Ultravate

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Ultravate

Classes

Plain Topical Corticosteroids

Administration
Topical Administration

For topical dermatologic use only. Not for ophthalmic, oral, or vaginal use.
Avoid contact with the eyes. Halobetasol is not recommended for use on the face, scalp, groin, or in the axillae.

Cream/Ointment/Lotion Formulations

Restrict application to the active lesions or affected areas and try to avoid normal surrounding skin.
The amount of cream, lotion, or ointment needed to cover a certain area can be calculated. A 1 gram application of cream covers 100 cm2 of skin. The entire skin surface of the average size adult will be covered by 30 grams of topical steroid cream.
Do not use cream or ointment with occlusive dressings. The lotion should only be used with occlusion under prescription order.
Very high potency corticosteroids such as halobetasol are not recommended for use in the diaper area of infants. If halobetasol is medically necessary, do not use tight-fitting diapers or plastic pants on children, as these garments may constitute occlusive dressings.
Apply sparingly in a thin film and rub gently into the affected area. Use gloves if required by universal precautions.
Wash hands after application. Patients should wash their hands after application unless the product is being used to treat the hands.

Other Topical Formulations

Topical foam
Prior to first application, remove cap and break the small tab at the base of the actuator; do not break the hinge on the actuator.
Shake well prior to each use.
Invert the can and dispense a small amount of the foam into the palm of the hand.
Apply a thin layer to the affected area and rub in gently until foam disappears. Use gloves if required by universal precautions.
Wash hands after application. Patients should wash their hands after application unless the foam is being used to treat the hands.
This product is flammable; avoid heat, flame, or smoking during and immediately following application of the foam.

Adverse Reactions
Severe

skin atrophy / Delayed / 1.0-1.0
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known

Moderate

hyperglycemia / Delayed / 1.0-1.0
erythema / Early / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
hypertension / Early / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
glycosuria / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
skin ulcer / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known
withdrawal / Early / Incidence not known
tolerance / Delayed / Incidence not known

Mild

xerosis / Delayed / 0-4.4
pruritus / Rapid / 0-4.4
skin irritation / Early / 1.6-4.4
telangiectasia / Delayed / 1.0-1.0
skin hypopigmentation / Delayed / 0.1-1.0
headache / Early / 0-1.0
pharyngitis / Delayed / 0.1-1.0
influenza / Delayed / 0.1-1.0
striae / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
infection / Delayed / Incidence not known
maculopapular rash / Early / Incidence not known
folliculitis / Delayed / Incidence not known
rash / Early / Incidence not known
acneiform rash / Delayed / Incidence not known
purpura / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known

Common Brand Names

BRYHALI, LEXETTE, Ultravate

Dea Class

Rx

Description

Very high-potency fluorinated topical corticosteroid
Used for moderate to severe corticosteroid-responsive dermatoses, including psoriasis
Generally use for short durations due to potential for systemic effects

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

Apply a thin layer topically to the affected skin area(s) once or twice daily. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis.

Children and Adolescents 12 to 17 years

Apply a thin layer topically to the affected skin area(s) once or twice daily. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis.

For the treatment of atopic dermatitis. Topical dosage (cream or ointment) Adults

Apply a thin layer topically to the affected skin area(s) once or twice daily until symptoms resolve. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Children and Adolescents 12 to 17 years

Apply a thin layer topically to the affected skin area(s) once or twice daily until symptoms resolve. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

For the treatment of moderate to severe chronic plaque-type psoriasis. Topical dosage (cream or ointment) Adults

Apply a thin layer topically to the affected skin area(s) once or twice daily. Max: 50 g/week. Discontinue therapy when control is achieved. Treatment beyond 2 weeks is not recommended. If no improvement is seen within 2 weeks, reassess diagnosis. 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.

Children† and Adolescents† 5 to 17 years

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

Topical dosage (Ultravate lotion) Adults

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Discontinue therapy when control is achieved. Treatment beyond 2 weeks is not recommended. If no improvement is seen within 2 weeks, reassess diagnosis. 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.

Children and Adolescents 12 to 17 years

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Discontinue therapy when control is achieved. Treatment beyond 2 weeks is not recommended. If no improvement is seen within 2 weeks, reassess diagnosis. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Topical dosage (Bryhali lotion) Adults

Apply a thin layer topically to the affected skin area(s) once daily. Max: 50 g/week. Treatment beyond 8 weeks is not recommended. Discontinue therapy if control is achieved before 8 weeks. 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.

Topical dosage (foam) Adults

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Discontinue therapy when control is achieved. Treatment beyond 2 weeks is not recommended. If no improvement is seen within 2 weeks, reassess diagnosis. 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.

