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Neomycin, polymyxin B, and hydrocortisone (topical): Drug information

Neomycin, polymyxin B, and hydrocortisone (topical): Drug information
(For additional information see "Neomycin, polymyxin B, and hydrocortisone (topical): Patient drug information" and see "Neomycin, polymyxin B, and hydrocortisone (topical): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cortisporin [DSC]
Pharmacologic Category
  • Antibiotic, Topical;
  • Antibiotic/Corticosteroid, Topical;
  • Corticosteroid, Topical
Dosing: Adult
Corticosteroid-responsive dermatoses with secondary infection

Corticosteroid-responsive dermatoses with secondary infection: Topical: Apply a thin layer 2 to 4 times daily. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Neomycin, polymyxin B, and hydrocortisone (topical): Pediatric drug information")

Dermatologic inflammation/infection

Dermatologic inflammation/infection: Limited data available: Infants, Children, and Adolescents: Topical: Apply a thin layer to affected areas 2 to 4 times daily for up to 7 days (Ref). Therapy should be discontinued when control is achieved or after 7 days.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

See Hydrocortisone (Topical) monograph.

Contraindications

Hypersensitivity to neomycin, polymyxin B, hydrocortisone, or any component of the formulation; tuberculous, fungal, or viral lesions of the skin (herpes simplex, vaccinia, and varicella); application to external ear canal if eardrum is perforated; ophthalmic administration

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Neomycin sensitization: Neomycin may cause cutaneous sensitization. Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.

• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Warnings: Additional Pediatric Considerations

The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to HPA axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Cortisporin: Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 0.5% per g (7.5 g [DSC]) [contains methylparaben, propylene glycol]

Generic Equivalent Available: US

No

Pricing: US

Cream (Cortisporin External)

3.5-10000-0.5 (per gram): $18.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only. Rub gently into affected area, as condition permits

Administration: Pediatric

Topical: Rub gently into affected area, as condition permits.

Use: Labeled Indications

Corticosteroid-responsive dermatoses with secondary infection: Treatment of corticosteroid-responsive dermatoses with secondary infection.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

Breastfeeding Considerations

It is not known if systemic absorption following topical administration results in detectable quantities in human milk. The manufacturer recommends that caution be exercised when administering neomycin/polymyxin B/hydrocortisone to nursing women. See individual agents.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Cortisporin
  1. Bradley JS, Nelson JD, Kimberlin DK, eds. Nelson's Pocket Book of Pediatric Antimicrobial Therapy. 21st ed. American Academy of Pediatrics; 2015.
  2. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone acetate) [prescribing information]. New York, NY: Pfizer Inc; August 2016.
  3. Goedert JJ, Vitale F, Lauria C, et al; Classical Kaposi's Sarcoma Working Group. Risk factors for classical Kaposi's sarcoma. J Natl Cancer Inst. 2002;94(22):1712-1718. [PubMed 12441327]
  4. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
Topic 103439 Version 68.0

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