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

Stem definition	Drug id	CAS RN
antibiotics, produced by Streptomyces strains	2684	32986-56-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: vantobra tobramycin Nebramycin 6 Nebramycin VI tobracin tobradistin tobralex tobramaxin tobramicin tobramycetin tobramycin sulfate nebcin Tobi Podhaler	An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species. Molecular weight: 467.52 Formula: C18H37N5O9 CLOGP: -3.44 LIPINSKI: 2 HAC: 14 HDO: 10 TPSA: 268.17 ALOGS: -0.94 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

vantobra
tobramycin
Nebramycin 6
Nebramycin VI
tobracin
tobradistin
tobralex
tobramaxin
tobramicin
tobramycetin
tobramycin sulfate
nebcin
Tobi Podhaler

An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.

Molecular weight: 467.52
Formula: C18H37N5O9
CLOGP: -3.44
LIPINSKI: 2
HAC: 14
HDO: 10
TPSA: 268.17
ALOGS: -0.94
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.11	g	Inhal.powder
0.30	g	Inhal.solution
0.24	g	P

ADMET properties:

Show entries

Search:

Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	93 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	50 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	19.25 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	1.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.23 L/kg	Lombardo F, Berellini G, Obach RS

Showing 1 to 9 of 9 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
July 20, 2011	EMA	MYLAN IRELAND LIMITED
June 11, 1975	FDA

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
Infective pulmonary exacerbation of cystic fibrosis	1810.75	14.39	433	17397	8384	63462808
Hospitalisation	560.31	14.39	329	17501	84752	63386440
Cystic fibrosis	383.56	14.39	103	17727	3193	63467999
Pulmonary function test decreased	259.33	14.39	79	17751	3868	63467324
Pseudomonas infection	245.76	14.39	99	17731	11114	63460078
Haemoptysis	191.01	14.39	112	17718	28614	63442578
Acute kidney injury	171.91	14.39	283	17547	263132	63208060
Cough	150.18	14.39	283	17547	292460	63178732
Pneumonia	130.98	14.39	350	17480	456417	63014775
Anti-neutrophil cytoplasmic antibody positive vasculitis	116.64	14.39	40	17790	2859	63468333

Showing 1 to 10 of 133 entries

Previous1 2 3 4 5…14Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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
Infective pulmonary exacerbation of cystic fibrosis	1581.22	16.65	401	14604	6400	34935526
Hospitalisation	444.40	16.65	286	14719	56616	34885310
Cystic fibrosis	279.89	16.65	76	14929	1582	34940344
Pulmonary function test decreased	204.97	16.65	78	14927	4897	34937029
Pseudomonas infection	199.08	16.65	100	14905	12282	34929644
Choroiditis	178.75	16.65	50	14955	1165	34940761
Endophthalmitis	155.38	16.65	58	14947	3450	34938476
Eye pain	144.15	16.65	83	14922	13379	34928547
Intraocular pressure increased	141.10	16.65	61	14944	5322	34936604
Ototoxicity	128.00	16.65	43	14962	1874	34940052

Showing 1 to 10 of 106 entries

Previous1 2 3 4 5…11Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
Infective pulmonary exacerbation of cystic fibrosis	2553.67	13.59	633	25426	12218	79706111
Hospitalisation	719.04	13.59	423	25636	93813	79624516
Cystic fibrosis	501.46	13.59	136	25923	3744	79714585
Pulmonary function test decreased	351.40	13.59	121	25938	7516	79710813
Pseudomonas infection	277.96	13.59	136	25923	20767	79697562
Haemoptysis	252.59	13.59	181	25878	55818	79662511
Acute kidney injury	190.59	13.59	480	25579	518924	79199405
Renal tubular necrosis	189.44	13.59	112	25947	24927	79693402
Ototoxicity	178.72	13.59	59	26000	3215	79715114
Choroiditis	171.85	13.59	47	26012	1334	79716995

Showing 1 to 10 of 209 entries

Previous1 2 3 4 5…21Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	J01GB01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE AMINOGLYCOSIDE ANTIBACTERIALS Other aminoglycosides
ATC	S01AA12	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics
CHEBI has role	CHEBI:27026	toxins
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:33282	bactericides
FDA CS	M0000946	Aminoglycosides
FDA EPC	N0000175477	Aminoglycoside Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

