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

Stem definition	Drug id	CAS RN
	4246	1405-20-5

Description:

Molecule	Description
Synonyms: Polymyxin B sulfate aerosporin mastimyxin Polymyxin B	A mixture of polymyxins B1 and B2, obtained from BACILLUS POLYMYXA strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for treatment of infections with gram-negative bacteria, but may be neurotoxic and nephrotoxic. Molecular weight: 2392.97 Formula: C111H194N32O26 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 490.66 ALOGS: ROTB: None

Molecule

Description

Synonyms:

Polymyxin B sulfate
aerosporin
mastimyxin
Polymyxin B

A mixture of polymyxins B1 and B2, obtained from BACILLUS POLYMYXA strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for treatment of infections with gram-negative bacteria, but may be neurotoxic and nephrotoxic.

Molecular weight: 2392.97
Formula: C111H194N32O26
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 490.66
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
3	MU	O
0.15	g	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 26, 1957	FDA	MONARCH PHARMS

FDA Adverse Event Reporting System (Female)

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
Drug hypersensitivity	349.00	16.44	227	3879	274978	56012983
Macular degeneration	226.74	16.44	75	4031	18833	56269128
Respiratory failure	38.94	16.44	41	4065	95021	56192940
Drug ineffective	33.88	16.44	144	3962	918845	55369116
Cytomegalovirus test positive	32.97	16.44	11	4095	2815	56285146
Septic arthritis staphylococcal	30.96	16.44	7	4099	419	56287542
Sepsis	26.35	16.44	41	4065	139799	56148162
Lymphatic disorder	26.31	16.44	6	4100	373	56287588
Engraft failure	21.35	16.44	5	4101	350	56287611

FDA Adverse Event Reporting System (Male)

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
Drug hypersensitivity	39.82	18.27	46	3719	72553	31621026
Respiratory paralysis	33.77	18.27	6	3759	61	31693518
Mucosal disorder	30.25	18.27	10	3755	1524	31692055
Disseminated intravascular coagulation	28.88	18.27	22	3743	20515	31673064
Chronic graft versus host disease	23.07	18.27	11	3754	4381	31689198
Pathogen resistance	20.97	18.27	13	3752	8688	31684891
Hepatic function abnormal	20.71	18.27	25	3740	41197	31652382
Drug resistance	20.30	18.27	19	3746	23434	31670145
Trichosporon infection	19.79	18.27	6	3759	691	31692888
Bacterial translocation	19.36	18.27	5	3760	320	31693259
Acute graft versus host disease in skin	19.16	18.27	10	3755	4822	31688757

FDA Adverse Event Reporting System (Geriatric)

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
Drug hypersensitivity	184.65	14.93	170	6486	262289	70659499
Respiratory failure	42.81	14.93	65	6591	168670	70753118
Drug resistance	39.53	14.93	31	6625	38159	70883629
Cytomegalovirus test positive	39.46	14.93	16	6640	5492	70916296
Respiratory paralysis	35.18	14.93	6	6650	61	70921727
Sepsis	33.46	14.93	72	6584	244473	70677315
Engraftment syndrome	30.09	14.93	9	6647	1255	70920533
Disseminated intravascular coagulation	29.95	14.93	25	6631	33573	70888215
Pathogen resistance	28.69	14.93	17	6639	13262	70908526
Hepatic function abnormal	26.03	14.93	32	6624	67964	70853824
Lymphatic disorder	25.54	14.93	6	6650	329	70921459
Septic arthritis staphylococcal	25.25	14.93	7	6649	745	70921043
Multiple organ dysfunction syndrome	24.98	14.93	40	6616	108475	70813313
Febrile neutropenia	23.30	14.93	56	6600	204262	70717526
Renal injury	23.29	14.93	16	6640	16078	70905710
Chronic graft versus host disease	21.01	14.93	11	6645	6759	70915029
Slow response to stimuli	19.50	14.93	7	6649	1726	70920062
Trichosporon infection	19.28	14.93	6	6650	955	70920833
Mucosal disorder	18.57	14.93	8	6648	3190	70918598
Platelet count decreased	18.36	14.93	47	6609	178175	70743613
Bacterial translocation	18.05	14.93	5	6651	531	70921257
Drug interaction	17.43	14.93	7	6649	381434	70540354
Tachypnoea	17.06	14.93	17	6639	28621	70893167
Mental status changes	16.96	14.93	25	6631	63076	70858712
Unevaluable event	16.01	14.93	22	6634	52041	70869747
Pyrexia	15.74	14.93	104	6552	606848	70314940
Skin hyperpigmentation	15.57	14.93	9	6647	6706	70915082
Blood chloride increased	15.23	14.93	8	6648	4945	70916843
Anaphylactic reaction	15.05	14.93	26	6630	74948	70846840
Corneal abrasion	14.94	14.93	5	6651	1001	70920787

