Professional Information
Neomycin, Polymyxin B, and Bacitracin (Topical)
VA CLASSIFICATION
Primary: DE101{04}
Commonly used brand name(s): Bactine First Aid Antibiotic; Foille; Mycitracin; Neosporin Maximum Strength Ointment; Neosporin Ointment; Topisporin.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antibacterial (topical)—
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Skin infections, bacterial, minor (prophylaxis)—Topical neomycin, polymyxin B, and bacitracin combination is indicated in the prophylaxis of superficial skin infections caused by susceptible organisms in minor abrasions, burns, and cuts. {01} {08} {20} {21}
[Skin infections, bacterial, minor (treatment)] or{01}
[Ulcer, dermal (treatment)]—Topical neomycin, polymyxin B, and bacitracin combination is used in the treatment of minor bacterial skin infections and dermal ulcer. {01}
—Not all species or strains of a particular organism may be susceptible to neomycin, polymyxin B, and bacitracin combination.
Unaccepted
Neomycin is not effective against Pseudomonas aeruginosa {08}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Source—
Neomycin: Derived from Streptomyces fradiae {02}.
Polymyxin B: Derived from polymyxin B 1 and polymyxin B 2, which are produced by the growth of Bacillus polymyxa {03}.
Bacitracin: Derived from a mixture of related antibiotics (mainly bacitracin A), which are produced by the growth of Bacillus subtilis ssp licheniformis {03}.
Chemical group—
Neomycin: Aminoglycosides.
Polymyxin B: Polypeptides. {09}
Bacitracin: Cyclic polypeptides. {03}
Mechanism of action/Effect:
Neomycin—See Neomycin (Topical).
Polymyxin B; bacitracin—See Neomycin, Polymyxin B, and Bacitracin (Ophthalmic).
Absorption:
Neomycin—Although not absorbed through intact skin, topical neomycin is readily absorbed through large denuded, burned, or granulating areas. {13}
Polymyxin B; bacitracin—Neither polymyxin B nor bacitracin appears to be significantly absorbed following topical application to intact or damaged skin or to mucous membranes. {12}
Precautions to Consider
Cross-sensitivity and/or related problems
Patients sensitive to one aminoglycoside or polymyxin may be sensitive to other aminoglycosides or polymyxins also. {08}
Pregnancy/Reproduction
Pregnancy—
Problems in humans have not been documented.
Breast-feeding
It is not known whether topical neomycin, polymyxin B, and bacitracin are distributed into breast milk. However, problems in humans have not been documented.
Pediatrics
No pediatrics-specific information is available on the relationship of age to the effects of topical neomycin, polymyxin B, and bacitracin in pediatric patients.
Geriatrics
No geriatrics-specific information is available on the relationship of age to the effects of topical neomycin, polymyxin B, and bacitracin in geriatric patients.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Aminoglycosides, other (concurrent topical and systemic use with neomycin or related drugs is not recommended since hypersensitivity reactions may occur more frequently during concurrent use; if significant systemic absorption occurs, hearing loss may also result, may progress to deafness even after discontinuation of the drug, and may be permanent {08})
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problem exists
Sensitivity to aminoglycosides or polymyxins
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence more frequent {09} {20}
Hypersensitivity (itching, skin rash, redness, swelling, or other sign of irritation not present before therapy)
Incidence rare {09}
Ototoxicity (any loss of hearing)
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Neomycin, Polymyxin B, and Bacitracin (Topical).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to aminoglycosides or polymyxins
Proper use of this medication
Not using on deep or puncture wounds, serious burns, or raw areas unless directed by physician {20}
Not for ophthalmic use
Before applying, washing affected area with soap and water, and drying thoroughly
After applying, covering treated area with gauze dressing if desired
» Compliance with full course of therapy
» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician or pharmacist if no improvement within 1 week
Side/adverse effects
Signs of side effects, especially hypersensitivity and ototoxicity
General Dosing Information
Use of topical antibacterials may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical or systemic use of the medication. {20}
The treated area(s) may be covered with a gauze dressing if desired.
