DescriptionSources: https://www.drugbank.ca/drugs/DB00798http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdfCurator's Comment: Description was created based on several sources, including:
http://www.drugbank.ca/drugs/DB00798
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca625340-377b-4256-92e2-d62471a8d852
Sources: https://www.drugbank.ca/drugs/DB00798http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf
Curator's Comment: Description was created based on several sources, including:
http://www.drugbank.ca/drugs/DB00798
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca625340-377b-4256-92e2-d62471a8d852
Gentamicin is an antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. Gentamicin is a complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1a. Gentamicin is a broad-spectrum antibiotic, but may cause ear and kidney damage. Gentamicin binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria. Adverse reactions include adverse renal effects, neurotoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss, peripheral neuropathy or encephalopathy), respiratory depression, lethargy, confusion, depression, visual disturbances, etc.
CNS Activity
Sources: https://www.ncbi.nlm.nih.gov/pubmed/6431059https://books.google.ru/books?id=tMfQvYKNVz4C&pg=PA5&lpg=PA5&dq=gentamicin+not+readily+crosses+the+blood-brain+barrier&source=bl&ots=1t9bQV5WFT&sig=4pWiwGUCNf8NuKWscVRE6Ag9aHI&hl=ru&sa=X&ved=0ahUKEwivs63J9u_LAhWrCpoKHUZgA90Q6AEIQzAE#v=onepage&q=gentamicin%20not%20readily%20crosses%20the%20blood-brain%20barrier&f=false
Curator's Comment: Gentamicin does not readily cross the blood–brain barrier.
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
Target ID: CHEMBL354 |
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Target ID: CHEMBL352 |
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Target ID: 30S subunit of the bacterial ribosome |
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Target ID: CHEMBL614640 |
2.0 µM [Kd] |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.46016E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.45152E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.45152E10 |
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| Curative | GARAMYCIN Approved UseGentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Launch Date1.45152E10 |
PubMed
| Title | Date | PubMed |
|---|---|---|
| Therapeutic efficacy of tobramycin--a clinical and laboratory evaluation. | 1975 Dec |
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| [Acute renal failure in the course of treatment with gentamicin alone or combined with other antibiotics. Report 6 cases]. | 1975 May 15 |
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| Renal damage caused by gentamicin: a study of the effects on renal morphology and urinary enzyme excretion. | 1976 Mar |
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| Effects of aminoglycoside antibiotics on the auditory brainstem response and post rotatory nystagmus in rats. | 1992 May |
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| Oscillopsia and pseudonystagmus in kidney transplant patients. | 1999 Dec |
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| Nephrotoxicity by dicloxacillin and gentamicin in 163 patients with intertrochanteric hip fractures. | 2000 |
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| Renoprotective role of nifedipine during gentamicin therapy: randomized controlled trial. | 2000 Dec |
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| Haemorrhagic cystitis and renal dysfunction associated with high dose benzylpenicillin. | 2000 Jan |
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| Factors that affect absorption behavior of cyclosporin a in gentamicin-induced acute renal failure in rats. | 2000 Mar |
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| Garlic ameliorates gentamicin nephrotoxicity: relation to antioxidant enzymes. | 2000 Oct 1 |
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| Antibacterials for the prophylaxis and treatment of bacterial endocarditis in children. | 2001 |
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| Effect of N-acetylcysteine on gentamicin-mediated nephropathy in rats. | 2001 Jul 13 |
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| Familial isolated parathyroid adenoma in a consanguineous family. | 2001 May |
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| FGFR3 expression during development and regeneration of the chick inner ear sensory epithelia. | 2001 Oct 15 |
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| Protective effect of Pongamia pinnata flowers against cisplatin and gentamicin induced nephrotoxicity in rats. | 2003 Jan |
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| Acute renal failure and cystic fibrosis. | 2003 Jul |
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| Diallyl disulfide ameliorates gentamicin-induced oxidative stress and nephropathy in rats. | 2003 Jul 18 |
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| Gentamicin administration in Duchenne patients with premature stop codon. Preliminary results. | 2003 May |
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| Classification and rescue of ROMK mutations underlying hyperprostaglandin E syndrome/antenatal Bartter syndrome. | 2003 Sep |
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| alpha-L-iduronidase premature stop codons and potential read-through in mucopolysaccharidosis type I patients. | 2004 Apr 30 |
