Cloderm

Plain Topical Corticosteroids

skin atrophy / Delayed / Incidence not known
papilledema / Delayed / Incidence not known
increased intracranial pressure / Early / 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
Cushing's syndrome / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
hypertension / Early / Incidence not known
hyperglycemia / Delayed / Incidence not known
glycosuria / Early / Incidence not known
pseudotumor cerebri / 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

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

Cloderm

Rx

Medium-potency topical, synthetic fluorinated corticosteroid
Used for corticosteroid-responsive dermatoses and psoriasis
Generally used for short durations due to potential for systemic effects

Apply a thin layer topically to the affected skin area(s) 3 times daily.

Apply a thin layer topically to the affected skin area(s) 3 times daily.

Apply a thin layer topically to the affected skin area(s) 3 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 layer topically to the affected skin area(s) 3 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 dosage adjustments are needed.

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

There are no drug interactions associated with Clocortolone products.

Clocortolone/Clocortolone Pivalate/Cloderm Topical Cream: 0.1%

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.

3 applications/day.

3 applications/day.

3 applications/day.

3 applications/day.

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.

Clocortolone is applied topically as cream. It is not metabolized in the skin because clocortolone is fluorinated and also contains a substituted 17-hydroxyl group. Instead clocortolone is metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. Absorption after topical application of clocortolone 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 clocortolone enhances penetration into the skin, and may increase the chance of systemic absorption. Anti-inflammatory effects are usually not seen for hours after clocortolone application, since the mechanism of action requires alterations in synthesis of proteins. Because clocortolone is fluorinated and also contains a substituted 17-hydroxyl group, it is not metabolized in the skin. 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 clocortolone during pregnancy. Topical corticosteroids, including clocortolone, 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.

Clocortolone has not been studied during breast-feeding. It is not known whether topical administration of clocortolone 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 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.