Amcinonide is a topical high-potency synthetic fluorinated corticosteroid. It is used to relieve the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses and psoriasis. The high potency of amcinonide is advantageous for treating affected areas with thicker skin such as the palms and soles. Like other high potency topical agents, amcinonide application should be avoided, if possible, on areas of thinner skin, such as the face and intertriginous areas, because of potential toxicities inherent in fluorinated compounds. Amcinonide was first approved by the FDA in 1979.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-For topical dermatologic use only.
-The manufacturer states that amcinonide may be used under an occlusive dressing for psoriasis or recalcitrant conditions. However, due to the potential for adverse systemic effects with very high potency corticosteroids, occlusive dressings should be used cautiously, if at all.
-High potency corticosteroids such as amcinonide are not recommended for use in the diaper area of infants. If amcinonide is medically necessary, do not use tight fitting diapers or plastic pants on infants, as these garments may constitute occlusive dressings.
-Wash hands before and after application. Apply sparingly in a thin film and rub gently into affected area.
The following adverse reactions (listed in decreasing order of occurrence) are reported with topical corticosteroids such as amcinonide and may occur more often when used with an occlusive dressing: skin irritation (including burning), pruritus, xerosis (dry skin), folliculitis, hypertrichosis, acneiform rash/eruptions, skin hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Erythema, telangiectasia, purpura, and maculopapular rash may also occur. Although skin atrophy usually occurs after prolonged use of amcinonide, this effect may occur even with short-term use of amcinonide on intertriginous or flexor areas, or on the face. If irritation develops, discontinue topical corticosteroids and institute appropriate therapy. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection. In the presence of dermatological infections, institute the use of an appropriate antifungal or antibacterial agent. If a favorable response does not promptly occur, discontinue the corticosteroid until the infection has been adequately controlled.
Signs and symptoms of corticosteroid withdrawal may occur with amcinonide dose reduction or discontinuation, and supplemental systemic corticosteroids may be needed. For example, disease flare may occur and HPA axis suppression may be present.
Systemic absorption of topical corticosteroids such as amcinonide can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after stopping treatment. In some patients, systemic absorption can produce manifestations of Cushing's syndrome, hypertension, hyperglycemia, and glycosuria. Percutaneous absorption of amcinonide is dependent on many factors, including the vehicle, the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenocortical insufficiency in children include linear growth inhibition and delayed weight gain. Increased intracranial pressure has also been reported in children receiving topical corticosteroids; manifestations of increased intracranial pressure include bulging fontanelles, headache, and bilateral papilledema (i.e., pseudotumor cerebri). Patients applying amcinonide to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test, A.M. plasma cortisol test, and urinary free cortisol test). To minimize risk of HPA axis suppression, discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid.
Use amcinonide with caution, if at all, on the face. Case reports describe visual impairment in rare patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) have been reported to be safer for short-term use around the eye area.
In general, excessive use of corticosteroids can lead to impaired wound healing. Since amcinonide is a topical corticosteroid, it should not be applied directly or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Tolerance may occur with the prolonged use of amcinonide. Tolerance is usually described as a decreased acute vasoconstrictive response to the agent after a period of days to weeks. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application.
Allergic contact dermatitis with corticosteroids such as amcinonide is usually diagnosed by observing a failure to heal. Appropriate diagnostic patch testing may help with the diagnosis.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which increase systemic absorption include application of high-potency corticosteroids (such as amcinonide), use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using ACTH stimulation, AM plasma cortisol and urinary free-cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Amcinonide is of high-potency and safe and effective use has not been established in infants or neonates. Administration of topical corticosteroids to children and adolescents should be limited to the least amount compatible with an effective regimen. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity, especially with very-high-potency products. Parents should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area as these may constitute occlusive dressings and increase systemic absorption. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy in children may also result in growth inhibition.
Amcinonide should be used with caution in patients with diabetes mellitus. Hyperglycemia and glucosuria have been reported with use of topical corticosteroids. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Amcinonide is contraindicated in any patient with a history of severe hypersensitivity to amcinonide or any ingredients in the preparation. True corticosteroid hypersensitivity is rare. It is possible, though also rare, that cross-hypersensitivity to other corticosteroids may occur. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
The normal inflammatory response to local infections can be masked by amcinonide. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (i.e., herpes infection, measles or varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. Herpes infections may be transmitted to other sites, including the eye. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers.
As with other potent fluorinated topical corticosteroids, amcinonide should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Amcinonide may aggravate these conditions. Care should be taken to avoid use around the eyes; use caution to avoid ophthalmic administration. Visual impairment and ocular hypertension have been reported with ocular exposure to other high potency topical corticosteroids. High potency corticosteroids have been noted to promote progression of cataracts. Preexisting glaucoma may be aggravated if amcinonide is used in the periorbital area.
Topical corticosteroids should be used for brief periods or under close medical supervision in patients with evidence of pre-existing skin atrophy. Geriatric patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in the elderly. Use amcinonide preparations cautiously in patients with markedly impaired circulation or peripheral vascular disease due to the potential for skin ulcer. Use of lower potency topical corticosteroids also may be necessary in some patients.
There are no adequate and well-controlled studies of topical application of amcinonide during pregnancy. Topical corticosteroids, including amcinonide, 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.
Amcinonide has not been studied during breast-feeding. It is not known whether topical administration of amcinonide 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.
General Comparative Topical Corticosteroid Potency:
NOTE: The following is a general representation. Check specific product formulations prior to making potency decisions.
Very High Potency
Betamethasone dipropionate (augmented)
Diflorasone diacetate ointment
Desoximetasone gel or ointment, or cream 0.25% or greater
Diflorasone diacetate cream
Fluocinolone cream 0.2% or greater
Triamcinolone 0.5% or greater
Desoximetasone cream less than 0.25%
Fluocinolone ointment or topical solution or cream less than 0.2%
Flurandrenolide 0.025% or greater
Triamcinolone less than 0.5%
Flurandrenolide less than 0.025%
For the treatment of moderate to severe corticosteroid-responsive dermatoses, like alopecia areata, atopic dermatitis, severe contact dermatitis, or severe Rhus dermatitis (due to plants like poison ivy), discoid lupus erythematosus, granuloma annulare, cutaneous lichen planus, lichen simplex chronicus, severe lichen striatus, severe eczema (including severe hyperkeratotic eczema, severe nummular eczema, and severe eczematous conditions of the hands or feet), exfoliative dermatitis, keloids, necrobiosis lipoidica diabeticorum, pemphigoid, pemphigus, pityriasis rosea, severe pruritus, sarcoidosis, sunburn, or urticaria:
Adults, Adolescents, and Children: Apply sparingly to the affected area 2 to 3 times daily. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.
Infants: Safety and efficacy have not been established.
Maximum Dosage Limits:
3 applications/day topically.
3 applications/day topically.
3 applications/day topically.
3 applications/day topically.
Safe and effective use have not been established.
Safe and effective use have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
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 Amcinonide products.
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.
Amcinonide is administered topically to the skin. Once absorbed, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids and are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Amcinonide may be absorbed from normal intact skin. Percutaneous absorption is increased in the presence of inflammation, other disease processes in the skin, and with the use of occlusive dressings.