bacitracin/hydrocortisone/neomycin/polymyxin topical (OTC)

Frequency Not Defined

Skin sensitization

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

Contraindications

Hypersensitivity

Cautions

For external use only

Pregnancy

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids; corticosteroids generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels; topical corticosteroids should be used during pregnancy only if potential benefits justify potential risk to fetus; should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time

Lactation

Not know whether topical administration could result in sufficient systemic absorption to produce detectable quantities in breast milk; systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on infant; nevertheless, caution should be exercised when topical corticosteroids are 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

Bacitracin: Inhibits bacterial cell wall synthesis, by preventing the incorporation of mucopeptides into the growing cell wall

Hydrocortisone: Antipruritic/anti-inflammatory action; mild-to-medium corticosteroid potency

Neomycin: Bacteriostatic when administered topically

Polymyxin: Bactericidal; causes leakage of bacterial membrane by binding to phospholipids