Neosporin

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Neosporin

Classes

Ophthalmological Anti-infectives
Ophthalmological Corticosteroid and Anti-infective Combinations
Topical Aminoglycosides, Plain or in Combination
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
hearing loss / Delayed / Incidence not known
C. difficile-associated diarrhea / Delayed / Incidence not known

Moderate

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

Mild

ocular pruritus / Rapid / Incidence not known
pruritus / Rapid / Incidence not known

Common Brand Names

Neo-Polycin, Neocidin, Neosporin, Neosporin Ophthalmic Ointment, Neosporin To Go, Ocu-Spore-B, Polymycin, Triple Antibiotic

Dea Class

OTC, Rx

Description

Neomycin; polymyxin B; bacitracin are available in topical and ophthalmic forms to treat infections of the eyes and skin. Neomycin and polymyxin B are primarily active against gram-negative, aerobic bacteria, while bacitracin is active against gram-positive bacteria.

Dosage And Indications
For the treatment of superficial ophthalmic infection (e.g., bacterial conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis) caused by susceptible bacteria. Ophthalmic dosage (ophthalmic ointment) Adults

Apply a thin strip (approximately 1/2 inch) of ointment to the affected eye(s) every 3 to 4 hours for 7 to 10 days, depending upon the severity of the infection.

For the prevention of skin and skin structure infections, including wound management for skin abrasion and minor burn wound infection. Topical dosage (topical skin ointment) Adults, Adolescents, and Children >= 2 years

Apply a thin film (amount equal to the surface area of the fingertip) 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; use topically with caution in situations where systemic exposure may occur.

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

Bacitracin, Neomycin, Polymyxin B/Neomycin, Polymyxin B, Bacitracin Zinc/Neosporin/Triple Antibiotic Topical Ointment: 1g, 3.5-5000-400U, 3.5-5000-500U, 400-3.5-5000U
Neocidin/Neomycin, Polymyxin B, Bacitracin Zinc/Neo-Polycin/Neosporin/Neosporin Ophthalmic Ointment/Ocu-Spore-B/Polymycin Ophthalmic Ointment: 1g, 3.5-10000-400U, 3.5-10000-400IU

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

Children

>= 2 years: Safety and efficacy have not been established for ophthalmic ointment; 3 applications/day for up to 7 days topically.
< 2 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Neomycin: Neomycin is an aminoglycoside antibiotic with bactericidal activity against many gram-positive and gram-negative bacteria. In susceptible bacteria, neomycin prevents the formation of functional proteins. This is accomplished through active transport into the bacterial cell and subsequent irreversible binding to receptors present on the 30S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. Neomycin may also inhibit DNA polymerase.
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: 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.

Pharmacokinetics

Neomycin; polymyxin B; bacitracin combination products are applied topically to the eyes or skin. If any systemic absorption occurs, bacitracin and neomycin are excreted renally.

Topical Route

Except when applied to large areas or for an extended period of time, systemic absorption of neomycin; polymyxin B; bacitracin is negligible. Polymyxin B has a high affinity for cell membranes so there is little systemic absorption even when applied to open wounds. Bacitracin and neomycin may be absorbed systemically if applied to damaged epithelium.

Pregnancy And Lactation
Pregnancy

Neomycin; polymyxin B; bacitracin products have not been studied in pregnant women and animal reproduction studies have not been conducted. It is not known if they can cause fetal harm when administered to a pregnant woman or if they can affect reproduction capacity. There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy; however, neomycin present in maternal blood can cross the placenta. Neomycin; polymyxin B; bacitracin ophthalmic ointment should be used during pregnancy only if clearly needed. Neomycin; polymyxin B; bacitracin topical ointment is not recommended in pregnancy.

It is not known whether neomycin; polymyxin B; bacitracin products are excreted in human milk. Topical and ophthalmic use would 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. Oral ingestion by the nursing infant would also result in minimal absorption. 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.