gentamicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
aminoglycosides, antibiotics obtained from various Micromonospora	4265	1405-41-0

Description:

Molecule	Description
Synonyms: gentamicin sulfate gentamicin alcomicin gentacin gentamicine sulfate	A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS. Molecular weight: 1390.73 Formula: C60H123N15O21 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

gentamicin sulfate
gentamicin
alcomicin
gentacin
gentamicine sulfate

A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.

Molecular weight: 1390.73
Formula: C60H123N15O21
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.24	g	P

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.28 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	4.70 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.33 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
June 19, 1970	FDA	SCHERING

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	623.66	14.65	576	19644	262839	63205963
Premature delivery	404.82	14.65	196	20024	30085	63438717
Normal labour	396.69	14.65	77	20143	440	63468362
Delivery	335.61	14.65	80	20140	1323	63467479
Drug reaction with eosinophilia and systemic symptoms	248.36	14.65	147	20073	33689	63435113
Renal tubular necrosis	199.21	14.65	90	20130	11788	63457014
Multiple organ dysfunction syndrome	190.19	14.65	152	20068	56600	63412202
Toxic epidermal necrolysis	157.48	14.65	99	20121	25235	63443567
Pathogen resistance	131.67	14.65	56	20164	6342	63462460
Septic shock	118.16	14.65	125	20095	66504	63402298

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	477.56	15.06	741	20542	304247	34631401
Drug reaction with eosinophilia and systemic symptoms	209.33	15.06	168	21115	32844	34902804
Pathogen resistance	202.69	15.06	104	21179	9378	34926270
Renal tubular necrosis	158.94	15.06	106	21177	15574	34920074
Eosinophilia	130.25	15.06	116	21167	26106	34909542
Drug resistance	91.44	15.06	95	21188	25832	34909816
Endocarditis	88.45	15.06	53	21230	6458	34929190
Rash maculo-papular	87.58	15.06	97	21186	28354	34907294
Crystalluria	86.48	15.06	25	21258	456	34935192
Spinal muscular atrophy	82.09	15.06	23	21260	373	34935275

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	1076.89	12.97	1223	33671	518181	79191313
Drug reaction with eosinophilia and systemic symptoms	439.46	12.97	300	34594	63944	79645550
Renal tubular necrosis	318.47	12.97	174	34720	24865	79684629
Pathogen resistance	298.12	12.97	139	34755	14203	79695291
Eosinophilia	204.64	12.97	165	34729	45180	79664314
Multiple organ dysfunction syndrome	197.50	12.97	253	34641	119993	79589501
Toxic epidermal necrolysis	161.59	12.97	143	34751	44438	79665056
Ototoxicity	158.13	12.97	58	34836	3216	79706278
Septic shock	148.50	12.97	223	34671	122578	79586916
Peritonitis bacterial	139.94	12.97	73	34821	9494	79700000

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Foetal exposure during pregnancy	63.65	27.04	9	603	12832	76348
Drug ineffective	42.28	27.04	43	569	1009	88171
Blister	28.01	27.04	7	605	0	89180

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Pharmacologic Action:

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Source	Code	Description
ATC	D06AX07	DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Other antibiotics for topical use
ATC	J01GB03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE AMINOGLYCOSIDE ANTIBACTERIALS Other aminoglycosides
ATC	S01AA11	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics
ATC	S02AA14	SENSORY ORGANS OTOLOGICALS ANTIINFECTIVES Antiinfectives
ATC	S03AA06	SENSORY ORGANS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS ANTIINFECTIVES Antiinfectives
FDA CS	M0000946	Aminoglycosides
FDA EPC	N0000175477	Aminoglycoside Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D004791	Enzyme Inhibitors

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Septicemia due to Escherichia coli	indication	9323009
Bacterial septicemia	indication	10001005	DOID:0040085
Infection due to Pseudomonas aeruginosa	indication	11218009
Folliculitis	indication	13600006	DOID:4409
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Pneumonia due to Pseudomonas	indication	41381004
Peritonitis	indication	48661000
Pneumonia due to Escherichia coli	indication	51530003
Bacterial pneumonia	indication	53084003	DOID:874
Blepharoconjunctivitis	indication	68659002	DOID:2456

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Urinary tract infections	Indication
Cats	Respiratory tract infections	Indication
Cats	Skin and soft tissue infections	Indication
Cats	Supportive therapy for secondary bacterial infections associated with panleucopenia	Indication
Cats	Conjunctivitis	Indication
Cattle	Infectious bovine keratoconjunctivitis associated with Moraxella bovis	Indication
Chickens	Prevention of early mortality caused by Escherichia coli	Indication
Chickens	Prevention of early mortality caused by Salmonella typhimurium	Indication
Chickens	Prevention of early mortality caused by Pseudomonas aeruginosa	Indication
Dogs	External eye infections	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Betagen Topical Spray	Med-Pharmex Inc.	2
Easotic	Virbac AH Inc.	3
Garacin	Intervet Inc.	1
Garacin Piglet Injection	Intervet Inc.	1
Garacin Soluble Powder	Intervet Inc.	1
Garasol Injection	Intervet Inc.	1
Garasol Solution	Intervet Inc.	1
GB Topical Spray	Dechra Veterinary Products LLC	2
GBC Ointment	Cronus Pharma Specialities India Private Limited	3
GEN-GARD	Huvepharma EOOD	1

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Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source
Dihydrofolate reductase	Enzyme	P00374	DYR_HUMAN		IC50	4.74	CHEMBL
Transient receptor potential cation channel subfamily V member 5	Ion channel	Q9NQA5	TRPV5_HUMAN	INHIBITOR	IC50	6	IUPHAR
Dihydrofolate reductase	Enzyme		DYR_BOVIN		IC50	4.60	CHEMBL
Transient receptor potential cation channel subfamily A member 1	Ion channel		TRPA1_MOUSE	GATING INHIBITOR	IC50	5.20	IUPHAR

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External reference:

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ID	Source
002778	NDDF
004898	NDDF
1403-66-3	SECONDARY_CAS_RN
1596450	RXNORM
1617	INN_ID
2249001	SNOMEDCT_US
228599	MMSL
2427	IUPHAR_LIGAND_ID
3467	PUBCHEM_CID
387321007	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gentamicin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9128	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	16 sections
Gentamicin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9129	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	16 sections
Gentamicin	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9866	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	13 sections
Gentamicin	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9866	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	13 sections
Gentamicin sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0078	OINTMENT	1 mg	TOPICAL	ANDA	10 sections
Gentamicin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9865	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	12 sections
Gentamicin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9865	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	12 sections
Gentamicin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1207	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	17 sections
Gentamicin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1207	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	17 sections
Gentamicin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1207	INJECTION, SOLUTION	40 mg	INTRAMUSCULAR	ANDA	17 sections

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