|
This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or
standards of non-Merck sources.
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Medication Safety Issues
Sound-alike/look-alike issues:
Garamycin® may be confused with kanamycin, Terramycin®
Gentamicin may be confused with gentian violet, kanamycin, vancomycin
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
Pronunciation
(jen ta MYE sin)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible bacterial infections, normally gram-negative organisms, including Pseudomonas, Proteus, Serratia, and gram-positive Staphylococcus; treatment of bone infections, respiratory tract infections, skin and soft tissue infections, as well as abdominal and urinary tract infections, and septicemia; treatment of infective endocarditis; used topically to treat superficial infections of the skin or ophthalmic infections caused by susceptible bacteria
Pregnancy Risk Factor
C (ophthalmic, topical); D (injection)
Pregnancy Considerations
Gentamicin crosses the placenta and produces detectable serum levels in the fetus. Because of several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy, manufacturers classify gentamicin as pregnancy risk factor D. Renal toxicity has been observed in animals. Other than a single case report of renal cystic dysplasia, reports of fetal toxicity in humans have not been located. Adequate and well-controlled studies have not been conducted in pregnant women and it is not known whether gentamicin can cause fetal harm. Although manufacturers consider systemic gentamicin pregnancy risk factor D, gentamicin-specific clinical data would suggest a pregnancy risk factor C.Due to pregnancy induced physiologic changes, some pharmacokinetic parameters of gentamicin may be altered. Pregnant women have an average-to-larger volume of distribution which may result in lower serum peak levels than for the same dose in nonpregnant women. Serum half-life is also shorter.
Lactation
Enters breast milk (small amounts)/use caution (AAP rates “compatible”)
Breast-Feeding Considerations
Gentamicin is excreted into breast milk; however, it is not well absorbed when taken orally. This limited oral absorption may minimize exposure to the nursing infant. Nondose-related effects could include modification of bowel flora. The AAP considers gentamicin to be “usually compatible with breast-feeding.”
Contraindications
Hypersensitivity to gentamicin or other aminoglycosides
Warnings/Precautions
Boxed Warnings:
• Nephrotoxicity: See “Concerns related to adverse effects” below.
• Neurotoxicity: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Nephrotoxicity: [U.S. Boxed Warning]: May cause nephrotoxicity; usual risk factors include pre-existing renal impairment, concomitant nephrotoxic medications, advanced age and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.
• Neuromuscular blockade and respiratory paralysis: May cause neuromuscular blockade and respiratory paralysis; especially when given soon after anesthesia or muscle relaxants.
• Neurotoxicity: [U.S. Boxed Warning]: May cause neurotoxicity; usual risk factors include pre-existing renal impairment, concomitant neuro-/nephrotoxic medications, advanced age and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage. Discontinue treatment if signs of ototoxicity occur.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hearing impairment: Use with caution in patients with pre-existing vertigo, tinnitus, or hearing loss.
• Hypocalcemia: Use with caution in patients with hypocalcemia.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis.
• Renal impairment: Use with caution in patients with pre-existing renal insufficiency; dosage modification required.
Other warnings/precautions:
• Long-term use: Not intended for long-term therapy due to toxic hazards associated with extended administration.
Adverse Reactions
>10%:
Central nervous system: Neurotoxicity (vertigo, ataxia)
Neuromuscular & skeletal: Gait instability
Otic: Ototoxicity (auditory), ototoxicity (vestibular)
Renal: Nephrotoxicity, decreased creatinine clearance
1% to 10%:
Cardiovascular: Edema
Dermatologic: Skin itching, reddening of skin, rash
<1%: Agranulocytosis allergic reaction, anorexia, burning, drowsiness, dyspnea, enterocolitis erythema, granulocytopenia headache, LFTs increased, muscle cramps, nausea, photosensitivity, pseudomotor cerebri, salivation increased, stinging, thrombocytopenia, tremor, vomiting, weakness, weight loss
Drug Interactions
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy
CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Risk C: Monitor therapy
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Risk D: Consider therapy modification
CycloSPORINE: Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE. Risk C: Monitor therapy
Gallium Nitrate: Aminoglycosides may enhance the nephrotoxic effect of Gallium Nitrate. Risk X: Avoid combination
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the respiratory depressant effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy
OnabotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of OnabotulinumtoxinA. Risk C: Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Cloxacillin; Dicloxacillin; Methicillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Potassium. Risk D: Consider therapy modification
RimabotulinumtoxinB: Aminoglycosides may enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Storage
Gentamicin is a colorless to slightly yellow solution which should be stored between 2°C to 30°C, but refrigeration is not recommended. I.V. infusion solutions mixed in NS or D5W solution are stable for 24 hours at room temperature and refrigeration. Premixed bag: Manufacturer expiration date; remove from overwrap stability: 30 days.