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A07AA05	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Antibiotics
ATC	J01XB02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Polymyxins
ATC	S01AA18	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics
ATC	S02AA11	SENSORY ORGANS OTOLOGICALS ANTIINFECTIVES Antiinfectives
ATC	S03AA03	SENSORY ORGANS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS ANTIINFECTIVES Antiinfectives
FDA CS	M0017217	Polymyxins
FDA EPC	N0000175499	Polymyxin-class Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

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

Disease	Relation	SNOMED_ID	DOID
Otitis externa	indication	3135009
Keratitis	indication	5888003	DOID:4677
Bacterial septicemia	indication	10001005	DOID:0040085
Urinary tract infectious disease	indication	68566005
Blepharoconjunctivitis	indication	68659002	DOID:2456
Corneal abrasion	indication	85848002
Bacterial conjunctivitis	indication	128350005	DOID:9700
Uveitis	indication	128473001	DOID:13141
Infective blepharitis	indication	312219000
Bacterial keratitis	indication	314557000
Superficial Ocular Infection	indication
Minor Bacterial Skin Infections	indication
Minor Skin Wound Pain	indication
Mastoidectomy Cavity Infections	indication
H. Influenzae Meningitis	indication
Chronic purulent otitis media	off-label use	38394007	DOID:14247
Dacryocystitis	off-label use	85777005	DOID:9938
Corneal ulcer	off-label use	91514001	DOID:8463
Meibomianitis	off-label use	309779001
Ocular hypertension	contraindication	4210003	DOID:9282
Herpes simplex keratitis	contraindication	9389005
Herpes zoster auricularis	contraindication	21954000	DOID:9210
Herpes simplex dendritic keratitis	contraindication	29943008
Fungal infection of eye	contraindication	31194008
Bullous myringitis	contraindication	33528003	DOID:13791
Dehydration	contraindication	34095006
Severe myopia	contraindication	34187009
Tuberculosis of eye	contraindication	49107007
Neuromuscular block, function	contraindication	55394004
Perforation of tympanic membrane	contraindication	60442001
Diabetes mellitus	contraindication	73211009	DOID:9351
Third degree burn injury	contraindication	80247002
Oliguria	contraindication	83128009
Open-angle glaucoma	contraindication	84494001	DOID:1067
Krukenberg spindle	contraindication	85430004
Herpes simplex	contraindication	88594005	DOID:8566
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Procedure on urinary system	contraindication	118677009
Open wound	contraindication	125643001
Eye infection	contraindication	128351009
Hearing disorder	contraindication	128540005
Bacterial infection of eye	contraindication	128984004
Tuberculosis of ear	contraindication	186269001
Telangiectasia disorder	contraindication	247479008
Rupture of bladder	contraindication	251925007
Injury of eye region	contraindication	282752000
Pregnancy, function	contraindication	289908002
Viral eye infection	contraindication	312132001
Viral ear infection	contraindication	312137007
Fungal ear infection	contraindication	312148000
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Vaccinia keratitis	contraindication	397552005
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Inflammation associated with topical ophthalmological conditions of the eye	Indication
Cats	Edema associated with topical ophthalmological conditions of the eye	Indication
Cats	Secondary bacterial infections associated with topical ophthalmological conditions of the eye	Indication
Cattle	Superficial ocular infections	Indication
Cattle	Infections caused by streptococci	Indication
Cattle	Infections caused by rickettsiae	Indication
Cattle	Infections caused by Escherichia coli	Indication
Cattle	Infections caused by A aerogenes	Indication
Dogs	Inflammation associated with topical ophthalmological conditions of the eye	Indication
Dogs	Edema associated with topical ophthalmological conditions of the eye	Indication
Dogs	Secondary bacterial infections associated with topical ophthalmological conditions of the eye	Indication
Horses	Inflammation associated with topical ophthalmological conditions of the eye	Indication
Horses	Edema associated with topical ophthalmological conditions of the eye	Indication
Horses	Secondary bacterial infections associated with topical ophthalmological conditions of the eye	Indication
Sheep	Inflammation associated with topical ophthalmological conditions of the eye	Indication
Sheep	Edema associated with topical ophthalmological conditions of the eye	Indication
Sheep	Secondary bacterial infections associated with topical ophthalmological conditions of the eye	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Terramycin Ophthalmic Ointment with Polymyxin	Zoetis Inc.	2
Anaprime Ophthalmic Solution	Zoetis Inc.	3
Anaprime Opthakote Ophthalmic	Zoetis Inc.	3
Optiprime Opthakote Ophthalmic Solution	Zoetis Inc.	2
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment, Vetropolycin HC Ophthalmic Ointment	Dechra, Ltd.	4
Bac-Neo-Poly Ophthalmic Ointment, Vetropolycin Ophthalmic Ointment	Dechra, Ltd.	3
Mycitracin Sterile Ophthalmic Ointment	Zoetis Inc.	3
Forte Topical Ointment	Zoetis Inc.	4
Cortisporin Veterinary Ophthalmic Ointment	Intervet Inc.	4
Neosporin Ophthalmic Ointment	Intervet Inc.	3
Surolan	Elanco US Inc.	3
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment	Akorn Animal Health Inc.	3

