Prednicarbate

Pregnancy Category: C

Lactation: not known whether topical corticosteroids are distributed into milk; however, systemic corticosteroids are distributed into milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Prednicarbate is used to treat symptoms of skin disorders that are responsive to corticosteroids such as:

• Redness
• Itching
• Swelling

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.b

• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.b

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.b

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.1 c

Apply creams and ointments topically to the skin or scalp.1 c

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.b

Apply cream or ointment sparingly in a thin film and rub gently into the affected area.1 c

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.b

Occlusive dressings may be used for severe or resistant dermatoses.1 3 11 (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream or ointment; rub gently into the lesion; and apply another thin film.b Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.b

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.b For added moisture in dry lesions, apply cream or ointment and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.b

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.b

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.b

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.b Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.b

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.b

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.b (See Occlusive Dressings under Cautions.)

Dosage

Pediatric Patients

Administer the least amount of topical preparations that provide effective therapy.b (See Pediatric Use under Cautions.)

Children ≥1 year of age: Apply cream sparingly twice daily.1

Children ≥10 years of age: Apply ointment sparingly twice daily.11

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.1

Adults

Apply cream or ointment sparingly twice daily.1 3 4 11

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.1

Prescribing Limits

Pediatric Patients

Children ≥ 1 year of age: Maximum 3 weeks.1

Special Populations

No special population dosage recommendations at this time.1 c

• Medium-range corticosteroid activity.1 c

• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.1 b c

• Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids.1 c Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).1 c

• Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.b

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In common with other topical corticosteroids, Prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with hydrocortisone for up to 24 hours have not been shown to increase penetration; however, occlusion of hydrocortisone for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Studies performed with Prednicarbate cream 0.1% (emollient) indicate that the drug product is in the medium range of potency compared with other topical corticosteroids.

• Dermatop

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.

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

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

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).