Compatibility
Stable in dextran 40, D5W, D10W, mannitol 20%, LR, NS; incompatible with fat emulsion 10%; variable stability (consult detailed reference) in peritoneal dialysis solution.
Y-site administration: Compatible: Acyclovir, alatrofloxacin, amifostine, amiodarone, amsacrine, atracurium, aztreonam, cefpirome, ciprofloxacin, cisatracurium, clarithromycin, cyclophosphamide, cytarabine, diltiazem, docetaxel, doxorubicin liposome, enalaprilat, esmolol, etoposide phosphate, famotidine, fluconazole, fludarabine, foscarnet, gatifloxacin, gemcitabine, granisetron, hydromorphone, IL-2, insulin (regular), labetalol, levofloxacin, linezolid, lorazepam, magnesium sulfate, melphalan, meperidine, meropenem, midazolam, morphine, multivitamins, ondansetron, paclitaxel, pancuronium, perphenazine, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, tolazoline, vecuronium, vinorelbine, vitamin B complex with C, zidovudine. Incompatible: Allopurinol, amphotericin B cholesteryl sulfate complex, cefamandole, furosemide, heparin, hetastarch, idarubicin, indomethacin, iodipamide meglumine, phenytoin, propofol, warfarin. Variable (consult detailed reference): Filgrastim.
Compatibility in syringe: Compatible: Clindamycin, diatrizoate meglumine 52% and diatrizoate sodium 8%, diatrizoate sodium 60%, iohexol, iopamidol, iothalamate meglumine 60%, penicillin G sodium. Incompatible: Ampicillin, cefamandole, heparin. Variable (consult detailed reference): Ioxaglate meglumine 39.3% and ioxaglate sodium 19.6%.
Compatibility when admixed: Compatible: Atracurium, aztreonam, bleomycin, cefoxitin, cimetidine, chloroprocaine, ciprofloxacin, fluconazole, hexylcaine, lidocaine, lidocaine with epinephrine, mepivacaine, meropenem, metronidazole, metronidazole with sodium bicarbonate, ofloxacin, penicillin G sodium, piperocaine, procaine, ranitidine, verapamil. Incompatible: Amphotericin B, ampicillin, cefamandole, cefazolin with clindamycin, cefepime, heparin, nafcillin, ticarcillin. Variable (consult detailed reference): Cefotaxime, cefotetan, cefuroxime, clindamycin, cytarabine, dopamine, floxacillin, furosemide.
Mechanism of Action
Interferes with bacterial protein synthesis by binding to 30S and 50S ribosomal subunits resulting in a defective bacterial cell membrane
Pharmacodynamics/Kinetics
Absorption:
Intramuscular: Rapid and complete
Oral: None
Distribution: Primarily into extracellular fluid (highly hydrophilic); high concentration in the renal cortex; minimal penetration to ocular tissues via I.V. route
Vd: Increased by edema, ascites, fluid overload; decreased with dehydration
Neonates: 0.4-0.6 L/kg
Children: 0.3-0.35 L/kg
Adults: 0.2-0.3 L/kg
Relative diffusion from blood into CSF: Minimal even with inflammation
CSF:blood level ratio: Normal meninges: Nil; Inflamed meninges: 10% to 30%
Protein binding: <30%
Half-life elimination:
Infants: <1 week: 3-11.5 hours; 1 week to 6 months: 3-3.5 hours
Adults: 1.5-3 hours; End-stage renal disease: 36-70 hours
Time to peak, serum: I.M.: 30-90 minutes; I.V.: 30 minutes after 30-minute infusion
Excretion: Urine (as unchanged drug)
Clearance: Directly related to renal function
Dosage
Note: Dosage Individualization is critical because of the low therapeutic index.
