Dosing & Uses
Dosage Forms & Strengths
hydrocortisone/neomycin/polymyxin
topical cream
- (0.5%/3.5mg/10,000 Units)/1gram
Steroid Responsive Dermatoses with Infection
Apply thin layer of cream topically to affected area(s) BID-QID for up to 7 days
Use sparingly
Safety and efficacy not established
Adverse Effects
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
Warnings
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 & Lactation
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.Pharmacology
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
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Formulary
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