Prednicarbate Ointment

In controlled clinical studies, the incidence of adverse reactions associated with the use of DERMATOP Ointment (prednicarbate ointment) 0.1% was approximately 1.5%. Reported reactions including burning, pruritis, drying, scaling, cracking and pain and irritant dermatitis.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings and especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Like other topical corticosteroids, prednicarbate has anti-inflammatory, anti-pruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, 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. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin while inflammation and/or other disease processes in the skin increase percutaneous absorption.

Studies performed with DERMATOP Ointment (prednicarbate ointment) 0.1% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Prednicarbate is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Prednicarbate topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Prednicarbate topical may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• Allergy Drugs: Prescription and OTC
• Itch (Itching or Pruritus)
• Rash
• Scabies

Prednicarbate Ointment 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Each gram of Prednicarbate Ointment 0.1% contains 1.0 mg of prednicarbate in a base consisting of white petrolatum, glyceryl monooleate, octyldodecanol NF, and propylene glycol.

Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58.

The CAS Registry Number is 73771-04-7.

The chemical structure is:

In controlled clinical studies, the incidence of adverse reactions associated with the use of Prednicarbate Ointment 0.1% was approximately 1.5%. Reported reactions including burning, pruritus, drying, scaling, cracking and pain and irritant dermatitis. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings and especially with higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.