Polysporin

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Polysporin

Classes

Ophthalmological Anti-infectives
Topical Polypeptide Anti-infectives, Plain or in Combination

Administration
Topical Administration

Clean affected area of any debris prior to treatment.
Apply sparingly in a thin film to the affected area.
Do not cover with an occlusive dressing. A light gauze dressing may be used if required.
To avoid risk of infection, use one tube per individual patient.

Cream/Ointment/Lotion Formulations

Do not apply topical ointment to eyes or ears.

Ophthalmic Administration

For topical ophthalmic administration only.
Inspect product prior to use. Do not use if cap and neck-ring are not intact.
Instruct patient on proper instillation of eye ointment.
Do not touch applicator tip to the eye, eyelid, fingers, or other surface.
Apply directly into the conjunctival sac. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins.
Instruct patient to avoid wearing contact lenses during treatment.
To avoid risk of infection, use one tube per individual patient.

Adverse Reactions
Severe

anaphylactoid reactions / Rapid / Incidence not known

Moderate

edema / Delayed / Incidence not known
erythema / Early / Incidence not known
superinfection / Delayed / Incidence not known

Mild

ocular pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known

Common Brand Names

AK-Poly Bac, Double Antibiotic, Polycin, Polycin-B, Polysporin, Polysporin Ophthalmic, Polytracin, Simply Neosporin

Dea Class

OTC, Rx

Description

Bacitracin; Polymyxin B is available in ophthalmic and topical forms. Polymyxin B is primarily active against gram-negative, aerobic bacteria, while bacitracin is effective against gram-positive bacteria.

Dosage And Indications
For the treatment of superficial ophthalmic infection involving the conjunctiva (i.e., bacterial conjunctivitis) and/or cornea. Ophthalmic dosage (ophthalmic ointment) Adults

0.5 inch ribbon in the affected eye(s) every 3 to 4 hours for 7 to 10 days.

For the prevention of skin and skin structure infections, including wound management of skin abrasion and minor burn wound infection. Topical dosage Adults

Apply as a thin film (amount equal to the surface area of the fingertip) or a light dusting of powder to the affected area 1 to 3 times daily. Continue for full course of treatment; therapy should be limited to 7 days.

Children and Adolescents

Apply as a thin film (amount equal to the surface area of the fingertip) or a light dusting of powder to the affected area 1 to 3 times daily. Continue for full course of treatment; therapy should be limited to 7 days.

Dosing Considerations
Hepatic Impairment

No dosage adjustment needed.

Renal Impairment

No dosage adjustment needed.

Drug Interactions

Amphotericin B lipid complex (ABLC): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Amphotericin B liposomal (LAmB): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Amphotericin B: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Bumetanide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Ethacrynic Acid: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Furosemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Loop diuretics: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Torsemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.

How Supplied

AK-Poly Bac/Bacitracin Zinc, Polymyxin B Sulfate/Bacitracin, Polymyxin B/Polycin/Polycin-B/Polysporin/Polysporin Ophthalmic/Polytracin Ophthalmic Ointment: 1g, 500-10000U
Bacitracin Zinc, Polymyxin B Sulfate/Bacitracin, Polymyxin B/Double Antibiotic/Polysporin/Simply Neosporin Topical Ointment: 500-10000U

Maximum Dosage
Adults

8 applications/day for up to 10 days for ophthalmic ointment; 3 applications/day for up to 7 days topically.

Elderly

8 applications/day for up to 10 days for ophthalmic ointment; 3 applications/day for up to 7 days topically.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Mechanism Of Action

•Bacitracin: Bacitracin is primarily bacteriostatic, but may have bactericidal activity depending upon the antibiotic concentration and the susceptibility of the bacteria. Bacitracin inhibits bacterial cell wall synthesis. This is achieved by preventing the final dephosphorylation step in the phospholipid carrier cycle, which interferes with the mucopeptide transfer to the growing cell wall. Bacitracin is active against many gram-positive and some gram-negative bacteria.
 
•Polymyxin B: Polymyxin B binds to phospholipids on cell membranes of gram-negative bacteria. This binding destroys bacterial membranes with a surface detergent-like mechanism resulting in increased cell membrane permeability and loss of essential metabolites. Polymyxin B is bactericidal against most gram-negative bacilli; however, some Proteus and Serratia species may be resistant. Polymyxin B has no in vitro activity against gram-positive bacteria.
 
Bacitracin and polymyxin B in combination are considered active against the following bacteria: Enterobacter sp., Escherichia coli, Haemophilus influenzae, Klebsiella sp., Neisseria sp., Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus sp., including Streptococcus pneumoniae. The combination does not provide adequate coverage against Serratia marcescens.

Pharmacokinetics

Bacitracin; polymyxin B combination products are applied topically to the eyes or skin.

Topical Route

Except when applied to large areas or for an extended period of time, systemic absorption of bacitracin; polymyxin B is negligible after topical administration. Polymyxin B has a high affinity for cell membranes so there is little systemic absorption even when applied to open wounds. Bacitracin may be absorbed systemically if applied to denuded or damaged epithelium. Any systemically absorbed bacitracin or polymyxin B are primarily excreted by the kidneys.

Pregnancy And Lactation
Pregnancy

The use of bacitracin and polymyxin B has not been studied in animals or pregnant women. Bacitracin and polymyxin B should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

It is not known whether bacitracin and polymyxin B products are excreted in human milk. Topical and ophthalmic use would result in minimal absorption. Oral ingestion by the nursing infant would also result in minimal absorption. To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.