Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1046
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Gentamicin Sulfate (Injection, Solution)
|
| dailymed-instance:dosage |
It is desirable to
limit the duration of treatment with aminoglycosides to short term. 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 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. 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. Generally, the peak
concentration is expected to be in the range of 4 to 6 mcg/mL. When
monitoring peak concentrations (at 30 to 60 minutes after injection),
prolonged levels above 12 mcg/mL should be avoided. When monitoring
trough concentrations (just prior to the next dose), levels above 2
mcg/mL should be avoided. Determination of the adequacy of 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. 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. The solution may be infused over a period of one
half to two hours. Isotonic Gentamicin
Sulfate Injection should not be physically premixed with other drugs,
but should be administered separately in accordance with the recommended
route of administration and dosage schedule. The dosage recommendations which follow are not intended as rigid schedules, but
are provided as guides for initial therapy, or when the measurement of
gentamicin serum levels during therapy is not feasible.<br/>Patients with
Normal Renal Function: Adults: The
recommended dosage of Isotonic Gentamicin Sulfate Injection for
patients with serious infections and normal renal function is 3
mg/kg/day, administered in three equal doses every eight hours
(Table I). For
patients with life-threatening infections, dosages up to 5
mg/kg/day may be administered in three or four equal doses. This
dosage should be reduced to 3 mg/kg/day as soon as clinically
indicated (Table II). This
container system may be inappropriate for the dosage
requirements of children, infants, and neonates. Other dosage
forms may be more appropriate.<br/>Patients with
Impaired Renal Function: Dosage must
be adjusted in patients with impaired renal function. 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 2mg/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 guidancefor
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 III). 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 should receive 30 mg (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 dosage 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. A variety
of methods are available to measure gentamicin concentrations in
body fluids; these include microbiologic, enzymatic and
radioimmunoassay techniques. Instructions for the Administration of
Isotonic Gentamicin Sulfate Injection. This product is intended for use only
as an IV secondary medication unit. Use aseptic
technique when removing contents from these units. Do not add other drugs to Isotonic
Gentamicin Sulfate Injection. Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever
solution and container permit. Use of a final filter is
recommended during administration of all parenteral solutions,
where possible. All
injections in VIAFLEX Plus plastic containers are intended for
intravenous administration using sterile equipment.
|
| dailymed-instance:descripti... |
Gentamicin Sulfate,
USP, a water soluble antibiotic of the aminoglycoside group, is derived
from Micromonospora purpurea, and
actinomycete. Isotonic Gentamicin
Sulfate Injection is a sterile, nonpyrogenic solution of Gentamicin
Sulfate, USP in water for injection with 9 mg/mL sodium chloride (NaCl)
to provide isotonicity. The solution is intended for intravenous use and
requires no further dilution. pH may be adjusted with sulfuric acid or
sodium hydroxide and is approximately 4.5. This VIAFLEX Plus
plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the
presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic
container system utilizes the same container as the VIAFLEX plastic
container system. The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the solution
significantly. Solutions in contact with the plastic container can leach
out certain of its chemical components in very small amounts within the
expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts
per million. However, the safety of the plastic has been confirmed in
tests in animals according to USP biological tests for plastic
containers as well as by tissue culture toxicity studies.
|
| dailymed-instance:clinicalP... |
When gentamicin is
administered by intravenous infusion over a two hour period, peak serum
concentrations usually occur between 30 and 60 minutes and serum levels
are measurable for six to eight hours. 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 dueto 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 tissue of patients
treated with higher doses and for prolonged periods, particularly in the
presence of impaired renal function. In adult patients, treatment with a
gentamicin dose of 4 mg/kg/day or higher over a seven to ten day
treatment period may result in a slight, progressive rise in both peak
and trough concentrations. In patients with impaired renal function,
serum concentrations of gentamicin are usually higher and measurable for
longer periods. 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 witha 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 gentamicin have been detected in the urine weeks after the 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 patients with urinary tract infections. Probenecid does not
affect renal tubular transport of gentamicin. Endogenous
creatinine clearance rate and 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 (and 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 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 sp. (indole-positive and
indole-negative), Pseudomonas
aeruginosa, species of the Klebsiella- Enterobacter-Serratia group, Citrobacter sp. and Staphylococcus sp. (including
penicillin and methicillin-resistant strains). Gentamicin is also activein vitro against species ofSalmonella and Shigella. The following bacteria areusually resistant to aminoglycosides: Streptococcus pneumoniae, most species of Streptococci, particularly group D and
anaerobic organisms, such as Bacteriods sp. or Clostridium sp. 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 ofStreptococcus faecalis and
its varieties (S faecalis var.liquifaciens, S faecalis var. zymogenes), S faecium and S durans. An enhanced killing effect
against many of these strains has also been shown in vitro with combinations of
gentamicin and ampicillin, carbenicillin, nafcillin, or oxacillin. The combined effect
of gentamicin and carbenicillin is synergistic for many strains ofPseudomonas 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 be given 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
substance is available for this purpose.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Hypersensitivity to
gentamicin is a contraindication to its use. A history of
hypersensitivity or serious toxic reactions to aminoglycosides may also
contraindicate use of gentamicin because of known cross-sensitivity of
patients to drugs in this class.
|
| dailymed-instance:supply |
Isotonic Gentamicin
Sulfate Injection in VIAFLEX Plus plastic container is available in the
following sizes and concentrations. Do not remove unit
from overwrap until ready for use. The overwrap is a moisture barrier.