Use of ideal body weight (IBW) for determining the mg/kg/dose appears to be more accurate than dosing on the basis of total body weight (TBW). In morbid obesity, dosage requirement may best be estimated using a dosing weight of IBW + 0.4 (TBW - IBW).
Initial and periodic plasma drug levels (eg, peak and trough with conventional dosing) should be determined, particularly in critically-ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery).
Usual dosage ranges:
Infants and Children <5 years: I.M., I.V.: 2.5 mg/kg/dose every 8 hours*
Children ?5 years: I.M., I.V.: 2-2.5 mg/kg/dose every 8 hours*
*Note: Higher individual doses and/or more frequent intervals (eg, every 6 hours) may be required in selected clinical situations (cystic fibrosis) or serum levels document the need
Children and Adults:
Ophthalmic:
Ointment: Instill 1/2” (1.25 cm) 2-3 times/day to every 3-4 hours
Solution: Instill 1-2 drops every 2-4 hours, up to 2 drops every hour for severe infections
Topical: Apply 3-4 times/day to affected area
Adults:
I.M., I.V.:
Conventional: 1-2.5 mg/kg/dose every 8-12 hours; to ensure adequate peak concentrations early in therapy, higher initial dosage may be considered in selected patients when extracellular water is increased (edema, septic shock, postsurgical, or trauma)
Once daily: 4-7 mg/kg/dose once daily; some clinicians recommend this approach for all patients with normal renal function; this dose is at least as efficacious with similar, if not less, toxicity than conventional dosing
Intrathecal: 4-8 mg/day
Indication-specific dosing:
Neonates: I.V.:
Meningitis:
0-7 days of age: <2000 g: 2.5 mg/kg every 18-24 hours; >2000 g: 2.5 mg/kg every 12 hours
8-28 days of age: <2000 g: 2.5 mg/kg every 8-12 hours; >2000 g: 2.5 mg/kg every 8 hours
Children and Adults: I.M., I.V.:
Brucellosis: 240 mg (I.M.) daily or 5 mg/kg (I.V.) daily for 7 days; either regimen recommended in combination with doxycycline
Cholangitis: 4-6 mg/kg once daily with ampicillin
Diverticulitis (complicated): 1.5-2 mg/kg every 8 hours (with ampicillin and metronidazole)
Endocarditis: Treatment: 3 mg/kg/day in 1-3 divided doses
Meningitis:
Enterococcus sp or Pseudomonas aeruginosa: Loading dose 2 mg/kg, then 1.7 mg/kg/dose every 8 hours (administered with another bacteriocidal drug)
Listeria: 5-7 mg/kg/day (with penicillin) for 1 week
Pelvic inflammatory disease: Loading dose: 2 mg/kg, then 1.5 mg/kg every 8 hours
Alternate therapy: 4.5 mg/kg once daily
Plague
(Yersinia pestis):
Treatment: 5 mg/kg/day, followed by postexposure prophylaxis with doxycycline
Pneumonia, hospital- or ventilator-associated: 7 mg/kg/day (with antipseudomonal beta-lactam or carbapenem)
Synergy (for gram-positive infections): 3 mg/kg/day in 1-3 divided doses (with ampicillin)
Tularemia: 5 mg/kg/day divided every 8 hours for 1-2 weeks
Urinary tract infection: 1.5 mg/kg/dose every 8 hours
Dosing interval in renal impairment:
Conventional dosing:
Clcr ?60 mL/minute: Administer every 8 hours
Clcr 40-60 mL/minute: Administer every 12 hours
Clcr 20-40 mL/minute: Administer every 24 hours
Clcr <20 mL/minute: Loading dose, then monitor levels
High-dose therapy: Interval may be extended (eg, every 48 hours) in patients with moderate renal impairment (Clcr 30-59 mL/minute) and/or adjusted based on serum level determinations.
