bacitracin/hydrocortisone/neomycin/polymyxin B [Topical]

Adult Dosing

Corticosteroid-responsive dermatoses w/ secondary infection

Apply a thin film to the affected area bid-qid x 7 days (max)

Pediatric Dosing

Safety and effectiveness in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of corticosteroid-responsive dermatoses with secondary infection

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Hypersensitivity to aminoglycosides
Perforated tympanic membrane
For use in eyes
Tuberculous skin lesions
Fungal skin lesions
Viral skin lesions

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Neomycin can cause permanent sensorineural hearing loss due to cochlear damage; prolonged use may increase the risk of ototoxicity. Duration of therapy should be limited to 7 days of treatment
Neomycin may cause cutaneous sensitization; promptly discontinue therapy if sensitization or irritation occurs
While treating secondary infections such as chronic otitis externa or stasis dermatitis using neomycin-containing products, it should be noted that skin in these conditions is more liable than normal skin to become sensitized to many substances, including neomycin
Sensitization to neomycin may present as low-grade reddening with swelling, dry scaling, and itching. Evaluate regularly for such signs, and advise patients to discontinue the product if such signs occur and also to avoid future use of neomycin-containing products
Prolonged therapy may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the organism and to determine whether therapy should be changed
Allergic cross-reactions may occur, which could prevent future use of any or all of the aminoglycoside antibiotics
Steroid use may encourage spread of infection. Discontinue use if this occurs and initiate appropriate antibacterial drugs
Therapy may cause signs and symptoms of exogenous hyperadrenocorticism, including adrenal suppression
Systemic absorption increases if topical steroids are applied over large body surface areas or if occlusive dressings are used; caution should be exercised when long-term use is anticipated
Systemic effects of excessive levels of hydrocortisone may include a decrease in number of circulating eosinophils and a reduction in urinary excretion of 17-hydroxycorticosteroids

Caution: Use cautiously in

Lactation

Supplemental Patient Information

Advise patients to discontinue use and inform a physician if redness, irritation, swelling or pain persists or increases

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Bacitracin is poorly absorbed following topical application; hence, considered a low risk to the nursing infant. Water-miscible ointments applied to the breast may expose the infant to high levels of mineral paraffins via licking. Topical hydrocortisone is absorbed systemically and may have minimal excretion in breastmilk. Topical neomycin is excreted in very low levels in breastmilk and presents negligible risk to the infant; however, topical application to the nipple may increase the risk of diarrhea in the infant. Polymyxin B is minimally absorbed after topical application; therefore, it poses a low risk to the nursing infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 June 2011). As per manufacturer's data, hydrocortisone may appear in human milk; caution should be exercised while using in nursing women.

Adverse Reactions ⬆ ⬇

CNS: Intracranial hypertension (pediatric patients)
DERM: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
EENT: Ototoxicity
ENDO: HPA axis suppression, cushing syndrome
METABOLIC: Hyperglycemia
GU: Nephrotoxicity
MISC: Superinfection (prolonged use), sensitization

Clinical Pharmacology ⬆ ⬇

Bacitracin

Polypeptide antibiotic; inhibits bacterial cell wall synthesis, active against bacterial protoplasts and damages the bacterial plasma membrane
Minimal systemic absorption
Not metabolized significantly
Excretion: Unknown
Half-life: Unknown

Hydrocortisone

Corticosteroid; exact mechanism of anti-inflammatory action unknown; induces phospholipase A2 inhibitory proteins (lipocortins)
These proteins inhibit the release of their common precursor arachidonic acid, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes
Minimal systemic availability after topical application. Presence of inflammation and occlusive dressings increase systemic absorption
Primarily metabolized by liver; CYP450: Unknown
Renally excreted
Half-life: 8-12 hrs

Neomycin

Aminoglycoside; bactericidal, inhibits protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits
Not absorbed after topical application to intact skin; however, readily absorbed if applied to denuded or abraded skin
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Polymyxin B

Lipopeptide antibiotic; increases bacterial cell permeability by interacting with the lipopolysaccharide component of the cytoplasmic outer membrane of Gram-negative bacteria, causing cell death
Not absorbed
Metabolism: Unknown
Excretion: unknown
Half-life: Unknown

Brands and Availability ⬆ ⬇