Topicort

Plain Topical Corticosteroids

Desoximetasone is for topical/external use. Avoid direct contact to the eyes or mucous membranes.
Apply a thin film and rub gently. Washing or soaking the area before application may increase drug penetration.

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

erythema / Early / 1.0-10.0
withdrawal / Early / Incidence not known
glycosuria / Early / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
hypertension / Early / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
adrenocortical insufficiency / 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

xerosis / Delayed / 1.0-10.0
maculopapular rash / Early / 1.0-10.0
skin irritation / Early / 1.0-10.0
pruritus / Rapid / 1.0-10.0
folliculitis / Delayed / 0.8-0.8
miliaria / Delayed / Incidence not known
striae / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
infection / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
purpura / Delayed / Incidence not known
headache / Early / Incidence not known

Topicort, Topicort LP

Rx

Topical synthetic fluorinated corticosteroid of medium- to-high potency
Used for the treatment of moderate-to-severe corticosteroid-responsive dermatoses and for psoriasis

Apply sparingly to the affected skin area(s) 2 times daily.

Apply sparingly to the affected skin area(s) 2 times daily.

Apply sparingly to the affected skin area(s) 2 times daily.

Apply sparingly to the affected skin area(s) 2 times daily.

Apply sparingly to the affected skin area(s) 2 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 sparingly to the affected skin area(s) 2 times daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Apply sparingly to the affected skin area(s) 2 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 sparingly to the affected skin area(s) 2 times daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Apply sparingly to the affected skin area(s) 2 times daily. Discontinue therapy when control is achieved. Treatment beyond 4 weeks is not recommended. 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.

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.

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.

Desoximetasone/Topicort Topical Gel: 0.05%
Desoximetasone/Topicort Topical Spray: 0.25%
Desoximetasone/Topicort/Topicort LP Topical Cream: 0.05%, 0.25%
Desoximetasone/Topicort/Topicort LP Topical Ointment: 0.05%, 0.25%

Maximum dosage information not available.

Maximum dosage information not available.

Maximum dosage information not available.

>= 10 years: Maximum dosage information not available.
< 10 years: Safety and efficacy have not been established.

Safety and efficacy 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.

Desoximetasone is administered topically as a cream, ointment, and gel.  Desoximetasone is metabolized in the liver and undergoes conjugation to form the glucuronide and sulfate ester. Desoximetasone and its metabolites are primarily excreted by the kidneys and to a lesser extent by the bile. The half-life of desoximetasone is about 15—17 hours.

Desoximetasone is absorbed from normal intact skin. Absorption of desoximetasone is dependent on many factors, including the vehicle, the integrity of the epidermis, and the use of occlusive dressings. Percutaneous absorption is increased by the use of occlusive dressings, which may be useful for treating resistant dermatoses. Absorption of topical corticosteroids is increased in areas that have skin damage, inflammation, or in areas where the stratum corneum is thin such as the eyelids, genitalia, axillae, and face. Pharmacokinetic studies following application of desoximetasone cream 0.25% show no detectable level (limit of sensitivity 0.0005 mcg/mL) in the blood when the cream is applied topically on the back followed by occlusion for 24 hours.  No detectable levels or very low levels (0.004—0.006 mcg/mL) are noted in subjects following application of desoximetasone ointment 0.25% on the back followed by occlusion for 24 hours. The extent of systemic ointment absorption is 7% of the total applied dosage based on radioactivity recovered from urine and feces.

There are no available data on desoximetasone use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Topical corticosteroids, including desoximetasone, should not be used in large amounts, on large areas, or for prolonged periods of time during pregnancy. 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. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of desoximetasone 0.25% cream, spray, or ointment and or in doses 15 to 150 times the 0.05% cream or gel. There are no adequate and well-controlled studies of teratogenic effects from topical application of desoximetasone in pregnant women.   

There is no information on the presence of topically administered desoximetasone in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of desoximetasone could result in sufficient systemic absorption to produce detectable quantities in breast milk to cause issues during breast-feeding. However, most dermatologists stress that topical corticosteroids can be safely used during lactation. The use of low to mid-potency topical corticosteroids is recommended in this patient population. 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. Advise patients to avoid application of the topical agent directly to the nipple and areola to prevent direct infant exposure, particularly when using high potency corticosteroids.   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.