Nephrotoxicity and moderate to severe ototoxicity may occur, especially if renal function is impaired and systemic nephrotoxic and/or ototoxic drugs are given concurrently. {08}
Neomycin, polymyxin B, and bacitracin ointment is available in a petrolatum base that helps retain moisture and may be useful in treating infections on dry or scaling skin. It is also available in a base containing polyethylene glycols, liquid and white petrolatum, and glyceride wax that is miscible with tissue exudates and skin oils and waxes and may be used on weeping, exudative lesions.
Topical Dosage Forms
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN OINTMENT USP
Usual adult and adolescent dose
Antibacterial
Topical, to the skin, two to five times a day. {08}
Usual pediatric dose
See Usual adult and adolescent dose.
Strength(s) usually available
U.S.—
3.5 mg of neomycin (base), 5000 Units of polymyxin B (base), and 400 Units of bacitracin per gram (OTC)[Generic]
3.5 mg of neomycin (base), 5000 Units of polymyxin B (base), and 500 Units of bacitracin per gram (OTC) [Bactine First Aid Antibiotic] [Foille] [Mycitracin][Generic]{21}
{05}{14}{15}
Canada—
Not commercially available.
Packaging and storage:
Store preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.
Auxiliary labeling:
• For external use only.
• Continue medication for full time of treatment.
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT USP
Usual adult and adolescent dose
See Neomycin and Polymyxin B Sulfates and Bacitracin Ointment USP. {08}
Usual pediatric dose
See Neomycin and Polymyxin B Sulfates and Bacitracin Ointment USP.
Strength(s) usually available
U.S.—
3.5 mg of neomycin (base), 5000 Units of polymyxin B (base), and 400 Units of bacitracin zinc per gram (OTC) [Neosporin Ointment] [Topisporin][Generic]{20}
3.5 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 500 Units of bacitracin zinc per gram (OTC) [Neosporin Maximum Strength Ointment]
{05}{17}{18}
Canada—
3.5 mg of neomycin (base), 5000 Units of polymyxin B (base), and 400 Units of bacitracin zinc per gram (Rx)[Generic]{22}
Packaging and storage:
Store preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container. Protect from freezing.
Auxiliary labeling:
• For external use only. {20}
• Continue medication for full time of treatment.
Revised: 07/25/1994
References
- Indications Index review, 1986.
- Mycifradin package insert (Upjohn—US), Rec 11/85.
- Neosporin Ophthalmic Ointment package insert (Burroughs-Wellcome—US), Rev 11/83, Rec 3/85.
- VA Medication Classification System, USP DI 1989, 2472.
- McEvoy GK, editor. AHFS Drug information 89. Bethesda, MD: American Society of Hospital Pharmacists, 1989: 1926.
- Hold
- Hold
- Neosporin package insert (Burroughs-Wellcome—US), Rev 10/83, Rec 11/85.
- Neosporin-Polymyxin B-Bacitracin-Hydrocortisone (Pharmafair—US), Rev 9/88, Rec 3/89.
- Hold
- Hold
- Neosporin ophthalmic ointment (Burroughs-Wellcome). In: PDR Physicians' desk reference. 43rd ed. 1989. Oradell, NJ: Medical Economics Company, 1989: 788.
- Neomycin tablets package insert (Lilly—US), Rev 4/88, Rec 1/89.
- Bactine First Aid Antibiotic package label, Rec 7/88.
- Foille package label (Blistex—US), Rec 2/84.
- Hold
- Neosporin Maximum Strength package label (Burroughs-Wellcome—US), Rev 89, Rec 3/89.
- Neosporin package label (Burroughs-Wellcome—US), Rev 84, Rec 3/89.
- Hold
- Neosporin ointment (Burroughs-Wellcome). In: PDR Physicians' desk reference. 48th ed. 1994. Oradell, NJ: Medical Economics Data Production Company, 1994: 734.
- Maximum Strength Mycitracin Triple Antibiotic First Aid ointment (Upjohn). In: PDR Physicians' desk reference for nonprescription drugs. 14th ed. 1993. Montvale, NJ: Medical Economics Data Production Co, 1993: 763.
- Bacitracin-Neomycin-Polymyxin Preparations (Metapharma). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 129.
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