Gentamicin: Difference between revisions

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{{Details0|Gentamicin (Injection)}}
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{{Details0|Gentamicin (ophthalmic)}}
 
{{Details0|Gentamicin (topical)}}
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Gentamicin
 
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<i><span style="color:#FF0000;"> </span></i>
 
*Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.
 
*As with other aminoglycosides, gentamicin injection 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, 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 (BUN), serum creatinine or creatinine clearance should be determined periodically.  When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients.  Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug.  As with the other aminoglycosides, on rare occasions changes in renal and eighth cranial nerve function may not become manifest until soon after completion of therapy.
 
*Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels.  When monitoring gentamicin peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided.  When monitoring gentamicin trough concentrations, dosage should be adjusted so that levels above 2 mcg/mL are avoided.  Excessive peak and/or trough serum concentrations of aminoglycosides may increase the risk of renal and eighth cranial nerve toxicity.
 
*In the event of 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.
 
*In the newborn infant, exchange transfusions may also be considered.
 
*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.
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP 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 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 injection 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 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 BOXED WARNINGS.  If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.
 
In serious infections when the causative organisms are unknown, gentamicin injection 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 injection 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 treatment of endocarditis caused by group D streptococci.
 
Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections.  While not the antibiotic of first choice, gentamicin injection 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.
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
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* Developed by:
 
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* Strength of Evidence:
 
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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
*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.
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
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=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
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=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
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There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
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There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
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* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
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There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
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<!--Mechanism of Action-->
 
|mechAction=
 
* Gentamicin, an aminoglycoside, binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria.  It is bactericidal in vitro against Gram-positive and Gram-negative bacteria.
 
<!--Structure-->
 
|structure=
 
* Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete.
 
*It has the following structural formula.
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
*Gentamicin injection is a sterile, nonpyrogenic aqueous solution for parenteral administration.
 
*Each mL contains: Gentamicin sulfate equivalent to 40 mg gentamicin, methylparaben 1.8 mg and propylparaben 0.2 mg as preservatives, sodium metabisulfite 3.2 mg and edetate disodium 0.1 mg, Water for Injection q.s.  Sodium hydroxide and/or sulfuric acid may have been added for pH adjustment.
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
*After intramuscular (IM) administration of gentamicin sulfate, peak serum concentrations usually occur between 30 and 60 minutes and serum levels are measurable for six to eight hours.  When gentamicin is administered by intravenous (IV) infusion over a two-hour period, the serum concentrations are similar to those obtained by IM administration.
 
*In patients with normal renal function, peak serum concentrations of gentamicin (mcg/mL) are usually up to four times the single IM 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/or 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 7 to 10 days may result in a slight, progressive rise in both peak and trough concentrations.  In patients with impaired renal function, gentamicin is cleared from the body more slowly than in patients with normal renal function.  The more severe the impairment, the slower the clearance.  (Dosage must be adjusted.)
 
*Since gentamicin is distributed in extra-cellular 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 IM or IV administration.
 
=====Microbiology=====
 
*Drug Resistance
:*Bacterial resistance to gentamicin is generally developed slowly.  Bacteria resistant to one aminoglycoside may be resistant to one or more other aminoglycosides.  The following bacteria are usually resistant to the aminoglycosides, including gentamicin: most streptococcal species (including Streptococcus pneumoniae and the Group D streptococci), most enterococcal species (including Enterococcus faecalis, E. faecium, and E. durans), and anaerobic organisms, such as Bacteroides species and Clostridium species.
:*Aminoglycosides are known to be not effective against Salmonella and Shigella species in patients.  Therefore, in vitro susceptibility test results should not be reported.
 
*Interactions with Other Antimicrobials
:*In vitro studies show that an aminoglycoside combined with an antibiotic that interferes with cell wall synthesis may act synergistically against some enterococcal strains. The combination of gentamicin and penicillin G has a synergistic bactericidal effect against strains of Enterococcus faecalis, E. faecium and E. 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.
 
*Antibacterial Activity
:*Gentamicin has been shown to be active against most of the following bacteria, both in vitro and in clinical infections.
Gram-Positive Bacteria
Staphylococcus species
Gram-Negative Bacteria
Citrobacter species
Enterobacter species
Escherichia coli
Klebsiella species
Proteus species
Serratia species
Pseudomonas aeruginosa
 
*Susceptibility Test Methods
:*When available, the clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility tests for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.  These reports should aid the physician in selecting the most effective antimicrobial.
 
*Dilution Technique
:*Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs).  These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds.  The MICs should be determined using a standardized test method.1, 3 Standardized procedures are based on a dilution method (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of gentamicin powder.  The MIC values should be interpreted according to the criteria provided in Table 1.
 
*Diffusion Technique
:*Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds.  One such standardized procedure requires the use of standardized inoculum concentrations and paper disks impregnated with 10 mcg of gentamicin. 2, 3  The disk diffusion values should be interpreted according to the criteria provided in Table 1.
 
t1
 
:*aFor Salmonella and Shigella spp., aminoglycosides may appear active in vitro but are not effective clinically; the results should not be reported as susceptible
:*bFor staphylococci that test susceptible, aminoglycosides are used only in combination with other active agents that test susceptible
:*A report of “Susceptible” indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration at the infection site necessary to inhibit growth of the pathogen.  A report of “Intermediate” indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated.  This category implies possible clinical applicability in body sites where the drug is physiologically concentrated.  This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation.  A report of “Resistant” indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.
 
*Quality Control
:*Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1, 2, 3 Standard gentamicin powder should provide the following range of MIC values provided in Table 2.  For the diffusion technique using the 10-mcg gentamicin disk the criteria provided in Table 2 should be achieved.
<!--Nonclinical Toxicology-->
 
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
 
|howSupplied=
 
*
 
<!--Patient Counseling Information-->
 
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
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[[Category:Drug]]

Latest revision as of 19:44, 7 May 2015

Further information: Gentamicin (Injection) and '''Gentamicin (Injection)'''
Further information: Gentamicin (ophthalmic) and '''Gentamicin (ophthalmic)'''
Further information: Gentamicin (topical) and '''Gentamicin (topical)'''
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