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4018100	VUID
N0000146438	NUI
D08401	KEGG_DRUG
1404-26-8	SECONDARY_CAS_RN
4018100	VANDF
4018594	VANDF
C0032535	UMLSCUI
CHEBI:8310	CHEBI
CHEMBL3989738	ChEMBL_ID
CHEMBL3989714	ChEMBL_ID
D011112	MESH_DESCRIPTOR_UI
DB00781	DRUGBANK_ID
10338	IUPHAR_LIGAND_ID
490	INN_ID
J2VZ07J96K	UNII
4868	PUBCHEM_CID
202404	RXNORM
1703	MMSL
5317	MMSL
5318	MMSL
d00344	MMSL
002803	NDDF
004902	NDDF
372824005	SNOMEDCT_US
61360007	SNOMEDCT_US
6960003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Polytrim	HUMAN PRESCRIPTION DRUG LABEL	2	0023-7824	SOLUTION/ DROPS	100000 [USPU]	OPHTHALMIC	NDA	19 sections
Polytrim	HUMAN PRESCRIPTION DRUG LABEL	2	0023-7824	SOLUTION/ DROPS	100000 [USPU]	OPHTHALMIC	NDA	19 sections
MAXITROL	HUMAN PRESCRIPTION DRUG LABEL	3	0065-0631	OINTMENT	10000 [USPU]	OPHTHALMIC	NDA	18 sections
MAXITROL	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0771	OINTMENT	10000 [USPU]	OPHTHALMIC	NDA	18 sections
MAXITROL	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0771	OINTMENT	10000 [USPU]	OPHTHALMIC	NDA	18 sections
Good Sense First Aid Antibiotic	HUMAN OTC DRUG LABEL	3	0113-0084	OINTMENT	5000 [USPU]	TOPICAL	OTC monograph final	13 sections
Good Sense Triple Antibioticand Pain Relief	HUMAN OTC DRUG LABEL	4	0113-0679	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
basic care first aid antibiotic	HUMAN OTC DRUG LABEL	3	0113-0701	OINTMENT	5000 [USPU]	TOPICAL	OTC monograph final	13 sections
good sense triple antibiotic	HUMAN OTC DRUG LABEL	4	0113-1140	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
Basic Care First Aid Antibiotic Plus Pain Relief	HUMAN OTC DRUG LABEL	4	0113-7679	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
Polymyxin B	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9941	INJECTION, POWDER, FOR SOLUTION	500000 [iU]	INTRAMUSCULAR	ANDA	14 sections
Bacitracin Zinc and Polymyxin B Sulfate	HUMAN PRESCRIPTION DRUG LABEL	2	0168-0273	OINTMENT	10000 1	OPHTHALMIC	ANDA	17 sections
Kaiser PermanenteDouble antibiotic	HUMAN OTC DRUG LABEL	2	0179-8707	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	14 sections
