Version May 2024
Steroid-responsive dermatoses: Topical: Cream, ointment: Apply a thin film to affected area twice daily. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
There are no specific dosage adjustments provided in the manufacturer’s labeling.
There are no specific dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Prednicarbate: Pediatric drug information")
Steroid-responsive dermatoses: Note: Therapy should be discontinued once control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Cream:
Infants ≥4 months: Limited data available: Topical: Apply a thin film to affected area twice daily (Ref).
Children and Adolescents: Topical: Apply a thin film to affected area twice daily; safety beyond 3 weeks has not been established.
Ointment: Children ≥10 years and Adolescents: Topical: Apply a thin film to affected area twice daily.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Dermatologic: Burning sensation of skin (≤2%), exfoliation of skin (≤2%), irritant dermatitis (≤2%), pruritus (≤2%), skin atrophy (1%), skin pain (≤2%), xeroderma (≤2%)
<1%:
Cardiovascular: Edema
Dermatologic: Allergic contact dermatitis, skin rash, urticaria
Nervous system: Paresthesia
Frequency not defined: Dermatologic: Taut and shiny skin, telangiectasia (mild)
Hypersensitivity to prednicarbate or any component of the formulation.
Canadian labeling: Additional contraindications (not in manufacturer's US labeling): Hypersensitivity to wool or lanolin; treatment of skin infections/diseases including bacterial, fungal, tuberculosis, syphilitic, chicken pox, viral, or eruptions following vaccination.
Concerns related to adverse effects:
• Adrenal suppression: 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.
• Contact dermatitis: Allergic contact dermatitis can occur and it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Immunosuppression: Prolonged use of corticosteroids may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• 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).
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Disease-related concerns:
• Diaper dermatitis: Do not use for diaper dermatitis.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts 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.
Dosage form specific issues:
• Petrolatum-based: Avoid contact with latex-containing products; may damage or reduce effectiveness of latex condoms or diaphragms. If contact occurs, throw away latex product. Do not use prednicarbate intravaginally.
Other warnings/precautions:
• Appropriate use: For topical use only; do not use intravaginally. Avoid contact with eyes, face, underarms, or groin area. Do not use occlusive dressings; discontinue use if irritation occurs.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Generic: 0.1% (60 g [DSC])
Ointment, External:
Generic: 0.1% (15 g [DSC], 60 g [DSC])
Yes
Ointment (Prednicarbate External)
0.1% (per gram): $2.00
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Dermatop: 0.1% (20 g, 60 g) [contains benzyl alcohol, edetate (edta) sodium (tetrasodium)]
Ointment, External:
Dermatop: 0.1% (60 g) [contains propylene glycol]
Topical: For external use only. Apply a thin film to clean, dry skin and rub in gently. Do not use on diaper area, face, groin area, underarm or open wounds. Do not cover with occlusive dressings. Wash hands after application.
Topical: For external use only. Apply a thin film to clean, dry skin and rub in gently. Do not use on diaper area, face, groin area, underarms, or open wounds. Do not cover with occlusive dressings. Wash hands after application.
Dermatoses: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (medium potency topical corticosteroid)
Dermatop may be confused with Dimetapp
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]).
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (integrity of skin, use of occlusion, etc) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes; however, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, armpit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if sufficient quantities of prednicarbate are absorbed following topical administration to produce detectable amounts in breast milk; however, systemic corticosteroids are present in breast milk.
Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding and then clean nipples prior to the next feeding (Vestergaard 2019).
If HPA axis suppression is suspected, evaluate patient using the following tests: ACTH stimulation test, AM plasma cortisol test, and urinary free cortisol test; growth in children.
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Prednicarbate has intermediate range potency.
Absorption: Topical corticosteroids are absorbed percutaneously. The extent is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children.
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