Hemodialysis: Dialyzable; removal by hemodialysis: 30% removal of aminoglycosides occurs during 4 hours of HD; administer dose after dialysis and follow levels
Removal by continuous ambulatory peritoneal dialysis (CAPD):
Administration via CAPD fluid:
Gram-negative infection: 4-8 mg/L (4-8 mcg/mL) of CAPD fluid
Gram-positive infection (eg, synergy): 3-4 mg/L (3-4 mcg/mL) of CAPD fluid
Administration via I.V., I.M. route during CAPD: Dose as for Clcr <10 mL/minute and follow levels
Removal via continuous arteriovenous or venovenous hemofiltration: Dose as for Clcr 10-40 mL/minute and follow levels
Dosing adjustment/comments in hepatic disease: Monitor plasma concentrations
Dental Usual Dosing
Children and Adults: I.M., I.V.: Endocarditis:
Prophylaxis: 1.5 mg/kg with ampicillin (50 mg/kg) 30 minutes prior to procedure. Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Treatment: 3 mg/kg/day in 1-3 divided doses
Administration: I.M.
Administer by deep I.M. route if possible. Slower absorption and lower peak concentrations, probably due to poor circulation in the atrophic muscle, may occur following I.M. injection; in paralyzed patients, suggest I.V. route.
Administration: I.V.
Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concurrent use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment. However, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside levels, CBC, and clinical response should be considered.
Administration: Other
Administer any other ophthalmics 10 minutes before or after gentamicin preparations.
Administration: I.V. Detail
pH: 3.0-5.5 (I.V./I.M. injection); ph: 4 (premixed infusion in sodium chloride)
Monitoring Parameters
Urinalysis, urine output, BUN, serum creatinine; hearing should be tested before, during, and after treatment; particularly in those at risk for ototoxicity or who will be receiving prolonged therapy (>2 weeks)
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro. This may be clinically-significant for certain penicillin (ticarcillin, piperacillin, carbenicillin) and aminoglycoside (gentamicin, tobramycin) combination therapy in patients with significant renal impairment. Close monitoring of aminoglycoside levels is warranted.
Reference Range
Timing of serum samples: Draw peak 30 minutes after 30-minute infusion has been completed or 1 hour after I.M. injection; draw trough immediately before next dose
Sample size: 0.5-2 mL blood (red top tube) or 0.1-1 mL serum (separated)
Therapeutic levels:
Peak:
Serious infections: 6-8 mcg/mL (12-17 ?mol/L)
Life-threatening infections: 8-10 mcg/mL (17-21 ?mol/L)
Urinary tract infections: 4-6 mcg/mL
Synergy against gram-positive organisms: 3-5 mcg/mL
Trough:
Serious infections: 0.5-1 mcg/mL
Life-threatening infections: 1-2 mcg/mL
The American Thoracic Society (ATS) recommends trough levels of <1 mcg/mL for patients with hospital-acquired pneumonia.
Obtain drug levels after the third dose unless renal dysfunction/toxicity suspected
Test Interactions
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.
Dietary Considerations
Calcium, magnesium, potassium: Renal wasting may cause hypocalcemia, hypomagnesemia, and/or hypokalemia.
Patient Education
Take exactly as directed and when prescribed. Drink adequate amounts of water unless instructed to restrict fluid intake. You may experience headaches, ringing in ears, dizziness, blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); GI upset, loss of appetite (small frequent meals and frequent mouth care may help); or photosensitivity (use sunscreen wear protective clothing and eyewear, and avoid direct sunlight). Report severe headache, changes in hearing acuity, ringing in ears, change in balance, changes in urine pattern, persistent diarrhea, respiratory difficulty, rash, fever, unhealed sores, sores in mouth, vaginal drainage, muscle or bone pain, change in gait, or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Ophthalmic: Wash hands before instilling. Sit or lie down to instill. Open eye, look at ceiling, and instill prescribed amount of solution; for ointment, pull lower lid down gently, instill thin ribbon of ointment inside lid. Close eye and roll eye in all directions, and apply gentle pressure to inner corner of eye. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). Temporary stinging or blurred vision may occur. Report persistent pain, burning, vision changes, swelling, itching, or worsening of condition.