Children and Adolescents 12 to 17 years

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Discontinue therapy when control is achieved. Treatment beyond 2 weeks is not recommended. If no improvement is seen within 2 weeks, reassess diagnosis. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

For the treatment of cutaneous T-cell lymphoma (CTCL)† (also known as mycosis fungoides†). Topical dosage (cream or ointment) Adults and Adolescents 14 years and older

Apply thoroughly and vigorously only to the lesioned skin areas twice daily. One study (n = 79) demonstrated complete remission in 88% of patients (age 14 to 84 years) with patch-stage mycosis fungoides treated with corticosteroids. Treatment was continued of 2 to 3 months before determining efficacy, and was continued for 1 month following clearing. The very high potency compounds studied, including halobetasol, were most effective. Thirteen percent of patients experienced reversible serum cortisol depression, but none had clinical symptoms. One patient discontinued therapy due to skin atrophy.

†Indicates off-label use

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

There are no drug interactions associated with Halobetasol products.

How Supplied

BRYHALI/Ultravate Topical Lotion: 0.01%, 0.05%
Halobetasol Propionate/LEXETTE Topical Foam: 0.05%
Halobetasol Propionate/Ultravate Topical Cream: 0.05%
Halobetasol Propionate/Ultravate Topical Ointment: 0.05%

Maximum Dosage
Adults

50 grams/week topically; no more than 2 weeks per treatment cycle for all products except Bryhali lotion, which is no more than 8 weeks per treatment cycle.

Geriatric

50 grams/week topically; no more than 2 weeks per treatment cycle for all products except Bryhali lotion, which is no more than 8 weeks per treatment cycle.

Adolescents

50 grams/week topically; no more than 2 weeks per treatment cycle.

Children

12 years: 50 grams/week topically; no more than 2 weeks per treatment cycle (Ultravate lotion, Lexette topical foam, and halobetasol cream and ointment).
5 to 11 years: Safety and efficacy have not been established; off-label short-term use reported; do not exceed 50 grams/week; use for 2 weeks or less per treatment cycle.
1 to 5 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

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 that 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

Halobetasol is administered topically to the skin; a variety of formulations are available for topical use. Once in the systemic circulation, halobetasol is metabolized in the liver, but systemic metabolism has not been fully quantified. Excretion of halobetasol and its metabolites occurs via the urine and bile.

Topical Route

The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the vehicle, integrity of the epidermis, and use of occlusive dressing. Absorption after topical application of halobetasol 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 halobetasol 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 halobetasol into the skin. Anti-inflammatory effects are usually not seen for hours after halobetasol application, since the mechanism of action requires alterations in the synthesis of proteins. Because halobetasol 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.
cream and ointment: Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration.
lotion: The pharmacokinetics of halobetasol lotion (Ultravate) were evaluated in 12 adult patients with plaque psoriasis who applied 3.5 grams of halobetasol lotion (Ultravate) twice daily and all of the patients had detectable plasma concentrations on day 8 of therapy. On Day 8, the mean maximum systemic concentration (Cmax) was 201.1 +/- 157.5 pg/mL, the median time to maximum concentration (Tmax) was 3 hours (range 0 to 6 hours), and the mean AUC was 1,632 +/- 1,147 pg/hour/mL. In a pharmacokinetic study involving 23 adult subjects with plaque psoriasis who applied 7 grams of halobetasol lotion (Bryhali) over a mean body surface area (BSA) of 27.7 +/- 11.3% once daily for 28 days, steady-state concentrations were achieved by day 14. Only 5 out of 20 subjects had 1 or more quantifiable systemic concentrations of halobetasol propionate on day 14. The mean Cmax on Day 14 was 31.2 +/- 62.2 pg/mL. The mean AUC could not be reliably estimated due to an insufficient number of quantifiable timepoints.
topical foam: In a study of 23 adults with moderate to severe plaque psoriasis receiving twice daily halobetasol foam for 14 days (mean dose of 7.4 grams/day), steady-state was achieved by day 14 with a mean Cmax of 199.7 +/- 217.3 pg/mL and a corresponding median time to maximum concentration (Tmax) of 1 hour (range 0 to 12 hours); mean AUC was 1,434 +/- 1,310.6 pg/hour/mL.

Pregnancy And Lactation
Pregnancy

There are no available data on halobetasol use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Halobetasol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids, including halobetasol, 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 birth weight have been reported with the use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in animal studies. Halobetasol has greater potency, and thus greater teratogenic potential, than other topical corticosteroids. After systemic halobetasol propionate administration to pregnant rats and rabbits at doses of 0.04 to 0.1 mg/kg/day and 0.01 mg/kg/day, respectively, increased malformations, such as cleft palate, were observed. Omphalocele was also seen in rats and halobetasol was found to be embryotoxic in rabbits.  

It is not known whether topical administration of halobetasol could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use of low to mid-potency topical corticosteroids is recommended in this patient population. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. 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, nipple, and areola.   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.