pharmacopeia
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/api/v1/drug/gentamicin

Boxed warning

BOXED 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 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.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Protein Synthesis Inhibitors.

Protein Synthesis

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

Gentamicin injection may be given IM or IV. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term. PATIENTS WITH NORMAL RENAL FUNCTION Adults The recommended dosage of gentamicin injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 3) . 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 3) . It is desirable to measure both peak and trough serum concentrations of gentamicin to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. For example, the peak concentration (at 30 to 60 minutes after IM injection) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations after IM or IV administration, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided.

Warnings & precautions

Sourced from openFDA

(See BOXED WARNINGS .) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Serious side effects to mother, fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.

Adverse reactions

Sourced from openFDA

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Nephrotoxicity Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment (especially if dialysis is required) and in patients treated for longer periods or with larger doses 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 hemodialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs. Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions and a myasthenia gravis-like syndrome have been reported. NOTE: The risk of toxic reactions is low in patients with normal renal function who did not receive gentamicin sulfate at higher doses or for longer periods of time than recommended.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Jun 5, 1980ANDAANDA062251Hikma
  • Jul 2, 1980ANDAANDA062196Sandoz
  • May 15, 1981ANDAANDA062307Padagis Us
  • Feb 18, 1982ANDAANDA062351Padagis Us
  • Sep 7, 1982ANDAANDA062373Baxter Hlthcare
  • Aug 4, 1983ANDAANDA062366Fresenius Kabi Usa
  • Aug 15, 1983ANDAANDA062420Hospira
  • Apr 29, 1994ANDAANDA064054Cosette

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
15,506 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,2087.8%
  2. 2Acute Kidney Injury1,1857.6%
  3. 3Pyrexia8905.7%
  4. 4Off Label Use8515.5%
  5. 5Renal Failure6994.5%
  6. 6Diarrhoea5533.6%
  7. 7Sepsis5013.2%
  8. 8Condition Aggravated4953.2%
  9. 9Hypotension4873.1%
  10. 10Nausea4773.1%
  11. 11Renal Failure Acute4633.0%
  12. 12Rash4442.9%
  13. 13Pneumonia4342.8%
  14. 14Chronic Kidney Disease4232.7%
  15. 15Product Use In Unapproved Indication4182.7%

Literature

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Recent PubMed references pinned to Gentamicin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 291 ClinicalTrials.gov registrations naming Gentamicin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Gentamicin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Gentamicin work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What is Gentamicin used for?
According to FDA labeling, Gentamicin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Gentamicin?
Gentamicin is classified as Antibiotics, Antiinfectives, Other aminoglycosides, Other antibiotics for topical use, Aminoglycoside Antibacterial, Protein Synthesis Inhibitors, Decreased Cell Membrane Integrity, Decreased Protein Synthesis.
What are the brand names for Gentamicin?
Gentamicin is marketed under brand names including Garasol, Genone, GentaVed, Gentacalm, Gentak, Mometamax, Mometamax Single, Mometavet.
What are the contraindications for Gentamicin?
Gentamicin labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for gentamicin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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