Topical: Apply thin film of ointment to affected area as often as recommended. May apply porous dressing. Report persistent burning, swelling, itching, worsening of condition, or lack of response to therapy.
Geriatric Considerations
The aminoglycosides are important therapeutic interventions for infections due to susceptible organisms and as empiric therapy in seriously ill patients. Their use is not without risk of toxicity, however, these risks can be minimized if initial dosing is adjusted for estimated renal function and appropriate monitoring performed. High dose, once daily aminoglycosides have been advocated as an alternative to traditional dosing regimens. Once daily or extended interval dosing is as effective and may be safer than traditional dosing. The interval must be adjusted for renal function.
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments: Gentamicin and tobramycin (lyophilized powder) are the only injectable aminoglycosides that are commercially available as preservative-free.
Cardiovascular Considerations
Loop diuretics may enhance the toxic effects (ototoxicity, nephrotoxicity). This is probably of most concern if the diuretic is administered in high doses for extended periods of time.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Infectious Diseases Comment
A well-documented reaction can occur between beta-lactam and aminoglycoside antibiotics in vitro, leading to complexation, opening of the beta-lactam ring and presumably, loss of antibacterial activity for one or both agents. However, the conditions under which this reaction occurs are variable and influenced by (but not limited to) assay methodology, sampling time and storage, and drug selection and concentration. In general, many of the in vitro studies employed artificial conditions that tested high concentrations of the penicillin derivative (equating to serum levels most likely observed only in severe renal impairment) in combination with gentamicin or tobramycin. Incubation of the agents at conditions of 37°C for up to 48 hours has definitely demonstrated inactivation and loss of bactericidal activity. However, some of these studies permitted a considerable time lapse prior to assaying the medium, or stored the samples at higher temperatures (-20°C or greater), which may have allowed continued chemical degradation prior to assay. In general, amikacin was the most resistant to penicillin-mediated chemical degradation, and cephalosporins were much less likely than penicillins to inactivate the aminoglycosides.
The more robust studies have been those which evaluated in vivo effects via rapid and frequent blood sampling during concomitant dosing. In vivo, there are a number of studies documenting significant changes in the half-life of gentamicin in combination with primarily ticarcillin and carbenicillin, but usually only in the setting of end-stage renal disease. A number of literature reports suggest that despite documented changes in gentamicin kinetics, this is not likely to lead to clinically significant differences in outcomes in patients with normal renal function. Furthermore, there are no published, prospective, outcomes-based studies that provide compelling evidence of changes in rates of clinical or microbiological response as a function of dosing separation.
Based on the weight of evidence to date, coadministration of (but not coadmixture of) a penicillin or cephalosporin antibiotic with an aminoglycoside should not pose a significant concern in patients with even mild renal impairment. However, specific circumstances exist in which this approach should be undertaken with caution. Concurrent administration of either gentamicin or tobramycin with piperacillin, carbenicillin, or ticarcillin (including combinations with beta-lactamase inhibitors), particularly in the face of moderate-to-severe renal failure, would warrant careful monitoring of aminoglycoside serum levels, CBCs and clinical response to avoid potentially reduced efficacy due to chemical inactivation.
