Adult Dosing

Superficial infections of the external eye and its adnexa

• Apply q3-4 hrs x7-10 days, depending on the severity of the infection

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria; these infections include conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Not indicated for injection into the eye; do not directly introduce into the anterior chamber of the eye
• Ophthalmic ointments may retard corneal wound healing
• Neomycin may cause cutaneous sensitization, including itching, reddening, and edema of the conjunctiva and eyelid
• A sensitization reaction may manifest simply as a failure to heal. Perform periodic examination for such signs during long-term use of topical antibiotics and suspend therapy if such signs are observed
• Long-term use may result in overgrowth of nonsusceptible organisms, including fungi; institute appropriate treatment if superinfection occurs
• Discontinue use and promptly consult a physician if purulent discharge, inflammation, or pain becomes aggravated
• Bacterial keratitis, such as a concurrent corneal disease or a disruption of the ocular epithelial surface, may develop due to contamination of ointment
• Allergic cross-sensitivity to kanamycin, streptomycin, paromomycin, and gentamycin may occur
• Bacterial resistance to these antibiotics may develop
• Secondary bacterial ocular infection following suppression of host responses may occur

Supplemental Patient Information

• Instruct patients to avoid touching the tip of the dispensing container to the eye, eyelid, or any other surface in order to prevent contamination of the product; serious damage to the eye and subsequent vision loss may result from using contaminated products
• Advise patients to stop use and consult a physician if the condition persists or gets worse, or if a rash or allergic reaction develops

Pregnancy Category:C

Breastfeeding: Safety unknown. Bacitracin is poorly absorbed after topical application; hence, poses a low risk to the nursing infant. Ophthalmic neomycin is excreted in very low levels in breastmilk and presents negligible risk to the infant. Polymyxin B also is poorly absorbed following topical application hence may have minimal excretion into breast milk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 June 2011). Manufacturer advises caution.

• LOCAL: Ocular pruritus, ocular inflammation, swelling, conjunctival erythema, irritation, ocular burning/stinging
• HYPERSENSITIVITY: Hypersensitivity reactions, anaphylaxis
• MISC: Superinfection (prolonged use)

Bacitracin

• Polypeptide antibiotic; interferes with bacterial cell wall synthesis by inhibiting regeneration of phospholipid receptors involved with peptidoglycan synthesis
• Minimal systemic absorption following ophthalmic administration
• Not metabolized significantly; CYP450: none
• Excretion: Unknown
• Half-life: Unknown

Neomycin

• Anti-bacterial agent; acts as bactericidal for many gram-positive and gram-negative organisms. Inhibits protein synthesis in susceptible bacteria by binding to ribosomal RNA and causing misreading of the bacterial genetic code
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

Polymyxin B

• Cyclic lipopeptide antibiotic; increases cell wall permeability by interacting with the phospholipid components of the bacterial cell membrane
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Only generic available

US Availability

bacitracin/neomycin/polymyxin B (generic)

• OPH OINT: [400 U/3.5 mg/10000 U]/g

Canadian Trade Name(s)

• Diosporin
• Neosporin

Canadian Availability

Diosporin (bacitracin/neomycin/polymyxin B)

• OPH OINT: [400 U/3.5 mg/10000 U]/g

Neosporin (bacitracin/neomycin/polymyxin B)

• OPH OINT: [400 U/3.5 mg/5000 U]/g

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Ophthalmic Anti-infectives

Infectious Disease

Ophthalmic Anti-infectives

Ophthalmic

Ophthalmic Anti-infectives