AntibioticMaximum Strength	HUMAN OTC DRUG LABEL	3	0363-0018	OINTMENT	10000 [iU]	TOPICAL	OTC monograph final	13 sections
Triple Antibiotic with Pain ReliefMaximum Strength	HUMAN OTC DRUG LABEL	4	0363-0123	OINTMENT	10000 [USPU]	TOPICAL	OTC MONOGRAPH FINAL	13 sections
Triple Antibiotic	HUMAN OTC DRUG LABEL	3	0363-0179	OINTMENT	5000 [iU]	TOPICAL	OTC monograph final	13 sections
Triple Antibiotic	HUMAN OTC DRUG LABEL	3	0363-0179	OINTMENT	5000 [iU]	TOPICAL	OTC monograph final	13 sections
triple antibiotic	HUMAN OTC DRUG LABEL	3	0363-0539	OINTMENT	5000 [USPU]	TOPICAL	OTC monograph final	15 sections
triple antibiotic	HUMAN OTC DRUG LABEL	3	0363-0539	OINTMENT	5000 [USPU]	TOPICAL	OTC monograph final	15 sections
triple antibiotic	HUMAN OTC DRUG LABEL	3	0363-0539	OINTMENT	5000 [USPU]	TOPICAL	OTC monograph final	15 sections
First Aid Antibiotic	HUMAN OTC DRUG LABEL	4	0363-0841	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
First Aid Antibiotic	HUMAN OTC DRUG LABEL	4	0363-0841	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
Walgreens Triple Antibiotic	HUMAN OTC DRUG LABEL	3	0363-2016	OINTMENT	5000 [iU]	TOPICAL	OTC MONOGRAPH FINAL	14 sections
Walgreens Multi-Antibiotic with Pain Relief Cream	HUMAN OTC DRUG LABEL	3	0363-2123	CREAM	10000 [USPU]	TOPICAL	OTC monograph not final	9 sections
Triple Antibiotic	HUMAN OTC DRUG LABEL	4	0363-2900	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	13 sections
Walgreens Maximum Strength Triple Antibiotic With Pain Relief	HUMAN OTC DRUG LABEL	4	0363-7872	OINTMENT	1000 [USPU]	TOPICAL	OTC monograph final	11 sections
Walgreens Wal-Sporin First Aid Antibiotic	HUMAN OTC DRUG LABEL	2	0363-8821	OINTMENT	10000 [USPU]	TOPICAL	OTC monograph final	12 sections
Triple Antibiotic Plus Pain Relief	HUMAN OTC DRUG LABEL	4	0363-8888	OINTMENT	10000 [USPU]	TOPICAL	OTC MONOGRAPH FINAL	14 sections
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate	HUMAN OTC DRUG LABEL	3	0404-0167	OINTMENT	5000 [iU]	TOPICAL	OTC monograph final	12 sections
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	HUMAN OTC DRUG LABEL	3	0404-0171	OINTMENT	50000 [iU]	TOPICAL	OTC monograph final	12 sections