Mental Health: Effects on Mental Status
Dizziness is common; may cause drowsiness
Mental Health: Effects on Psychiatric Treatment
May rarely cause agranulocytosis; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess effectiveness and interactions of other medications patient may be taking. Assess kidney function and hearing before, during, and following therapy. Note: This medication has a very low TI. Monitor for decreased renal function, ototoxicity, and neurotoxicity. Perform hearing tests prior to initiating treatment and periodically during therapy (>2 weeks) if at high risk. Monitor therapeutic effectiveness, laboratory values and adverse reactions at beginning of therapy and periodically throughout therapy. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Oncology: Emetic Potential
Very low (<10%)
Oncology: Vesicant
No
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 30 g)
Infusion [premixed in NS]: 40 mg (50 mL); 60 mg (50 mL, 100 mL); 70 mg (50 mL); 80 mg (50 mL, 100 mL); 90 mg (100 mL); 100 mg (50 mL, 100 mL); 120 mg (100 mL)
Injection, solution: 10 mg/mL (6 mL, 8 mL, 10 mL)
Injection, solution: 40 mg/mL (2 mL, 20 mL)
Injection, solution [pediatric]: 10 mg/mL (2 mL)
Injection, solution [pediatric] [preservative free]: 10 mg/mL (2 mL)
Ointment, ophthalmic:
Gentak®: 0.3% [3 mg/g] (3.5 g)
Ointment, topical: 0.1% (15 g, 30 g)
Solution, ophthalmic: 0.3% (5 mL, 15 mL) [contains benzalkonium chloride]
Gentak®: 0.3% (5 mL; 15 mL [DSC]) [contains benzalkonium chloride]
Gentasol™: 0.3% (5 mL) [contains benzalkonium chloride]
Pricing: U.S. (www.drugstore.com)
Cream (Gentamicin Sulfate)
0.1% (15): $12.99
Ointment (Gentamicin Sulfate)
0.1% (15): $9.99
Solution (Genoptic)
0.3% (1): $8.99
Solution (Gentamicin Sulfate)
0.3% (5): $11.99
10 mg/mL (50): $125.00
References
Abramowicz M, “Antimicrobial Prophylaxis in Surgery,” Medical Letter on Drugs and Therapeutics, Handbook of Antimicrobial Therapy, 16th ed, New York, NY: Medical Letter, 2002.
Ahkee S, Smith R, and Ritter GW, “Once-Daily Aminoglycoside Dosing in Lower Respiratory Tract Infections,” Pharm Therapeut, 1995, 20:226-34.
“American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,” Pediatrics, 2001, 108(3):776-89.
American Thoracic Society and Infectious Diseases Society of America, “Guidelines for the Management of Adults With Hospital-Acquired, Ventilator-Associated, and Healthcare-Associated Pneumonia,” Am J Respir Crit Care Med, 2005, 171(4):388-416.
Baddour LM, Wilson WR, Bayer AS, et al, “Infective Endocarditis. Diagnosis, Antimicrobial Therapy, and Management of Complications. A Statement for Healthcare Professionals From the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association,” Circulation, 2005, 111(23):e394-434.
Begg EJ and Barclay ML, “Aminoglycosides - 50 Years On,” Br J Clin Pharmacol, 1995, 39(6):597-603.
Bhatt-Mehta V, Johnson CE and Schumacher RE, “Gentamicin Pharmacokinetics in Term Neonates Receiving Extracorporeal Membrane Oxygenation,” Pharmacotherapy, 1992, 12(1):28-32.
Brummett RE, Bendrick T, and Himes D, "Comparative Ototoxicity of Bumetanide and Furosemide When Used in Combination With Kanamycin," J Clin Pharmacol, 1981, 21(11-12 Pt 2):628-36.
Chow MS, Quintiliani, and Nightingale CH, "In Vivo Inactivation of Tobramycin by Ticarcillin. A Case Report," JAMA, 1982, 247(5):658-9.
Cunha BA, “Aminoglycosides: Current Role in Antimicrobial Therapy,” Pharmacotherapy, 1988, 8(6):334-50.
Daly JS, Dodge RA, Glew RH, et al, "Effect of Time and Temperature on Inactivation of Aminoglycosides by Ampicillin at Neonatal Dosages," J Perinatol, 1997, 17(1):42-5.
Dowell JA, Korth-Bradley J, Milisci M, et al, "Evaluating Possible Pharmacokinetic Interactions Between Tobramycin, Piperacillin, and a Combination of Piperacillin and Tazobactam in Patients With Various Degrees of Renal Impairment," J Clin Pharmacol, 2001, 41:979-86.
