Aclovate

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Aclovate

Classes

Plain Topical Corticosteroids

Administration
Topical Administration

For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use.
Apply a thin film to the affected area and rub in gently but completely.
Occlusive dressings may be used for the management of refractory or chronic dermatoses or more severe conditions. Do not apply to the diaper area if the child still requires diapers or plastic pants as these garments may constitute an occlusive dressing and increase the risk of toxicity.

Adverse Reactions
Severe

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

Moderate

erythema / Early / 1.0-2.0
withdrawal / Early / Incidence not known
growth inhibition / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
glycosuria / Early / Incidence not known
hypertension / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
Cushing's syndrome / Delayed / 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

Mild

xerosis / Delayed / 2.0-2.0
pruritus / Rapid / 1.0-2.0
skin irritation / Early / 1.0-2.0
maculopapular rash / Early / 2.0-2.0
infection / Delayed / Incidence not known
striae / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
purpura / Delayed / Incidence not known
headache / Early / Incidence not known

Common Brand Names

Aclovate

Dea Class

Rx

Description

Topical low-to-medium potency synthetic corticosteroid
Equivalent in efficacy to desonide and hydrocortisone
Used for corticosteroid-responsive dermatoses

Dosage And Indications
For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, localized vitiligo, eczema, phimosis, lichen planus, and localized bullous pemphigoid. Topical dosage Adults

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess treatment options.

Children and Adolescents

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess treatment options.

Dosing Considerations
Hepatic Impairment

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

Renal Impairment

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

Drug Interactions

Deferasirox: (Moderate) Because gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
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.

How Supplied

Aclovate/Alclometasone/Alclometasone Dipropionate Topical Cream: 0.05%
Aclovate/Alclometasone/Alclometasone Dipropionate Topical Ointment: 0.05%

Maximum Dosage
Adults

Maximum dosage information not available.

Elderly

Maximum dosage information not available.

Adolescents

Maximum dosage information not available.

Children

Do not exceed 3 weeks of treatment.

Infants

Safety and efficacy have not been established.

Mechanism Of Action

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.

Pharmacokinetics

Alclometasone is applied topically as a cream or ointment. Once in the systemic circulation, alclometasone is metabolized in the liver, but systemic metabolism has not been fully quantified. After hepatic metabolism, alclometasone metabolites are excreted by the kidney.

Topical Route

The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. In normal volunteers, approximately 3% of the alclometasone dose is absorbed during 8 hours of contact with intact skin. Absorption after topical application of alclometasone 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 alclometasone enhances penetration into the skin, and may increase the chance of systemic absorption. Ointments have a hydrating effect, are lipophilic, and enhance the penetration of alclometasone into the skin. Because alclometasone 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. Circulating levels of alclometasone are normally below the level of detection.

Pregnancy And Lactation
Pregnancy

There are no adequate and well-controlled studies of topical application of alclometasone during pregnancy. Topical corticosteroids, including alclometasone, 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.

According to the manufacturer, it is not known whether topical administration of alclometasone could result in sufficient systemic absorption to produce detectable quantities in breast milk during breast-feeding. 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.