      Document 0126
 DOCN  DRG0126
 UNIQUE IDENTIFIER        DRG-0121
 NAME OF SUBSTANCE        Polymyxin B sulfate / Bacitracin zinc
                          ointment [PDR 1995]
 REGISTRY NUMBER          1405-89-6
 RELATED REGISTRY NUMBER  1405-20-5
 STANDARD CHEMICAL NAME   Polymyxin B Sulfate and bacitracin zinc [PDR
                          1995]
 SYNONYMS                 Polysporin Ophthalmic Ointment [PDR 1995]
 PROTOCOL ID NUMBERS      NIAID ACTG 172
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Antibiotic combination used
                          to ensure a broad spectrum of action.
                          Bacitracin is active against many
                          gram-positive organisms such as staphylococci
                          (including some penicillin-resistant
                          staphylococci), streptococci, anaerobic
                          cocci, corynebacteria, and clostridia. Also
                          active against gonococci, meningococci, and
                          fusobacteria, but not against most other
                          gram-negative organisms. Bacitracin is also
                          active against Actinomyces israelli,
                          Treponema pallidum and T. vinventi. Polymyxin
                          B is active against gram-negative bacilli,
                          including virtually all strains of
                          Pseudomonas aeruginosa, and H. influenza
                          species. [AHFS Drug Information 1995]
 DISEASES STUDIED/TREATED Applied over trifluridine in a clinical study
                          of the effectiveness of trifluridine for HZV
                          infection in AIDS patients (ACTG 172) [NIAID
                          ACTG 172]
 CLASSIFICATION CODE      Antibacterial [USAN 1996]
 OTHER MAJOR USES         Treatment of superficial ocular infections
                          involving the conjunctiva and/or cornea [PDR
                          1995]
 SUBSTANCE INTERACTIONS   Topical corticosteroids, when used in
                          combination with topical anti-infectives
                          including bacitracin and polymyxin B, may
                          mask clinical signs of bacterial, fungal or
                          viral infections, or may suppress
                          hypersensitivity reactions to the antibiotics
                          or other ingredients in the formulation.
                          [AHFS Drug Information 1995]
 ADVERSE EFFECTS          Adverse effects include itching, burning,
                          inflammation, rashes, and allergic
                          anaphylactoid reaction. [AHFS Drug
                          Information 1995]
 CONTRAINDICATIONS        Contraindicated in patients with
                          hypersensitivity to bacitracin, polymyxin B
                          sulfate, or any ingredients in the
                          formulation. [PDR 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Ointment consisting of
                          a special white petrolatum base where each
                          gram contains polymyxin B sulfate 10,000
                          units and bacitracin zinc 500 units [PDR
                          1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMULA:  C66H103N17O16S
                          (Bacitracin A) [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY:  Bacitracin zinc is sparingly
                          soluble in water. Polymyxin B sulfate is
                          freely soluble in water and in 0.9 percent
                          sodium chloride injection and is slightly
                          soluble in alcohol [AHFS Drug Information
                          1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Bacitracin is a polypeptide
                          produced by Bacillus subtilis. Polymyxin B is
                          one of several polymyxin antibiotics derived
                          from various strains of Bacillus polymyxa.
                          [AHFS Drug Information 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL COMMENT: The antibiotic bacitracin
                          consists of 3 separate compounds, bacitracin
                          A, B and C; bacitracin A is the chief
                          constituent [AHFS Drug Information 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL COMMENT: Bacitracin zinc for topical
                          use has not less than 40 units of bacitracin
                          activity per mg of bacitracin zinc. Polymyxin
                          B sulfate contains not less than 6000 units
                          of polymyxin [AHFS Drug Information 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Ointment. Tube of 1/8 oz. with
                          ophthalmic tip. [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Topical. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at 15-25 C (59-77 F). [Proc
                          AACR 1987]
 MANUFACTURERS            Glaxo Wellcome
 REFERENCES               Walton MA, Carino E, Herndon DN, Heggers JP.
                          The efficacy of Polysporin First Aid
                          Antibiotic Spray (polymyxin B sulfate and
                          bacitracin zinc) against clinical burn wound
                          isolates [published erratum appears in J Burn
                          Care Rehabil 1991 Jul-Aug;12(4):384] J Burn
                          Care Rehabil 1991 Mar-Apr;12(2):116-9.
 REFERENCES               Hansbrough JF, Zapata-Sirvent RL, Cooper ML.
                          Effects of topical antimicrobial agents on
                          the human neutrophil respiratory burst. Arch
                          Surg 1991 May;126(5):603-8.
 REFERENCES               Eedy DJ, McMillan JC, Bingham EA.
                          Anaphylactic reactions to topical antibiotic
                          combinations. Postgrad Med J 1990
                          Oct;66(780):858-9.
 REFERENCES               Sharma S, Srinivasan M, George C.
                          Acanthamoeba keratitis in non-contact lens
                          wearers [see comments] Arch Opthalmol 1990
                          May;108(5):676-8. Comment in: Arch Opthalmol
                          1991 Apr;109(4):463-4.
 REFERENCES               Cooper ML, Boyce ST, Hansbrough JF, Foreman
                          TJ, Frank DH. Cytotoxicity to cultured human
                          keratinocytes of topical antimicrobial
                          agents. J Surg Res 1990 Mar;48(3):190-5.
 ENTRY MONTH              9111
 LAST REVISION DATE       960612
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