Edson RS and Terrell CL, “The Aminoglycosides,” Mayo Clin Proc, 1999, 74(5):519-28.
Farchione LA, "Inactivation of Aminoglycosides by Penicillins," J Antimicrob Chemother, 1982, 8(Suppl A):27-36.
Fuchs PC, Stickel S, Anderson PH, et al, "In Vitro Inactivation of Aminoglycosides by Sulbactam, Other Beta-Lactams, and Sulbactam-Beta-Lactam Combinations," Antimicrob Agents Chemother, 1991, 35(1):182-4.
Fuquay D, Koup J, and Smith AL, “Management of Neonatal Gentamicin Overdosage,” J Pediatr, 1981, 99(3):473-6.
Gilbert DN, Moellering RC, Eliopoulos GM, et al, eds, The Sanford Guide To Antimicrobial Therapy, 2006, 36th ed, Hyde Park, VT: Antimicrobial Therapy, Inc, 2006, 6-7.
Gilbert DN, “Once-Daily Aminoglycoside Therapy,” Antimicrob Agents Chemother, 1991, 35(3):399-405.
Halstenson CE, Wong MO, Herman CS, et al, "Effect of Concomitant Administration of Piperacillin on the Dispositions on Isepamicin and Gentamicin in Patients With End-Stage Renal Disease," Antimicrob Agents Chemother, 1992, 36(9):1832-36.
Hitt CM, Patel KB, Nicolau DP, et al, "Influence of Piperacillin-Tazobactam on Pharmacokinetics of Gentamicin Given Once Daily," Am J Health Syst Pharm, 1997, 54(23):2704-8.
Hustinx WN, and Hoepelman IM, “Aminoglycoside Dosage Regimens. Is Once a Day Enough?” Clin Pharmacokinet, 1993, 25(6):427-32.
Iseman MD, “Treatment of Multidrug-Resistant Tuberculosis,” N Engl J Med, 1993, 329(11):784-91.
Kaka JS, Lyman C, and Kilarski DJ, "Tobramycin-Furosemide Interaction," Drug Intell Clin Pharm, 1984, 18(3):235-8.
Konishi H, Goto M, Nakamoto Y, et al, "Tobramycin Inactivation by Carbenicillin, Ticarcillin, and Piperacillin," Antimicrob Agents Chemother, 1983, 23(5):653-57.
Lau A, Lee M, Flascha S, et al, "Effect of Piperacillin on Tobramycin Pharmacokinetics in Patients with Normal Renal Function," Antimicrob Agents Chemother, 1983, 24(4):533-37.
Lawson DH, Tilstone WJ, Gray JM, et al, "Effect of Furosemide on the Pharmacokinetics of Gentamicin in Patients," J Clin Pharmacol, 1982, 22(5-6):254-8.
Lortholary O, Tod M, Cohen Y, et al, “Aminoglycosides,” Med Clin North Am, 1995, 79(4):761-87.
Lucena MI, Andrade RJ, Cabello MR, et al, “Aminoglycoside-Associated Nephrotoxicity in Extrahepatic Obstructive Jaundice,” J Hepatol, 1995, 22(2):189-96.
Mann HJ, Fuhs DW, Awang R, et al, “Altered Aminoglycoside Pharmacokinetics in Critically Ill Patients With Sepsis,” Clin Pharm, 1987, 6(2):148-53.
Matz GJ, “Aminoglycoside Ototoxicity,” Am J Otolaryngol, 1986, 7(2):117-9.
Matzke GR, Jameson JJ, and Halstenson CE, “Gentamicin Disposition in Young and Elderly Patients With Various Degrees of Renal Function,” J Clin Pharmacol, 1987, 27(3):216-20.
McCormack JP and Jewesson PJ, “A Critical Re-Evaluation of the “Therapeutic Range” of Aminoglycosides,” Clin Infect Dis, 1992, 14(1):320-39.