The inner bag maintains the sterility of the product. After removing
overwrap, check for minute leaks by squeezing inner bag firmly. If leaks
are found, discard solution as sterility may be impaired. Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.<br/>Directions for Use of VIAFLEX Plus Plastic Container: Warning: Do not use plastic
containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary
container before administration of the fluid from the secondary
container is completed.<br/>To Open: Tear
overwrap down side at slit and remove solution container. Some
opacity of the plastic due to moisture absorption during the
sterilization process may be observed. This is normal and does
not affect the solution quality or safety. The opacity will
diminish gradually. Check for leaks. Do not add supplementary medication.<br/>Preparation for
Administration: 1. Suspend
container from eyelet support. 2. Remove
protector from outlet port at bottom of container. 3. Attach
administration set. Refer to complete directions accompanying
set. Baxter, VIAFLEX and
PL 146 are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield,
IL 60015 USA Printed in
USA 07-19-48-344 Rev. November 2006
|
| dailymed-instance:boxedWarn... |
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 of prolonged therapy. Neurotoxicity
manifested by ototoxicity, both vestibular and auditory, can occur in
patients treated with gentamicin sulfate, primarily those with
preexisting renal damage and in patients with normal renal functions
treated with higher doses 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 nephrotoxicityrequires 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 peaks
and/or trough serum concentrations of aminoglycosides may increase the
risk of renal and eighth cranial nerve toxicity. In the event of
overdosage 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 of 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).
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General - Prescribing Isotonic Gentamicin Sulfate Injection in the absence of a proven or strongly suspected
bacterial infection or a prophylactic indication is unlikely to provide
benefit to the patient and increases the risk of the development of
drug-resistant bacteria. Do not use
additives or premix with other drugs. (see DOSAGE AND
ADMINSTRATION). 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
blockage 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 thein 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. Caution must be
exercised in the administration of parenteral fluids, especially those
containing sodium ion, to patients receiving corticosteroids or
corticotropin.<br/>Information for
Patients: Patients
should be counseled that antibacterial drugs including Isotonic
Gentamicin Sulfate Injection, should only be used to treat
bacterial infections. They do not treat viral infections (e.g.,
the common cold). When Isotonic Gentamicin Sulfate Injection is
prescribed to treat a bacterial infection, patients should be
told that although it is common to feel better early in the
course of therapy, the medication should be taken exactly as
directed. Skipping doses or not completing the full course of
therapy may (1) decrease the effectiveness of the immediate
treatment and (2) increase the likelihood that bacteria will
develop resistance and will not be treatable by Isotonic
Gentamicin Sulfate Injection or other antibacterial drugs in the
future.
|
| dailymed-instance:overdosag... |
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 lower by peritoneal dialysis than it is by
hemodialysis.
|
| dailymed-instance:genericMe... |
Gentamicin Sulfate
|
| dailymed-instance:fullName |
Gentamicin Sulfate (Injection, Solution)
|
| dailymed-instance:adverseRe... |
Nephrotoxicity - Adverse renal effects, as demonstrated by the presence of casts, cells, or protein in the urine
or by rising BUN, NPN, serum creatinine and 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 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: This 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, 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 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 rarely reported. Reactions which may
occur because of the solution or the technique of administration,
include febrile response, infection at the site of injection, venous
thrombosis or phlebitis extending from the site of injection,
extravasation, and hypervolemia. If an adverse
reaction does occur, discontinue the infusion, evaluate the patient,
institute appropriate therapeutic countermeasures, and save the
remainder of the fluid for examination if deemed necessary.
|
| dailymed-instance:warning |
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 of prolonged therapy. Neurotoxicity
manifested by ototoxicity, both vestibular and auditory, can occur in
patients treated with gentamicin sulfate, primarily those with
preexisting renal damage and in patients with normal renal functions
treated with higher doses 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 nephrotoxicityrequires 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 peaks
and/or trough serum concentrations of aminoglycosides may increase the
risk of renal and eighth cranial nerve toxicity. In the event of
overdosage 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 of 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).
|
| dailymed-instance:indicatio... |
To reduce the
development of drug-resistant bacteria and maintain the effectiveness of
Isotonic Gentamicin Sulfate Injection and other antibacterial drugs,
Isotonic Gentamicin Sulfate Injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology
and susceptibility patterns may contribute to the empiric selection of
therapy. Isotonic Gentamicin
Sulfate Injection is indicated in the treatment of serious infections
caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus sp. (indole-positive and
indole-negative), Escherichia
coli, Klebsiella-Enterobacter-
Serratia sp., Citrobacter sp., and Staphylococcus sp. (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. Isotonic Gentamicin
Sulfate Injection 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 WARNINGSBox above. If the causative organisms are resistant to
gentamicin, other appropriate therapy should be instituted. In serious
infections when the causative organisms are unknown, Isotonic Gentamicin
Sulfate Injection may be administered as initial therapy in conjunction
with a penicillin 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 sulfate
has also been shown to be effective in the treatment of serious
staphylococcal infections. While not the antibiotic of first choice,
gentamicin sulfate may be considered when penicillins or other less
potentially toxic drugs are contraindicated and bacterial susceptibility
tests and clinical judgement 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 sepsis or staphylococcal pneumonia, a penicillin type drug is
also usually indicated as concomitant therapy with gentamicin.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Gentamicin Sulfate
|