neomycin/polymyxin B/gramicidin ophthalmic (Rx)

Frequency Not Defined

Hypersensitivity

Itching, swelling, and conjunctival erythema

Local transient irritation

Vesicular and maculopapular dermatitis

Angioneurotic edema

Urticaria

Contraindications

Aminglycoside/neomycin hypersensitivity; hypersensitivity to any product component

Cautions

Watch for NEOMYCIN ocular sensitivity

Defects in visual acuity may occur with prolonged use

Posterior subpapular cataract formation, and secondary ocular infections reported with prolonged use

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; if superinfection occurs, appropriate measures should be initiated

Bacterial resistance to may develop; if purulent discharge, inflammation, or pain becomes aggravated, patient should discontinue use and consult a physician

Allergic cross-reactions may occur which could prevent use of any or all of the following antibiotics for treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin

Pregnancy

Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin; not known whether therapy can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity; treatment should be given to a pregnant woman only if clearly needed

Lactation

Not known whether drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution when drug is administered to a nursing woman

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Inhibits bacterial cell wall synthesis by preventing the incorporation of amino acids and nucleotides into the cell wall