Cyclocort

Plain Topical Corticosteroids

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.

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
pseudotumor cerebri / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
hypertension / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
glycosuria / Early / 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

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

Cyclocort

Rx

Topical high-potency corticosteroid
Used to treat moderate to severe corticosteroid-responsive dermatoses and psoriasis

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily.

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily.

Apply a thin layer topically to the affected skin area(s) 2 to 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) 2 to 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 Amcinonide products.

Amcinonide/Cyclocort Topical Cream: 0.1%
Amcinonide/Cyclocort Topical Lotion: 0.1%
Amcinonide/Cyclocort Topical Ointment: 0.1%

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.

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.

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.