Nicolau DP, Freeman CD, Belliveau PP, et al, “Experience With a Once-Daily Aminoglycoside Program Administered to 2184 Adult Patients,” Antimicrob Agents Chemother, 1995, 39(3):650-5.
O'Brien RK and Sparling TG, “Gentamicin and Fludarabine Ototoxicity,” Ann Pharmacother, 1995, 29(2):200-1.
Oparaoji EC, Siram S, Shoheiber O, et al, "Appropriateness of a 4 mg/kg Gentamicin or Tobramycin Loading Dose in Post-Operative Septic Shock Patients," J Clin Pharm Ther, 1998, 23(3):185-90.
Preston SL and Briceland LL, “Single Daily Dosing of Aminoglycosides,” Pharmacotherapy, 1995, 15(3):297-316.
Reimche LD, Rooney, ME, Hindmarsh KW, et al, “An Evaluation of Gentamicin Dosing According to Renal Function in Neonates With Suspected Sepsis,” Am J Perinatol, 1987, 4(3):262-5.
Russoe ME and Atkins-Thor E, "Gentamicin and Ticarcillin in Subjects With End-Stage Renal Disease. Comparison of Two Assay Methods and Evaluation of Inactivation Rate," Clin Nephrol, 1981, 15(4):175-80.
Schentag JJ, Simons GW, Schultz RW, et al, “Complexation Versus Hemodialysis to Reduce Elevated Aminoglycoside Serum Concentrations,” Pharmacotherapy, 1984, 4(6):374-80.
Shevchuk YM and Taylor DM, “Aminoglycoside Volume of Distribution in Pediatric Patients,” DICP, 1990, 24(3):273-6.
Smith CR and Lietman PS, "Effect of Furosemide on Aminoglycoside-Induced Nephrotoxicity and Auditory Toxicity in Humans," Antimicrob Agents Chemother, 1983, 23(1):133-7.
Terrell CL, “Antifungal Agents. Part II. The Azoles,” Mayo Clin Proc, 1999, 74(1):78-100.
Thompson MIB, Russo ME, Saxon BJ, et al, "Gentamicin Inactivation by Piperacillin or Carbenicillin in Patients With End-Stage Renal Disease," Antimicrob Agents Chemother, 1982, 21(2):268-73.
Townsend PL, Fink MP, Stein KL, et al, “Aminoglycoside Pharmacokinetics: Dosage Requirements and Nephrotoxicity in Trauma Patients,” Crit Care Med, 1989, 17(2):154-7.
Tunkel AR, Hartman BJ, Kaplan SL, et al, “Practice Guidelines for the Management of Bacterial Meningitis,” Clin Infect Dis, 2004, 39(9):1267-84.
Viollier AF, Standiford HC, Drusano GL, et al, "Comparative Pharmacokinetics and Serum Bactericidal Activity of Mezlocillin, Ticarcillin and Piperacillin, With and Without Gentamicin," J Antimicrob Chemother, 1985, 15(5):597-606.
Walterspiel JN, Feldman S, Van R, et al, "Comparative Inactivation of Isepamicin, Amikacin, and Gentamicin by Nine Beta-Lactams and Two Beta-Lactamase Inhibitors, Cilastatin and Heparin," Antimicrob Agents Chemother, 1991, 35(9):1875-8.
Watling SM and Dasta JF, “Aminoglycoside Dosing Considerations in Intensive Care Unit Patients,” Ann Pharmacother, 1993, 27(3):351-7.
Wilson W, Taubert KA, Gewitz M, et al, “Prevention of Infective Endocarditis. Guidelines From the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group,” Circulation, 2007, 116(15):1736-54. Available at http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.183095v1.
Wynn RL, “Gentamicin for Prophylaxis of Bacterial Endocarditis: A Review for the Dentist,” Oral Surg Oral Med Oral Pathol, 1985, 60(2):159-65.
Zaske DE, Irvine P, Strand LM, et al, “Wide Interpatient Variations in Gentamicin Dose Requirements for Geriatric Patients,” JAMA, 1982, 248(23):3122-6.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
| 
