Polymyxin B

Overview

Polymyxin B was discovered in the 1940s. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa. Polymyxin B has a narrow therapeutic index and so its use is limited and unlikely to be used first line.

Indication

Polymyxin B is indicated for the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.

Associated Conditions

Acute Otitis Media (AOM)
Bacteremia caused by Enterobacter aerogenes
Bacterial Conjunctivitis
Bacterial Infections
Chronic Otitis Media
Escherichia urinary tract infection
Klebsiella bacteraemia
Meningitis caused by Haemophilus influenzae
Meningitis, Bacterial
Ocular Inflammation
Otitis Externa
Otorrhoea
Superficial ocular infections of the conjunctiva caused by susceptible bacteria
Superficial ocular infections of the cornea caused by susceptible bacteria
Urinary Tract Infection
Ocular bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB	2024/09/19	NCT06595979	N/A	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency	2022/05/04	NCT05359627	Phase 1	Completed	TTY Biopharm
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae	2019/05/15	NCT03950544	Early Phase 1	UNKNOWN	Shanghai 10th People's Hospital
Tacrolimus for Malar Edema	2018/10/23	NCT03715387	Phase 2	UNKNOWN	University of British Columbia
Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens	2017/05/18	NCT03159078	Phase 3	UNKNOWN	University of Puerto Rico
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria	2014/12/31	NCT02328183	Phase 4	UNKNOWN	Mahidol University
Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria	2014/05/08	NCT02134106	Phase 2	Withdrawn	Tan Tock Seng Hospital
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis	2012/05/31	NCT01608880	Not Applicable	Completed	University of British Columbia
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections	2009/10/06	NCT00990392	Not Applicable	Withdrawn	Fraser Health
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy	2008/06/12	NCT00695578	Phase 4	Completed	Wake Forest University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Polymyxin B Sulfate and Trimethoprim	Aidarex Pharmaceuticals LLC	53217-305	OPHTHALMIC	10000 [USP'U] in 1 mL	5/23/2018
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	MWI	13985-608	OPHTHALMIC	10000 [USP'U] in 1 g	3/23/2015
Neomycin and Polymyxin B Sulfates and Dexamethasone	Aidarex Pharmaceuticals LLC	33261-551	OPHTHALMIC	10000 [USP'U] in 1 mL	8/14/2018
Polymyxin B Sulfate and Trimethoprim	RPK Pharmaceuticals, Inc.	53002-8620	OPHTHALMIC	10000 [USP'U] in 1 mL	2/4/2020
Polymyxin B Sulfate and Trimethoprim	STAT RX LLC USA	16590-233	OPHTHALMIC	10000 1 in 1 mL	11/18/2010
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	Bausch & Lomb Incorporated	24208-780	OPHTHALMIC	10000 [USP'U] in 1 g	6/30/2023
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DIRECT RX	61919-113	OPHTHALMIC	10000 [USP'U] in 1 g	1/21/2020
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NuCare Pharmaceuticals,Inc.	68071-4229	AURICULAR (OTIC)	10000 [USP'U] in 1 mL	6/16/2023
Neomycin and Polymyxin B Sulfates and Dexamethasone	Physicians Total Care, Inc.	54868-1070	OPHTHALMIC	10000 [USP'U] in 1 mL	6/1/2012
Tripleantibioticointmentandpainrelief	Trifecta Pharmaceuticals USA	69396-061	TOPICAL	10000 [USP'U] in 100 g	5/12/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TERRAMYCIN OPHTHALMIC OINTMENT	PT PFIZER INDONESIA	SIN09695P	OINTMENT	10000 iu/g	4/6/1998
POLYDEXA EAR DROPS	PHARMASTER	SIN04945P	SOLUTION	1000000 iu/100 ml	7/16/1990
POLYGYNAX VAGINAL CAPSULE	Catalent France Beinheim SA, SWISS CAPS AG, Innothera Chouzy	SIN07745P	CAPSULE	35000 iu	6/15/1994
MAXITROL STERILE OPHTHALMIC SUSPENSION	ALCON-COUVREUR NV	SIN04358P	SOLUTION	6000 iu/ml	5/2/1990
POLYBAMYCIN OINT.	SHIN POONG PHARMACEUTICAL CO LTD	SIN04413P	OINTMENT	5000 u/g	5/3/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
POLYDEXA EAR SOLUTION-DROPS	N/A	REICH PHARM LIMITED	N/A	N/A	9/5/1998
MEVODEX EYE OINTMENT	N/A	LSB (HK) LIMITED	N/A	N/A	10/22/2024
MAXITROL OPHTH SUSP	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	2/5/1982
MAXITROL OPHTH OINT	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	3/10/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ANTIBIOTIC OINTMENT USP	Taro Pharmaceuticals Inc	02230251	Ointment - Topical	10000 UNIT / G	6/10/2002
PULMOSIRUM PASTILLE	nutribon (1986) inc.	01912461	Lozenge - Oral	1500 UNIT / LOZ	12/31/1994
ANTIBIOTIC CREAM	cellchem pharmaceuticals inc.	02311844	Cream - Topical	10000 UNIT / G	12/23/2009
TRIPLE ANTIBIOTIC OINTMENT	cellchem pharmaceuticals inc.	02297949	Ointment - Topical	10000 UNIT / G	12/23/2009
POLY ANTIBIOTIC OINTMENT	the avon company canada limited	02510383	Ointment - Topical	10000 UNIT / G	3/3/2021
ANTIBIOTIC COLD SORE OINTMENT	columbia laboratories canada inc	01910914	Ointment - Topical	500 UNIT / G	12/31/1992
LANABIOTIC ONT	COMBE INCORPORATED	00611328	Ointment - Topical	5000 UNIT / G	12/31/1984
CORTISPORIN	GlaxoSmithKline Inc	01912828	Solution - Otic	10000 UNIT / ML	12/31/1991
ANTIBIOTIC OINTMENT	canadian custom packaging company	02372037	Ointment - Topical	10000 UNIT / G	5/16/2012
POLYDERM ANTIBIOTIC OINTMENT	pharmetics (2011) inc	00758213	Ointment - Topical	10000 UNIT / G	12/31/1989

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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