Medically reviewed by Drugs.com. Last updated on Oct 5, 2020.
(pred ni KAR bate)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Dermatop: 0.1% (60 g [DSC]) [contains cetostearyl alcohol, edetate disodium]
Generic: 0.1% (60 g)
Dermatop: 0.1% (60 g [DSC]) [contains propylene glycol]
Generic: 0.1% (15 g, 60 g)
Brand Names: U.S.
- Dermatop [DSC]
- Corticosteroid, Topical
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.
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.
Use: Labeled Indications
Dermatoses: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (medium potency topical corticosteroid)
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.
Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
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.
Refer to adult dosing.
Steroid-responsive dermatoses: Topical: Note: Therapy should be discontinued once control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Cream: Children ≥1 year and Adolescents: Apply a thin film to affected area twice daily; safety beyond 3 weeks has not been established
Ointment: Children ≥10 year and Adolescents: Apply a thin film to affected area twice daily
For external use only. Do not use on diaper area, face, groin area, underarm or open wounds. Do not cover with occlusive dressings.
Cream: Store at 5°C to 25°C (41°F to 77°F).
Ointment: Store at 15°C to 30°C (59°F to 86°F).
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Dermatologic: Skin atrophy (children: 3% to 8%; adults: 1%), telangiectasia (mild; children: 5%), taut and shiny skin (children: 3%)
<1%, postmarketing, and/or case reports: Acneiform eruption, allergic contact dermatitis, atrophic striae, burning sensation of skin, edema, folliculitis, hypopigmentation, miliaria, paresthesia, perioral dermatitis, pruritus, secondary infection, skin rash, urticaria
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.
• Diaper dermatitis: Do not use for diaper dermatitis.
• 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.
• 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.
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.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Topical corticosteroids are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women (Koutroulis, 2011; Leachman, 2006).
What is this drug used for?
• It is used to treat skin irritation.
• It is used to treat skin rashes.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Dry skin
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes like pimples, stretch marks, slow healing, or hair growth.
• Severe skin irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: topical steroids
Other brands: Dermatop