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	333.71	17.09	229	4280	310458	63174055
Macular degeneration	284.16	17.09	94	4415	24282	63460231
Drug ineffective	44.49	17.09	168	4341	1044597	62439916
Respiratory failure	37.49	17.09	41	4468	101817	63382696
Cytomegalovirus test positive	32.55	17.09	11	4498	3007	63481506
Septic arthritis staphylococcal	30.42	17.09	7	4502	466	63484047
Lymphatic disorder	26.44	17.09	6	4503	375	63484138
Chronic sinusitis	25.17	17.09	14	4495	12829	63471684
Sepsis	23.07	17.09	40	4469	153083	63331430
Engraft failure	21.33	17.09	5	4504	361	63484152
Procedural pain	20.78	17.09	15	4494	21554	63462959
Paraesthesia oral	19.95	17.09	14	4495	19242	63465271

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	38.20	17.56	46	3863	80483	34872539
Respiratory paralysis	33.29	17.56	6	3903	71	34952951
Mucosal disorder	29.68	17.56	10	3899	1716	34951306
Disseminated intravascular coagulation	28.87	17.56	22	3887	21794	34931228
Chronic graft versus host disease	23.75	17.56	11	3898	4362	34948660
Pathogen resistance	20.66	17.56	13	3896	9469	34943553
Hepatic function abnormal	20.45	17.56	25	3884	44338	34908684
Trichosporon infection	19.84	17.56	6	3903	728	34952294
Drug resistance	19.65	17.56	19	3890	25908	34927114
Bacterial translocation	19.15	17.56	5	3904	355	34952667
Sepsis	19.13	17.56	51	3858	166510	34786512
Acute graft versus host disease in skin	19.04	17.56	10	3899	5191	34947831
Multiple organ dysfunction syndrome	18.82	17.56	32	3877	76534	34876488
Engraftment syndrome	18.03	17.56	6	3903	991	34952031

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	175.19	15.45	172	7020	298744	79438452
Respiratory failure	42.72	15.45	66	7126	180845	79556351
Drug resistance	39.99	15.45	32	7160	42181	79695015
Cytomegalovirus test positive	38.88	15.45	16	7176	5931	79731265
Respiratory paralysis	33.78	15.45	6	7186	82	79737114
Sepsis	32.88	15.45	74	7118	269354	79467842
Pathogen resistance	30.71	15.45	18	7174	14324	79722872
Engraftment syndrome	29.47	15.45	9	7183	1400	79735796
Disseminated intravascular coagulation	29.41	15.45	25	7167	35817	79701379
Macular degeneration	29.10	15.45	16	7176	11280	79725916
Multiple organ dysfunction syndrome	27.15	15.45	43	7149	120203	79616993
Lymphatic disorder	25.69	15.45	6	7186	334	79736862
Hepatic function abnormal	25.19	15.45	32	7160	73075	79664121
Septic arthritis staphylococcal	25.01	15.45	7	7185	804	79736392
Paraesthesia oral	24.85	15.45	18	7174	20453	79716743
Renal injury	23.13	15.45	16	7176	16911	79720285
Chronic graft versus host disease	21.41	15.45	11	7181	6770	79730426
Febrile neutropenia	21.30	15.45	57	7135	230942	79506254
Slow response to stimuli	19.42	15.45	7	7185	1818	79735378
Trichosporon infection	19.23	15.45	6	7186	1002	79736194
Drug interaction	18.77	15.45	7	7185	415176	79322020
Procedural pain	18.72	15.45	16	7176	23068	79714128
Mucosal disorder	18.12	15.45	8	7184	3520	79733676
Skin hyperpigmentation	17.87	15.45	10	7182	7293	79729903
Pyrexia	17.68	15.45	113	7079	678596	79058600
Bacterial translocation	17.20	15.45	5	7187	657	79736539
Vaginal flatulence	17.08	15.45	7	7185	2568	79734628
Chronic sinusitis	17.07	15.45	12	7180	13014	79724182
Platelet count decreased	16.90	15.45	47	7145	194617	79542579
Mental status changes	16.58	15.45	25	7167	66934	79670262
Tachypnoea	16.02	15.45	17	7175	32046	79705150
Unevaluable event	15.57	15.45	22	7170	55563	79681633

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
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
202404	RXNORM
1703	MMSL
5317	MMSL
5318	MMSL
d00344	MMSL
002803	NDDF
004902	NDDF
372824005	SNOMEDCT_US
61360007	SNOMEDCT_US
6960003	SNOMEDCT_US
1404-26-8	SECONDARY_CAS_RN
4868	PUBCHEM_CID

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
MAXITROL	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0771	OINTMENT	10000 [USPU]	OPHTHALMIC	NDA	18 sections
Maxitrol	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0792	SUSPENSION	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
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	0363-0179	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 Kids Multi-Antibiotic with Pain Relief Cream	HUMAN OTC DRUG LABEL	3	0363-2122	CREAM	10000 [USPU]	TOPICAL	OTC monograph not final	11 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