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| Influence of spironolactone treatment on gentamicin-induced nephrotoxicity in rats. | 2004 Jul |
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| Altered NMDA receptor expression in renal toxicity: Protection with a receptor antagonist. | 2004 Jul |
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| Gentamicin treatment induces simultaneous mesangial proliferation and apoptosis in rats. | 2004 Jun |
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| Identification of putative gene based markers of renal toxicity. | 2004 Mar |
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| Hematopoietic and nonhematopoietic potentials of Hoechst(low)/side population cells isolated from adult rat kidney. | 2004 May |
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| Deficiency of polycystin-2 reduces Ca2+ channel activity and cell proliferation in ADPKD lymphoblastoid cells. | 2004 May |
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| In vivo efficacy of linezolid in combination with gentamicin for the treatment of experimental endocarditis due to methicillin-resistant Staphylococcus aureus. | 2004 Oct |
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| Early gene expression in the organ of Corti exposed to gentamicin. | 2004 Sep |
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| Protective effect of L-arginine intake on the impaired renal vascular responses in the gentamicin-treated rats. | 2005 |
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| Role of the renin-angiotensin system on the parathyroid hormone-related protein overexpression induced by nephrotoxic acute renal failure in the rat. | 2005 Apr |
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| Pyomyositis caused by methicillin-resistant Staphylococcus aureus. | 2005 Apr 7 |
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| Aminoglycosides induce acute cell signaling and chronic cell death in renal cells that express the calcium-sensing receptor. | 2005 May |
Patents
Sample Use Guides
In Vivo Use Guide
Curator's Comment: Gentamicin injection may be given IM or IV. Gentamicin is recommended to be administered in three equal doses every eight hours. For adult patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses.
Adults: 3 mg/kg/day
Adult patients with life-threatening infections: 5 mg/kg/day
Children: 6 to 7.5 mg/kg/day
Infants and Neonates: 7.5 mg/kg/day
Premature or Full-Term Neonates One Week of Age or Less: 5 mg/kg/day
For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated
Route of Administration:
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| Classification Tree | Code System | Code | ||
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CFR |
21 CFR 520.1044B
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EMA VETERINARY ASSESSMENT REPORTS |
EASOTIC (AUTHORISED)
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EPA PESTICIDE CODE |
6325
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CFR |
21 CFR 520.1044
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NCI_THESAURUS |
C2363
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CFR |
21 CFR 520.1044C
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CFR |
21 CFR 520.1044A
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CFR |
21 CFR 556.300
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FDA ORPHAN DRUG |
231206
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DBSALT000690
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CHEMBL3039597
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8X7386QRLV
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M5697
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SUB02327MIG
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1289003
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C65803
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DTXSID0037235
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757042
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1405-41-0
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82261
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8X7386QRLV
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GENTAMICIN SULFATE
Created by
admin on Fri Dec 16 15:46:08 UTC 2022 , Edited by admin on Fri Dec 16 15:46:08 UTC 2022
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PRIMARY | Description: A white to cream-coloured powder; odourless. Solubility: Soluble in water; practically insoluble in ethanol (~750 g/l) TS and ether R. Category: Antibacterial drug.Storage: Gentamicin sulfate should be kept in a tightly closed container, protected from light. Labelling: The designation sterile Gentamicin sulfate indicates that the substance complies with the additional requirements for sterile Gentamicin sulfate and may be used for parenteral administration or for other sterile applications. Additional information: Gentamicin sulfate is hygroscopic. Even in the absence of light, it is gradually degraded on exposure to ahumid atmosphere, the decomposition being faster at higher temperatures. | ||
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215-778-9
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1870193
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All of the following components must be present:
ACTIVE MOIETY
SUBSTANCE RECORD