Dermatop

Plain Topical Corticosteroids

For external application to the skin only. Not for ophthalmic or intravaginal use.
Occlusive Dressing Technique: Apply a thin film of ointment to the lesion. For the cream, gently rub a small amount into the lesion until it disappears then reapply, leaving a thin coating on the lesion. Cover the lesion with a pliable, nonporous film and seal the edges. If additional moisture is needed, apply a dampened clean cotton cloth before the nonporous film is applied or briefly wet the affected area with water immediately prior to applying the medication. The frequency of dressing changes is best determined on an individual basis. It may be convenient to apply prednicarbate under an occlusive dressing in the evening and remove the dressing in the morning (i.e. 12 hour occlusion). When utilizing the 12 hour occlusion regimen, additional prednicarbate should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Cream or ointment: Apply sparingly in a thin film and rub gently. When applying to hairy areas, part the hair and apply a small amount to the affected area; rub in gently. Until the medication has dried, do not wash or rub the treated area or apply clothing. Hair may be washed as usual during the treatment period, but not immediately after applying the medication.

skin atrophy / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known

erythema / Early / 1.0-10.0
withdrawal / Early / Incidence not known
glycosuria / Early / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
hypertension / Early / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
skin ulcer / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
tolerance / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known

pruritus / Rapid / 1.0-10.0
skin irritation / Early / 1.0-10.0
maculopapular rash / Early / 1.0-10.0
xerosis / Delayed / 1.0-10.0
acneiform rash / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
striae / Delayed / Incidence not known
purpura / Delayed / Incidence not known
infection / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
headache / Early / Incidence not known

Dermatop

Rx

Topical low- to medium-potency synthetic non-fluorinated and non-halogenated corticosteroid
Used for mild to moderate corticosteroid-responsive dermatoses
Used in adult and pediatric patients 1 year of age and older

Apply a thin film topically to the affected skin area(s) 2 times daily. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis.

Apply a thin film topically to the affected skin area(s) 2 times daily. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis.

Apply a thin film topically to the affected skin area(s) 2 times daily.

Apply a thin film topically to the affected skin area(s) 2 times daily.

Apply a thin film topically to the affected skin area(s) 2 times daily. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin film topically to the affected skin area(s) 2 times daily. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Apply a thin film topically to the affected skin area(s) 2 times daily. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin film topically to the affected skin area(s) 2 times daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no topical dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.

Dermatop/Prednicarbate Topical Cream: 0.1%
Dermatop/Prednicarbate Topical Ointment: 0.1%

NOTE: In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, dosage form selected, and patient age and response.

Mechanism of Action: Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.

Prednicarbate is applied topically as a cream or ointment. The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. Metabolism of prednicarbate occurs primarily in the skin, but the portion of the dose that reaches the systemic circulation is metabolized primarily in the liver and excreted renally. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

After topical application, absorption of prednicarbate is increased in areas that have skin damage, inflammation, or occlusion, or in areas where the stratum corneum is thin such as the eyelids, genitalia, axillae, and face. The use of occlusive dressings with the application of prednicarbate enhances penetration into the skin, and may increase the chance of systemic absorption. Ointments have a hydrating effect, are lipophilic, and may enhance the penetration of prednicarbate into the skin. Anti-inflammatory effects are usually not seen for hours after prednicarbate application, since the mechanism of action requires alterations in synthesis of proteins. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action and increased systemic absorption.

There are no adequate and well-controlled studies of topical application of prednicarbate during pregnancy. Topical corticosteroids, including prednicarbate, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

It is not known whether topical administration of prednicarbate could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider therapy with less-potent topical agents, like hydrocortisone or triamcinolone, in nursing mothers requiring long-term therapy with a topical corticosteroid. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.