administration of many aminoglycosides.
Neuromuscular blockade, respiratory failure, and prolonged respiratory
paralysis may occur more commonly in patients with myasthenia gravis
or Parkinson's disease. Prolonged respiratory paralysis may
also occur in patients receiving decamethonium, tubocurarine, or succinylcholine.
If neuromuscular blockade occurs, it may be reversed by the administration
of calcium salts but mechanical assistance may be necessary. If tobramycin were ingested, toxicity would be less likely
because aminoglycosides are poorly absorbed from an intact gastrointestinal
tract. Treatment���In all cases of suspected overdosage, call your Regional
Poison Control Center to obtain the most up-to-date information about
the treatment of overdose. This recommendation is made because, in
general, information regarding the treatment of overdose may change
more rapidly than the package insert. In managing overdosage, consider
the possibility of multiple drug overdoses, interaction among drugs,
and unusual drug kinetics in your patient. The
initial intervention in a tobramycin overdose is to establish an airway
and ensure oxygenation and ventilation. Resuscitative measures should
be initiated promptly if respiratory paralysis occurs. Patients that have received an overdose of tobramycin
and have normal renal function should be adequately hydrated to maintain
a urine output of 3 to 5 mL/kg/hr. Fluid balance, creatinine clearance,
and tobramycin plasma levels should be carefully monitored until the
serum tobramycin level falls below 2 mcg/mL. Patients in whom the elimination half-life is greater than 2 hours
or whose renal function is abnormal may require more aggressive therapy.
In such patients, hemodialysis may be beneficial.
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Tobramycin sulfate
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Tobramycin (Injection, Solution, Concentrate)
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Neurotoxicity���Adverse effects on
both the vestibular and auditory branches of the eighth nerve have
been noted, especially in patients receiving high doses or prolonged
therapy, in those given previous courses of therapy with an ototoxin,
and in cases of dehydration. Symptoms include dizziness, vertigo,
tinnitus, roaring in the ears, and hearing loss. Hearing loss is usually
irreversible and is manifested initially by diminution of high-tone
acuity. Tobramycin and gentamicin closely parallel each other in regard
to ototoxic potential. Nephrotoxicity���Renal function
changes, as shown by rising BUN, NPN, and serum creatinine and by
oliguria, cylindruria, and increased proteinuria, have been reported,
especially in patients with a history of renal impairment who are
treated for longer periods or with higher doses than those recommended.
Adverse renal effects can occur in patients with initially normal
renal function. Clinical studies and studies
in experimental animals have been conducted to compare the nephrotoxic
potential of tobramycin and gentamicin. In some of the clinical studies
and in the animal studies, tobramycin caused nephrotoxicity significantly
less frequently than gentamicin. In some other clinical studies, no
significant difference in the incidence of nephrotoxicity between
tobramycin and gentamicin was found. Other reported
adverse reactions possibly related to tobramycin include anemia, granulocytopenia,
and thrombocytopenia; and fever, rash, itching, urticaria, nausea,
vomiting, diarrhea, headache, lethargy, pain at the injection site,
mental confusion, and disorientation. Laboratory abnormalities possibly
related to tobramycin include increased serum transaminases (AST,
ALT); increased serum LDH and bilirubin; decreased serum calcium,
magnesium, sodium, and potassium; and leukopenia, leukocytosis, and
eosinophilia.
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To reduce the development of drug-resistant bacteria
and maintain the effectiveness of tobramycin and other antibacterial
drugs, tobramycin 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. Tobramycin is indicated for the treatment of serious bacterial
infections caused by susceptible strains of the designated microorganisms
in the diseases listed below: Septicemia in
the pediatric patient and adult caused by P aeruginosa, E coli, and Klebsiella sp Lower respiratory tract infections caused by P aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E coli, and S aureus (penicillinase and non-penicillinase-producing
strains) Serious central-nervous-system infections
(meningitis) caused by susceptible organisms Intra-abdominal infections, including peritonitis, caused by E coli, Klebsiella sp, and Enterobacter sp Skin, bone, and skin-structure infections
caused by P aeruginosa, Proteus sp, E coli, Klebsiella sp, Enterobacter sp, and S aureus Complicated
and recurrent urinary tract infections caused by P aeruginosa, Proteus sp (indole-positive and indole-negative), E coli, Klebsiella sp, Enterobacter sp, Serratia sp, S aureus, Providencia sp, and Citrobacter sp Aminoglycosides, including tobramycin,
are not indicated in uncomplicated initial episodes of urinary tract
infections unless the causative organisms are not susceptible to antibiotics
having less potential toxicity. Tobramycin may be considered in serious
staphylococcal infections when penicillin or other potentially less
toxic drugs are contraindicated and when bacterial susceptibility
testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment
to isolate and identify etiologic organisms and to test their susceptibility
to tobramycin. If susceptibility tests show that the causative organisms
are resistant to tobramycin, other appropriate therapy should be instituted.
In patients in whom a serious life-threatening gram-negative infection
is suspected, including those in whom concurrent therapy with a penicillin
or cephalosporin and an aminoglycoside may be indicated, treatment
with tobramycin sulfate may be initiated before the results of susceptibility
studies are obtained. The decision to continue therapy with tobramycin
should be based on the results of susceptibility studies, the severity
of the infection, and the important additional concepts discussed
in the WARNINGS box above.
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Tobramycin
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