hydrocortisone/neomycin/polymyxin topical (Rx)

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 to drug or excipients

Use in eyes or in external ear canal if eardrum is perforated.

Use in tuberculous, fungal, or viral lesions of skin (herpes simplex, vaccinia, and varicella)

Cautions

For external use only

Because of concerns of nephrotoxicity and ototoxicity associated with neomycin, this combination should not be used over a wide area or for extended periods of time

As with any antibacterial preparation, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi; appropriate measures should be taken if this occurs

Supervise with care when using on infected areas as anti-inflammatory steroids may encourage spread of infection; if this occurs, stop steroid therapy and use appropriate anti-bacterial drugs

Generalized dermatological conditions may require systemic corticosteroid therapy

Signs and symptoms of exogenous hyperadrenocorticism can occur with the use of topical corticosteroids, including adrenal suppression; systemic absorption of topically applied steroids will be increased if extensive body surface areas are treated or if occlusive dressings are used; under these circumstances, take suitable precautions when long-term use anticipated

Sufficient percutaneous absorption of hydrocortisone can occur in pediatric patients during prolonged use to cause cessation of growth, as well as other systemic signs and symptoms of hyperadrenocorticism

If redness, irritation, swelling, or pain persists or increases, discontinue use and notify physician; do not use in eyes

Pregnancy

There are no adequate and well-controlled studies in pregnant women; corticosteroids should be used during pregnancy only if potential benefit justifies potential risk to fetus

Animal data

• Corticosteroids shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6-18 of gestation and in mice when applied topically at concentration of 15% on days 10-13 of gestation.

Lactation

Hydrocortisone acetate appears in human milk following oral administration of drug; since systemic absorption of hydrocortisone may occur when applied topically, exercise caution when breastfeeding

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.

Corticosteroid potency: Mild to medium

Mechanism of Action

Neomycin and polymyxin: Active against: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa

Hydrocortisone: Antipruritic/anti-inflammatory action