Showing 1 to 9 of 9 entries

Previous1Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Septicemia due to Escherichia coli	indication	9323009
Bacterial septicemia	indication	10001005	DOID:0040085
Staphylococcal pneumonia	indication	22754005
Pneumonia due to Pseudomonas	indication	41381004
Punctate keratitis	indication	42513006	DOID:12197
Pneumonia due to Escherichia coli	indication	51530003
Blepharoconjunctivitis	indication	68659002	DOID:2456
Infection due to Escherichia coli	indication	71057007
Bacterial infection due to Serratia	indication	71120004
Rhinoscleroma	indication	72409005	DOID:11336

Showing 1 to 10 of 91 entries

Previous1 2 3 4 5…10Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Show entries

Search:

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.15	acidic
pKa2	13.85	acidic
pKa3	8.34	Basic
pKa4	7.59	Basic
pKa5	6.94	Basic
pKa6	6.81	Basic
pKa7	5.55	Basic

Showing 1 to 7 of 7 entries

Previous1Next

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.05%;0.3%	TOBRADEX ST	EYEVANCE	N050818	Feb. 13, 2009	RX	SUSPENSION/DROPS	OPHTHALMIC	8101582	Dec. 19, 2027	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.05%;0.3%	TOBRADEX ST	EYEVANCE	N050818	Feb. 13, 2009	RX	SUSPENSION/DROPS	OPHTHALMIC	7795316	Aug. 3, 2028	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
28MG	TOBI PODHALER	MYLAN SPECIALITY LP	N201688	March 22, 2013	RX	POWDER	INHALATION	11484671	Nov. 7, 2024	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG	TOBI PODHALER	MYLAN SPECIALITY LP	N201688	March 22, 2013	RX	POWDER	INHALATION	8664187	June 20, 2025	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG	TOBI PODHALER	MYLAN SPECIALITY LP	N201688	March 22, 2013	RX	POWDER	INHALATION	8869794	Sept. 12, 2028	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG	TOBI PODHALER	MYLAN SPECIALITY LP	N201688	March 22, 2013	RX	POWDER	INHALATION	10207066	Nov. 4, 2030	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA

Showing 1 to 6 of 6 entries

Previous1Next

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Taste receptor type 2 member 20	GPCR	P59543	T2R20_HUMAN	AGONIST	EC50	4.29		IUPHAR
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B)	Enzyme		O32553_ECOLX		Km	5.82		WOMBAT-PK

Showing 1 to 2 of 2 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
TOY	PDB_CHEM_ID
002779	NDDF
002780	NDDF
10627	RXNORM
1090	MMSL
10930	IUPHAR_LIGAND_ID
13188003	SNOMEDCT_US
182011	MMSL
2138	MMSL
2990	INN_ID

Showing 1 to 10 of 31 entries

Previous1 2 3 4Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BETHKIS	HUMAN PRESCRIPTION DRUG LABEL	1	10122-820	SOLUTION	300 mg	RESPIRATORY (INHALATION)	NDA	34 sections
BETHKIS	HUMAN PRESCRIPTION DRUG LABEL	1	10122-820	SOLUTION	300 mg	RESPIRATORY (INHALATION)	NDA	34 sections
TOBI	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0494	SOLUTION	300 mg	ORAL	NDA	30 sections
TOBI	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0494	SOLUTION	300 mg	ORAL	NDA	30 sections
TOBI Podhaler	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0630	CAPSULE	28 mg	ORAL	NDA	29 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0065-0647	SUSPENSION/ DROPS	3 mg	OPHTHALMIC	NDA	18 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0065-0647	SUSPENSION/ DROPS	3 mg	OPHTHALMIC	NDA	18 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0065-0648	OINTMENT	3 mg	OPHTHALMIC	NDA	18 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0876	OINTMENT	3 mg	OPHTHALMIC	NDA	18 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0876	OINTMENT	3 mg	OPHTHALMIC	NDA	18 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next