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Pronunciation:

(hal oh BAY ta sol)

U.S. Brand Names:

Ultravate®

Synonyms:

Halobetasol Propionate

Generic Available:

Yes

Canadian Brand Names:

Ultravate®

Use:

Relief of inflammatory and pruritic manifestations of corticosteroid-response dermatoses [super high potency topical corticosteroid]

Pregnancy Risk Factor:

Pregnancy Implications:

There are no adequate and well-controlled studies in pregnant women, however, halobetasol is teratogenic in animals; use during pregnancy with caution. Increased incidence of cleft palate, neonatal adrenal suppression, low birth weight, and cataracts in the infant have been reported following corticosteroid use during pregnancy. In general, the use of large amounts, or prolonged use, of topical corticosteroids during pregnancy should be avoided.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to halobetasol or any component of the formulation; viral, fungal, or tubercular skin lesions

Warnings/Precautions:

Not for ophthalmic use. May cause suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods; use should be limited to <50 g/week. Application to abraded or inflamed areas or too large of areas of the body may increase the risk of systemic absorption and the risk of adrenal suppression. Topical halobetasol should not be used for the treatment of rosacea or perioral dermatitis. Not recommended for application to the face, groin, or axillae. Safety and efficacy have not been established in pediatric patients; use in children <12 years of age is not recommended.

Adverse Reactions:

1% to 4%: Dermatologic: Burning, itching, stinging

<1%: Acneiform eruptions, allergic contact dermatitis, dry skin, erythema, HPA axis suppression, hypopigmentation, leukoderma, miliaria, perioral dermatitis, pustulation, rash, secondary infection, skin atrophy, striae, vesicles

Overdosage/Toxicology:

When applied in excessive quantities, systemic hypercorticism and adrenal suppression may occur; HPA axis suppression was observed in psoriasis patients using 7 g/day for 1 week; discontinuation of the corticosteroid should be done judiciously

Drug Interactions:

No data reported

Mechanism of Action:

Corticosteroids inhibit the initial manifestations of the inflammatory process (ie, capillary dilation and edema, fibrin deposition, and migration and diapedesis of leukocytes into the inflamed site) as well as later sequelae (angiogenesis, fibroblast proliferation)

Pharmacodynamics/Kinetics:

Absorption: Percutaneous absorption varies by location of topical application; ~6% of a topically applied dose of ointment enters circulation within 96 hours

Metabolism: Primarily hepatic

Excretion: Urine

Dosage:

Children 12 years and Adults: Topical: Steroid-responsive dermatoses: Apply sparingly to skin twice daily, rub in gently and completely; treatment should not exceed 2 consecutive weeks and total dosage should not exceed 50 g/week. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Administration:

Topical: Use of occlusive dressings is not recommended. Do not apply to the face, groin, or axillae. Apply thin film to affected area and rub in completely.

Patient Education:

A thin film of cream or ointment is effective; do not overuse. Use only as prescribed, and for no longer than the period prescribed. Apply sparingly in a light film and rub in lightly. Avoid contact with eyes. Notify prescriber if condition being treated persists or worsens. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None noted

Dosage Forms:

Cream, as propionate: 0.05% (15 g, 50 g)

Ointment, as propionate: 0.05% (15 g, 50 g)

International Brand Names:

Ultravate® (CA)

References

Reed BR, "Dermatologic Drugs, Pregnancy, and Lactation. A Conservative Guide,"Arch Dermatol, 1997, 133(7):894-8.

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