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

Stem definitionDrug idCAS RN
4246 1405-20-5

Description:

MoleculeDescription

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:

DoseUnitRoute
3 MU O
0.15 g P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 26, 1957 FDA MONARCH PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 875.37 14.99 497 6497 264745 53077327
Macular degeneration 234.00 14.99 80 6914 12281 53329791
Eye irritation 113.22 14.99 53 6941 18396 53323676
Ocular hyperaemia 82.05 14.99 45 6949 21746 53320326
Eye pain 77.60 14.99 49 6945 30676 53311396
Eye pruritus 59.65 14.99 31 6963 13438 53328634
Retinal pigment epitheliopathy 53.79 14.99 11 6983 222 53341850
Punctate keratitis 48.09 14.99 12 6982 605 53341467
Corneal disorder 43.56 14.99 14 6980 1767 53340305
Ulcerative keratitis 39.08 14.99 14 6980 2455 53339617
Vulval cancer stage III 31.86 14.99 5 6989 19 53342053
Endophthalmitis 30.63 14.99 13 6981 3574 53338498
Rash 30.29 14.99 127 6867 446064 52896008
Corneal abrasion 29.69 14.99 9 6985 937 53341135
Cytomegalovirus test positive 29.67 14.99 12 6982 2923 53339149
Vision blurred 27.42 14.99 44 6950 85560 53256512
Septic arthritis staphylococcal 26.67 14.99 7 6987 432 53341640
Foreign body sensation in eyes 26.49 14.99 10 6984 2029 53340043
Eye swelling 25.88 14.99 22 6972 21672 53320400
Drug ineffective 24.19 14.99 186 6808 817059 52525013
Infectious thyroiditis 23.09 14.99 4 6990 31 53342041
Lymphatic disorder 22.72 14.99 6 6988 379 53341693
Respiratory failure 22.30 14.99 44 6950 100468 53241604
Lacrimation increased 21.03 14.99 18 6976 17885 53324187
Corneal perforation 21.00 14.99 6 6988 508 53341564
Eye infection 20.69 14.99 14 6980 9824 53332248
Persistent corneal epithelial defect 19.42 14.99 3 6991 10 53342062
Visual acuity reduced 19.37 14.99 19 6975 22466 53319606
Ear discomfort 19.31 14.99 12 6982 7289 53334783
Ear infection 18.88 14.99 20 6974 25880 53316192
Corneal thinning 18.10 14.99 4 6990 118 53341954
Engraft failure 17.97 14.99 5 6989 385 53341687
Product dispensing error 17.87 14.99 13 6981 10227 53331845
Visual impairment 17.49 14.99 33 6961 72879 53269193
Infective keratitis 15.27 14.99 3 6991 49 53342023

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 101.89 16.49 89 5227 73311 32434899
Eye irritation 45.71 16.49 22 5294 6496 32501714
Respiratory paralysis 37.45 16.49 7 5309 68 32508142
Ulcerative keratitis 30.84 16.49 11 5305 1525 32506685
Eye pain 29.34 16.49 21 5295 12927 32495283
Mucosal disorder 25.95 16.49 10 5306 1719 32506491
Uveitis-glaucoma-hyphaema syndrome 23.55 16.49 4 5312 21 32508189
Disseminated intravascular coagulation 22.30 16.49 23 5293 23153 32485057
Dermatitis contact 22.11 16.49 11 5305 3487 32504723
Central vision loss 21.98 16.49 4 5312 33 32508177
Chronic graft versus host disease 19.64 16.49 11 5305 4429 32503781
Sepsis 18.93 16.49 63 5253 158771 32349439
Bacterial translocation 18.39 16.49 5 5311 282 32507928
Trichosporon infection 17.13 16.49 6 5310 789 32507421

Pharmacologic Action:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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

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:

IDSource
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
1404-26-8 SECONDARY_CAS_RN
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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
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 0363-0539 OINTMENT 5000 [USPU] TOPICAL OTC monograph final 14 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
Schein Triple Antibiotic HUMAN OTC DRUG LABEL 3 0404-0360 OINTMENT 5000 [iU] TOPICAL OTC monograph final 8 sections
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc HUMAN PRESCRIPTION DRUG LABEL 3 0404-7194 OINTMENT 10000 [USPU] OPHTHALMIC ANDA 19 sections
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 4 0404-7195 OINTMENT 10000 [USPU] OPHTHALMIC ANDA 19 sections
Triple Antibiotic HUMAN OTC DRUG LABEL 3 0472-0179 OINTMENT 5000 [iU] TOPICAL OTC monograph final 14 sections
North Triple Antibiotic HUMAN OTC DRUG LABEL 3 0498-0740 OINTMENT 5000 [iU] TOPICAL OTC monograph final 13 sections
Triple Antibiotic HUMAN OTC DRUG LABEL 3 0498-0750 OINTMENT 5000 [iU] TOPICAL OTC monograph final 13 sections
Double Antibiotic HUMAN OTC DRUG LABEL 2 0536-1174 OINTMENT 10000 [USPU] TOPICAL OTC MONOGRAPH FINAL 14 sections
polycin HUMAN PRESCRIPTION DRUG LABEL 2 0574-4021 OINTMENT 10000 [USPU] OPHTHALMIC ANDA 19 sections
Neo Polycin HC HUMAN PRESCRIPTION DRUG LABEL 4 0574-4144 OINTMENT 10000 [USPU] OPHTHALMIC ANDA 20 sections