Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Dermatop: 0.1% (60 g [DSC]) [contains cetostearyl alcohol, edetate disodium]
Generic: 0.1% (60 g)
Ointment, External:
Dermatop: 0.1% (60 g [DSC]) [contains propylene glycol]
Generic: 0.1% (15 g, 60 g)
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
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.
Use: Labeled Indications
Dermatoses: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (medium potency topical corticosteroid)
Contraindications
Hypersensitivity to prednicarbate or any component of the formulation
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.
Dosage and Administration
Dosing: Adult
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.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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
Administration
For external use only. Do not use on diaper area, face, groin area, underarm or open wounds. Do not cover with occlusive dressings.
Storage
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).
Drug Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
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
Warnings/Precautions
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.
Monitoring Parameters
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
Pregnancy Risk Factor
C
Pregnancy Considerations
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).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry skin, burning, itching, or stinging. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit, signs of skin changes (pimples, stretch marks, slow healing, or hair growth), or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
